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Propranolol and Hydrochlorothiazide

30/06/10

Generic Name: propranolol hydrochloride and hydrochlorothiazide
Dosage Form: tablets

Propranolol and Hydrochlorothiazide Description

Propranolol hydrochloride and hydrochlorothiazide tablets for oral administration combine two antihypertensive agents: propranolol hydrochloride, a beta-adrenergic blocking agent, and hydrochlorothiazide, a thiazide diuretic-antihypertensive.

Propranolol hydrochloride and hydrochlorothiazide tablets are available in 40 mg/25 mg and 80 mg/25 mg strengths. The 40 mg/25 mg tablets contain 40 mg propranolol hydrochloride and 25 mg hydrochlorothiazide; the 80 mg/25 mg tablets contain 80 mg propranolol hydrochloride and 25 mg hydrochlorothiazide.

Propranolol hydrochloride is a stable, white to off-white crystalline powder which is soluble in water and in alcohol. Its molecular weight is 295.81. Propranolol hydrochloride is a synthetic beta-adrenergic receptorblocking agent chemically described as 1-(Isopropylamino)-3 -(1- naphthyloxy)-2-propanol hydrochloride, which may be represented by the following structural formula:

Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution; sparingly soluble in methanol; insoluble in ether, chloroform, benzene, and dilute mineral acids. Its chemical name is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide, which may be represented by the following structural formula:

The following inactive ingredients are contained in propranolol hydrochloride and hydrochlorothiazide tablets: Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate and Magnesium Stearate.

Propranolol and Hydrochlorothiazide – Clinical Pharmacology

Propranolol Hydrochloride: Propranolol hydrochloride is a non-selective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately.

Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately metabolized by the liver on its first pass through the portal circulation.

Peak effect occurs in one to one and one-half hours. The biologic half-life is approximately four hours. Propranolol is not significantly dialyzable. There is no simple correlation between dose or plasma level and therapeutic effect, and the dose-sensitivity range, as observed in clinical practice, is wide. The principal reason for this is that sympathetic tone varies widely between individuals. Since there is no reliable test to estimate sympathetic tone or to determine whether total beta blockade has been achieved, proper dosage requires titration.

The mechanism of the antihypertensive effect of propranolol has not been established. Among the factors that may be involved in contributing to antihypertensive action are: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to, or below, the pretreatment level with chronic use. Effects on plasma volume appear to be minor and somewhat variable. Propranolol has been shown to cause a small increase in serum potassium concentration when used in the treatment of hypertensive patients. Propranolol hydrochloride decreases heart rate, cardiac output, and blood pressure.

Beta-receptor blockade can be useful in conditions in which, because of pathologic or functional changes, sympathetic activity is detrimental to the patient. But there are also situations in which sympathetic stimulation is vital. For example, in patients with severely damaged hearts, adequate ventricular function is maintained by virtue of sympathetic drive, which should be preserved. In the presence of AV block, greater than first degree, beta blockade may prevent the necessary facilitating effect of sympathetic activity on conduction. Beta blockade results in bronchial constriction by interfering with adrenergic bronchodilator activity, which should be preserved in patients subject to bronchospasm.

The proper objective of beta-blockade therapy is to decrease adverse sympathetic stimulation, but not to the degree that may impair necessary sympathetic support.

Hydrochlorothiazide: Hydrochlorothiazide is a benzothiadiazine (thiazide) diuretic closely related to chlorothiazide. The mechanism of the antihypertensive effect of the thiazides is unknown. Thiazides do not affect normal blood pressure.

Thiazides affect the renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage, all thiazides are approximately equal in their diuretic potency.

Thiazides increase excretion of sodium and chloride in approximately equivalent amounts. Natriuresis causes a secondary loss of potassium and bicarbonate. Onset of diuretic action of hydrochlorothiazide occurs in two hours, and the peak effect in about four hours. Its action persists for approximately six to 12 hours. Thiazides are eliminated rapidly by the kidney.

Indications and Usage for Propranolol and Hydrochlorothiazide

Propranolol hydrochloride and hydrochlorothiazide tablets are indicated in the management of hypertension. This fixed combination is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management.

Contraindications

Propranolol Hydrochloride: Propranolol is contraindicated in: 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; 4) congestive heart failure (see WARNINGS) unless the failure is secondary to a tachyarrhythmia treatable with propranolol.

Hydrochlorothiazide: Hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs.

Warnings

Propranolol Hydrochloride: Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and inhibition with beta blockade always carries the potential hazard of further depressing myocardial contractility and precipitating cardiac failure. Propranolol acts selectively without abolishing the inotropic action of digitalis on the heart muscle (i.e., that of supporting the strength of myocardial contractions). In patients already receiving digitalis, the positive inotropic action of digitalis may be reduced by propranolol’s negative inotropic effect. The effects of propranolol and digitalis are additive in depressing AV conduction.

Patients Without a History of Heart Failure: Continued depression of the myocardium over a period of time can, in some cases, lead to cardiac failure. In rare instances, this has been observed during propranolol therapy. Therefore, at the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or given additional diuretic, and the response observed closely: a) if cardiac failure continues, despite adequate digitalization and diuretic therapy, propranolol therapy should be withdrawn (gradually, if possible); b) if tachyarrhythmia is being controlled, patients should be maintained on combined therapy and the patient closely followed until threat of cardiac failure is over.

Angina Pectoris: There have been reports of exacerbation of angina and, in some cases, myocardial infarction following abrupt discontinuation of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced and the patient should be carefully monitored. In addition, when propranolol is prescribed for angina pectoris, the patient should be cautioned against interruption or cessation of therapy without the physician’s advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of unstable angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease, who are given propranolol for other indications.

Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema): PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Propranolol should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta receptors.

Major Surgery:The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial. It should be noted, however, that the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Propranolol, like other beta blockers, is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents; e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Difficulty in starting and maintaining the heartbeat has also been reported with beta blockers.

Diabetes and Hypoglycemia:Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia in labile insulin-dependent diabetes. In these patients, it may be more difficult to adjust the dosage of insulin. Hypoglycemic attack may be accompanied by a precipitous elevation of blood pressure in patients on propranolol.

Propranolol therapy, particularly in infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia also has been found after this type of drug therapy and prolonged physical exertion and has occurred in renal insufficiency, both during dialysis, and sporadically, in patients on propranolol.

Acute increases in blood pressure have occurred after insulin-induced hypoglycemia in patients on propranolol.

Thyrotoxicosis:Beta blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T4, and reverse T3, and decreasing T3.

Wolff-Parkinson-White Syndrome:Several cases have been reported in which, after propranolol, the tachycardia was replaced by a severe bradycardia requiring a demand pacemaker. In one case this resulted after an initial dose of 5 mg propranolol.

Hydrochlorothiazide: Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. In patients with impaired renal function, cumulative effects of the drug may develop.

Thiazides should also be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Thiazides may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic-blocking drugs.

Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Precautions

General

Propranolol Hydrochloride:Propranolol should be used with caution in patients with impaired hepatic or renal function. Propranolol hydrochloride and hydrochlorothiazide tablets are not indicated for the treatment of hypertensive emergencies.

Risk of anaphylactic reaction: While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Hydrochlorothiazide:All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance, namely: hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop, especially with brisk diuresis or when severe cirrhosis is present.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability).

Hypokalemia may be avoided or treated by use of potassium supplements or foods with a high potassium content.

Any chloride deficit is generally mild, and usually does not require specific treatment except under extraordinary circumstances (as in liver or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Diabetes mellitus which has been latent may become manifest during thiazide administration.

The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.

If progressive renal impairment becomes evident, consider withholding or discontinuing diuretic therapy.

Calcium excretion is decreased by thiazides. Pathologic changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism, such as renal lithiasis, bone resorption, and peptic ulceration, have not been seen.

Information for Patients

Beta-adrenoreceptor blockade can cause reduction of intraocular pressure. Patients should be told that propranolol hydrochloride and hydrochlorothiazide may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.

Laboratory Tests

Propranolol Hydrochloride:Elevated blood urea levels in patients with severe heart disease, elevated serum transaminase, alkaline phosphatase, lactate dehydrogenase.

Hydrochlorothiazide:Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Drug/Drug Interactions

Propranolol Hydrochloride:Patients receiving catecholamine-depleting drugs such as reserpine should be closely observed if propranolol hydrochloride and hydrochlorothiazide tablets are administered. The added catecholamine-blocking action may produce an excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.

Caution should be exercised when patients receiving a beta blocker are administered a calcium-channel blocking drug, especially intravenous verapamil, for both agents may depress myocardial contractility or atrioventricular conduction. On rare occasions, the concomitant intravenous use of a beta blocker and verapamil has resulted in serious adverse reactions, especially in patients with severe cardiomyopathy, congestive heart failure, or recent myocardial infarction.

Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by nonsteroidal anti-inflammatory drugs has been reported.

