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bumetanide (Oral route)

30/06/10

bue-MET-a-nide

Injection routeSolution

Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule have to be adjusted to the individual patient’s needs .

Oral routeTablet

Commonly used brand name(s):

In the U.S.

Bumex

Available Dosage Forms:

Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic, Loop

Uses For bumetanide

Bumetanide belongs to a group of medicines called loop diuretics or “water pills.” Bumetanide is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine .

bumetanide is available only with your doctor’s prescription .

Before Using bumetanide

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 bumetanide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bumetanide 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 bumetanide in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of bumetanide 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 bumetanide .

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using bumetanide 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.

Arsenic Trioxide
Bepridil
Digitoxin
Dofetilide
Droperidol
Ketanserin
Levomethadyl
Lithium
Metolazone
Sotalol

Using bumetanide 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.

Aceclofenac
Acemetacin
Alacepril
Alclofenac
Apazone
Benazepril
Benoxaprofen
Bromfenac
Bufexamac
Captopril
Carprofen
Celecoxib
Cilazapril
Clometacin
Clonixin
Delapril
Dexketoprofen
Dibekacin
Diclofenac
Diflunisal
Dipyrone
Droxicam
Enalaprilat
Enalapril Maleate
Etodolac
Etofenamate
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Flurbiprofen
Fosinopril
Germanium
Ginseng
Gossypol
Ibuprofen
Imidapril
Indomethacin
Indoprofen
Isoxicam
Kanamycin
Ketoprofen
Ketorolac
Licorice
Lisinopril
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Moexipril
Nabumetone
Naproxen
Neomycin
Niflumic Acid
Nimesulide
Oxaprozin
Oxyphenbutazone
Pentopril
Perindopril
Phenylbutazone
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Quinapril
Ramipril
Rofecoxib
Spirapril
Streptomycin
Sulindac
Suprofen
Temocapril
Tenidap
Tenoxicam
Tiaprofenic Acid
Tolmetin
Trandolapril
Valdecoxib
Zofenopril
Zomepirac

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 bumetanide

Dosing

The dose of bumetanide 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 bumetanide. 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 oral dosage form (tablets):
- For edema:
  - Adults—0.5 to 2 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of bumetanide, 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 bumetanide

It is very important that your doctor check your progress at regular visits to make sure bumetanide is working properly. Blood tests may be needed to check for unwanted effects .

bumetanide may cause you to lose more potassium from your body than normal. Your doctor will monitor the potassium in your blood while you are taking bumetanide. To prevent the loss of too much water and potassium, tell your doctor if you become sick with severe or continuing nausea, vomiting, or diarrhea. Check with your doctor right away if you have one or more of these symptoms: dry mouth; increased thirst; muscle cramps; or nausea or vomiting .

Bumetanide can lower the number of platelets in your blood. Platelets are necessary for proper blood clotting. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin .

bumetanide may cause changes in your blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor .

bumetanide 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:

More common

Abdominal pain
blurred vision
confusion
decreased urine output
dizziness
drowsiness
dry mouth
fast or irregular heartbeat
flushed, dry skin
fruit-like breath odor
headache
increased hunger
increased thirst
increased urination
irritability
joint pain, stiffness, or swelling
loss of appetite
loss of mental alertness
lower back, side, or stomach pain
mood or mental changes
muscle pain or cramps
nausea or vomiting
numbness or tingling in the hands, feet, or lips
shortness of breath
sweating
swelling of face, hands, feet, ankles, or lower legs
troubled breathing
unexplained weight loss
unusual tiredness or weakness
weak pulse

Rare

Agitation
back pain
black, tarry stools
bleeding gums
blood in the urine or stools
chest pain
convulsions (seizures)
deep or fast breathing with dizziness
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fever
hallucinations
hives
increase in heart rate
increased blood pressure
numbness of feet, hands, and around the mouth
pinpoint red spots on the skin
rapid breathing
stiff neck
sunken eyes
trembling, jerking of hands
unusual bleeding or bruising
weight gain
wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Difficulty breathing
pain in chest, groin, or legs, especially the calves
severe, sudden headache
slurred speech
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
sudden, unexplained shortness of breath
unusual drowsiness, dullness, or feeling of sluggishness
vision changes

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:

Rare

Decreased interest in sexual intercourse
diarrhea
difficulty with moving
ear discomfort
feeling of constant movement of self or surroundings
inability to have or keep an erection
itching skin
loss in sexual ability, desire, drive, or performance
muscle or bone pain
muscle stiffness
nipple tenderness
pain, swelling, or redness in joints
rash
sensation of spinning
shorter than usual time to ejaculation of semen
trouble with hearing
upset stomach

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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Bumetanide Tablets

30/06/10

Dosage Form: tablet

Bumetanide Tablets USP

Warning

Bumetanide Tablets Description

Bumetanide is a loop diuretic, available as scored tablets, 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) for oral administration; each tablet also contains: anhydrous lactose, magnesium stearate, microcrystalline cellulose, corn starch and talc, with the following colorants: 0.5 mg (D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake); 1 mg (D&C Yellow No. 10 Aluminum Lake); 2 mg (Ferric oxide red).

Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoyl-benzoic acid. It is a practically white powder. It is slightly soluble in water and soluble in alkaline solutions. It has the following structural formula:

Bumetanide Tablets – Clinical Pharmacology

Bumetanide is a loop diuretic with a rapid onset and short duration of action. Pharmacological and clinical studies have shown that 1 mg bumetanide has a diuretic potency equivalent to approximately 40 mg furosemide. The major site of bumetanide action is the ascending limb of the loop of Henle. The mode of action has been determined through various clearance studies in both humans and experimental animals. Bumetanide inhibits sodium reabsorption in the ascending limb of the loop of Henle, as shown by marked reduction of free-water clearance (CH2O) during hydration and tubular free-water reabsorption (TCH2O) during hydropenia. Reabsorption of chloride in the ascending limb is also blocked by bumetanide, and bumetanide is somewhat more chloruretic than natriuretic.

Potassium excretion is also increased by bumetanide, in a dose-related fashion.

