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Hexabrix

30/06/10

Generic Name: ioxaglate meglumine and ioxaglate sodium
Dosage Form: injection

February 2005

NOT FOR INTRATHECAL USE

Hexabrix Description

Hexabrix is a sterile, non-pyrogenic, aqueous solution intended for use as a diagnostic radiopaque medium. Hexabrix contains 39.3% w/v N-(2-hydroxyethyl)-2,4,6-triiodo-5-[2-[2,4,6-triiodo-3-(N-methylacetamido)-5-(methylcarbamoyl) benzamido] acetamido]-isophthalamic acid, compounded with 1-deoxy-1-(methylamino)-D-glucitol (1:1) and 19.6% w/v sodium N-(2-hydroxyethyl)-2,4,6 triiodo-5-[2-[2,4,6-triiodo-3-(N-methylacetamido)-5-(methylcarbamoyl) benzamido] acetamido]-isophthalamate.

The two salts have the following structural formulae:

†Licensed by Guerbet, S.A.

Registered U.S. Patent and Trademark Office

Each milliliter contains 393 mg of ioxaglate meglumine, 196 mg of ioxaglate sodium and 0.10 mg edetate calcium disodium as a stabilizer. The solution contains 3.48 mg (0.15 mEq) sodium in each milliliter and provides 32% (320 mg/mL) organically bound iodine.

Solutions of ioxaglate (Hexabrix) provide six iodine atoms for each two dissociated ions. Hexabrix is an ionic contrast agent. Hexabrix has an osmolarity of approximately 460 mOsmol/L, an osmolality of approximately 600 mOsmol/kg of water and is, therefore, hypertonic under conditions of use.

Hexabrix has a viscosity (cps) of 15.7 at 20° and 7.5 at 37°. The pH has been adjusted to 6.0 to 7.6 with meglumine, sodium hydroxide or ioxaglic acid.

Hexabrix is a clear, colorless to pale yellow solution containing no undissolved solids. Crystallization does not occur at normal room temperatures. It is supplied in containers from which the air has been displaced by nitrogen.

Hexabrix – Clinical Pharmacology

Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures of the human body until significant hemodilution occurs.

Following intravascular injection, Hexabrix is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine. The pharmacokinetics of intravascularly administered radiopaque contrast media are usually best described by a two compartment model with a rapid alpha phase for drug distribution and a slower beta phase for drug elimination. In 10 patients with normal renal function, the alpha and beta half-lives of Hexabrix were 12 (4-17) and 92 (61-140) minutes, respectively. Following the intravenous administration of 50 mL of Hexabrix in 10 normal volunteers, the mean peak plasma concentration occurred at two (1-3) minutes, reaching a concentration of 2.1 (1.8-2.8) mg/mL. Approximately 50 (42-67) percent of the intravenously administered dose was recovered in the urine at two hours, and 90 (68-105) percent was recovered at 24 hours.

The joint spaces as well as the uterus and fallopian tubes may be visualized by the direct injection of the contrast medium into the region to be studied.

Injectable iodinated contrast agents are excreted either through the kidneys or through the liver. These two excretory pathways are not mutually exclusive, but the main route of excretion seems to be related to the affinity of the contrast medium for serum albumin. Ioxaglate salts are poorly bound to serum albumin, and are excreted mainly through the kidneys.

The liver and small intestine provide the major alternate route of excretion. In patients with severe renal impairment, the excretion of this contrast medium through the gallbladder and into the small intestine sharply increases.

Ioxaglate salts cross the placental barrier in humans and are excreted unchanged in human milk.

CT SCANNING OF THE HEAD

When used for contrast enhancement in computed tomographic head imaging, the degree of enhancement is directly related to the amount of iodine administered. Rapid injection of the entire dose yields peak blood iodine concentrations immediately following the injection, which falls rapidly over the next five to ten minutes as a result of dilution in the vascular and extravascular fluid compartments. Equilibration is reached in about ten minutes and thereafter the fall in iodine plasma concentration becomes exponential.

In brain scanning, contrast media do not accumulate in normal brain tissue due to the blood brain barrier (BBB). The increase in x-ray attenuation usually seen in normal tissue following contrast medium injection is due to the presence of the contrast medium in the blood pool. Disruption in the BBB, such as occurs in malignant tumors of the brain, allows accumulation of contrast medium within the interstitial tumor tissue; adjacent normal brain tissue does not contain the contrast medium. Maximum contrast enhancement frequently occurs after peak blood iodine levels are reached. A delay in maximum contrast enhancement can occur depending on the peak iodine level achieved and the cell type of the lesion. This lag in enhancement is probably associated with the accumulation of the contrast medium within the lesion and outside the blood pool.

The image enhancement of non-tumor lesions, such as arteriovenous malformations and aneurysms, is dependent on the iodine content of the circulating blood pool.

CT SCANNING OF THE BODY

Hexabrix may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space.

In non-neural tissues (during computed tomography of the body), Hexabrix diffuses rapidly from the vascular to the extra-vascular space. Increase in x-ray absorption is related to blood flow, concentration of the contrast medium and extraction of the contrast medium by interstitial tissue since no barrier exists; contrast enhancement is thus due to the relative differences in extra-vascular diffusion between normal and abnormal tissue, a situation quite different than that in the brain.

The pharmacokinetics of Hexabrix in normal and abnormal tissues has been shown to be variable.

Enhancement of CT with Hexabrix may be of benefit in establishing diagnoses of certain lesions in some sites with greater assurance than is possible with unenhanced CT and in supplying additional features of the lesions. In other cases, the contrast medium may allow visualization of lesions not seen with CT alone or may help to define suspicious lesions seen with unenhanced CT.

Contrast enhancement appears to be greatest within the 30-90 seconds after bolus administration of the contrast agent, and after intra-arterial rather than intravenous administration. Therefore, the use of a continuous scanning technique (a series of two to three second scans beginning at the injection — dynamic CT scanning) may improve enhancement and diagnostic assessment of tumors and other lesions such as an abscess, occasionally revealing more extensive disease.

Because unenhanced scanning may provide adequate information in the individual patient, the decision to employ contrast enhancement, which is associated with additional risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological and unenhanced CT findings.

Indications and Usage for Hexabrix

Hexabrix is indicated for use in pediatric angiocardiography, selective coronary arteriography with or without left ventriculography, peripheral arteriography, aortography, selective visceral arteriography, cerebral angiography, intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, peripheral venography (phlebography), excretory urography, contrast enhancement of computed tomographic head imaging and body imaging, arthrography and hysterosalpingography.

Contraindications

Hexabrix is contraindicated for use in myelography. Refer to PRECAUTIONS, General, concerning hypersensitivity. Hysterosalpingography should not be performed during the menstrual period; in pregnant patients; in patients with known infection in any portion of the genital tract; or in patients in whom cervical conization or curettage has been performed within 30 days. Arthrography should not be performed if infection is present in or near the joint.

Warnings

SEVERE ADVERSE EVENTS — INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.

Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media. Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic contrast media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/ or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

Serious or fatal reactions have been associated with the administration of iodine containing radiopaque media. It is of utmost importance to be completely prepared to treat any contrast medium reaction.

As with any contrast medium, serious neurologic sequelae, including permanent paralysis, can occur following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. The injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.

In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported. Therefore, administration of intravascular iodinated contrast media in these patients should be undertaken with caution.

A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma. In such instances anuria has developed resulting in progressive uremia, renal failure and eventually death. Although neither the contrast agent nor dehydration has separately proved to be the cause of anuria in myeloma, it has been speculated that the combination of both may be causative factors. The risk in myelomatous patients is not a contraindication to the procedure; however, partial dehydration in the preparation of these patients for the examination is not recommended since this may predispose to precipitation of myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing the effect. Myeloma, which occurs most commonly in persons over 40, should be considered before instituting intravascular administration of contrast agents.

Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure, and measures for treatment of a hypertensive crisis should be available.

Since intravascular administration of contrast media may promote sickling in individuals who are homozygous for sickle cell disease, fluid restriction is not advised.

In patients with advanced renal disease, iodinated contrast media should be used with caution and only when the need for the examination dictates, since excretion of the medium may be impaired. Patients with combined renal and hepatic disease, those with severe hypertension or congestive heart failure and recent renal transplant recipients present an additional risk.