Hypotension and cardiac arrest have been reported with the concomitant use of propranolol and haloperidol.

Aluminum hydroxidegel greatly reduces intestinal absorption of propranolol.

Ethanolslows the rate of absorption of propranolol.

Phenytoin, phenobarbitone,and rifampinaccelerate propranolol clearance.

Chlorpromazine, when used concomitantly with propranolol, results in increased plasma levels of both drugs.

Antipyrineand lidocainehave reduced clearance when used concomitantly with propranolol.

Thyroxinemay result in a lower than expected T3 concentration when used concomitantly with propranolol.

Cimetidinedecreases the hepatic metabolism of propranolol, delaying elimination and increasing blood levels.

Theophyllineclearance is reduced when used concomitantly with propranolol.

Hydrochlorothiazide:Thiazide drugs may increase the responsiveness to tubocurarine.

Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Insulin requirements in diabetic patients may be increased, decreased, or unchanged.

Hypokalemia may develop during concomitant use of corticosteroids or ACTH.

Drug/Laboratory Test Interactions:

Hydrochlorothiazide:Thiazides may decrease serum PBI levels without signs of thyroid disturbance.

Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS — General).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Combinations of Propranolol and Hydrochlorothiazide have not been evaluated for carcinogenic or mutagenic potential or for potential to adversely affect fertility.

Propranolol Hydrochloride:In dietary administration studies in which mice and rats were treated with propranolol for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. In a study in which both male and female rats were exposed to propranolol in their diets at concentrations of up to 0.05%, from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of propranolol in bacteria (S.typhimurium strain TA 1538.)

Hydrochlorothiazide:Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

Hydrochlorothiazide was not genotoxic in vitro in the Ames bacterial mutagen assay (S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538) or in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations. Nor was it genotoxic in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained in the in vitro CHO Sister Chromatid Exchange (clastogenicity), Mouse Lymphoma Cell (mutagenicity) and Aspergillus nidulans non-disjunction assays.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 mg/kg and 4 mg/kg, respectively, prior to mating and throughout gestation.

Pregnancy

Pregnancy Category C

Combinations of Propranolol and Hydrochlorothiazide have not been evaluated for effects on pregnancy in animals. Nor are there adequate and well-controlled studies of propranolol, hydrochlorothiazide, or the combination in pregnant women. Propranolol and Hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Propranolol Hydrochloride:In a series of reproduction and developmental toxicology studies, propranolol was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day (>30 times the dose of propranolol contained in the maximum recommended human daily dose of propranolol hydrochloride and hydrochlorothiazide), but not at doses of 80 mg/kg/day, treatment was associated with embryotoxicity (reduced litter size and increased resorption sites) as well as neonatal toxicity (deaths). Propranolol also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (>45 times the dose of propranolol contained in the maximum recommended daily human dose of propranolol hydrochloride and hydrochlorothiazide). No evidence of embryo or neonatal toxicity was noted. Intrauterine growth retardation has been reported in human neonates whose mothers received propranolol during pregnancy. Neonates whose mothers received propranolol at parturition have exhibited bradycardia, hypoglycemia and respiratory depression. Adequate facilities for monitoring these infants at birth should be available.

Hydrochlorothiazide:Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats at doses of up to 3000 and 1000 mg/kg/day, respectively, provided no evidence of harm to the fetus.

Thiazides cross the placental barrier and appear in cord blood. The use of thiazides in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

Nursing Mothers

Propranolol Hydrochloride:Propranolol is excreted in human milk. Caution should be exercised when propranolol hydrochloride and hydrochlorothiazide tablets are administered to a nursing woman.

Hydrochlorothiazide:Thiazides appear in breast milk. If the use of drug is deemed essential, the patient should stop nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of propranolol hydrochloride and hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Within each category, adverse reactions are listed in decreasing order of severity. Although many side effects are mild and transient, some require discontinuation of therapy.

Propranolol Hydrochloride: Cardiovascular:Congestive heart failure; hypotension; intensification of AV block; bradycardia; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type; paresthesia of hands.

Central Nervous System:Reversible mental depression progressing to catatonia; mental depression manifested by insomnia, lassitude, weakness, fatigue; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, decreased performance on neuropsychometrics; hallucinations; visual disturbances; vivid dreams; light-headedness. Total daily doses above 160 mg (when administered as divided doses of greater than 80 mg each) may be associated with an increased incidence of fatigue, lethargy, and vivid dreams.

Gastrointestinal:Mesenteric arterial thrombosis; ischemic colitis; nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation.

Allergic:Laryngospasm and respiratory distress; pharyngitis and agranulocytosis; fever combined with aching and sore throat; erythematous rash.

Respiratory:Bronchospasm.

Hematologic:Agranulocytosis; nonthrombocytopenic purpura; thrombocytopenic purpura.

Autoimmune:In extremely rare instances, systemic lupus erythematosus has been reported.

Miscellaneous:Male impotence. Alopecia, LE-like reactions, psoriasiform rashes, dry eyes, and Peyronie’s disease have been reported rarely. Oculomucocutaenous reactions involving the skin, serous membranes, and conjunctivae reported for a beta blocker (practolol) have not been associated with propranolol.

Hydrochlorothiazide: Cardiovascular:Orthostatic hypotension (may be aggravated by alcohol, barbiturates or narcotics).

Central Nervous System:Dizziness; vertigo; headache; xanthopsia, paresthesias.

Gastrointestinal:Pancreatitis; jaundice (intrahepatic cholestatic jaundice); sialadenitis; anorexia, nausea, vomiting, gastric irritation, cramping, diarrhea, constipation.

Hypersensitivity:Anaphylactic reactions; necrotizing angiitis (vasculitis, cutaneous vasculitis); respiratory distress including pneumonitis; fever; urticaria, rash, purpura, photosensitivity.

Hematologic:Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia.

Miscellaneous:Hyperglycemia; glycosuria; hyperuricemia; muscle spasm; weakness; restlessness; transient blurred vision.

Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Overdosage

The propranolol hydrochloride component may cause bradycardia, cardiac failure, hypotension, or bronchospasm. Propranolol is not significantly dialyzable.

The hydrochlorothiazide component can be expected to cause diuresis. Lethargy of varying degree may appear and may progress to coma within a few hours, with minimal depression of respiration and cardiovascular function, and in the absence of significant serum electrolyte changes or dehydration. The mechanism of central nervous system depression with thiazide overdosage is unknown. Gastrointestinal irritation and hypermotility can occur, temporary elevation of BUN has been reported, and serum electrolyte changes could occur, especially in patients with impairment of renal function. The oral LD50 dosages in rats and mice for propranolol, hydrochlorothiazide, and combined propranolol/hydrochlorothiazide (40/25, 80/25) are 364 to 533 mg/kg, greater than 2,750 to 5,000 mg/kg, and 538 to 845 mg/kg, respectively.

Treatment

The following measures should be employed:

General— If ingestion is, or may have been, recent, evacuate gastric contents taking care to prevent pulmonary aspiration.

Bradycardia— Administer atropine (0.25 to 1 mg). If there is no response to vagal blockade, administer isoproterenol cautiously.

Cardiac Failure— Digitalization and diuretics.

Hypotension— Vasopressors; e.g., norepinephrine or epinephrine.

Bronchospasm— Administer isoproterenol and aminophylline.

Stupor or Coma— Administer supportive therapy as clinically warranted. Gastrointestinal Effects—Though usually of short duration, these may require symptomatic treatment.

Abnormalities in BUN and/or Serum Electrolytes—Monitor serum electrolyte levels and renal function; institute supportive measures as required individually to maintain hydration, electrolyte balance, respiration, and cardiovascular-renal function.

Propranolol and Hydrochlorothiazide Dosage and Administration

The dosage must be determined by individual titration.

Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. The initial dose of propranolol is 80 mg daily, and it may be increased gradually until optimal blood pressure control is achieved. The usual effective dose when used alone is 160 to 480 mg per day.

One propranolol hydrochloride and hydrochlorothiazide tablet twice daily can be used to administer up to 160 mg of propranolol and 50 mg of hydrochlorothiazide. For doses of propranolol greater than 160 mg the combination products are not appropriate, because their use would lead to an excessive dose of the thiazide component.

When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.

How is Propranolol and Hydrochlorothiazide Supplied

40 mg/25 mg — Each white, round tablet imprinted with on one side and 358 and

bisect on the other side contains 40 mg propranolol hydrochloride and 25 mg hydrochlorothiazide. Tablets are supplied in bottles of 100 (NDC 0228-2358-10) and 500 (NDC 0228-2358-50).

80 mg/25 mg — Each white, round tablet imprinted with on one side and 360 and

bisect on the other side contains 80 mg propranolol hydrochloride and 25 mg hydrochlorothiazide. Tablets are supplied in bottles of 100 (NDC 0228-2360-10).

Dispense in well-closed, light-resistant containers.

Store at room temperature (approximately 25°C).

Protect from moisture, freezing, and excessive heat.