Bumetanide may have an additional action in the proximal tubule. Since phosphate reabsorption takes place largely in the proximal tubule, phosphaturia during bumetanide-induced diuresis is indicative of this additional action. This is further supported by the reduction in the renal clearance of bumetanide by probenecid, associated with diminution in the natriuretic response. This proximal tubular activity does not seem to be related to an inhibition of carbonic anhydrase. Bumetanide does not appear to have a noticeable action on the distal tubule.

Bumetanide decreases uric acid excretion and increases serum uric acid. Following oral administration of bumetanide the onset of diuresis occurs in 30 to 60 minutes. Peak activity is reached between 1 and 2 hours. At usual doses (1 to 2 mg) diuresis is largely complete within 4 hours; with higher doses, the diuretic action lasts for 4 to 6 hours. Diuresis starts within minutes following an intravenous injection and reaches maximum levels within 15 to 30 minutes.

Several pharmacokinetic studies have shown that bumetanide, administered orally or parenterally, is eliminated rapidly in humans, with a half-life of between 1 and 1 1/2 hours. Plasma protein-binding is in the range of 94% to 96%.

Oral administration of carbon-14 labeled bumetanide to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug. Urinary and biliary metabolites identified in this study were formed by oxidation of the N-butyl side chain. Biliary excretion of bumetanide amounted to only 2% of the administered dose.

Pediatric Pharmacology

Elimination of bumetanide appears to be considerably slower in neonatal patients compared with adults, possibly because of immature renal and hepatobiliary function in this population. Small pharmacokinetic studies of intravenous bumetanide in preterm and full term neonates with respiratory disorders have reported an apparent half-life of approximately 6 hours with a range up to 15 hours and a serum clearance ranging from 0.2 to 1.1 mL/min/kg. In a population of neonates receiving bumetanide for volume overload, mean serum clearance rates were 2.17 mL/min/kg in patients less than 2 months of age and 3.8 mL/min/kg in patients aged 2 to 6 months. Mean serum half-life of bumetanide was 2.5 hours and 1.5 hours in patients aged less than 2 months and those aged 2 to 6 months, respectively. Elimination half-life decreased considerably during the first month of life, from a mean of approximately 6 hours at birth to approximately 2.4 hours at 1 month of age.

In preterm neonates, mean serum concentrations following a single 0.05 mg/kg dose ranged from 126 mcg/L at 1 hour to 57 mcg/L at 8 hours. In another study, mean serum concentrations following a single 0.05 mg/kg dose were 338 ng/mL at 30 minutes and 176 ng/mL after 4 hours.

A single dose of 0.1 mg/kg produced mean serum levels of 314 ng/mL at 1 hour, and 195 ng/mL at 6 hours. Mean volume of distribution in neonates and infants has been reported to range from 0.26 L/kg to 0.39 L/kg.

The degree of protein binding of bumetanide in cord sera from healthy neonates was approximately 97%, suggesting the potential for bilirubin displacement. A study using pooled sera from critically ill neonates found that bumetanide at concentrations of 0.5 to 50 mcg/mL, but not 0.25 mcg/mL, caused a linear increase in unbound bilirubin concentrations.

In 56 infants aged 4 days to 6 months, bumetanide doses ranging from 0.005 mg/kg to 0.1 mg/kg were studied for pharmacodynamic effect. Peak bumetanide excretion rates increased linearly with increasing doses of drug. Maximal diuretic effect was observed at a bumetanide excretion rate of about 7 mcg/kg/hr, corresponding to doses of 0.035 to 0.040 mg/kg. Higher doses produced a higher bumetanide excretion rate but no increase in diuretic effect. Urine flow rate peaked during the first hour after drug administration in 80% of patients and by 3 hours in all patients.

Geriatric Pharmacology

In a group of ten geriatric subjects between the ages of 65 and 73 years, total bumetanide clearance was significantly lower (1.8 ± 0.3 mL/min•kg) compared with younger subjects (2.9 ± 0.2 mL/min•kg) after a single oral bumetanide 0.5 mg dose. Maximum plasma concentrations were higher in geriatric subjects (16.9 ± 1.8 ng/mL) compared with younger subjects (10.3 ± 1.5 ng/mL). Urine flow rate and total excretion of sodium and potassium were increased less in the geriatric subjects compared with younger subjects, although potassium excretion and fractional sodium excretion were similar between the two age groups. Nonrenal clearance, bioavailability, and volume of distribution were not significantly different between the two groups.

Indications and Usage for Bumetanide Tablets

Bumetanide Tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route.

Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Contraindications

Bumetanide is contraindicated in anuria. Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

Warnings

Volume and Electrolyte Depletion

The dose of bumetanide should be adjusted to the patient’s need. Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients.

Hypokalemia

Hypokalemia can occur as a consequence of bumetanide administration. Prevention of hypokalemia requires particular attention in the following conditions: patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, i.e., history of ventricular arrhythmias.

In patients with hepatic cirrhosis and ascites, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient’s clinical status and electrolyte balance. Supplemental potassium and/or spironolactone may prevent hypokalemia and metabolic alkalosis in these patients.

Ototoxicity

In cats, dogs and guinea pigs, bumetanide has been shown to produce ototoxicity. In these test animals bumetanide was 5 to 6 times more potent than furosemide and, since the diuretic potency of bumetanide is about 40 to 60 times furosemide, it is anticipated that blood levels necessary to produce ototoxicity will rarely be achieved. The potential exists, however, and must be considered a risk of intravenous therapy, especially at high doses, repeated frequently in the face of renal excretory function impairment. Potentiation of aminoglycoside ototoxicity has not been tested for bumetanide. Like other members of this class of diuretics, bumetanide probably shares this risk.

Allergy to Sulfonamides

Patients allergic to sulfonamides may show hypersensitivity to bumetanide.

Thrombocytopenia

Since there have been rare spontaneous reports of thrombocytopenia from postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.