Renal failure has been reported in patients with liver dysfunction who were given an oral cholecystographic agent followed by an intravascular iodinated radiopaque agent and also in patients with occult renal disease, notably diabetics and hypertensives. In these classes of patients there should be no fluid restriction and every attempt made to maintain normal hydration, prior to contrast medium administration, since dehydration is the single most important factor influencing further renal impairment.

Caution should be exercised in performing contrast medium studies in patients with endotoxemia and/or those with elevated body temperatures.

Reports of thyroid storm occurring following the intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of this drug. Iodine containing contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g., PBI, and may also affect results of radioactive iodine uptake studies. Such tests, if indicated, should be performed prior to the administration of this preparation.

Precautions

General

Diagnostic procedures which involve the use of iodinated intravascular contrast agents should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed. All procedures utilizing contrast media carry a definite risk of producing adverse reactions. While most reactions are minor, life-threatening and fatal reactions may occur without warning, and this risk must be weighed against the benefit of the procedure. A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all types should always be available. If a serious reaction should occur, immediately discontinue administration. Since severe delayed reactions have been known to occur, emergency facilities and competent personnel should be available for at least 30 to 60 minutes after administration. (See ADVERSE REACTIONS, General.)

Preparatory dehydration is dangerous and may contribute to acute renal failure in infants, young children, the elderly, patients with pre-existing renal insufficiency, patients with multiple myeloma, patients with advanced vascular disease and diabetic patients.

Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible nondiabetic patients (often elderly with pre-existing renal disease) following the administration of iodinated contrast agents. Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients.

Severe reactions to contrast media often resemble allergic responses. This has prompted the use of several provocative pretesting methods, none of which can be relied on to predict severe reactions. No conclusive relationship between severe reactions and antigen-antibody reactions or other manifestations of allergy has been established. The possibility of an idiosyncratic reaction in patients who have previously received a contrast medium without ill effect should always be considered. Prior to the injection of any contrast medium, the patient should be questioned to obtain a medical history with emphasis on allergy and hypersensitivity. A positive history of bronchial asthma or allergy (including food), a family history of allergy, or a previous reaction or hypersensitivity to a contrast agent may imply a greater than usual risk. Such a history may be more accurate than pre-testing in predicting the potential for reaction, although not necessarily the severity or type of reaction in the individual case. A positive history of this type does not arbitrarily contraindicate the use of a contrast agent, when a diagnostic procedure is thought essential, but does call for caution. (See ADVERSE REACTIONS, General.)

Prophylactic therapy including corticosteroids and antihistamines should be considered for patients who present with a strong allergic history, a previous reaction to a contrast medium, or a positive pre-test since in these patients the incidence of reaction is two to three times that of the general population. Adequate doses of corticosteroids should be started early enough prior to contrast medium injection to be effective and should continue through the time of injection and for 24 hours after injection. Antihistamines should be administered within 30 minutes of the contrast medium injection. Recent reports indicate that such pre-treatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity. A separate syringe should be used for these injections.

General anesthesia may be indicated in the performance of some procedures in selected patients; however, a higher incidence of adverse reactions has been reported in these patients, and may be attributable to the inability of the patient to identify untoward symptoms or to the hypotensive effect of anesthesia which can prolong the circulation time and increase the duration of contact of the contrast agent.

Angiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

Information for Patients: Patients receiving iodinated intravascular contrast agents should be instructed to:

Inform your physician if you are pregnant.
Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease or known thyroid disease. (See WARNINGS).
Inform your physician if you are allergic to any drugs, food or if you had any reactions to previous injections of dyes used for x-ray procedures. (See PRECAUTIONS, General).
Inform your physician about any other medications you are currently taking including non-prescription drugs.

Carcinogenesis, Mutagensis, Impairment of Fertility: No long-term animal studies have been performed to evaluate carcinogenic potential. However, animal studies suggest that this drug is not mutagenic and does not affect fertility in males or females.

Pregnancy Category B: Reproduction studies have been performed in rats, and rabbits at doses up to two times the maximum adult human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Hexabrix. There are however no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Ioxaglate salts are excreted unchanged in human milk. Because of the potential for adverse effects in nursing infants, bottle feedings should be substituted for breast feedings for 24 hours following the administration of this drug.

Pediatric Use: Safety and effectiveness in children have been established in pediatric angiocardiography and intravenous excretory urography. Data have not been submitted to support the safety and effectiveness of Hexabrix in any other indication.

(Precautions for specific procedures receive comment under that procedure.)

Adverse Reactions

General

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physio-chemical properties of the contrast media, the dose and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the dose injected, the speed of injection, the mode of injection and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

NOTE: Not all of the following adverse reactions have been reported with Hexabrix. Because Hexabrix is an iodinated intravascular contrast agent, all of the side effects and toxicity associated with agents of this class are theoretically possible, and this should be borne in mind when Hexabrix is administered.

Severe, life-threatening anaphylactoid reactions, mostly of cardiovascular origin, have occurred following the administration of Hexabrix as well as other iodine-containing contrast agents. Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. Based upon clinical literature, reported deaths from the administration of conventional iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent).

Regardless of the contrast agent employed, the overall estimated incidence of serious adverse reactions is higher with coronary arteriography than with other procedures. Cardiac decompensation, serious arrhythmias, or myocardial ischemia or infarction may occur during coronary arteriography and left ventriculography.

The most frequent adverse reactions are nausea, vomiting, facial flush and a feeling of body warmth. These are usually of brief duration. In double-blind clinical trials, Hexabrix produced less discomfort upon injection (pain and heat) when compared to various other contrast agents. Other reactions include the following:

Hypersensitivity reactions: Dermal manifestations of urticaria with or without pruritus, erythema and maculopapular rash. Dry mouth. Sweating. Conjunctival symptoms. Facial, peripheral and angioneurotic edema. Symptoms related to the respiratory system include sneezing, nasal stuffiness, coughing, choking, dyspnea, chest tightness and wheezing, which may be initial manifestation of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm with or without edema, pulmonary edema, apnea and cyanosis. Rarely, these allergic-type reactions can progress into anaphylaxis with loss of consciousness, coma, severe cardiovascular disturbances, and death.

Cardiovascular reactions: Generalized vasodilation, flushing and venospasm. Occasionally, thrombosis or rarely, thrombophlebitis. Extremely rare cases of disseminated intravascular coagulation resulting in death have been reported. Severe cardiovascular responses include rare cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest. These severe reactions are usually reversible with prompt and appropriate management; however, fatalities have occurred.

Technique reactions: Extravasation with burning pain, hematomas, ecchymosis and tissue necrosis, vascular constriction due to injection rate, thrombosis and thrombophlebitis.

Neurological reactions: Spasm, convulsions, aphasia, syncope, paresis, paralysis resulting from spinal cord injury and pathology associated with the syndrome of transverse myelitis, visual field losses which are usually transient but may be permanent, coma and death.

Other reactions: Headache, trembling, shaking, chills without fever, hyperthermia and lightheadedness. Temporary renal shutdown or other nephropathy.

(Adverse reactions to specific procedures receive comment under that procedure.)

Overdosage

Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms may include cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma and cardiac arrest. Treatment of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy.

Ioxaglate salts are dialyzable.

The intravenous LD50 values of Hexabrix (in grams of iodine/kilogram body weight) were 11.2 g/kg in mice, >8 g/kg in rats, >6.4 g/kg in rabbits and >10.2 g/kg in dogs.

Hexabrix Dosage and Administration

It is advisable that Hexabrix be at or close to body temperature when injected.

The patient should be instructed to omit the meal that precedes the examination. Appropriate premedication, which may include a barbiturate, tranquilizer or analgesic drug, may be administered prior to the examination.

A preliminary film is recommended to check the position of the patient and the x-ray exposure factors prior to the injection of the contrast medium.

If during administration a minor reaction occurs the injection should be slowed or stopped until the reaction has subsided. If a major reaction occurs the injection should be discontinued immediately.

Under no circumstances should other drugs be administered concomitantly in the same syringe or IV administration set because of a potential for chemical incompatibility.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

PEDIATRIC ANGIOCARDIOGRAPHY

Hexabrix may be administered by catheter injection into the chambers of the heart or associated large blood vessels. Rapid injection is essential and satisfactory results usually require injection of the total dosage in 1-2 seconds.

Precautions

In addition to the general precautions previously described, it is advisable to monitor for ECG and vital signs changes throughout the procedure.

When large individual doses are administered sufficient time should be allowed for any observed changes to return to or near baseline prior to making the next injection.

Caution should be used when making right heart injections in patients with pulmonary hypertension or incipient heart failure since this may lead to increased right side pressures with subsequent bradycardia and systemic hypotension. Patients with pulmonary disease present additional risks.