Rx Only

Manufactured by:

PUREPAC PHARMACEUTICAL CO.

Elizabeth, NJ 07207 USA 40-8717 Revised — June 2002

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
propranolol hydrochloride and hydrochlorothiazide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0228-2358
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Propranolol Hydrochloride (Propranolol)	Active	40 MILLIGRAM In 1 TABLET
Hydrochlorothiazide (Hydrochlorothiazide)	Active	25 MILLIGRAM In 1 TABLET
colloidal solicon dioxide	Inactive
corn starch	Inactive
lactose monohydrate	Inactive
magnesium stearate	Inactive

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	R358
Contains
Coating	false	Symbol	true

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0228-2358-10	100 TABLET In 1 BOTTLE	None
2	0228-2358-50	500 TABLET In 1 BOTTLE	None

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
propranolol hydrochloride and hydrochlorothiazide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0228-2360
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Propranolol Hydrochloride (Propranolol)	Active	80 MILLIGRAM In 1 TABLET
Hydrochlorothiazide (Hydrochlorothiazide)	Active	25 MILLIGRAM In 1 TABLET
colloidal solicon dioxide	Inactive
corn starch	Inactive
lactose monohydrate	Inactive
magnesium stearate	Inactive

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	11mm
Flavor		Imprint Code	360
Contains
Coating	false	Symbol	true

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0228-2360-10	100 TABLET In 1 BOTTLE	None

Revised: 07/2007Actavis Elizabeth LLC

P,Professional

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Propranolol HCl Intensol

30/06/10

Generic Name: propranolol (Oral route)

proe-PRAN-oh-lol

Oral routeCapsule, Extended Release

Angina Pectoris:
- There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks, and the patient should be cautioned against interruption or cessation of therapy without a physician’s advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it is usually advisable to reinstitute propranolol therapy and take other measures appropriate for the management of angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications .

Reports of exacerbation of angina and myocardial infarction have been noted following abrupt discontinuance of propranolol. When discontinuance of propranolol is planned, dosage should be gradually reduced over at least a few weeks, and the patient should be cautioned against interruption or cessation of therapy. If propranolol therapy is interrupted and exacerbation of angina occurs, reinstitution of propranolol and management of angina is advised. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications .

Commonly used brand name(s):

In the U.S.

Inderal
Inderal LA
InnoPran XL
Propranolol HCl Intensol

Available Dosage Forms:

Tablet
Capsule, Extended Release
Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For Propranolol HCl Intensol

Propranolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Propranolol is also used to treat severe chest pain (angina), migraine headaches, or hypertrophic subaortic stenosis (thickened heart muscle) .

This medicine may also be used to treat irregular heartbeats, tremors, or pheochromocytoma (adrenal gland tumor). It may also be used to reduce the risk of death in patients who have heart attacks .

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

This medicine is available only with your doctor’s prescription .

Before Using Propranolol HCl Intensol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of propranolol capsules and tablets in the pediatric population. Safety and efficacy have not been established .

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of propranolol oral solution in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of propranolol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving propranolol .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Albuterol
Amiodarone
Arformoterol
Bambuterol
Bitolterol
Broxaterol
Bupivacaine
Clenbuterol
Clonidine
Colterol
Diatrizoate
Diltiazem
Dronedarone
Epinephrine
Fenoldopam
Fenoterol
Fentanyl
Formoterol
Haloperidol
Hexoprenaline
Isoetharine
Levalbuterol
Lidocaine
Mefloquine
Mepivacaine
Metaproterenol
Pirbuterol
Prilocaine
Procaterol
Reproterol
Rimiterol
Ritodrine
Salmeterol
Terbutaline
Tretoquinol
Tulobuterol
Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose
Acetohexamide
Alfuzosin
Aluminum Carbonate, Basic
Aluminum Hydroxide
Aluminum Phosphate
Amlodipine
Arbutamine
Benfluorex
Bunazosin
Calcium Carbonate
Chlorpromazine
Chlorpropamide
Cimetidine
Digoxin
Dihydroergotamine
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Disopyramide
Doxazosin
Ergotamine
Felodipine
Flecainide
Fluvoxamine
Gliclazide
Glimepiride
Glipizide
Gliquidone
Glyburide
Guar Gum
Guggul
Insulin
Insulin Aspart, Recombinant
Insulin Glulisine
Insulin Lispro, Recombinant
Lacidipine
Lercanidipine
Magaldrate
Manidipine
Metformin
Mibefradil
Miglitol
Moxisylyte
Nicardipine
Nifedipine
Nilvadipine
Nimodipine
Nisoldipine
Nitrendipine
Phenoxybenzamine
Phentolamine
Phenylephrine
Piperine
Pranidipine
Prazosin
Propoxyphene
Quinidine
Repaglinide
Rifapentine
Rizatriptan
Sertraline
St John’s Wort
Tamsulosin
Terazosin
Tolazamide
Tolbutamide
Trimazosin
Troglitazone
Tubocurarine
Urapidil
Zileuton

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of propranolol

This section provides information on the proper use of a number of products that contain propranolol. It may not be specific to Propranolol HCl Intensol. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

Swallow the long-acting oral capsules whole. Do not chew, crush, or open them .

Measure the concentrated oral solution, Intensol™ with the dropper that comes with the medicine. You may mix the concentrated solution with water, juice, soda, applesauce, or pudding to make it easier to swallow, then take the mixture right away .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For acute heart attack:
- For oral dosage form (solution):
  - Adults—180 to 240 milligrams (mg) per day, given in divided doses.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—At first, 40 milligrams (mg) three times a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
For adrenal gland tumor (pheochromocytoma):
- For oral dosage form (solution):
  - Adults—60 milligrams (mg) per day, given in divided doses for three days before having surgery. In patients who cannot have surgery, the usual dose is 30 mg per day, given in divided doses.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—60 milligrams (mg) per day, given in divided doses for three days before having surgery. In patients who cannot have surgery, the usual dose is 30 mg per day, given in divided doses.
  - Children—Use and dose must be determined by your doctor .
For chest pain (angina):
- For oral dosage form (long-acting oral capsules):
  - Adults—At first, 80 milligrams (mg) once a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (solution):
  - Adults—80 to 320 milligrams (mg) per day, given in divided doses.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—80 to 320 milligrams (mg) per day, given in divided doses.
  - Children—Use and dose must be determined by your doctor .
For high blood pressure (hypertension):
- For oral dosage form (long-acting oral capsules):
  - Adults—At first, 80 milligrams (mg) once a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (solution):
  - Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
For hypertrophic subaortic stenosis (thickened heart muscle):
- For oral dosage form (long-acting oral capsules):
  - Adults—80 to 160 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (solution):
  - Adults—20 to 40 milligrams (mg) three or four times a day, given before meals and at bedtime.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—20 to 40 milligrams (mg) three or four times a day, given before meals and at bedtime.
  - Children—Use and dose must be determined by your doctor .
For irregular heartbeats:
- For oral dosage form (solution):
  - Adults—10 to 30 milligrams (mg) three or four times a day, given before meals and at bedtime.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—10 to 30 milligrams (mg) three or four times a day, given before meals and at bedtime.
  - Children—Use and dose must be determined by your doctor .
For migraine headaches:
- For oral dosage form (long-acting oral capsules):
  - Adults—At first, 80 milligrams (mg) once a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (solution):
  - Adults—At first, 80 milligrams (mg) per day, given in divided doses. Your doctor may increase your dose if needed.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—At first, 80 milligrams (mg) per day, given in divided doses. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
For tremors:
- For oral dosage form (solution):
  - Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
  - Children—Dose is based on body weight and must be determined by your doctor .
- For oral dosage form (tablets):
  - Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Propranolol HCl Intensol

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Propranolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking propranolol .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in your mouth or lips; or unusual tiredness or weakness .