Precautions

General

Serum potassium should be measured periodically and potassium supplements or potassium-sparing diuretics added if necessary. Periodic determinations of other electrolytes are advised in patients treated with high doses or for prolonged periods, particularly in those on low salt diets.

Hyperuricemia may occur; it has been asymptomatic in cases reported to date. Reversible elevations of the BUN and creatinine may also occur, especially in association with dehydration and particularly in patients with renal insufficiency. Bumetanide may increase urinary calcium excretion with resultant hypocalcemia.

Diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Laboratory Tests

Studies in normal subjects receiving bumetanide revealed no adverse effects on glucose tolerance, plasma insulin, glucagon and growth hormone levels, but the possibility of an effect on glucose metabolism exists. Periodic determinations of blood sugar should be done, particularly in patients with diabetes or suspected latent diabetes.

Patients under treatment should be observed regularly for possible occurrence of blood dyscrasias, liver damage or idiosyncratic reactions, which have been reported occasionally in foreign marketing experience. The relationship of these occurrences to bumetanide use is not certain.

Drug Interactions

Drugs With Ototoxic Potential (see WARNINGS)

Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.

Drugs With Nephrotoxic Potential

There has been no experience with the concurrent use of bumetanide with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.

Lithium

Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.

Probenecid

Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide. This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with bumetanide.

Indomethacin

Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide is thus not recommended.

Antihypertensives

Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.

Digoxin

Interaction studies in humans have shown no effect on digoxin blood levels.

Anticoagulants

Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Bumetanide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system. An 18-month study showed an increase in mammary adenomas of questionable significance in female rats receiving oral doses of 60 mg/kg/day (2000 times a 2 mg human dose). A repeat study at the same doses failed to duplicate this finding. Reproduction studies were performed to evaluate general reproductive performance and fertility in rats at oral dose levels of 10, 30, 60 or 100 mg/kg/day. The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant.

Pregnancy

Teratogenic Effects

Pregnancy category C

Bumetanide is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose. Bumetanide has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given in doses of 3400 times the maximum human therapeutic dose and in rabbits at doses of 3.4 times the maximum human therapeutic dose. In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, 3400 times the maximum human therapeutic dose. These effects were associated with maternal weight reductions noted during dosing. No such adverse effects were observed at 30 mg/kg/day (1000 times the maximum human therapeutic dose). No fetotoxicity was observed at 1000 to 2000 times the human therapeutic dose.

In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 and 0.3 mg/kg/day (3.4 and 10 times the maximum human therapeutic dose). A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day. The sensitivity of the rabbit to bumetanide parallels the marked pharmacologic and toxicologic effects of the drug in this species.

Bumetanide was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (17 times the maximum human therapeutic dose). Bumetanide was not teratogenic when given intravenously to mice and rats at doses up to 140 times the maximum human therapeutic dose.

There are no adequate and well-controlled studies in pregnant women. A small investigational experience in the United States and marketing experience in other countries to date have not indicated any evidence of adverse effects on the fetus, but these data do not rule out the possibility of harmful effects. Bumetanide should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while the patient is on bumetanide since it may be excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

In vitro studies using pooled sera from critically ill neonates have shown bumetanide to be a potent displacer of bilirubin (see CLINICAL PHARMACOLOGY, Pediatric Pharmacology). The administration of bumetanide could present a particular concern if given to critically ill or jaundiced neonates at risk for kernicterus.

Geriatric Use

Clinical studies of bumetanide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded 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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

The most frequent clinical adverse reactions considered probably or possibly related to bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%), and encephalopathy (in patients with preexisting liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of bumetanide-treated patients.

Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use.

Less frequent clinical adverse reactions to bumetanide are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%), and vomiting (0.2%). One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with bumetanide.

Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, premature ejaculation and difficulty maintaining an erection.

Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients tested), hypochloremia (14.9%), hypokalemia (14.7%), azotemia (10.6%), hyponatremia (9.2%), increased serum creatinine (7.4%), hyperglycemia (6.6%), and variations in phosphorus (4.5%), C02 content (4.3%), bicarbonate (3.1%) and calcium (2.4%). Although manifestations of the pharmacologic action of bumetanide, these conditions may become more pronounced by intensive therapy.

Also reported have been thrombocytopenia (0.2%) and deviations in hemoglobin (0.8%), prothrombin time (0.8%), hematocrit (0.6%), WBC (0.3%) and differential counts (0.1%). There have been rare spontaneous reports of thrombocytopenia from postmarketing experience.

Diuresis induced by bumetanide may also rarely be accompanied by changes in LDH (1.0%), total serum bilirubin (0.8%), serum proteins (0.7%), SGOT (0.6%), SGPT (0.5%), alkaline phosphatase (0.4%), cholesterol (0.4%) and creatinine clearance (0.3%). Increases in urinary glucose (0.7%) and urinary protein (0.3%) have also been seen.

Overdosage

Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.

Bumetanide Tablets Dosage and Administration

Dosage should be individualized with careful monitoring of patient response.

Oral Administration

The usual total daily dosage of bumetanide is 0.5 to 2 mg and in most patients is given as a single dose.

If the diuretic response to an initial dose of bumetanide is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5-hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby bumetanide is given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, the dosage should be kept to a minimum, and if necessary, dosage increased very carefully. Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide to furosemide in patients allergic to furosemide.

Parenteral Administration

Bumetanide Injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.

Parenteral treatment should be terminated and oral treatment instituted as soon as possible.

How is Bumetanide Tablets Supplied

Bumetanide Tablets USP are available as light green, flat, round, bevel-edged tablets, debossed “0.5” on one side and bisected on the other side with company logo on the upper half and “4232” on the lower, containing 0.5 mg bumetanide, USP packaged in bottles of 100 tablets.

Bumetanide Tablets USP are available as yellow, flat, round, bevel-edged tablets, debossed “1” on one side and bisected on the other side with company logo on the upper half and “4233” on the lower, containing 1 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets.

Bumetanide Tablets USP are available as peach, flat, round, bevel-edged tablets, debossed “2” on one side and bisected on the other side with company logo on the upper half and “4234” on the lower, containing 2 mg bumetanide, USP packaged in bottles of 100 and 1000 tablets.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured In India By:

EMCURE PHARMACEUTICALS LTD.