Caution is advised in cyanotic infants since apnea, bradycardia, other arrhythmias and a tendency to acidosis are more likely to occur.

Since infants are more likely to respond with convulsions than are adults, the amount of total dosage is of particular importance. Repeated injections are hazardous in infants weighing less than 7 kg, particularly when these infants have pre-existing compromised right heart function or obliterated pulmonary vascular beds.

Adverse Reactions

In addition to the adverse reactions previously listed, this procedure has been complicated by intramural injection with marked adverse effects on cardiac function.

Usual Dosage

The volume of individual doses should be determined by the size of the structure to be visualized and the anticipated degree of hemodilution at the site of injection. Valvular competence should also be taken into consideration.

Older Children: Catheter angiocardiography usually requires single doses of 30-45 mL of Hexabrix.

Infants and Young Children: The recommended single dose of Hexabrix is about 1.5 mL/kg (range 1 mL/kg to 2 mL/kg). In addition, small test volumes of about 2 mL may be used for catheter placement.

The usual total dose of Hexabrix per procedure, which includes diagnostic and test doses is about 4 mL/kg. This dosage may be as small as 1.5 mL/kg and should not normally exceed 5 mL/kg.

SELECTIVE CORONARY ARTERIOGRAPHY WITH OR WITHOUT LEFT VENTRICULOGRAPHY

Precautions

During the administration of large doses of Hexabrix, continuous monitoring of vital signs is desirable. Caution is advised in the administration of large volumes to patients with incipient heart failure because of the possibility of aggravating the pre-existing condition. Hypotension should be corrected promptly since it may result in serious arrhythmias.

Special care regarding dosage should be observed in patients with right ventricular failure, pulmonary hypertension, or stenotic pulmonary vascular beds because of hemodynamic changes which may occur after injection into the right heart outflow tract.

Adverse Reactions

Patients may have clinically insignificant ECG changes during the procedure. The following adverse effects have occurred in conjunction with the administration of iodinated intravascular contrast agents for this procedure: hypotension, shock, anginal pain, myocardial infarction, cardiac arrhythmias (bradycardia, ventricular tachycardia, ventricular fibrillation) and cardiac arrest. Fatalities have been reported.

Complications to the procedure include dissection of coronary arteries, dislodgement of atheromatous plaques, perforation, hemorrhage and thrombosis.

Usual Dosage

The usual adult dose for left coronary arteriography is 8 mL (range 2-14 mL) and for right coronary arteriography is 5 mL (range 1-10 mL). The doses may be repeated as necessary; doses up to a total of 150 mL have been given. For left ventriculography, the usual adult dose in a single injection is 45 mL (range 35-45 mL) and repeated as necessary. The total dose for combined selective coronary arteriography and left ventriculography should not exceed 250 mL.

PERIPHERAL ARTERIOGRAPHY

Hexabrix may be injected to visualize the peripheral arterial circulation. Arteriograms of the upper and lower extremities may be obtained by any of the established techniques.

Patient Preparation

The procedure is normally performed with local anesthesia. Rarely, general anesthesia may be required. (See PRECAUTIONS, General.)

A preliminary radiograph is usually made prior to the injection of the contrast agent.

Precautions

In addition to the general precautions previously described, moderate decreases in blood pressure occur frequently with intra-arterial (brachial) injections. This change is usually transient and requires no treatment, however, the blood pressure should be monitored for approximately ten minutes following injection.

Extreme caution during injection of the contrast agent is necessary to avoid extravasation and fluoroscopy is recommended. This is especially important in patients with severe arterial disease.

Adverse Reactions

In addition to the general adverse reactions previously described, hemorrhage and thrombosis have occurred at the puncture site of the percutaneous injection. Brachial plexus injury has been reported following axillary artery injection.

Usual Dosage

The single adult dose for aorto-iliac runoff studies is 45 mL (range 20-80 mL). The single adult dose for the common iliac, the external iliac and the femoral arteries is 30 mL (range 10-50 mL). These doses may be repeated as necessary. For the upper limb, the usual single adult dose is 20 mL (range 15-30 mL), repeated as necessary. The total procedural dose should not exceed 250 mL.

AORTOGRAPHY AND SELECTIVE VISCERAL ARTERIOGRAPHY

Hexabrix may be used to visualize the aorta and its major abdominal branches.

Usual Dosage

The usual dose for injections into the aorta is 25 to 50 mL; the celiac artery is 40 mL; the superior mesenteric artery is 20 to 40 mL; the inferior mesenteric artery is 8 to 15 mL. These doses may be repeated as necessary. The total dose should not exceed 250 mL.

CEREBRAL ANGIOGRAPHY

Hexabrix may be used to visualize the cerebral vasculature by any of the accepted techniques.

Patient Preparation

Cerebral angiography is normally performed with local or general anesthesia. (See PRECAUTIONS, General.)

Precautions

In addition to the general precautions previously described, cerebral angiography should be performed with special caution in patients with advanced arteriosclerosis, severe hypertension, cardiac decompensation, senility, recent cerebral thrombosis or embolism, and migraine.

Adverse Reactions

The major causes of cerebral arteriographic adverse reactions appear to be repeated injections of the contrast material, administration of doses higher than those recommended, the presence of occlusive atherosclerotic vascular disease and the method and technique of injection.

Adverse reactions are normally mild and transient. A feeling of warmth in the face and neck is frequently experienced. Infrequently, a more severe burning discomfort is observed. Transient visual hallucinations have been reported.

Serious neurological reactions that have been associated with cerebral angiography and not listed under Adverse Reactions, General, include stroke, amnesia and respiratory difficulties.

Visual field defects with anopsia and reversible neurological deficit lasting from 24 hours to 48 hours have been reported. Confusion, disorientation with hallucination, and absence of vision sometimes lasting for one week have also been reported.

Cardiovascular reactions that may occur with some frequency are bradycardia and either an increase or decrease in systemic blood pressure. The blood pressure change is transient and usually requires no treatment.

Usual Dosage

The usual dosage employed varies with the site and method of injection and the age and condition of the patient. In adults, cerebral angiography is usually performed by a selective injection of 9 mL (range 6-12mL) for the common carotid arteries and 8 mL (range 5-12 mL) for the vertebral arteries. Additional injections may be made as indicated. When aortic arch injections (four vessel studies) are performed in conjunction with cerebral angiography, the usual dose is 40 mL (range 30-50 mL). Other dosages may be employed for more selective injections, depending upon the vessel injected. The total dose per procedure should not exceed 150 mL.

INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY (IA-DSA)

Intra-arterial digital subtraction angiography (IA-DSA) is a radiographic modality which produces arterial images similar to conventional film-screen systems following arterial injection. The advantages include: the use of less contrast medium; the use of lower iodine concentrations; a decreased need for selective arterial catheterization; and a shortened examination time.

Patient Preparation

No special patient preparation is required for IA-DSA. However, it is advisable to insure that patients are well hydrated prior to examination.

Precautions

In addition to the general precautions described, the risks associated with IA-DSA are those usually attendant with catheter procedures. Following the procedure, gentle pressure hemostasis is required, followed by observation and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Patient motion, including respiration and swallowing, can result in misregistration leading to image degradation and non-diagnostic studies.

Usual Dosage

As a general rule, the volume and concentration used for IA-DSA are about 50%, or less, of that used for conventional procedures. The actual dosage and flow rate will vary depending on the selectivity of the injection site and the area being examined.

The most versatile concentration of Hexabrix is a 1:1 dilution with Sterile Water for Injection, U.S.P. This dilution provides 16% iodine and is isotonic.

The following suggested volumes per injection are intended only as a guide. Injections may be repeated as necessary. It is advisable to inject at rates approximately equal to the flow rate of the vessel being injected.

Carotid Arteries	6-10 mL
Vertebral Arteries	4-8 mL
Aorta	25-50 mL
Subclavian or Brachial Arteries	2-10 mL
Major Branches of the Abdominal Aorta	2-20 mL

INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY

Intravenous digital subtraction angiography (IV DSA) is a radiographic modality which allows dynamic imaging of the arterial system following intravenous injection of iodinated x-ray contrast media through the use of image intensification, enhancement of the iodine signal and digital processing of the image data. Temporal subtraction of the images obtained prior to and during the “first arterial pass” of the injected contrast medium yields images which are devoid of bone and soft tissue.