Propranolol HCl Intensol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not determined

Abdominal pain and tenderness
black, tarry stools
blistering, peeling, or loosening of skin
blood in urine
bloody nose
bloody stools
blurred or loss of vision
body aches or pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain or discomfort
confusion about identity, place, and time
congestion
constipation
cough
cracks in the skin
crying
decreased awareness or responsiveness
decreased urine output
depersonalization
diarrhea
difficulty in breathing and/or swallowing
difficulty swallowing
dilated neck veins
disturbed color perception
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
double vision
dryness or soreness of throat
dysphoria
euphoria
extreme fatigue
fast, pounding, slow, or irregular heartbeat
fever and chills
general feeling of discomfort, illness, or weakness
hair loss
halos around lights
headaches
heavier menstrual periods
hives
hoarseness
irregular breathing
itching
lightheadedness, dizziness, or fainting
loss of heat from the body
mental depression
mimicry of speech or movements
muscle or joint pain
mutism
nausea
negativism
night blindness
noisy breathing
overbright appearance of lights
paleness or cold feeling in fingertips and toes
paranoia
peculiar postures or movements, mannerisms, or grimacing
pinpoint red or purple spots on skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
quick to react or overreact emotionally
rapidly changing moods
rectal bleeding
red irritated eyes
red skin lesions, often with a purple center
red, swollen skin
reddening of the skin, especially around the ears
runny nose
scaly skin
seeing, hearing, or feeling things that are not there
severe sleepiness
short-term memory loss
shortness of breath
skin irritation or rash, including rash that looks like psoriasis
skin rash
sores, ulcers, or white spots in mouth or on lips
sweating
swelling of eyes, face, fingers, feet, or lower legs
swollen glands
tender, swollen glands in neck
tightness in chest
tingling or pain in fingers or toes when exposed to cold
trouble in swallowing
troubled breathing
tunnel vision
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
vomiting
weight gain
wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not determined

Dry eyes
heartburn
loss of strength or energy
muscle weakness
pain or discomfort in chest, upper stomach, or throat
sleeplessness
stomach cramps
trouble sleeping
unable to sleep
unusual drowsiness, dullness, or feeling of sluggishness
vivid dreams

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Propranolol hydrochloride

30/06/10

Brand names: Inderal LA, Inderal

Why is Propranolol hydrochloride prescribed?

Inderal, a type of medication known as a beta blocker, is used in the treatment of high blood pressure, angina pectoris (chest pain, usually caused by lack of oxygen to the heart due to clogged arteries), changes in heart rhythm, prevention of migraine headache, hereditary tremors, hypertrophic subaortic stenosis (a condition related to exertional angina), and tumors of the adrenal gland. It is also used to reduce the risk of death from recurring heart attack. InnoPran XL is used to treat high blood pressure.

When Inderal and InnoPran XL are used for the treatment of high blood pressure, they are effective alone or combined with other high blood pressure medications, particularly thiazide-type diuretics. Beta blockers decrease the force and rate of heart contractions, reducing the heart’s demand for oxygen and lowering blood pressure.

Most important fact about Propranolol hydrochloride

If you have high blood pressure, you must take Inderal regularly for it to be effective. Since blood pressure declines gradually, it may be several weeks before you get the full benefit of Inderal; and you must continue taking it even if you are feeling well. Inderal does not cure high blood pressure; it merely keeps it under control.

How should you take Propranolol hydrochloride?

Inderal works best when taken before meals. Take it exactly as prescribed, even if your symptoms have disappeared. InnoPran XL should be taken once before bedtime, with or without food.

Try not to miss any doses. If Propranolol hydrochloride is not taken regularly, your condition may worsen.

If you miss a dose…
Take it as soon as you remember. If it is within 8 hours of your next scheduled dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

Storage instructions…
Store at room temperature in a tightly closed, light-resistant container. Protect from freezing or excessive heat.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Propranolol hydrochloride.

Side effects of Inderal may include:
Allergic reactions, congestive heart failure, decreased white blood cells, depression, light-headedness, low blood pressure, nausea, slow heartbeat,

Side effects of InnoPran XL may include:
Constipation, dizziness, fatigue

Why should Propranolol hydrochloride not be prescribed?

If you have inadequate blood supply to the circulatory system (cardiogenic shock), certain types of irregular heartbeat, a slow heartbeat, bronchial asthma, or severe congestive heart failure, you should not take Propranolol hydrochloride.

Special warnings about Propranolol hydrochloride

If you have a history of congestive heart failure, your doctor will prescribe Inderal cautiously.

Inderal should not be stopped suddenly. This can cause increased chest pain and heart attack. Dosage should be gradually reduced.

If you suffer from asthma or other bronchial conditions, coronary artery disease, or kidney or liver disease, Propranolol hydrochloride should be used with caution.

Ask your doctor if you should check your pulse while taking Inderal. This medication can cause your heartbeat to become too slow.

This medication may mask the symptoms of low blood sugar or alter blood sugar levels. In addition, diabetics who experience a severe drop in blood sugar after taking insulin may suffer a spike in blood pressure if they are also taking Inderal.

Notify your doctor or dentist that you are taking Inderal if you have a medical emergency, and before you have surgery or dental treatment.

Possible food and drug interactions when taking Propranolol hydrochloride

If Inderal is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Inderal with the following:

Alcohol
Aluminum hydroxide gel
Antipyrine
Calcium-blocking blood pressure drugs such as diltiazem, nifedipine, and verapamil
Certain high blood pressure medications such as reserpine
Chlorpromazine
Cimetidine
Epinephrine
Haloperidol
Insulin
Lidocaine
Nonsteroidal anti-inflammatory drugs such as ibuprofen and naproxen
Oral diabetes drugs such as glyburide
Phenobarbitone
Phenytoin
Rifampin
Theophylline
Thyroid medications such as levothyroxine

Special information if you are pregnant or breastfeeding

The effects of Inderal during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Inderal appears in breast milk and could affect a nursing infant. If Propranolol hydrochloride is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with Propranolol hydrochloride is finished.

Recommended dosage for Propranolol hydrochloride

ADULTS

All dosages of Inderal, for any problem, must be tailored to the individual. Your doctor will determine when and how often you should take Propranolol hydrochloride. If you are over 65, the doctor will probably start with a relatively low dosage. Remember to take it exactly as directed.

Hypertension

The usual starting dose of Inderal is 40 milligrams 2 times a day. This dose may be in combination with a diuretic. Dosages are gradually increased to between 120 milligrams and 240 milligrams per day for maintenance. In some cases, a dose of 640 milligrams per day may be needed. Depending on the individual, maximum effect of Propranolol hydrochloride may not be reached for a few days or even several weeks. Some people may do better taking Propranolol hydrochloride 3 times a day.

The usual starting dose of InnoPran XL is 80 milligrams once daily at bedtime. Depending on your response, the doctor may increase your dose to 120 milligrams.

Angina Pectoris

The usual daily dosage is 80 milligrams to 320 milligrams, divided into 2, 3, or 4 smaller doses. When your treatment is being discontinued, your doctor will reduce the dosage gradually over a period of several weeks.

Irregular Heartbeat

The usual dose is 10 milligrams to 30 milligrams 3 or 4 times a day, before meals and at bedtime.

Heart Attack

The usual daily dosage is 180 milligrams to 240 milligrams divided into smaller doses. The usual maximum dose is 240 milligrams, although your doctor may increase the dose when treating heart attack with angina or high blood pressure.

Migraine

The usual starting dosage is 80 milligrams per day divided into smaller doses. Dosages can be increased gradually to between 160 milligrams and 240 milligrams per day. If this dose does not relieve your symptoms in 4 to 6 weeks, your doctor will slowly take you off the drug.

Tremors

The usual starting dose is 40 milligrams, 2 times per day. Symptoms will usually be relieved with a dose of 120 milligrams per day; however, on occasion, dosages of 240 milligrams to 320 milligrams per day may be necessary.

Hypertrophic Subaortic Stenosis

The usual dose is 20 milligrams to 40 milligrams, 3 to 4 times a day, before meals and at bedtime.

Before Adrenal Gland Surgery

The usual dose is 60 milligrams a day divided into smaller doses for 3 days before surgery in combination with an alpha-blocker drug.

Inderal may also be taken by people with inoperable tumors in doses of 30 milligrams a day, divided into smaller doses.

CHILDREN

Inderal will be carefully individualized for use in children and is used only for high blood pressure. Doses in children are calculated by body weight, and range from 2 milligrams to 4 milligrams per 2.2 pounds daily, divided into 2 equal doses. The maximum dose is 16 milligrams per 2.2 pounds per day.

If treatment is stopped, Propranolol hydrochloride must be gradually reduced over a 7- to 14-day period.

Inderal is also available in a sustained-release formulation, called Inderal LA, for once-a-day dosing.

Overdosage

No specific information on Inderal overdosage is available; however, overdose symptoms with other beta blockers include:
Extremely slow heartbeat, irregular heartbeat, low blood pressure, severe congestive heart failure, seizures, wheezing

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

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Propranolol

30/06/10

Generic Name: Propranolol (proe-PRAN-oh-lol)
Brand Name: Generic only. No brands available.

Do not suddenly stop taking Propranolol. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop taking Propranolol. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking Propranolol. This should be done even if you only take Propranolol for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Propranolol again.

Propranolol is used for:

Treating certain types of irregular heartbeat. It may also be used for other conditions as determined by your doctor.

Propranolol is a beta-blocker. It works by decreasing the action of pacemaker cells and slowing certain impulses in the heart. This helps to control irregular heartbeat.