Hinjwadi, Pune, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 3/2010

PRINCIPAL DISPLAY PANEL

Bumetanide Tablets 0.5 mg 100s Label Text

NDC 0093-4232-01

Bumetanide Tablets USP

0.5 mg

Each tablet contains: bumetanide, USP 0.5 mg

Rx only

100 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL

Bumetanide Tablets 1 mg 100s Label Text

NDC 0093-4233-01

Bumetanide Tablets USP

1 mg

Each tablet contains: bumetanide, USP 1 mg

Rx only

100 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL

Bumetanide Tablets 2 mg 100s Label Text

NDC 0093-4234-01

Bumetanide Tablets USP

2 mg

Each tablet contains: bumetanide, USP 2 mg

Rx only

100 TABLETS

TEVA

BUMETANIDE
bumetanide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0093-4232
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUMETANIDE (BUMETANIDE)	BUMETANIDE	0.5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
D&C YELLOW NO. 10
FD&C BLUE NO. 1

Product Characteristics
Color	GREEN (light green)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	0;5;Z;4232
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0093-4232-01	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074225	05/26/2010

BUMETANIDE
bumetanide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0093-4233
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUMETANIDE (BUMETANIDE)	BUMETANIDE	1 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
D&C YELLOW NO. 10

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	1;Z;4233
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0093-4233-01	100 TABLET In 1 BOTTLE	None
2	0093-4233-10	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074225	05/26/2010

BUMETANIDE
bumetanide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0093-4234
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUMETANIDE (BUMETANIDE)	BUMETANIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
FERRIC OXIDE RED

Product Characteristics
Color	ORANGE (peach)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	2;Z;4234
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0093-4234-01	100 TABLET In 1 BOTTLE	None
2	0093-4234-10	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074225	05/26/2010

Labeler - TEVA Pharmaceuticals USA Inc (118234421)

Establishment
Name	Address	ID/FEI	Operations
Emcure Pharmaceuticals Ltd.		916921919	ANALYSIS, MANUFACTURE

Revised: 05/2010TEVA Pharmaceuticals USA Inc

B,Professional

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Bumex

30/06/10

Generic Name: bumetanide (byoo MET a nide)
Brand Names: Bumex

What is Bumex (bumetanide)?

Bumetanide is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine.

Bumetanide treats fluid retention (edema) in people with congestive heart failure, liver disease, or a kidney disorder such as nephrotic syndrome.

Bumetanide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Bumex (bumetanide)?

Do not use this medication if you are unable to urinate, if you have severe liver disease, or if you are severely dehydrated.

Before using this medication, tell your doctor if you have kidney disease, liver disease, gout, lupus, diabetes, or an allergy to sulfa drugs.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Bumetanide will make you urinate more often and you may get dehydrated easily. Follow your doctor’s instructions about using potassium supplements or getting enough salt and potassium in your diet.

Avoid becoming dehydrated. Follow your doctor’s instructions about the type and amount of liquids you should drink while you are taking bumetanide.

There are many other medicines that can interact with bumetanide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my healthcare provider before taking Bumex (bumetanide)?

Do not use this medication if you have:

severe kidney disease or are unable to urinate;
severe liver disease; or
if you are severely dehydrated.

Before using bumetanide, tell your doctor if you have:

kidney disease;
liver disease;
gout;
lupus;
diabetes; or
an allergy to sulfa drugs.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take bumetanide.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether bumetanide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Bumex (bumetanide)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Bumetanide will make you urinate more often and you may get dehydrated easily. Follow your doctor’s instructions about using potassium supplements or getting enough salt and potassium in your diet.

Store this medication at room temperature away from heat, light, and moisture.

See also: Bumex dosage in more detail

What happens if I miss a dose?

Bumetanide is sometimes used only once, so you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include ringing in your ears, loss of appetite, weakness, dizziness, or confusion.

What should I avoid while taking Bumex (bumetanide)?

Avoid becoming dehydrated. Follow your doctor’s instructions about the type and amount of liquids you should drink while you are taking bumetanide.

What are the possible side effects of bumetanide

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using bumetanide and call your doctor at once if you have any of these serious side effects:

dry mouth, thirst, nausea, vomiting;
feeling weak, drowsy, restless, or light-headed;
fast or uneven heartbeat;
muscle pain or weakness;
easy bruising or bleeding, unusual weakness; or
hearing loss.

Less serious side effects may include:

mild nausea or stomach pain;
headache;
dizziness; or
mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Bumex (bumetanide)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

lithium;
digoxin (Lanoxin);
cyclosporine (Neoral, Sandimmune, Gengraf);
pentamidine (Nebupent, Pentam);
probenecid (Benemid);
tacrolimus (Prograf);
other diuretics;
blood pressure medications;
amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
amikacin (Amikin), gentamicin (Garamycin), netilmicin (Netromycin), streptomycin, tobramycin (Nebcin, Tobi);
indomethacin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Voltaren), naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others; or
cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with bumetanide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about bumetanide.

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.

B,Concise

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Bupap

30/06/10

Generic Name: acetaminophen and butalbital (a SEET a MIN oh fen and bue TAL bi tal)
Brand Names: Bupap, Cephadyn, Marten-Tab, Phrenilin, Phrenilin Forte, Promacet, Sedapap

What is Bupap (acetaminophen and butalbital)?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

The combination of acetaminophen and butalbital is used to treat tension headaches. This medicine is not for treating headaches that come and go.

Acetaminophen and butalbital may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Bupap (acetaminophen and butalbital)?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Before you take acetaminophen and butalbital, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, a stomach or intestinal disorder, or a history of drug or alcohol addiction.

Butalbital may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and butalbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol while taking acetaminophen and butalbital. Alcohol may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Bupap (acetaminophen and butalbital)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or butalbital, or if you have porphyria. Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take acetaminophen and butalbital, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;
kidney disease;
a stomach or intestinal disorder; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it can cause seizures in a newborn if the mother takes the medication late in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and butalbital can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I take Bupap (acetaminophen and butalbital)?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

An overdose of acetaminophen can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day. Take this medicine with a full glass of water. Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Acetaminophen can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and butalbital.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and butalbital. You may need to stop using the medicine for a short time.