IV DSA is most frequently used to examine the heart, including coronary bypass grafts; the pulmonary arteries; arteries of the brachiocephalic circulation; the aortic arch; the abdominal aorta and its major branches; the iliac arteries; and the arteries of the extremities.

Patient Preparation

No special patient preparation is required for IV DSA. However it is advisable to insure that patients are well hydrated prior to examination.

Precautions

In addition to the general precautions previously described, the risks associated with IV DSA include those usually attendant with catheter procedures and include intramural injections, vessel dissection and tissue extravasation. The potential risk is reduced when small test injections of contrast medium are made under fluoroscopic observation to insure that the catheter tip is properly positioned and, in the case of peripheral placement, that the vein is of adequate size.

Patient motion, including respiration and swallowing, can result in misregistration leading to image degradation and non-diagnostic studies.

Usual Dosage

Hexabrix may be injected centrally, in either the superior or inferior vena cava or right atrium; or peripherally into an appropriate arm vein. For central injections, catheters may be introduced at the antecubital fossa into either the basilic or cephalic vein or at the leg into the femoral vein and advanced to the distal segment of the corresponding vena cava. For peripheral injections, the catheter is introduced at the antecubital fossa into an appropriate size arm vein. In order to reduce the potential for extravasation during peripheral injection, a catheter of approximately 20 cm in length should be employed.

Depending on the area to be imaged, the usual dose range per injection is 30-50 mL. Injections may be repeated as necessary. The total procedural dose should not exceed 250 mL.

Injection rates will vary depending on the site of catheter placement and vessel size. Central catheter injections are usually made at a rate of between 10 and 30 mL/second. Peripheral injections are usually made at a rate of between 12 and 20 mL/second. Since the injected medium can sometimes remain in the arm vein for an extended period, it may be advisable to flush the vein, immediately following injection with an appropriate volume (20-25 mL) of 5% Dextrose in water or normal saline.

PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)

Hexabrix may be injected to visualize the peripheral venous circulation. Venograms are obtained by injection or infusion into an appropriate vein in the upper or lower extremity. Post-venography thrombophlebitis, as detected by fibrinogen I-125 uptake studies, is significantly less in patients receiving Hexabrix when compared to conventional contrast agents.

Precautions

In addition to the general precautions previously described, special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system.

Extreme caution during injection of contrast media is necessary to avoid extravasation and fluoroscopy is recommended. This is especially important in patients with severe arterial or venous disease.

Usual Dosage

The dose for adults will usually range from 50-100 mL per extremity of full strength (32% iodine) Hexabrix as a single rapid injection. The dosage will vary according to the patient’s size and condition and the technique employed. Smaller or larger volumes may be indicated in some cases.

Reduced concentrations to as low as 20% w/v iodine may be effectively employed. These dilute solutions may be prepared by addition of normal saline (Sodium Chloride Injection, U.S.P.), 5% Dextrose in water (D5W) or Water for Injection, U.S.P. To prepare a 20% w/v solution, dilute each milliliter of Hexabrix with 0.6 milliliters of the diluent selected (e.g., 50 mL Hexabrix plus 30 mL of diluent equals 80 mL of a 20% iodine concentration). The usual dose of dilute medium will range from 75-150 mL per extremity.

Following the procedure, the venous system should be flushed with any one of the diluents listed above. Massage and elevation are also helpful for clearing the contrast medium from the extremity.

EXCRETORY UROGRAPHY

Following intravenous injection, Hexabrix is rapidly excreted by the kidneys. Hexabrix may be visualized in the renal parenchyma one minute following bolus injection. Maximum radiographic density in the calyces and pelves occurs in most instances within 7 to 12 minutes after injection. In patients with severe renal impairment, contrast visualization may be substantially delayed.

Patient Preparation

A low residue diet the day preceding the examination and a laxative the evening before the examination may be given, unless contraindicated.

Precautions

Infants and small children should not have any fluid restrictions prior to excretory urography. (See WARNINGS and PRECAUTIONS, General concerning preparatory dehydration.)

Usual Dosage

Adults — The usual adult dose is 50 to 75 mL (0.7 to 1.0 mL/kg). The total dose is normally injected within 30 to 90 seconds. A higher dosage may be indicated where poor visualization is anticipated (e.g., elderly patients, obese patients, patients with impaired renal function or patients in whom dense opacification of the pelvo-calyceal system and ureters is desired). In these patients, a dose of 100 to 150 mL (1.5 to 2.0 mL/kg) may be used.

Children — The following schedule is recommended for infants and children.

Under 6 months of age	3 mL/kg
Over 6 months of age	2 mL/kg
The total dosage in children should not exceed	5 mL/kg

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC (CT)
HEAD IMAGING

Hexabrix may be useful to enhance the presence and better define the extent of primary and metastatic malignancies of the head. In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.

The use of Hexabrix may also be beneficial in the image enhancement of non-neoplastic lesions, such as cerebral infarcts, sites of active infection, arterio-venous malformations and aneurysms.

The opacification of the inferior vermis occurs occasionally in normal studies.

Patient Preparation

No special preparation is required, however, it is advisable to insure that patients are well hydrated prior to examination.

Usual Dosage

For adults weighing up to 150 pounds, the usual dosage is 0.9 mL/lb. Patients weighing more than 150 pounds can usually undergo satisfactory examination with a dose of 135 mL not to exceed 150 mL.

CONTRAST ENHANCEMENT IN BODY COMPUTED TOMOGRAPHY

Patient Preparation

No special patient preparation is required. However, it is advisable to insure that patients are well hydrated. In patients undergoing abdominal or pelvic examination, opacification of the bowel may be valuable in scan interpretation.

Precautions

In addition to the general precautions described, patient cooperation is essential since patient motion, including respiration, can markedly affect image quality. The use of an intravascular contrast medium can obscure tumors in patients undergoing CT evaluation of the liver resulting in a false negative diagnosis. Dynamic CT scanning is the procedure of choice for malignant tumor enhancement. (See CLINICAL PHARMACOLOGY.)

Usual Dosage

Hexabrix may be administered by bolus injection, rapid infusion or by a combination of both. Depending on the area to be examined, doses of 30-150 mL (0.4-0.9 mL/lb) may be administered. When prolonged enhancement is required up to 150 mL can be used, usually with 25-50 mL as a rapid bolus and the remainder as an infusion.

ARTHROGRAPHY

Due to the low osmolality of Hexabrix, the concomitant use of epinephrine is not necessary since the rate of contrast medium absorption as well as the production of synovial fluid and consequent dilution of the medium are reduced.

Precautions

In addition to the general precautions previously described, strict aseptic technique is required to prevent the introduction of infection. Fluoroscopic control should be used to insure proper introduction of the needle into the synovial space and prevent extracapsular injection. Aspiration of excessive synovial fluid will reduce the pain on injection and prevent the dilution of the contrast agent. It is important that undue pressure not be exerted during the injection.

Adverse Reactions

In addition to the general adverse reactions previously described, arthrography may induce joint pain or discomfort which is usually mild and transient but occasionally may be severe and persist for 24 to 48 hours following the procedure. Effusion requiring aspiration may occur in patients with rheumatoid arthritis.

Usual Dosage

Arthrography is usually performed under local anesthesia. The amount of contrast agent required is solely dependent on the size of the joint to be injected and the technique employed.

The following dosage schedule for normal adult joints should serve only as a guide since joints may require more or less contrast medium for optimal visualization.

Knee, hip	5-15 mL
Shoulder, ankle	5-20 mL
Temporomandibular	0.5-0.7 mL

Passive or active manipulation is used to disperse the medium throughout the joint space.

The lower volumes of contrast medium are usually employed for double contrast examinations in which 30-100 cc of either filtered room air or carbon dioxide may be introduced for examination of the knee and lesser volumes for other joints.

HYSTEROSALPINGOGRAPHY

Patient Preparation

It is preferable to perform the procedure approximately eight to ten days after the onset of menses. The patient should empty the bladder before the examination.

Precautions

Caution should be exercised in patients suspected of having cervical or tubal carcinoma to avoid possible spread of the lesion by the procedure. Delayed onset of pain and fever (1-2 days) may be indicative of pelvic infection.

Adverse Reactions

In addition to the general adverse reactions described previously, fever and pain, cramping and tenderness of the abdomen have been reported.

Usual Dosage

The total volume administered will vary depending upon anatomical variations and/or disease processes. The usual dose varies from 5 to 15 mL, administered slowly under fluoroscopic control, without undue pressure.