Do NOT use Propranolol if:

you are allergic to any ingredient in Propranolol
you have moderate to severe heart block, sick sinus syndrome, or a very slow heartbeat and you do not have a permanent pacemaker
you have uncontrolled heart failure, shock caused by serious heart problems, or very low blood pressure after a heart attack
you have asthma
the patient is a child with diabetes or heart failure
you are taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propranolol:

Some medical conditions may interact with Propranolol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine (eg, medicines to treat colds or congestion), herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances, or are taking medicine for allergies
if you have a history of other heart problems (eg, angina, congestive heart failure, slow heartbeat)
if you have a history of liver or kidney problems, blood vessel disease, lung or breathing problems (eg, chronic bronchitis, emphysema, chronic obstructive pulmonary disease [COPD]), diabetes, low blood sugar, overactive thyroid, or glaucoma
if you have Wolff-Parkinson-White syndrome, Down syndrome, Raynaud syndrome, or an adrenal gland tumor (pheochromocytoma)
if you smoke or drink alcohol

Some MEDICINES MAY INTERACT with Propranolol. Tell your health care provider if you are taking any other medicines, especially any of the following:

Mibefradil because the risk of serious heart side effects may be increased
Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma, high cholesterol, seizures, local anesthesia), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John’s wort) may interact with Propranolol, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol:

Use Propranolol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Propranolol is usually given as an injection at your doctor’s office, hospital, or clinic.
Do not use Propranolol if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Propranolol, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Propranolol.

Important safety information:

Propranolol may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you use it with alcohol or certain medicines. Use Propranolol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are using Propranolol; it may increase the risk of Propranolol’s side effects.
Do NOT use more than the recommended dose without checking with your doctor.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel “normal.” Tell your doctor if you develop any new symptoms.
Tell your doctor or dentist that you use Propranolol before you receive any medical or dental care, emergency care, or surgery.
If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Propranolol.
Propranolol may lower your blood sugar levels. This is most likely to happen in infants and children, or in patients who have diabetes or kidney problems. It may also occur after prolonged physical activity or during fasting. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If this occurs, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.
Diabetes patients – Propranolol may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Propranolol may interfere with certain lab tests, including glaucoma screening and dobutamine stress echocardiography. Be sure your doctor and lab personnel know you are using Propranolol.
Lab tests, including blood pressure and heart function, may be performed while you use Propranolol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Propranolol with caution in the ELDERLY; they may be more sensitive to its effects.
Propranolol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol while you are pregnant. Propranolol is found in breast milk. If you are or will be breast-feeding while you use Propranolol, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Propranolol suddenly, you may have WITHDRAWAL symptoms. These may include worsening chest pain along with possible heart attack.

Possible side effects of Propranolol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; fatigue; lightheadedness; mild pain, swelling, or redness at the injection site; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; disorientation; fever with aching and sore throat; hallucinations; memory loss; mental or mood changes; numbness or tingling of the hands; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising; unusually slow heartbeat; very cold or blue fingers or toes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include severe dizziness; shortness of breath; swelling of the hands, ankles, or feet; trouble breathing; very slow heart rate; wheezing.

Proper storage of Propranolol:

Propranolol is usually handled and stored by a health care provider. If you are using Propranolol at home, store Propranolol as directed by your pharmacist or health care provider. Keep Propranolol out of the reach of children and away from pets.

General information:

If you have any questions about Propranolol, please talk with your doctor, pharmacist, or other health care provider.
Propranolol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propranolol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

Propranolol Concentrate

30/06/10

Generic Name: Propranolol (proe-PRAN-oh-lol)
Brand Name: Generic only. No brands available.

If you have angina or have had heart problems, DO NOT suddenly stop taking Propranolol Concentrate without first consulting with your doctor. Severe chest pain, heart attack, very fast heart rate, and irregular heart rhythm may occur. If your doctor decides you should no longer take Propranolol Concentrate, the dosage should be gradually reduced according to your doctor’s instructions. You should be closely watched by your doctor and limit physical activity to a minimum, particularly if you have certain kinds of heart disease. Some medicines or medical conditions may interact with Propranolol Concentrate.

Propranolol Concentrate is used for:

Treating high blood pressure; prevention of angina pectoris (chest pain); management of a heart condition called hypertrophic subaortic stenosis; treating and preventing certain abnormal or rapid heart rhythms; improvement of survival after a heart attack in certain patients; treatment of tremor; prevention of migraine headaches; and treating symptoms of adrenal gland tumors. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Propranolol Concentrate is a beta-adrenergic blocking agent. It works by slowing down the heart and reducing blood pressure, which helps it pump more efficiently and reduces the workload on the heart. It may also interfere with the action of adrenalin and other similar chemicals in the brain preventing migraine headaches.

Do NOT use Propranolol Concentrate if:

you are allergic to any ingredient in Propranolol Concentrate
you have a very slow heartbeat and heart block; had a heart attack and have very low blood pressure or uncontrolled heart failure or shock caused by heart failure
you have asthma or Raynaud phenomenon
you are a child with diabetes or heart failure
you are taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propranolol Concentrate:

Some medical conditions may interact with Propranolol Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances or are taking medicine for allergies
if you have ever had an adrenal gland tumor; anaphylaxis; asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other lung disease; congestive heart failure; narrowing of blood vessels of the legs, arms, stomach, or kidneys; an unusually slow heartbeat; diabetes; kidney problems; low blood sugar; or an overactive thyroid
if you have Wolff-Parkinson-White syndrome
if you are having surgery

Some MEDICINES MAY INTERACT with Propranolol Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antiarrhythmics (eg, amiodarone, flecainide, quinidine), antipsychotics (eg, chlorpromazine, haloperidol), bupivacaine, calcium channel blockers (eg, mibefradil, nifedipine, verapamil), cimetidine, ketanserin, mefloquine, or thioamines (eg, tapazole) because potentially life-threatening heart-related side effects may occur, including very slow heart rate; abnormal heartbeat; lightheadedness, especially upon standing; difficulty breathing, especially when lying down; loss of function in the heart and lungs; and swelling of ankles
Barbiturates (eg, phenobarbital), clonidine, phenytoin, rifampin, or thyroid hormones (eg, levothyroxine) because they may decrease Propranolol Concentrate’s effectiveness
Certain stimulants (adrenalin, pseudoephedrine), hydralazine, insulin, lidocaine, quinazolines (eg, doxazosin), rizatriptan, or theophylline because their actions and side effects may be increased by Propranolol Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol Concentrate:

Use Propranolol Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Propranolol Concentrate by mouth with or without food, but it should be taken at the same time daily and consistently either on an empty stomach or with food.
Use the dropper that comes with Propranolol Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
Do not take antacids containing aluminum within 2 hours of taking Propranolol Concentrate.
Continue to use Propranolol Concentrate even if you feel well. Do not miss any doses.
If you miss a dose of Propranolol Concentrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol Concentrate.

Important safety information:

Propranolol Concentrate may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Propranolol Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Propranolol Concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel “normal.” Tell your doctor if you develop any new symptoms.
Propranolol Concentrate may mask the signs of hyperthyroidism (overactive thyroid). If you have an overactive thyroid and stop taking Propranolol Concentrate too suddenly, symptoms of hyperthyroidism (eg, fast heartbeat) may occur.
Patients with a history of severe allergic reactions may be more sensitive to allergens while taking Propranolol Concentrate. These patients may not respond to the usual dose of epinephrine (adrenalin).
Diabetes patients – Propranolol Concentrate may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Tell your doctor or dentist that you take Propranolol Concentrate before you receive any medical or dental care, emergency care, or surgery.
Propranolol Concentrate may interfere with certain lab tests, including the glaucoma screening test. Be sure your doctor and lab personnel know you are taking Propranolol Concentrate.
Lab tests, including blood pressure and heart function tests, may be performed while you use Propranolol Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Caution is advised when using Propranolol Concentrate in CHILDREN; they may be more sensitive to its effects, especially breathing problems and high blood sugar levels.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol Concentrate while you are pregnant. Propranolol Concentrate is found in breast milk. If you are or will be breast-feeding while you use Propranolol Concentrate, check with your doctor. Discuss any possible risks to your baby.

If you suddenly stop taking Propranolol Concentrate, you may experience WITHDRAWAL symptoms, including worsening chest pain along with possible heart attack.

Possible side effects of Propranolol Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; depression; diarrhea; dizziness; drowsiness; fatigue; hallucinations; lightheadedness; nausea; sleeplessness; stomach cramps; tiredness; vision problems; vivid dreams; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include difficulty breathing, especially when lying down; lightheadedness, especially upon standing; pale or blue skin; seizures (convulsions); shortness of breath; swelling of ankles; unconsciousness, possibly leading to lack of heartbeat or breathing; very slow heart rate; wheezing.

Proper storage of Propranolol Concentrate:

Store Propranolol Concentrate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propranolol Concentrate out of the reach of children and away from pets.

General information:

If you have any questions about Propranolol Concentrate, please talk with your doctor, pharmacist, or other health care provider.
Propranolol Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propranolol Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

Propranolol Sustained-Release Capsules

30/06/10

Generic Name: Propranolol (proe-PRAN-oh-lol)
Brand Name: Inderal LA

Do not suddenly stop taking Propranolol Sustained-Release Capsules. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Propranolol Sustained-Release Capsules. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking Propranolol Sustained-Release Capsules. This should be done even if you only take Propranolol Sustained-Release Capsules for high blood pressure. Heart disease is common, and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Propranolol Sustained-Release Capsules again.