Store acetaminophen and butalbital at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Butalbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since acetaminophen and butalbital is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen and butalbital can be fatal.

Overdose symptoms may include loss of appetite, nausea, vomiting, sweating, extreme drowsiness, confusion, fainting, shallow breathing, or no breathing.

What should I avoid while taking Bupap (acetaminophen and butalbital)?

Bupap (acetaminophen and butalbital) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

fast or pounding heart rate, feeling short of breath;
feeling like you might pass out;
confusion, depression;
feeling restless, excited, or agitated;
seizure (convulsions); or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

headache, dizziness, drowsiness, shaky feeling;
drunk feeling;
vomiting, constipation;
heartburn, trouble swallowing;
numbness or tingly feeling;
dry mouth;
sweating or urinating more than usual;
leg pain, tired muscles;
stuffy nose, ear pain, ringing in your ears; or
mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Bupap (acetaminophen and butalbital)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by butalbital. Tell your doctor if you need to use any of these other medicines while you are taking acetaminophen and butalbital.

Tell your doctor about all other medications you are using, especially:

an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with acetaminophen and butalbital. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and butalbital.

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.

B,Concise

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Buphenyl

30/06/10

Generic Name: sodium phenylbutyrate (SOE dee um FEN il BUE ti rate)
Brand Names: Buphenyl

What is Buphenyl (sodium phenylbutyrate)?

Sodium phenylbutyrate is converted to a substance in the body that helps the kidneys eliminate waste substances from the body. These waste substances can produce ammonia, which is toxic if it builds up in your blood.

Sodium phenylbutyrate is used to treat urea cycle disorders in people who lack certain liver enzymes needed to properly eliminate waste substances from the body. This medication helps prevent a build-up of ammonia in the blood.

Sodium phenylbutyrate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Buphenyl (sodium phenylbutyrate)?

Before taking sodium phenylbutyrate, tell your doctor if you have congestive heart failure, high blood pressure, severe kidney disease, swelling or fluid retention, or a seizure disorder.

Take this medication with each meal. Divide your total daily dose among all of your meals for the day.

Sodium phenylbutyrate is only part of a complete program of treatment that may also include diet, dialysis, or other medications. Follow your diet and medication routines very closely.

Do not give this medication to a child who weighs less than 44 pounds unless your doctor tells you to.

What should I discuss with my health care provider before taking Buphenyl (sodium phenylbutyrate)?

Before using sodium phenylbutyrate, tell your doctor if you are allergic to any drugs, or if you have:

congestive heart failure;
high blood pressure;
severe kidney disease;
swelling or fluid retention; or
epilepsy or other seizure disorder.

If you have any of these conditions, you may not be able to take sodium phenylbutyrate, or you may need a dose adjustment or special tests to safely take this medication.

Your doctor will tell you if any of your medication doses need to be changed.

FDA pregnancy category C. It is not known whether sodium phenylbutyrate is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sodium phenylbutyrate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child who weighs less than 44 pounds unless your doctor tells you to.

How should I take Buphenyl (sodium phenylbutyrate)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medication with each meal. Divide your total daily dose among all of your meals for the day.

Sodium phenylbutyrate powder should be mixed with food before consuming.

Shake the powder lightly before mixing it with food. Do not stop using this medication without your doctor’s advice, even if you feel better. If the urea cycle disorder is not under control, you may have a build-up of ammonia, which can cause life-threatening side effects.

Call your doctor right away if you have any signs of infection such as fever, chills, redness, swelling, body aches, or weakness. An infection may cause your condition to go out of control even while you are taking sodium phenylbutyrate.

You may need to take sodium phenylbutyrate for the rest of your life. It is important to use the medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Sodium phenylbutyrate is only part of a complete program of treatment that may also include diet, dialysis, or other medications. Follow your diet and medication routines very closely.

Store sodium phenylbutyrate at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Be sure to take the medication with food.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a sodium phenylbutyrate overdose are not known.

What should I avoid while taking Buphenyl (sodium phenylbutyrate)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using sodium phenylbutyrate.

Buphenyl (sodium phenylbutyrate) side effects

Even with treatment, urea cycle disorders can cause a build-up of ammonia in the blood which can result in life-threatening side effects. Seek emergency medical attention if you notice any signs of ammonia build-up, including mood or behavior changes, memory loss, thinking problems, muscle twitching, back and forth movement of the eyes, vomiting, increasing weakness, slurred speech, seizure (convulsions), and fainting. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using sodium phenylbutyrate and call your doctor at once if you have any of these serious side effects: Call your doctor at once if you have a serious side effect such as:

fast, slow, or uneven heart rate;
swelling, rapid weight gain;
feeling like you might pass out; or
changes in mood, personality, or behavior.

Less serious side effects may include:

changes in menstrual periods;
loss of appetite;
headache;
increased body odor;
unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Buphenyl (sodium phenylbutyrate)?

The following drugs can interact with sodium phenylbutyrate. Tell your doctor if you are using any of these:

valproic acid (Depakene);
haloperidol (Haldol);
probenecid (Benemid); or
steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there may be other drugs that can interact with sodium phenylbutyrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sodium phenylbutyrate.

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.

B,Concise

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Buphenyl Powder

30/06/10

Generic Name: Sodium Phenylbutyrate (SOE-dee-um FEN-il-BUE-ti-rate)
Brand Name: Buphenyl

Buphenyl Powder is used for:

Treating urea cycle (nitrogen or ammonia excretion) disorders along with a prescribed diet.

Buphenyl Powder is a nutritional modifier. It works by helping rid the body of excess nitrogen waste by bypassing the urea cycle.