How is Hexabrix Supplied

Hexabrix Glass Vials/Bottles	NDC Number
10×20 mL vials	0019-5505-51
25×50 mL vials	0019-5505-06
12×100 mL fill/150 mL bottles	0019-5505-08
12×150 mL bottles	0019-5505-10
12×200 mL fill/250 mL bottles	0019-5505-21

Storage: Store below 30° (86°). Do not freeze. If product is frozen or if crystallization of the salt has occurred, examine the container for physical damage. If no damage has occurred, the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are dissolved and that the container and closure have not been damaged.

This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun.

As with all contrast media, glass containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.

tyco
Healthcare

Mallinckrodt

Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com

MKR 55052505
Revised 2/05
Printed in U.S.A.

Hexabrix
ioxaglate meglumine and ioxaglate sodium injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0019-5505
Route of Administration	INTRAVASCULAR	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Ioxaglate Meglumine (Ioxaglic acid)	Active	393 MILLIGRAM In 1 MILLILITER
Ioxaglate Sodium (Ioxaglic acid)	Active	196 MILLIGRAM In 1 MILLILITER
Edetate Calcium Disodium	Inactive	0.10 MILLIGRAM In 1 MILLILITER
Meglumine	Inactive
Sodium Hydroxide	Inactive
Ioxaglic Acid	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0019-5505-51	10 BOTTLE In 1 CASE	contains a BOTTLE, GLASS
1		20 mL (MILLILITER) In 1 BOTTLE, GLASS	This package is contained within the CASE (0019-5505-51)
2	0019-5505-06	25 BOTTLE In 1 CASE	contains a BOTTLE, GLASS
2		50 mL (MILLILITER) In 1 BOTTLE, GLASS	This package is contained within the CASE (0019-5505-06)
3	0019-5505-08	12 BOTTLE In 1 CASE	contains a BOTTLE, GLASS
3		100 mL (MILLILITER) In 1 BOTTLE, GLASS	This package is contained within the CASE (0019-5505-08)
4	0019-5505-10	12 BOTTLE In 1 CASE	contains a BOTTLE, GLASS
4		150 mL (MILLILITER) In 1 BOTTLE, GLASS	This package is contained within the CASE (0019-5505-10)
5	0019-5505-21	12 BOTTLE In 1 CASE	contains a BOTTLE, GLASS
5		200 mL (MILLILITER) In 1 BOTTLE, GLASS	This package is contained within the CASE (0019-5505-21)

Revised: 11/2007Mallinckrodt Inc.

H,Professional

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hexachlorophene (Topical application route)

30/06/10

Commonly used brand name(s):

In the U.S.

Phisohex

Available Dosage Forms:

Liquid
Powder for Suspension
Foam

Therapeutic Class: Antibacterial Cleansing Agent

Uses For hexachlorophene

Hexachlorophene is a topical antibacterial cleanser. It is used to clean the skin before surgery to prevent the spread of infection. It works like a detergent to cleanse the skin by killing or preventing the growth of bacteria.

hexachlorophene is available only with your doctor’s prescription.

Before Using hexachlorophene

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 hexachlorophene, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hexachlorophene 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

Because of hexachlorophene’s potential for the risk of increased drug absorption, use in infants and premature babies is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hexachlorophene in the elderly. However, elderly patients are more likely to have skin diseases, circulation problems, delayed wound healing, and age-related liver, kidney, and heart problems, which may require caution in patients receiving hexachlorophene.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 hexachlorophene

It is very important that you use hexachlorophene only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Hexachlorophene should only be used on the skin. Do not swallow it or use it in the eyes, ears, mouth, nose, genital area (sex organs), or anal area. If it does get on these areas, rinse it right away with water.

Follow your doctor’s instructions about how to clean and care for your skin before and after you use hexachlorophene. Make sure you understand all of the directions, and ask questions if you find something is not clear.

Dosing

The dose of hexachlorophene 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 hexachlorophene. 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 topical dosage form (emulsion):
- For cleaning the skin:
  - Adults and children—Apply 5 milliliters (mL) to the hands and make it into a lather by adding a small amount of water. Apply to the area to be cleansed, rinse thoroughly with running water, and pat dry.
  - Infants—Use is not recommended.

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 hexachlorophene

Check with your doctor if your skin problem becomes worse. Call your doctor if you develop a constant skin irritation, such as redness, itching or burning, in the area where you used hexachlorophene.

hexachlorophene should not be used on a regular basis on large areas of the body. Follow your doctor’s instructions about how long to use hexachlorophene.

hexachlorophene may cause serious and permanent injury when placed in the eyes, ears, mouth, or vagina. Carefully follow all instructions before using hexachlorophene to prevent serious side effects.

Hexachlorophene must not be used to bathe infants on a regular basis unless your doctor tells you otherwise. This may increase risk for more serious side effects.

Do not use hexachlorophene as an occlusive dressing, wet pack, lotion, or tampon. Also, using other skin products that contain alcohol may decrease the effectiveness of hexachlorophene.

hexachlorophene 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 or nurse immediately if any of the following side effects occur:

Incidence not known

Blistering, crusting, irritation, itching, or reddening of the skin
cracked, dry, or scaly skin
increased sensitivity of the skin to sunlight
redness or other discoloration of the skin
severe sunburn
skin rash
swelling

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

Symptoms of overdose

Abdominal or stomach cramps
blurred vision
cold, clammy skin
confusion
convulsions
decreased urination
diarrhea
dizziness
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
fainting
fast, weak pulse
increase in heart rate
lightheadedness
loss of appetite
rapid breathing
sunken eyes
sweating
thirst
unusual tiredness or weakness
vomiting
weight loss
wheezing
wrinkled skin

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Hexachlorophene

30/06/10

Generic Name: Hexachlorophene (hex-a-KLOR-oh-feen)
Brand Name: pHisoHex

Hexachlorophene is used for:

Cleansing skin and preventing the spread of infection. It may also be used for other conditions as determined by your doctor.

Hexachlorophene is a topical antibacterial cleanser. It works like a detergent to cleanse skin and prevents the growth of certain bacteria.

Do NOT use Hexachlorophene if:

you are allergic to any ingredient in Hexachlorophene or to similar medicines
you have burns or have lost several layers of skin
you will be using it as part of a bandage, wet pack, or lotion
you will be using it on any mucous membrane (eg, mouth, nose, eyes, vagina)
you will be using it routinely for bathing the whole body to prevent infection

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

Before using Hexachlorophene:

Some medical conditions may interact with Hexachlorophene. 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 skin lesions

Some MEDICINES MAY INTERACT with Hexachlorophene. Because little, if any, of Hexachlorophene is absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

Hexachlorophene is for topical use only.
To use, wet hands with water. Place 1 teaspoon of Hexachlorophene into your palm and work up a lather with water. Apply to the area to be cleansed.
Rinse thoroughly after use, especially sensitive areas such as the genitals.
If you miss an application of Hexachlorophene and you are using it regularly, resume your regular schedule as soon as possible.

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

Important safety information:

Do not apply Hexachlorophene to skin that is burned, broken, or has any kind of rash or sores. Doing so increases the risk of toxicity from the medicine, which may result in irritability or seizures.
Using soaps or other products that contain alcohol may decrease the antibacterial effectiveness of Hexachlorophene.
Hexachlorophene may be harmful if swallowed. If you may have taken Hexachlorophene by mouth, contact your local poison control center or emergency room immediately.
Do not allow this product to come into contact with the eyes. If this occurs, rinse thoroughly with water.
Long-term or repeated use of Hexachlorophene may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
Hexachlorophene may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Hexachlorophene. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
Hexachlorophene is not recommended for use in INFANTS. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Hexachlorophene during pregnancy. It is unknown if Hexachlorophene is excreted in breast milk. If you are or will be breast-feeding while you are using Hexachlorophene, check with your doctor or pharmacist to discuss the risk to your baby.

Possible side effects of Hexachlorophene:

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:

Dryness; mild scaling; skin redness; skin sensitivity to light; swelling of the skin.

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

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

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:

Proper storage of Hexachlorophene:

Store Hexachlorophene at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not store in metal containers. Keep Hexachlorophene out of the reach of children and away from pets.

General information:

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

H,Med-facts

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Hexafed Controlled-Release Tablets

30/06/10

Generic Name: Dexchlorpheniramine/Pseudoephedrine (dex-klor-fen-IR-a-meen/soo-doe-e-FED-rin)
Brand Name: Hexafed

Hexafed Controlled-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, nasal or throat itching, and itchy or watery eyes caused by colds, hay fever, or other allergic conditions. It may also be used for other conditions as determined by your doctor.