Propranolol Sustained-Release Capsules are used for:

Treating high blood pressure. It is used in patients with angina to decrease angina frequency and increase exercise tolerance. It is used to manage a heart condition called hypertrophic subaortic stenosis and to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Propranolol Sustained-Release Capsules are a beta-blocker. It works by slowing down the heart and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart. Exactly how Propranolol Sustained-Release Capsules works to treat migraines is not known.

Do NOT use Propranolol Sustained-Release Capsules if:

you are allergic to any ingredient in Propranolol Sustained-Release Capsules
you have moderate to severe heart block, sick sinus syndrome, or a very slow heartbeat and you do not have a permanent pacemaker
you have uncontrolled heart failure, shock caused by serious heart problems, or very low blood pressure after a heart attack
you have asthma
the patient is a child with diabetes or heart failure
you are taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propranolol Sustained-Release Capsules:

Some medical conditions may interact with Propranolol Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are taking medicine for allergies
if you have a history of other heart problems (eg, angina, congestive heart failure, slow heartbeat)
if you have a history of liver or kidney problems, blood vessel disease, lung or breathing problems (eg, chronic bronchitis, chronic obstructive pulmonary disease [COPD], emphysema), diabetes, low blood sugar, overactive thyroid, or glaucoma
if you have Wolff-Parkinson-White syndrome, Down syndrome, Raynaud syndrome, or an adrenal gland tumor (pheochromocytoma)
if you smoke or drink alcohol

Some MEDICINES MAY INTERACT with Propranolol Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Mibefradil because the risk of serious heart side effects may be increased
Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma, high cholesterol, seizures, local anesthesia), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John’s wort) may interact with Propranolol Sustained-Release Capsules, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol Sustained-Release Capsules:

Use Propranolol Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Propranolol Sustained-Release Capsules by mouth with or without food.
Swallow Propranolol Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
If you are taking an antacid with aluminum in it, take it at least 2 hours after you take Propranolol Sustained-Release Capsules.
Take Propranolol Sustained-Release Capsules on a regular schedule to get the most benefit from it. Taking Propranolol Sustained-Release Capsules at the same time each day will help you remember to take it.
Continue to use Propranolol Sustained-Release Capsules even if you feel well. Do not miss any doses.
Do not suddenly stop taking Propranolol Sustained-Release Capsules. You may have an increased risk of side effects. If you need to stop Propranolol Sustained-Release Capsules or add a new medicine, your doctor will gradually lower your dose.
If you miss a dose of Propranolol Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol Sustained-Release Capsules.

Important safety information:

Propranolol Sustained-Release Capsules may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Propranolol Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are taking Propranolol Sustained-Release Capsules; it may increase the risk of Propranolol Sustained-Release Capsules’s side effects.
Do NOT take more than the recommended dose without checking with your doctor.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel “normal.” Tell your doctor if you develop any new symptoms.
Tell your doctor or dentist that you take Propranolol Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Propranolol Sustained-Release Capsules.
Propranolol Sustained-Release Capsules may lower your blood sugar levels. This is most likely to happen in infants and children, or in patients who have diabetes or kidney problems. It may also occur after prolonged physical activity or during fasting. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If this occurs, eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.
Diabetes patients – Propranolol Sustained-Release Capsules may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Propranolol Sustained-Release Capsules may interfere with certain lab tests, including glaucoma screening test and dobutamine stress echocardiography. Be sure your doctor and lab personnel know you are taking Propranolol Sustained-Release Capsules.
Lab tests, including blood pressure and heart function tests, may be performed while you use Propranolol Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Propranolol Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Caution is advised when using Propranolol Sustained-Release Capsules in CHILDREN; they may be more sensitive to its effects, especially low blood sugar levels or shortness of breath.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol Sustained-Release Capsules while you are pregnant. Propranolol Sustained-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Propranolol Sustained-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Propranolol Sustained-Release Capsules suddenly, you may have WITHDRAWAL symptoms. These may include worsening chest pain along with possible heart attack.

Possible side effects of Propranolol Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; fatigue; lightheadedness; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; disorientation; fever with aching and sore throat; hallucinations; memory loss; mental or mood changes; numbness or tingling of the hands; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising; unusually slow heartbeat; very cold or blue fingers or toes.

If OVERDOSE is suspected:

Proper storage of Propranolol Sustained-Release Capsules:

Store Propranolol Sustained-Release Capsules between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propranolol Sustained-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Propranolol Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Propranolol Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propranolol Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

Propranolol Sustained-Release Bead Capsules

30/06/10

Generic Name: Propranolol (proe-PRAN-oh-lol)
Brand Name: InnoPran XL

Do not suddenly stop taking Propranolol Sustained-Release Bead Capsules. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Propranolol Sustained-Release Bead Capsules. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking Propranolol Sustained-Release Bead Capsules. This should be done even if you only take Propranolol Sustained-Release Bead Capsules for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Propranolol Sustained-Release Bead Capsules again.

Propranolol Sustained-Release Bead Capsules are used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Propranolol Sustained-Release Bead Capsules are a beta-blocker. It works by slowing down the heart and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart.

Do NOT use Propranolol Sustained-Release Bead Capsules if:

you are allergic to any ingredient in Propranolol Sustained-Release Bead Capsules
you have moderate to severe heart block, sick sinus syndrome, or a very slow heartbeat and you do not have a permanent pacemaker
you have uncontrolled heart failure, shock caused by serious heart problems, or very low blood pressure after a heart attack
you have asthma
the patient is a child with diabetes or heart failure
you are taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propranolol Sustained-Release Bead Capsules:

Some medical conditions may interact with Propranolol Sustained-Release Bead Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances, or you are taking medicine for allergies
if you have a history of other heart problems (eg, angina, congestive heart failure, slow heartbeat)
if you have a history of liver or kidney problems, blood vessel disease, lung or breathing problems (eg, chronic bronchitis, emphysema, chronic obstructive pulmonary disease [COPD]), diabetes, low blood sugar, overactive thyroid, or glaucoma
if you have Wolff-Parkinson-White syndrome, Down syndrome, Raynaud syndrome, or an adrenal gland tumor (pheochromocytoma)
if you smoke or drink alcohol

Some MEDICINES MAY INTERACT with Propranolol Sustained-Release Bead Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Mibefradil because the risk of serious heart side effects may be increased
Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma, high cholesterol, seizures, local anesthesia), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John’s wort) may interact with Propranolol Sustained-Release Bead Capsules, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol Sustained-Release Bead Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol Sustained-Release Bead Capsules:

Use Propranolol Sustained-Release Bead Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Propranolol Sustained-Release Bead Capsules by mouth. It may be taken with or without food, but you should always take it the same way (either with or without food).
Swallow Propranolol Sustained-Release Bead Capsules whole. Do not break, crush, or chew before swallowing.
If you are taking an antacid with aluminum in it, take it at least 2 hours after you take Propranolol Sustained-Release Bead Capsules.
Take Propranolol Sustained-Release Bead Capsules on a regular schedule to get the most benefit from it. Taking Propranolol Sustained-Release Bead Capsules at the same time each day will help you remember to take it.
Continue to take Propranolol Sustained-Release Bead Capsules even if you feel well. Do not miss any doses.
Do not suddenly stop taking Propranolol Sustained-Release Bead Capsules. You may have an increased risk of side effects. If you need to stop Propranolol Sustained-Release Bead Capsules or add a new medicine, your doctor will gradually lower your dose.
If you miss a dose of Propranolol Sustained-Release Bead Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol Sustained-Release Bead Capsules.

Important safety information:

Propranolol Sustained-Release Bead Capsules may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Propranolol Sustained-Release Bead Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are taking Propranolol Sustained-Release Bead Capsules; it may increase the risk of Propranolol Sustained-Release Bead Capsules’s side effects.
Do NOT take more than the recommended dose without checking with your doctor.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel “normal.” Tell your doctor if you develop any new symptoms.
Tell your doctor or dentist that you take Propranolol Sustained-Release Bead Capsules before you receive any medical or dental care, emergency care, or surgery.
If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Propranolol Sustained-Release Bead Capsules.
Propranolol Sustained-Release Bead Capsules may lower your blood sugar levels. This is most likely to happen in infants and children, or in patients who have diabetes or kidney problems. It may also occur after prolonged physical activity or during fasting. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.
Diabetes patients – Propranolol Sustained-Release Bead Capsules may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Propranolol Sustained-Release Bead Capsules may interfere with certain lab tests, including the glaucoma screening test and dobutamine stress echocardiography. Be sure your doctor and lab personnel know you are taking Propranolol Sustained-Release Bead Capsules.
Lab tests, including blood pressure and heart function tests, may be performed while you use Propranolol Sustained-Release Bead Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Propranolol Sustained-Release Bead Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Propranolol Sustained-Release Bead Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Children may be more sensitive to Propranolol Sustained-Release Bead Capsules’s effects, especially low blood sugar levels or shortness of breath.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol Sustained-Release Bead Capsules while you are pregnant. Propranolol Sustained-Release Bead Capsules are found in breast milk. If you are or will be breast-feeding while you use Propranolol Sustained-Release Bead Capsules, check with your doctor. Discuss any possible risks to your baby.