Do NOT use Buphenyl Powder if:

you are allergic to any ingredient in Buphenyl Powder
you have sudden high levels of ammonia in the blood

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

Before using Buphenyl Powder:

Some medical conditions may interact with Buphenyl Powder. 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 have edema (swelling or water retention), heart failure or other heart problems, high blood pressure, or kidney or liver disease

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

Corticosteroids (eg, prednisone), haloperidol, or valproic acid because these medicines increase blood ammonia levels
Probenecid because it may increase the actions of Buphenyl Powder and the risk of Buphenyl Powder’s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Buphenyl Powder 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 Buphenyl Powder:

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

An extra patient leaflet is available with Buphenyl Powder. Talk to your pharmacist if you have questions about this information.
Take Buphenyl Powder orally (by mouth, gastrostomy, or nasogastric tube) with meals.
Buphenyl Powder must be mixed with food or a liquid before you take it. If you mix Buphenyl Powder with food (solid or liquid), you must take it right away. If you mix Buphenyl Powder with water, it may be stored at room temperature or in the refrigerator for up to one week for later use.
Do not mix Buphenyl Powder with coffee, tea, or grapefruit, orange, or tomato juice.
Shake lightly before each use.
Use the measuring device included with your medicine. Ask your pharmacist for help if you are unsure of how to measure your dose.
It is very important that your full dose for a 24-hour period is taken. The total daily dose should be taken in equally divided amounts (3 to 6 times per day).
It is very important to follow the prescribed diet given to you by your doctor.
If you miss a dose of Buphenyl Powder, take it as soon as possible that same day.

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

Important safety information:

Follow the diet plan given to you by your health care provider.
Carry an ID card at all times that states that you have a urea cycle disorder.
Lab tests, including blood tests for ammonia and acid levels, may be performed while you use Buphenyl Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
PREGNANCY and BREAST-FEEDING: It is not known if Buphenyl Powder can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Buphenyl Powder while you are pregnant. It is not known if Buphenyl Powder is found in breast milk. If you are or will be breast-feeding while you take Buphenyl Powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Buphenyl Powder:

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:

Bad taste in the mouth; body odor; decreased appetite; absent or irregular menstrual periods.

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); decreased hearing; disorientation; headache; lightheadedness; memory problems; sleepiness.

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.

Proper storage of Buphenyl Powder:

Store Buphenyl Powder at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. After opening, keep the bottle tightly closed. Do not store in the bathroom. Keep Buphenyl Powder out of the reach of children and away from pets.

General information:

If you have any questions about Buphenyl Powder, please talk with your doctor, pharmacist, or other health care provider.
Buphenyl Powder 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 Buphenyl Powder. 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

B,Med-facts

Comments (0)

budesonide

30/06/10

Generic Name: budesonide (oral) (bue DES oh nide)
Brand Names: Entocort EC

What is budesonide?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation..

Budesonide is used to treat mild to moderate Crohn’s disease.

Budesonide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about budesonide?

While taking budesonide, tell your doctor if you have changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist), high blood pressure, (severe headache, fast or uneven heart rate, blurred vision), or a general ill feeling with headache, tiredness, nausea, and vomiting.

Grapefruit and grapefruit juice may interact with budesonide and cause increased levels of the medication in your blood. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using budesonide.

What should I discuss with my healthcare provider before taking budesonide?

You should not take this medication if you are allergic to budesonide, or if you have active tuberculosis or any other type of a serious bacterial, viral, or fungal infection.

Before taking budesonide, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;
liver disease (including cirrhosis);
stomach ulcer, intestinal bleeding or blockage;
measles, scarlet fever, or any other condition with a skin rash;
diverticulitis;
osteoporosis;
high blood pressure;
heart disease or coronary artery disease;
overactive thyroid;
mental illness;
a muscle disorder called myasthenia gravis; or
a personal or family history of diabetes, glaucoma, or cataract.

FDA Pregnancy Category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Budesonide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take budesonide?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Budesonide should be taken before a meal.

Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you take budesonide long term, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using budesonide. You may need to stop using the medicine for a short time. Store budesonide at room temperature away from moisture and heat.

See also: Budesonide dosage in more detail

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of budesonide is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking budesonide?

Budesonide side effects

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
increased blood pressure (severe headache, fast or uneven heart rate, blurred vision); or
general ill feeling with headache, tiredness, nausea, and vomiting.

Less serious side effects may include:

thinning of the skin, easy bruising;
headache;
runny or stuffy nose, cough, sore throat;
muscle pain;
mild nausea, stomach pain, indigestion;
mild skin rash; or
changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Budesonide Dosing Information

Usual Adult Dose for Crohn’s Disease — Acute:

Mild to moderate active Crohn’s Disease involving the ileum and or ascending colon:
9 mg orally once daily in the morning for up to 8 weeks. Treatment can be tapered to 6 mg daily for 2 weeks prior to complete cessation. For recurring episodes of active Crohn’s Disease, repeated eight-week courses can be given. Following 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled, 6 mg once daily is recommended for maintenance of clinical remission up to 3 months.

Usual Adult Dose for Asthma — Maintenance:

Pulmicort Turbuhaler (200 mcg/inh):

Previously treated with bronchodilators alone:
I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.

Previously treated with inhaled corticosteroids:
I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.

Previously treated with oral corticosteroids:
I to 4 inhalations (400 mcg to 800 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.

Pulmicort Flexhaler (90 and 180 mcg/inh):
2 inhalations (360 mcg) twice daily. In some patients, a starting dose of 180 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

Usual Pediatric Dose for Asthma — Maintenance:

inhalation powder:
6 years or older:

Pulmicort Turbuhaler (200 mcg/inh):
Previously treated with bronchodilators alone or with inhaled corticosteroids:
I inhalation (200 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.
Previously treated with oral corticosteroids:
2 inhalations (400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.

Pulmicort Flexhaler (90 and 180 mcg/inh):
1 inhalation (180 mcg) twice daily. In some patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

inhalation suspension:
1 to 8 years:
Previously treated with bronchodilators alone:
0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 0.5 mg /day.
Previously treated with inhaled corticosteroids:
0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.
Previously treated with oral corticosteroids:
1 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.

Symptomatic children not responding to nonsteroidal asthma medications: Initial: 0.25 mg once daily may be considered

Usual Pediatric Dose for Crohn’s Disease — Acute:

Limited data available; optimal dose and duration of treatment not established.
Children 6 years or older:
Active Crohn’s disease (treatment): 9 mg/day given once daily for 7 to 8 weeks.
Maintenance of remission: 6 mg/day given once daily for 3 to 4 weeks.
Note: One study in children 10 to 19 years of age showed a trend for higher remission rates using an induction dose of 12 mg/day given once daily for 4 weeks, followed by 9 mg/day for 3 weeks, followed by 6 mg/day for 3 weeks.
Further studies are needed to establish optimal dosing regimen.

What other drugs will affect budesonide?

Before taking budesonide, tell your doctor if you are also using ketoconazole (Nizoral).

There may be other drugs that can interact with budesonide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about budesonide.

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.

B,Concise

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budesonide (Inhalation route)

30/06/10

bue-DES-oh-nide

Commonly used brand name(s):

In the U.S.

Pulmicort
Pulmicort Flexhaler
Pulmicort Respules
Pulmicort Turbuhaler

In Canada

Pulmicort Nebuamp
Rhinocort Turbuhaler

Available Dosage Forms:

Suspension
Powder
Solution
Aerosol Powder
Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For budesonide

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

budesonide is available only with your doctor’s prescription.

Before Using budesonide

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 budesonide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to budesonide 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

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

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

Interactions with Medicines

Using budesonide 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.

Bupropion

Using budesonide 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.

Erythromycin
Itraconazole
Ketoconazole

Interactions with Food/Tobacco/Alcohol

Proper Use of budesonide

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use budesonide only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking budesonide without telling your doctor. To do so may increase the chance of side effects.

In order for budesonide to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. budesonide usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

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

When using the Pulmicort Flexhaler™:

budesonide comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.
The medicine comes with patient instructions. Read the instructions carefully before using budesonide. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.
When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using budesonide, test or prime it.
Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.
You do not have to prime it again after this, even if you have not used it for a long time.
After the inhaler is primed, twist the cover and lift it off.
To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.
Turn your head away from the inhaler and breathe out. Do not shake the inhaler.
Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.
Do not chew or bite on the mouthpiece.
Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.
Repeat these steps if more than one dose is needed.
When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.
Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.
Do not use a spacer with the Pulmicort Flexhaler™.
Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.
The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.
Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

budesonide comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.
Your doctor will tell you which type of nebulizer to use with budesonide and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.
Use budesonide at the same time each day, unless your child’s doctor tells you otherwise.
Do not mix this liquid with other medicines.
Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.
Each container has one dose of medicine.
Place the unused containers back in the foil pouch. This will protect the medicine from light.
Shake the container in a circular motion before using it.
Hold the container upright and open it by twisting off the cap.
Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.
If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.
Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.
After the dose is completed, wash your child’s face to prevent skin irritation.
Rinsing your child’s mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of budesonide 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 budesonide. If your dose is different, do not change it unless your doctor tells you to do so.

For preventing an asthma attack:
- For inhalation dosage form (powder inhaler):
  - Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For inhalation dosage form (suspension in a nebulizer):
  - Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
  - Infants younger than 12 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of budesonide, 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

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.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Precautions While Using budesonide

It is very important that your doctor check you or your child’s progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by budesonide.

You or your child should not use budesonide if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child’s symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

budesonide may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to budesonide, stop using the medicine and check with your doctor as soon as possible.

budesonide may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

budesonide may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

budesonide may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child’s doctor if you think this is a problem or if you have any concerns.

budesonide may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using budesonide.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using budesonide. You might need to stop using budesonide several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says budesonide is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

budesonide 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:

More common

Body aches or pain
chills
congestion
cough
diarrhea
dryness or soreness of the throat
fever
general feeling of discomfort or illness
headache
hoarseness
joint pain
loss of appetite
muscle aches and pains
nausea
pain or tenderness around the eyes and cheekbones
shivering
shortness of breath or troubled breathing
sneezing
sore throat
stuffy or runny nose
sweating
tender, swollen glands in the neck
tightness of the chest or wheezing
trouble with sleeping
trouble with swallowing
unusual tiredness or weakness
voice changes
vomiting

Less common

Bruising
darkening of the skin
depression
dizziness
earache
excessive muscle tone
fainting
fractures
large, flat, blue, or purplish patches in the skin
lower back or side pain
muscle stiffness
muscle tension or tightness
painful or difficult urination
redness or swelling in the ear
skin rash
sore mouth or tongue
white patches in the mouth or on the tongue

More common

Back pain

Less common

Acid or sour stomach
belching
change in taste or bad, unusual, or unpleasant (after) taste
difficulty with breathing
difficulty with moving
dry mouth
ear congestion
headache, severe and throbbing
heartburn
indigestion
muscle cramping
neck pain
sleeplessness
stomach discomfort, upset, or pain
swollen joints
unable to sleep
unexplained runny nose or sneezing
weakness

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.

Advanced,B

Comments (0)

budesonide (Oral route)

30/06/10

bue-DES-oh-nide

Commonly used brand name(s):

In the U.S.

Entocort EC

In Canada

Pulmicort
Pulmicort Spacer

Available Dosage Forms:

Capsule, Delayed Release
Capsule, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For budesonide

Budesonide is used to treat an inflammatory bowel disease called Crohn’s disease. budesonide works inside the intestine (bowel) to reduce inflammation and symptoms of the disease. Budesonide is a steroid (cortisone-like medicine).

budesonide is available only with your doctor’s prescription.

Before Using budesonide

Allergies

Pediatric

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

Geriatric

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

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

Interactions with Medicines

Bupropion

Erythromycin
Itraconazole
Ketoconazole

Interactions with Food/Tobacco/Alcohol

Using budesonide with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use budesonide, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Proper Use of budesonide

Take budesonide exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking budesonide without first checking with your doctor.

budesonide comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not chew, crush, or open it.

Keep using budesonide for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Dosing

For oral dosage form (capsules):
- For Crohn’s disease:
  - Adults—9 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of budesonide, 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 budesonide

It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by budesonide.

If your condition does not improve or if it become worse, check with your doctor.

You may get infections more easily while using budesonide. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

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

Grapefruits and grapefruit juice may increase the effects of budesonide by increasing the amount of budesonide in your body. You should not eat grapefruit or drink grapefruit juice while you are taking budesonide.

budesonide 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:

More common

Bruising easily
chills
colds
cough or hoarseness
fever
flu-like symptoms
sneezing
sore throat

Less common

Abdominal or stomach pain
bleeding after defecation
blurred vision
burning while urinating
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain
convulsions
cough producing mucus
decreased urine
diarrhea
difficult or labored breathing
difficult or painful urination
dizziness
dry mouth
eye pain
fast, irregular, pounding, or racing heartbeat or pulse
feeling of warmth
general feeling of discomfort or illness
headache
heartburn
increase in body movements
increased thirst
increased urge to urinate during the night
irregular heartbeat
joint pain
loss of appetite
mood changes
muscle aches and pains
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
pain or discomfort in the chest, upper stomach, or throat
pounding in the ears
rectal bleeding
redness of the face, neck, arms, and occasionally, upper chest
runny nose
severe constipation
shakiness in the legs, arms, hands, or feet
shivering
shortness of breath
slow or fast heartbeat
stomach cramps
sweating
swelling of the legs and feet
swelling or puffiness of the face
tightness in the chest
trouble sleeping
uncomfortable swelling around the anus
unusual tiredness or weakness
waking to urinate at night
weight gain
weight loss
wheezing

Incidence not known

Bulging soft spot on the head of an infant
change in the ability to see colors, especially blue or yellow
difficulty with swallowing
hives
itching
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash

More common

Acid or sour stomach
belching
blemishes on the skin
heartburn
indigestion
pain or tenderness around the eyes and cheekbones
pimples
rounded or moon face
stomach discomfort, upset, or pain
stuffy nose

Less common

Accumulation of pus
agitation
blistering, crusting, irritation, itching, or reddening of the skin
change in hearing
changes in vision
cracked, dry, or scaly skin
difficulty with moving
dizziness or lightheadedness
ear drainage
earache or pain in the ear
feeling of constant movement of self or surroundings
hair loss or thinning of the hair
increased appetite
increased hair growth, especially on the face
lack or loss of strength
loss of memory
muscle pains or stiffness
nervousness
pain, swelling, or redness in the joints
pinpoint red or purple spots on the skin
problems with memory
redness, swelling, or soreness of the tongue
sensation of spinning
skin rash cracks in the skin at the corners of mouth soreness or redness around the fingernails and toenails
skin rash, encrusted, scaly, and oozing
sleepiness or unusual drowsiness
sleeplessness
swollen joints
unable to sleep
uterine bleeding between menstrual periods

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.

Advanced,B

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Budesonide Sustained-Release Capsules

30/06/10

Generic Name: Budesonide (byoo-DESS-oh-nide)
Brand Name: Entocort EC

Budesonide Sustained-Release Capsules are used for:

Treating mild to moderate Crohn disease and maintaining remission for up to 3 months. It may also be used for other conditions as determined by your doctor.

Budesonide Sustained-Release Capsules are a corticosteroid. It works by decreasing inflammation.

Do NOT use Budesonide Sustained-Release Capsules if:

you are allergic to any ingredient in Budesonide Sustained-Release Capsules
you are taking mifepristone

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

Before using Budesonide Sustained-Release Capsules:

Some medical conditions may interact with Budesonide 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 have heart problems; diabetes; esophagus inflammation; stomach problems; intestinal problems; heart attack; ulcer; kidney problems; liver disease; osteoporosis; high blood pressure; glaucoma; cataracts; a herpes eye infection; a bacterial, fungal, parasitic, or viral infection; diarrhea; measles; tuberculosis; chicken pox; or shingles
if you have had a positive TB skin test or have recently been vaccinated

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

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Budesonide Sustained-Release Capsules’s effectiveness
Clarithromycin, steroidal contraceptives (eg, birth control pills), or imidazole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of Budesonide Sustained-Release Capsules’s side effects
Ritodrine or live vaccines because the risk of their side effects may be increased by Budesonide Sustained-Release Capsules
Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Budesonide Sustained-Release Capsules
Mifepristone because risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide 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 Budesonide Sustained-Release Capsules:

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

An extra patient leaflet is available with Budesonide Sustained-Release Capsules. Talk to your pharmacist if you have questions about this information.
Take Budesonide Sustained-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Budesonide Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
Use Budesonide Sustained-Release Capsules on a regular schedule to get the most benefit from it.
Do not eat grapefruit or drink grapefruit juice while you use Budesonide Sustained-Release Capsules.
If you miss a dose of Budesonide 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 Budesonide Sustained-Release Capsules.

Important safety information:

Budesonide Sustained-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Take Budesonide Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Tell your doctor or dentist that you take Budesonide Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
Budesonide Sustained-Release Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Budesonide Sustained-Release Capsules. Talk with your doctor before you receive any vaccine.
Diabetes patients – Budesonide Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Lab tests, including adrenal function assessment, may be performed while you use Budesonide 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.
Budesonide Sustained-Release Capsules 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 Budesonide Sustained-Release Capsules while you are pregnant. Budesonide Sustained-Release Capsules are found in breast milk. Do not breast-feed while taking Budesonide Sustained-Release Capsules.

Possible side effects of Budesonide 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:

Back pain; changes in menstrual cycle; dizziness; gas; headache; indigestion; nausea; nervousness; pain; respiratory tract infection; stomach pain; tiredness; tremor; trouble sleeping; vomiting.

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); acne; change in mood or behavior; chest pain; confusion; severe headache; sudden increase in weight; swelling of the ankles; unusual bruising; vision changes.

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.

Proper storage of Budesonide Sustained-Release Capsules:

Store Budesonide Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Budesonide Sustained-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Budesonide Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Budesonide 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 Budesonide 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

B,Med-facts

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