Hexafed Controlled-Release Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Hexafed Controlled-Release Tablets if:

you are allergic to any ingredient in Hexafed Controlled-Release Tablets
you are also taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
you have severe high blood pressure or severe coronary artery disease or ischemic heart disease

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

Before using Hexafed Controlled-Release Tablets:

Some medical conditions may interact with Hexafed Controlled-Release Tablets. 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 asthma, breathing problems (eg, emphysema, chronic bronchitis), heart or blood vessel disease, ulcer, blockage of the stomach or intestines, difficulty urinating, blockage of the bladder, an overactive thyroid (hyperthyroidism), diabetes, seizures, glaucoma, increased pressure in the eye, or high blood pressure
if you have an enlarged prostate or prostate disease
if you have trouble sleeping

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

Furazolidone or MAO inhibitors (eg, phenelzine) because side effects, such as severe headaches, high fever, and high blood pressure, may occur
Droxidopa because side effects, such as irregular heartbeat or heart attack, may occur
Urinary alkalinizers (eg, sodium bicarbonate) because the side effects of Hexafed Controlled-Release Tablets may be increased
Sodium oxybate because side effects, such as severe drowsiness, may occur
Bromocriptine because the risk of side effects and toxic effects may be increased by Hexafed Controlled-Release Tablets
Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Hexafed Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hexafed Controlled-Release Tablets 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 Hexafed Controlled-Release Tablets:

Use Hexafed Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Hexafed Controlled-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Hexafed Controlled-Release Tablets whole. Do not crush or chew before swallowing. Hexafed Controlled-Release Tablets may be broken in half and swallowed without crushing or chewing.
If you miss a dose of Hexafed Controlled-Release Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hexafed Controlled-Release Tablets.

Important safety information:

Hexafed Controlled-Release Tablets may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Hexafed Controlled-Release Tablets. Using Hexafed Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Hexafed Controlled-Release Tablets. Hexafed Controlled-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
If you have trouble sleeping, ask your doctor or pharmacist about the best time of day to take Hexafed Controlled-Release Tablets.
If you are scheduled for allergy skin testing, do not take Hexafed Controlled-Release Tablets for several days before the test because it may decrease your response to the skin tests.
Hexafed Controlled-Release Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain if it does, contact your doctor or pharmacist.
Do not exceed the recommended dose or take Hexafed Controlled-Release Tablets for longer than prescribed without checking with your doctor.
Do not take diet or appetite control medicines while you are taking Hexafed Controlled-Release Tablets without checking with your doctor.
Use Hexafed Controlled-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
Hexafed Controlled-Release Tablets are not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
Caution is advised when using Hexafed Controlled-Release Tablets in CHILDREN because they may be more sensitive to its effects, especially excitability.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Hexafed Controlled-Release Tablets during pregnancy. Hexafed Controlled-Release Tablets are excreted in breast milk. Do not breast-feed while taking Hexafed Controlled-Release Tablets.

Possible side effects of Hexafed Controlled-Release Tablets:

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

Constipation; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; excitability; headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; ringing in the ears; seizures; severe dizziness or drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors; trouble breathing.

Proper storage of Hexafed Controlled-Release Tablets:

Store Hexafed Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hexafed Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Hexafed Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Hexafed Controlled-Release Tablets 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 Hexafed Controlled-Release Tablets. 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

H,Med-facts

Comments (0)

Hexaflu

30/06/10

Generic Name: Acetaminophen/Dexchlorpheniramine/Pseudoephedrine (ah-seet-ah-MIN-oh-fen/dex-klor-fen-IR-a-meen/soo-doe-e-FED-rin)
Brand Name: Hexaflu

Hexaflu is used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Hexaflu is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages.

Do NOT use Hexaflu if:

you are allergic to any ingredient in Hexaflu
you are taking sodium oxybate (GHB) or you have taken furazolidone a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
you are unable to urinate or are having an asthma attack

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

Before using Hexaflu:

Some medical conditions may interact with Hexaflu. 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 a fast, slow, or irregular heartbeat
if you have a history of asthma; lung problems (eg, emphysema); heart problems; diabetes; difficulty urinating; an enlarged prostate or other prostate problems; glaucoma; high blood pressure; an overactive thyroid; liver problems (eg, hepatitis) or severe kidney problems; adrenal gland problems (eg, pheochromocytoma); sleep apnea; trouble sleeping; stomach problems; ulcers; seizures; blood vessel problems; stroke; or a blockage of your stomach, intestines, or bladder
if you drink more than 3 alcohol-containing drinks per day

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

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), furazolidone, indomethacin, isoniazid, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Hexaflu may be increased
Anticoagulants (eg, warfarin), bromocriptine, digoxin, droxidopa, or hydantoins (eg, phenytoin) because the risk of side effects may be increased by Hexaflu
Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because the effectiveness of these medicines may be decreased

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

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

Hexaflu may be taken with food if it upsets your stomach.
If you miss a dose of Hexaflu and you are taking it regularly, 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 Hexaflu.

Important safety information:

Hexaflu may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Hexaflu. Using Hexaflu alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Hexaflu will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
Do not exceed the recommended dose of Hexaflu. Doing so will not improve your condition faster and may increase your risk for side effects.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.
Hexaflu contains acetaminophen, dexchlorpheniramine, and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen, dexchlorpheniramine, or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
Do not take diet or appetite control medicines while you are taking Hexaflu without checking with your doctor.
If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Hexaflu or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Hexaflu may increase your risk for liver damage.
If you are scheduled for allergy skin testing, do not take Hexaflu for several days before the test because it may decrease your response to the skin tests.
If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Hexaflu.
Use Hexaflu with caution in the ELDERLY because they may be more sensitive to its effects.
Use Hexaflu with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is unknown if Hexaflu can cause harm to the fetus. If you become pregnant while taking Hexaflu, discuss with your doctor the benefits and risks of using Hexaflu during pregnancy. Some of the ingredients in Hexaflu are excreted in breast milk. If you are or will be breast-feeding while you are using Hexaflu, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Hexaflu:

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:

Dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine or pale stools; difficulty urinating; excessive sweating; frequent urination; hallucinations; pounding in the chest; rapid pulse; severe nervousness; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of Hexaflu:

Store Hexaflu at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hexaflu out of the reach of children and away from pets.

General information:

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

H,Med-facts

Comments (0)

Hespan

30/06/10

Generic Name: hetastarch (HET a starch)
Brand Names: Hespan, Hextend

What is Hespan (hetastarch)?

Hetastarch (hydroxyethyl) is a plasma volume expander derived from natural sources of starch. It works by restoring blood plasma lost through severe bleeding.

Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Hetastarch is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

Hetastarch also contains electrolytes (sodium, calcium potassium, magnesium) which are minerals essential for many functions in the body, including the brain and nervous system, heartbeat, and fluid balance.

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

What is the most important information I should know about Hespan (hetastarch)?

You should not be given this medication if you are allergic to hetastarch, or if you have a bleeding or blood clotting disorder, congestive heart failure, urination problems not caused by hypovolemia, or lactic acidosis.

Before you receive hetastarch, tell your doctor if you have kidney or liver disease, heart disease, congestive heart failure, diabetes, or an electrolyte imbalance.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin), steroid medications, digoxin (digitalis, Lanoxin), or a diuretic (water pill).

Tell your caregivers at once if you have a serious side effect such as chest pain, fast or slow heart rate, wheezing or gasping for breath, feeling like you might pass out, weak pulse, slow breathing (breathing may stop), pale skin, easy bruising, blood in your urine or stools, swelling in your hands or feet, unusual bleeding, or any bleeding that will not stop.

Rare but serious side effects may include unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing, or fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

What should I discuss with my health care provider before I receive Hespan (hetastarch)?

You should not be given this medication if you are allergic to hetastarch, or have certain conditions. Be sure your doctor knows if you have:

a bleeding or blood clotting disorder;
congestive heart failure;
urination problems not caused by hypovolemia; or
lactic acidosis.

Before you receive hetastarch, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;
liver disease;
heart disease;
congestive heart failure;
diabetes;
high potassium levels in your blood (hyperkalemia), or any other electrolyte imbalance; or
if you are allergic to corn.

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

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 hetastarch passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is hetastarch given?

Hetastarch is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication.

To be sure hetastarch is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hetastarch.

What happens if I miss a dose?

Since hetastarch is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

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

An overdose of hetastarch is not expected to produce life-threatening symptoms.

What should I avoid while receiving Hespan (hetastarch)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are receiving hetastarch.

Hespan (hetastarch) 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. Tell your caregivers at once if you have a serious side effect such as:

chest pain, fast or slow heart rate;
wheezing or gasping for breath, sweating, and anxiety;
feeling like you might pass out;
weak pulse, slow breathing (breathing may stop);
pale skin, easy bruising, weakness, blood in your urine or stools;
unusual bleeding, or any bleeding that will not stop;
unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing;
swelling in your hands or feet; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Rare but serious side effects may include:

unusual headache, vision or speech problems, mental changes;
drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

mild itching or skin rash;
cough or sneezing;
warmth, redness, or tingly feeling under your skin;
vomiting;
swollen glands;
headache;
muscle pain; or
flu symptoms.

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 Hespan (hetastarch)?

Before you receive hetastarch, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);
steroids (prednisolone and others);
corticotropin (Acthar, ACTH);
digoxin (digitalis, Lanoxin); or
a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

This list is not complete and there may be other drugs that can interact with hetastarch. 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 doctor or pharmacist can provide more information about hetastarch.

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.

Concise,H

Comments (0)

hetastarch

30/06/10

Generic Name: hetastarch (HET a starch)
Brand Names: Hespan, Hextend

What is hetastarch?

Hetastarch (hydroxyethyl) is a plasma volume expander derived from natural sources of starch. It works by restoring blood plasma lost through severe bleeding.

Hetastarch is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.

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

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

Before you receive hetastarch, tell your doctor if you have kidney or liver disease, heart disease, congestive heart failure, diabetes, or an electrolyte imbalance.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin), steroid medications, digoxin (digitalis, Lanoxin), or a diuretic (water pill).

What should I discuss with my health care provider before I receive hetastarch?

You should not be given this medication if you are allergic to hetastarch, or have certain conditions. Be sure your doctor knows if you have:

a bleeding or blood clotting disorder;
congestive heart failure;
urination problems not caused by hypovolemia; or
lactic acidosis.

Before you receive hetastarch, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;
liver disease;
heart disease;
congestive heart failure;
diabetes;
high potassium levels in your blood (hyperkalemia), or any other electrolyte imbalance; or
if you are allergic to corn.

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

How is hetastarch given?

To be sure hetastarch is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hetastarch.

What happens if I miss a dose?

Since hetastarch is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

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

An overdose of hetastarch is not expected to produce life-threatening symptoms.

What should I avoid while receiving hetastarch?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are receiving hetastarch.

Hetastarch side effects

chest pain, fast or slow heart rate;
wheezing or gasping for breath, sweating, and anxiety;
feeling like you might pass out;
weak pulse, slow breathing (breathing may stop);
pale skin, easy bruising, weakness, blood in your urine or stools;
unusual bleeding, or any bleeding that will not stop;
unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing;
swelling in your hands or feet; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Rare but serious side effects may include:

unusual headache, vision or speech problems, mental changes;
drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

mild itching or skin rash;
cough or sneezing;
warmth, redness, or tingly feeling under your skin;
vomiting;
swollen glands;
headache;
muscle pain; or
flu symptoms.

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 hetastarch?

Before you receive hetastarch, tell your doctor if you are also using:

a blood thinner such as warfarin (Coumadin);
steroids (prednisolone and others);
corticotropin (Acthar, ACTH);
digoxin (digitalis, Lanoxin); or
a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).

Where can I get more information?

Your doctor or pharmacist can provide more information about hetastarch.

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.

Concise,H

Comments (0)

Heptovir

30/06/10

Generic Name: lamivudine (Oral route)

la-MIV-ue-deen

Oral routeTabletSolution

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals . Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur .

EPIVIR(R)
- Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
- EPIVIR(R) tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV® tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 .

EPIVIR-HBV(R)
- Human immunodeficiency virus (HIV) counseling and testing should be offered to all patients before beginning EPIVIR-HBV(R) and periodically during treatment, because EPIVIR-HBV(R) tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR(R) tablets and oral solution used to treat HIV infection. If treatment with EPIVIR-HBV(R) is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy.
- Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV(R)). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Severe acute exacerbations of hepatitis B have been reported in patients who have hepatitis B infection or are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy. EPIVIR(R) tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV(R) tablets and oral solution (used to treat chronic hepatitis B). Patients with HIV infection should receive only dosage forms appropriate for treatment of HIV-1. EPIVIR-HBV(R) tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR(R) tablets and oral solution used to treat HIV infection. If treatment with EPIVIR-HBV(R) is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy .

Commonly used brand name(s):

In the U.S.

Epivir
Epivir A/F
Epivir HBV

In Canada

3tc
Heptovir

Available Dosage Forms:

Solution
Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Heptovir

Lamivudine is used in the treatment of the infection caused by the human immunodeficiency virus (HIV) or hepatitis B virus. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Lamivudine is taken together with zidovudine (AZT) or other medications used to treat HIV.

Lamivudine will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lamivudine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease. Lamivudine is not a cure for the hepatitis B virus; the long-term effects of the drug on the infection and the liver are unknown at this time.

Lamivudine is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, lamivudine is used in certain patients with the following medical condition:

Human immunodeficiency virus (HIV) infection due to occupational exposure (possible prevention of)

Before Using Heptovir

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

Allergies

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

Pediatric

Lamivudine can cause serious side effects. In one study, children with advanced AIDS were more likely than children who were less ill to develop pancreatitis (inflammation of the pancreas) and peripheral neuropathy (a problem involving the nerves). Therefore, it is especially important that you discuss with your child’s doctor the good that this medicine may do as well as the risks of using it. Your child must be seen frequently and your child’s progress carefully followed by the doctor while the child is taking lamivudine.

Geriatric

Lamivudine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults. Talk to your doctor first if you have liver, kidney, heart problems or other diseases. Your doctor may need to adjust your dose.

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

Interferon Alfa
Ribavirin
Zalcitabine

Interactions with Food/Tobacco/Alcohol

Proper Use of lamivudine

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

Take this medicine 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 lamivudine or zidovudine without checking with your doctor first.

Keep taking lamivudine for the full time of treatment , even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses . If you need help in planning the best times to take your medicine, check with your health care professional.

If you are using lamivudine oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid. The lamivudine oral suspension contains sucrose. Tell your doctor if you are diabetic before you start taking this medicine.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing

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

For oral dosage forms (oral solution and tablets):
- For treatment of hepatitis B infection:
  - Adults —100 milligrams (mg) once a day.
  - Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For treatment of HIV infection or AIDS:
  - Adults weighing 50 kilograms (kg) (110 pounds) or more—150 milligrams (mg) twice a day together with other HIV medications.
  - Adults weighing less than 50 kg (110 pounds)—2 mg per kg of body weight twice a day together with other HIV medications.
  - Children 3 months to 16 years of age—4 mg per kg of body weight, up to 150 mg per dose, twice a day together with other HIV medications.
  - Children younger than 3 months of age—Use and dose must be determined by your doctor.

Note: Patients that require treatment for both hepatitis B and either AIDS or HIV should follow the dosing schedule for HIV or AIDS

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Heptovir

It is very important that your doctor check your progress at regular visits.

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from lamivudine.

If you have both HIV and hepatitis B virus (HBV) infections, deterioration of liver disease has occurred when lamivudine treatment is stopped. Discuss any changes in your treatment and medicines with your doctor.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Heptovir 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—especially in children

Abdominal or stomach pain (severe)
feeling of fullness
nausea
sensation or pins and needles
skin rash
stabbing pain
tingling, burning, numbness, or pain in the hands, arms, feet, or legs
unsteadiness or awkwardness
vomiting

Rare

Abdominal discomfort
decreased appetite
diarrhea
fast, shallow breathing
feeling of fullness
fever, chills, or sore throat
general feeling of discomfort
muscle pain or cramping
nausea
shortness of breath
sleepiness
unusual tiredness or weakness

Incidence not determined

Cough
dark urine
difficulty swallowing
dizziness
fast heartbeat
fever
hives or welts
itching
light-colored stools
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of skin
tightness in chest
upper right abdominal pain
wheezing
yellow eyes and skin

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:

More common

Canker sores
difficulty in moving
discouragement
ear discharge
ear swelling
feeling sad or empty
general feeling of discomfort or illness
irritability
loss of appetite
loss of interest or pleasure
nasal discharge or congestion
pain in joints
sores, ulcers, or white spots on lips or tongue or inside the mouth
stomach pain or cramps
swollen and painful spots on neck, armpit, or groin
swollen joints
trouble concentrating
trouble sleeping
unusually warm skin
weight loss

Less common

Acid or sour stomach
belching
cough
heartburn
indigestion
stomach discomfort or upset

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.

Incidence not determined

Body fat redistribution or accumulation
blurred vision
dry mouth
flushed, dry skin
fruit-like breath odor
hair loss
increased hunger or thirst
increased urination
sweating
thinning of hair

Advanced,H

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Herceptin

30/06/10

Generic Name: trastuzumab (Intravenous route)

tras-too-zoo-mab

Intravenous routePowder for Solution

Cardiomyopathy
- Trastuzumab can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF). The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received trastuzumab concurrently with anthracycline-containing chemotherapy regimens.
- Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab. Discontinue trastuzumab treatment in patients receiving adjuvant therapy and strongly consider discontinuation of trastuzumab treatment in patients with metastatic breast cancer for clinically significant decrease in left ventricular function.
Infusion Reactions/Pulmonary Toxicity
- Trastuzumab administration can result in serious infusion reactions and pulmonary toxicity. Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of trastuzumab. Trastuzumab infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue trastuzumab for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

Trastuzumab can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF), and decreased left ventricular ejection fraction (LVEF), with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab for cardiomyopathy. Discontinue trastuzumab for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome .

Commonly used brand name(s):

In the U.S.

Herceptin

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Herceptin

Trastuzumab is a monoclonal antibody. It is used to treat new cases of breast cancer or disease that has spread to other parts of the body. Trastuzumab may prevent the growth of some breast tumors that produce extra amounts of a certain substance known as the HER2 protein. Trastuzumab should only be used in patients whose breast tumors have been shown to produce extra amounts of this protein. It can be used alone or with other cancer medicines (chemotherapy) such as doxorubicin, cyclophosphamide, paclitaxel, docetaxel, and carboplatin .

Trastuzumab is to be administered only by or under the immediate supervision of your doctor .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, trastuzumab is used in certain patients with the following medical conditions:

Breast cancer, HER2-overexpressing disease, primary treatment in combination with chemotherapy, before surgery .

Before Using Herceptin

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of trastuzumab 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 trastuzumab in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving trastuzumab .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Interactions with Medicines

Aclarubicin
Cyclophosphamide
Daunorubicin
Daunorubicin Citrate Liposome
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride Liposome
Epirubicin
Idarubicin
Pirarubicin

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

Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of Herceptin

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins .

Precautions While Using Herceptin

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

Contact your doctor right away if you experience any chest pain, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems .

This medicine can cause harm to your unborn baby. Make sure your doctor knows if you are pregnant before taking this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away .

Trastuzumab may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, chest pain, headache, dizziness, rash, pain, nausea, vomiting, or weakness within a few hours after you receive it .

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If this occurs, there are certain precautions you can take to reduce the risk of infection :

If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, a cough or hoarseness, lower back or side pain, or have painful or difficult urination.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime .

Herceptin 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

Dizziness
fever or chills
headache
muscle aches
nausea or vomiting
shortness of breath
skin rash
sore throat
stuffy or runny nose
unusual tiredness or weakness

Less common

Bloody nose
cough
diarrhea
difficult or labored breathing
ear congestion or pain
fast or irregular heartbeat
general feeling of discomfort or illness
head congestion
hoarseness or other voice changes
increased cough
joint pain
loss of appetite
nasal congestion
pain or tenderness around the eyes and cheekbones
shivering
sneezing
sweating
swelling of the feet or lower legs
tightness in the chest
trouble sleeping
vomiting
wheezing

Rare

Blue lips and fingernails
blurred vision
chest pain
confusion
cough or hoarseness, accompanied by fever or chills
faintness or lightheadedness when getting up from a lying or sitting position suddenly
itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, feet, or sex organs
lower back or side pain, accompanied by fever or chills
painful or difficult urination, accompanied by fever or chills
pale skin
redness of the skin
trouble with breathing

Incidence not known

Black, tarry stools
sores, ulcers, or white spots in the mouth
unusual bleeding or bruising

More common

Pain

Less common

Numbness or tingling of the hands or feet

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,H

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Herplex

30/06/10

Generic Name: idoxuridine ophthalmic (eye dox YOOR i deen)
Brand Names: Herplex

What is Herplex (idoxuridine ophthalmic)?

Idoxuridine ophthalmic is an antiviral medication. It prevents the replication (reproduction) of the herpes simplex virus. Thus, it reduces the amount of active virus in your system.

Idoxuridine ophthalmic is used to treat eye infections caused by the herpes virus.

Idoxuridine ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Herplex (idoxuridine ophthalmic)?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Idoxuridine ophthalmic may increase your sensitivity to bright light. Wear sunglasses to prevent irritation.

Who should not use Herplex (idoxuridine ophthalmic)?

Do not use idoxuridine ophthalmic if you have a bacterial or fungal infection in your eye. It is used to treat infections caused by viruses only. It is not known whether idoxuridine ophthalmic will harm an unborn baby. Do not use idoxuridine ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether idoxuridine ophthalmic passes into breast milk. Do not use idoxuridine ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Herplex (idoxuridine ophthalmic)?

Use idoxuridine ophthalmic eye drops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops.

To apply the eyedrops:

Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store idoxuridine ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is not expected to cause harm.

If an overdose occurs in the eye, flush the eye with water for several minutes. If the drops are ingested, drink plenty of fluid to dilute the medicine. The ingestion of a whole bottle of idoxuridine ophthalmic is not expected to cause harm. Call an emergency room or poison control center for additional advice in either of these situations.

What should I avoid while taking Herplex (idoxuridine ophthalmic)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Idoxuridine ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities. Idoxuridine ophthalmic may increase your sensitivity to bright light. Wear sunglasses to prevent irritation.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Herplex (idoxuridine ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some burning, stinging, pain, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur. Continue to use idoxuridine ophthalmic and talk to your doctor about any side effects that you experience.

What other drugs will affect Herplex (idoxuridine ophthalmic)?

Eyedrops that contain boric acid may cause irritation if they are used with idoxuridine ophthalmic.

Avoid other eye medications unless they are approved by your doctor.

Drugs other than those listed here may also interact with idoxuridine ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about idoxuridine ophthalmic written for health professionals that you may read.

What does my medication look like?

Idoxuridine ophthalmic is available with a prescription under the brand name Herplex in a 0.1% strength. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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.

Concise,H

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30/06/10

Hexabrix Description

Hexabrix – Clinical Pharmacology

CT SCANNING OF THE HEAD

CT SCANNING OF THE BODY

Indications and Usage for Hexabrix

Contraindications

Precautions

General

Adverse Reactions

General

Overdosage

Hexabrix Dosage and Administration

PEDIATRIC ANGIOCARDIOGRAPHY

Precautions

Adverse Reactions

Usual Dosage

SELECTIVE CORONARY ARTERIOGRAPHY WITH OR WITHOUT LEFT VENTRICULOGRAPHY

Precautions

Adverse Reactions

Usual Dosage

PERIPHERAL ARTERIOGRAPHY

Patient Preparation

Precautions

Adverse Reactions

Usual Dosage

AORTOGRAPHY AND SELECTIVE VISCERAL ARTERIOGRAPHY

Usual Dosage

CEREBRAL ANGIOGRAPHY

Patient Preparation

Precautions

Adverse Reactions

Usual Dosage

INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY (IA-DSA)

Patient Preparation

Precautions

Usual Dosage

INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY

Patient Preparation

Precautions

Usual Dosage

PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)

Precautions

Usual Dosage

EXCRETORY UROGRAPHY

Patient Preparation

Precautions

Usual Dosage

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC (CT) HEAD IMAGING

Patient Preparation

Usual Dosage

CONTRAST ENHANCEMENT IN BODY COMPUTED TOMOGRAPHY

Patient Preparation

Precautions

Usual Dosage

ARTHROGRAPHY

Precautions

Adverse Reactions

Usual Dosage

HYSTEROSALPINGOGRAPHY

Patient Preparation

Precautions

Adverse Reactions

Usual Dosage

How is Hexabrix Supplied

30/06/10

Uses For hexachlorophene

Before Using hexachlorophene

Allergies

Pediatric

Geriatric

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of hexachlorophene

Dosing

Storage

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC (CT)
HEAD IMAGING