If you suddenly stop taking Propranolol Sustained-Release Bead Capsules, you may experience WITHDRAWAL symptoms, including worsening chest pain along with possible heart attack.

Possible side effects of Propranolol Sustained-Release Bead Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; fatigue; lightheadedness; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; disorientation; fever with aching and sore throat; hallucinations; memory loss; mental or mood changes; numbness or tingling of the hands; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising; unusually slow heartbeat; very cold or blue fingers or toes.

If OVERDOSE is suspected:

Proper storage of Propranolol Sustained-Release Bead Capsules:

Store Propranolol Sustained-Release Bead Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propranolol Sustained-Release Bead Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Propranolol Sustained-Release Bead Capsules, please talk with your doctor, pharmacist, or other health care provider.
Propranolol Sustained-Release Bead Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propranolol Sustained-Release Bead Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

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Propranolol Solution

30/06/10

Generic Name: Propranolol (proe-PRAN-oh-lol)
Brand Name: Generic only. No brands available.

Do not suddenly stop taking Propranolol Solution. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Propranolol Solution. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking Propranolol Solution. This should be done even if you only take Propranolol Solution for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Propranolol Solution again.

Propranolol Solution is used for:

Treating high blood pressure or certain types of irregular heartbeat. It is used in patients with angina to decrease angina frequency and increase exercise tolerance. It is used to decrease the risk of heart death in certain patients who have survived a heart attack. It is used to manage certain types of tremors, a heart condition called hypertrophic subaortic stenosis, or certain symptoms of pheochromocytoma (an adrenal tumor). It is also used to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Propranolol Solution is a beta-blocker. It works by slowing down the heart and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart. Exactly how Propranolol Solution works to treat migraines or tremors is not known.

Do NOT use Propranolol Solution if:

you are allergic to any ingredient in Propranolol Solution
you have moderate to severe heart block, sick sinus syndrome, or a very slow heartbeat and you do not have a permanent pacemaker
you have uncontrolled heart failure, shock caused by serious heart problems, or very low blood pressure after a heart attack
you have asthma
the patient is a child with diabetes or heart failure
you are taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Propranolol Solution:

Some medical conditions may interact with Propranolol Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are taking medicine for allergies
if you have a history of other heart problems (eg, angina, congestive heart failure, slow heartbeat)
if you have a history of liver or kidney problems, blood vessel disease, lung or breathing problems (eg, chronic bronchitis, chronic obstructive pulmonary disease [COPD], emphysema), diabetes, low blood sugar, overactive thyroid, or glaucoma
if you have Wolff-Parkinson-White syndrome, Down syndrome, Raynaud syndrome, or an adrenal gland tumor (pheochromocytoma)
if you smoke or drink alcohol

Some MEDICINES MAY INTERACT with Propranolol Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Mibefradil because the risk of serious heart side effects may be increased
Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma, high cholesterol, seizures, local anesthesia), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John’s wort) may interact with Propranolol Solution, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol Solution:

Use Propranolol Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Propranolol Solution by mouth. Talk to your doctor about how you should take it with regard to food.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you are taking an antacid with aluminum in it, take it at least 2 hours after you take Propranolol Solution.
Take Propranolol Solution on a regular schedule to get the most benefit from it. Taking Propranolol Solution at the same time each day will help you remember to take it.
Continue to take Propranolol Solution even if you feel well. Do not miss any doses.
Do not suddenly stop taking Propranolol Solution. You may have an increased risk of side effects. If you need to stop Propranolol Solution or add a new medicine, your doctor will gradually lower your dose.
If you miss a dose of Propranolol Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol Solution.

Important safety information:

Propranolol Solution may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Propranolol Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol while you are taking Propranolol Solution; it may increase the risk of Propranolol Solution’s side effects.
Do NOT take more than the recommended dose without checking with your doctor.
Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel “normal.” Tell your doctor if you develop any new symptoms.
Tell your doctor or dentist that you take Propranolol Solution before you receive any medical or dental care, emergency care, or surgery.
If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Propranolol Solution.
Propranolol Solution may lower your blood sugar levels. This is most likely to happen in infants and children or in patients who have diabetes or kidney problems. It may also occur after prolonged physical activity or during fasting. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If this occurs, eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.
Diabetes patients – Propranolol Solution may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Propranolol Solution may interfere with certain lab tests, including glaucoma screening and dobutamine stress echocardiography. Be sure your doctor and lab personnel know you are taking Propranolol Solution.
Lab tests, including blood pressure and heart function, may be performed while you use Propranolol Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Propranolol Solution with caution in the ELDERLY; they may be more sensitive to its effects.
Caution is advised when using Propranolol Solution in CHILDREN; they may be more sensitive to its effects, especially low blood sugar levels or shortness of breath.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol Solution while you are pregnant. Propranolol Solution is found in breast milk. If you are or will be breast-feeding while you use Propranolol Solution, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Propranolol Solution suddenly, you may have WITHDRAWAL symptoms. These may include worsening chest pain along with possible heart attack.

Possible side effects of Propranolol Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; fatigue; lightheadedness; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; disorientation; fever with aching and sore throat; hallucinations; memory loss; mental or mood changes; numbness or tingling of the hands; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising; unusually slow heartbeat; very cold or blue fingers or toes.

If OVERDOSE is suspected:

Proper storage of Propranolol Solution:

Store Propranolol Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propranolol Solution out of the reach of children and away from pets.

General information:

If you have any questions about Propranolol Solution, please talk with your doctor, pharmacist, or other health care provider.
Propranolol Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Propranolol Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

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Propoxyphene Compound 65

30/06/10

Generic Name: aspirin/caffeine/propoxyphene (AS pir in/CAF feen/proe POX ih feen)
Brand Names: Darvon Compound 32, Darvon Compound-65, PC-CAP, Propoxyphene Compound 65

What is Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene)?

Propoxyphene (related to codeine) is in a class of drugs called narcotic analgesics. It relieves pain.

Aspirin is a less potent pain reliever, as well as an anti-inflammatory and a fever reducer. Aspirin increases the effects of propoxyphene.

Caffeine constricts blood vessels. This is believed to help relieve tension headaches by constricting dilated blood vessels in the head.

The combination, aspirin/caffeine/propoxyphene, is used to treat moderate-to-severe pain.

Aspirin/caffeine/propoxyphene may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene)?

Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose. Avoid alcohol while taking aspirin/caffeine/propoxyphene. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol increases the risk of stomach bleeding when taking aspirin. Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Do not take other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

Drowsiness or dizziness caused by aspirin/caffeine/propoxyphene may be increased by other drugs such as antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

What should I discuss with my healthcare provider before taking Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene)?

Before taking this medication, tell your doctor if you have

kidney disease;
liver disease;
a bleeding or blood clotting disorder;
a stomach ulcer;
asthma;
urinary retention;
an enlarged prostate;
hypothyroidism;
seizures or epilepsy;
gallbladder disease;
a head injury;
Addison’s disease; or
a history of drug or alcohol addiction.

You may not be able to take aspirin/caffeine/propoxyphene, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Propoxyphene may cause addiction and withdrawal symptoms as well as other harmful effects in an unborn baby. Do not take aspirin/caffeine/propoxyphene without first talking to your doctor if you are pregnant or could become pregnant during treatment. Propoxyphene may also cause addiction and withdrawal symptoms in a nursing baby. Do not take aspirin/caffeine/propoxyphene without first talking to your doctor if you are breast-feeding a baby. If you are older than 60 years of age, you may be more likely to experience side effects from this therapy. Your doctor may prescribe a lower dose of the medication. Do not use any product that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye’s syndrome, a rare but often fatal condition.

How should I take Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene)?

Take aspirin/caffeine/propoxyphene exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.

Take each dose with a full glass of water. Aspirin/caffeine/propoxyphene can be taken with food or milk if it causes stomach upset. Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor. Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking aspirin/caffeine/propoxyphene suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose. Constipation may be a side effect of treatment with aspirin/caffeine/propoxyphene. Increasing the amount of fiber and water (six to eight full glasses) in the diet may reduce constipation.

Do not share this medication with anyone else.

Store aspirin/caffeine/propoxyphene at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking the next dose.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an aspirin/caffeine/propoxyphene overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, small pupils, nausea, vomiting, ringing in the ears, and sweating.

What should I avoid while taking Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene)?

Avoid alcohol while taking aspirin/caffeine/propoxyphene. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol increases the risk of stomach bleeding when taking aspirin. Use caution when driving, operating machinery, or performing other hazardous activities. Propoxyphene may cause drowsiness. If you experience drowsiness, avoid these activities.

Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene) side effects

If you experience any of the following serious side effects, stop taking aspirin/caffeine/propoxyphene and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
slow, weak breathing;
seizures;
cold, clammy skin;
severe weakness or dizziness;
unconsciousness; or
black, bloody, or tarry stools or blood in your urine or vomit.

Other, less serious side effects may be more likely to occur. Continue to take aspirin/caffeine/propoxyphene and talk to your doctor if you experience

constipation;
dry mouth, nausea, vomiting, or decreased appetite;
dizziness, tiredness, or lightheadedness;
muscle twitches;
sweating;
itching
decreased urination;
decreased sex drive; or
ringing in the ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Propoxyphene Compound 65 (aspirin/caffeine/propoxyphene)?

Aspirin/caffeine/propoxyphene may increase the effects of oral anticoagulants such as warfarin (Coumadin) which could lead to bleeding. It may also increase the effects of carbamazepine (Tegretol) leading to toxicity. Be sure your doctor is aware if you are taking either of these medications.

Do not take aspirin/caffeine/propoxyphene if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.

Drugs other than those listed here may also interact with aspirin/caffeine/propoxyphene. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about aspirin/caffeine/propoxyphene written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Propoxyphene napsylate, Acetaminophen

30/06/10

Brand names: Darvon Compound-65, Darvon-N, Darvon, Darvocet-N

Why is Propoxyphene napsylate, Acetaminophen prescribed?

Darvocet-N and Darvon Compound-65 are mild narcotic analgesics prescribed for the relief of mild to moderate pain, with or without fever.

Darvon-N and Darvon are prescribed for the relief of mild to moderate pain.

Most important fact about Propoxyphene napsylate, Acetaminophen

You can build up tolerance to, and become dependent on, these drugs if you take them in higher than recommended doses over long periods of time.

How should you take Propoxyphene napsylate, Acetaminophen?

Take these drugs exactly as prescribed. Do not increase the amount you take without your doctor’s approval. Do not take them for any reason other than those for which they are prescribed. Do not give them to others who may have similar symptoms.

If you miss a dose…
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

Storage instructions…
Store at room temperature.

What side effects may occur?

Side effects may include:
Drowsiness, dizziness, nausea, sedation, vomiting

If these side effects occur, it may help if you lie down after taking the medication.

Why should Propoxyphene napsylate, Acetaminophen not be prescribed?

If you are sensitive to or have ever had an allergic reaction to propoxyphene, any of the other ingredients in these drugs, or other pain relievers of this type, you should not take Propoxyphene napsylate, Acetaminophen. Make sure your doctor is aware of any drug reactions you have experienced.

Special warnings about Propoxyphene napsylate, Acetaminophen

These medicines may cause you to become drowsy or less alert; therefore, you should not drive or operate dangerous machinery or participate in any hazardous activity that requires full mental alertness until you know how the drug affects you.

If you have a kidney or liver disorder, consult your doctor before taking Darvocet-N.

Abnormal liver function may result from taking Darvocet-N. A typical sign includes jaundice (yellowing of the skin or eyes). If you experience this symptom, contact your doctor immediately for proper evaluation and treatment.

Darvon Compound-65 contains aspirin and caffeine. If you have an ulcer or a blood clotting problem, consult your doctor before taking Propoxyphene napsylate, Acetaminophen. Aspirin may irritate the stomach lining and could cause bleeding.

Because there is a possible association between aspirin and the severe neurological disorder known as Reye’s syndrome, children and teenagers with chickenpox or flu should not take Darvon Compound-65 unless prescribed by a doctor.

Aspirin may cause asthma attacks. If you have had an asthma attack while taking aspirin, consult your doctor before you take Darvon Compound-65.

Possible food and drug interactions when taking Propoxyphene napsylate, Acetaminophen

The propoxyphene in these drugs slows down the central nervous system and intensifies the effects of alcohol. Heavy use of alcohol with Propoxyphene napsylate, Acetaminophen may cause overdose symptoms. Therefore, limit or avoid use of alcohol while you are taking Propoxyphene napsylate, Acetaminophen.

If these medications are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining them with the following:

Antiseizure medications such as carbamazepine
Antidepressant drugs such as amitriptyline
Antihistamines such as diphenhydramine
Aspirin
Muscle relaxants such as cyclobenzaprine
Narcotic pain relievers such as meperidine
Sleep aids such as triazolam
Tranquilizers such as alprazolam and diazepam
Warfarin-like drugs

The use of these drugs with propoxyphene can lead to potentially fatal overdose symptoms.

Severe neurologic disorders, including coma, have occurred with the use of propoxyphene in combination with carbamazepine.

The use of anticoagulants (blood thinners such as Coumadin) in combination with Darvon Compound-65 may cause bleeding. If you are taking an anticoagulant, consult your doctor before taking Propoxyphene napsylate, Acetaminophen.

The use of aspirin with drugs for gout may alter the effects of the antigout medication. Consult your doctor before taking Darvon Compound-65.

Special information if you are pregnant or breastfeeding

Do not take these medications if you are pregnant or planning to become pregnant unless you are directed to do so by your doctor. Temporary drug dependence may occur in newborns when the mother has taken Propoxyphene napsylate, Acetaminophen consistently in the weeks before delivery. The use of Darvon Compound-65 (which contains aspirin) during pregnancy may cause problems in the developing baby or complications during delivery. Do not take it during the last 3 months of pregnancy. Darvocet-N does appear in breast milk. However, no adverse effects have been found in nursing infants.

Recommended dosage for Propoxyphene napsylate, Acetaminophen

ADULTS

These medicines may be taken every 4 hours as needed for pain. The usual doses are:

Darvocet-N 50: 2 tablets

Darvocet-N 100: 1 tablet

Darvon: 1 capsule

Darvon Compound-65: 1 capsule

Your doctor may lower the total daily dosage if you have kidney or liver problems.

The most you should take of Darvon or Darvon Compound-65 is 6 capsules a day.

CHILDREN

The safety and effectiveness of Darvocet-N have not been established in children.

OLDER ADULTS

Your doctor may lengthen the time between doses.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Symptoms of a propoxyphene overdose may include:
Bluish tinge to the skin, coma, convulsions, decreased or difficult breathing to the point of temporary stoppage, decreased heart function, extreme sleepiness, irregular heartbeat, low blood pressure, pinpoint pupils becoming dilated later, stupor

Additional symptoms of overdose with Darvocet-N:
Abdominal pain, excessive sweating, general feeling of illness, kidney failure, liver problems, loss of appetite, nausea, vomiting

Additional symptoms of overdose with Darvon Compound-65:
Confusion, deafness, excessive perspiration, headache, mental dullness, nausea, rapid breathing, rapid pulse, ringing in the ears, vertigo, vomiting

Extreme overdosage may lead to unconsciousness and death.

Detailed,P

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30/06/10

Propranolol and Hydrochlorothiazide Description

Propranolol and Hydrochlorothiazide – Clinical Pharmacology

Indications and Usage for Propranolol and Hydrochlorothiazide

Contraindications

Warnings

Precautions

General

Information for Patients

Laboratory Tests

Drug/Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use

Adverse Reactions

Overdosage

Propranolol and Hydrochlorothiazide Dosage and Administration

How is Propranolol and Hydrochlorothiazide Supplied

30/06/10

Uses For Propranolol HCl Intensol

Before Using Propranolol HCl Intensol

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of propranolol

Dosing

Missed Dose

Storage

Precautions While Using Propranolol HCl Intensol

Propranolol HCl Intensol Side Effects

30/06/10

Why is Propranolol hydrochloride prescribed?

Most important fact about Propranolol hydrochloride

How should you take Propranolol hydrochloride?

What side effects may occur?

Why should Propranolol hydrochloride not be prescribed?

Special warnings about Propranolol hydrochloride

Possible food and drug interactions when taking Propranolol hydrochloride

Special information if you are pregnant or breastfeeding

Recommended dosage for Propranolol hydrochloride

Overdosage

30/06/10

Propranolol is used for:

Do NOT use Propranolol if:

Before using Propranolol:

How to use Propranolol:

Important safety information:

Possible side effects of Propranolol:

If OVERDOSE is suspected:

General information:

30/06/10

Propranolol Concentrate is used for:

Do NOT use Propranolol Concentrate if:

Before using Propranolol Concentrate:

How to use Propranolol Concentrate:

Important safety information:

Possible side effects of Propranolol Concentrate:

If OVERDOSE is suspected:

General information:

30/06/10

Propranolol Sustained-Release Capsules are used for:

Do NOT use Propranolol Sustained-Release Capsules if:

Before using Propranolol Sustained-Release Capsules:

How to use Propranolol Sustained-Release Capsules:

Important safety information:

Possible side effects of Propranolol Sustained-Release Capsules:

If OVERDOSE is suspected:

General information:

30/06/10

Propranolol Sustained-Release Bead Capsules are used for: