Alupent

metaproterenol sulfate

Dosage Form: aerosol

Prescribing Information

Pharmacist:

Tear off “Instruction for Use” and dispense with container in carton.

Alupent Description

Alupent® (metaproterenol sulfate USP) Inhalation Aerosol is a bronchodilator administered by oral inhalation. The Alupent Inhalation Aerosol containing 75 mg of metaproterenol sulfate as micronized powder is sufficient medication for 100 inhalations. The Alupent Inhalation Aerosol containing 150 mg of metaproterenol sulfate as micronized powder is sufficient medication for 200 inhalations. Each metered dose delivers through the mouthpiece 0.65 mg of metaproterenol sulfate (each ml contains 15 mg). The inert ingredients are dichlorodifluoromethane, dichlorotetrafluoroethane and trichloromonofluoromethane as propellants, and sorbitan trioleate.

Alupent, 1-(3,5-dihydroxyphenyl)-2-isopropylaminoethanol sulfate, is a white, crystalline, racemic mixture of two optically active isomers. It has the following chemical structure:

Alupent - Clinical Pharmacology

In vitro studies and in vivo pharmacologic studies have demonstrated that Alupent® (metaproterenol sulfate USP) has a preferential effect on beta-2 adrenergic receptors compared with isoproterenol. While it is recognized that beta-2 adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that there is a population of beta-2 receptors in the human heart existing in a concentration between 10-50%. The precise function of these, however, is not yet established (See WARNINGS section).

The pharmacologic effects of beta adrenergic agonist drugs, including Alupent, are at least in part attributable to stimulation through beta adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Pharmacokinetics

Absorption, biotransformation and excretion studies in humans following administration by inhalation have shown that approximately 3 percent of the actuated dose is absorbed intact through the lungs. The major metabolite, metaproterenol-3-0-sulfate, is produced in the gastrointestinal tract. Alupent is not metabolized by catechol-0-methyltransferase nor have glucuronide conjugates been isolated to date.

Pulmonary function tests performed concomitantly usually show improvement following aerosol Alupent administration, e.g. an increase in the one-second forced expiratory volume (FEV1) maximum expiratory flow rate, forced vital capacity, and/or a decrease in airway resistance. The resultant decrease in airway obstruction may relieve the dyspnea associated with bronchospasm.

Controlled single- and multiple-dose studies have been performed with pulmonary function monitoring. The duration of effect of a single dose of two to three inhalations of Alupent (that is, the period of time during which there is a 20 percent or greater increase in FEV1) has varied from 1 to 5 hours.

In repetitive-dosing studies (up to q.i.d.) the duration of effect for a similar dose of Alupent has ranged from about 1 to 2.5 hours. Present studies are inadequate to explain the divergence in duration of the FEV1 effect between single- and repetitive-dosing studies, respectively.

Recent studies in laboratory animals (minipigs, rodents and dogs) recorded the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta agonists and methylxanthines were administered concurrently. The significance of these findings when applied to humans is currently unknown.

Indications and Usage for Alupent

Alupent® (metaproterenol sulfate USP) is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema.

Contraindications

Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.

Although rare, immediate hypersensitivity reactions can occur. Therefore, Alupent® (metaproterenol sulfate USP) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to any of its components.

WARNINGS

Fatalities have been reported following excessive use of Alupent® (metaproterenol sulfate USP) as with other sympathomimetic inhalation preparations, and the exact cause is unknown. Cardiac arrest was noted in several cases.

Alupent, like other beta adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes. As with other beta adrenergic aerosols, Alupent can produce paradoxical bronchospasm (which can be life threatening). If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.

Alupent should not be used more often than prescribed. Patients should be advised to contact their physician in the event that they do not respond to their usual dose of a sympathomimetic amine aerosol.

Precautions

General

Extreme care must be exercised with respect to the administration of additional sympathomimetic agents.

Since metaproterenol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension or cardiac arrhythmias, in patients with hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients after use of any beta adrenergic bronchodilator.

Information for Patients

Appropriate care should be exercised when considering the administration of additional sympathomimetic agents. A sufficient interval of time should elapse prior to administration of another sympathomimetic agent.

Drug Interactions

Other beta adrenergic aerosol bronchodilators should not be used concomitantly with Alupent® (metaproterenol sulfate USP) because they may have additive effects. Beta adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists on the vascular system may be potentiated.

Carcinogenesis/Mutagenesis/Impairment of Fertility

In an 18-month study in mice, Alupent produced an increase in benign ovarian tumors in females at doses corresponding to 320 and 640 times the maximum recommended dose (based on a 50 kg individual). In a two-year study in rats, a non-significant incidence of benign leiomyomata of the mesovarium was noted at 640 times the maximum recommended dose. The relevance of the findings to man is not known. Mutagenic studies with Alupent have not been conducted. Reproduction studies in rats revealed no evidence of impaired fertility.

Pregnancy

Teratogenic Effects

PREGNANCY CATEGORY C:

Alupent has been shown to be teratogenic and embryotoxic in rabbits when given in doses corresponding to 640 times the maximum recommended dose. These effects included skeletal abnormalities, hydrocephalus and skull bone separation. Results of other studies in rabbits, rats or mice have not revealed any teratogenic, embryocidal or fetotoxic effects. There are no adequate and well-controlled studies in pregnant women. Alupent should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Alupent is excreted in human milk; therefore, Alupent should be used during nursing only if the potential benefit justifies the possible risk to the newborn.

Pediatric Use

Safety and effectiveness in the pediatric population below the age of 12 have not been established. Studies are currently under way in this age group.

Adverse Reactions

Adverse reactions are similar to those noted with other sympathomimetic agents. The most frequent adverse reaction to Alupent® (metaproterenol sulfate USP) administered by metered-dose inhaler among 251 patients in 90-day controlled clinical trials was nervousness. This was reported in 6.8% of patients. Less frequent adverse experiences, occurring in 1-4% of patients were headache, dizziness, palpitations, gastrointestinal distress, tremor, throat irritation, nausea, vomiting, cough and asthma exacerbation. Tachycardia occurred in less than 1% of patients.

Overdosage

The expected symptoms with overdosage are those of excessive beta-stimulation and/or any of the symptoms listed under adverse reactions, e.g. angina, hypertension or hypotension, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise and insomnia.

Treatment consists of discontinuation of metaproterenol together with appropriate symptomatic therapy.

Alupent Dosage and Administration

The usual single dose is two to three inhalations. With repetitive dosing, inhalation should usually not be repeated more often than about every three to four hours. Total dosage per day should not exceed 12 inhalations.

Alupent® (metaproterenol sulfate USP) Inhalation Aerosol is not recommended for children under 12 years of age.

It is recommended that the physician titrate dosage according to each individual patient’s response to therapy.

How is Alupent Supplied

Each 100 inhalations of Alupent® (metaproterenol sulfate USP) Inhalation Aerosol contains 75 mg of metaproterenol sulfate as a micronized powder in inert propellants. Each metered dose delivers through the mouthpiece 0.65 mg metaproterenol sulfate (each ml contains 15 mg). Alupent Inhalation Aerosol with Mouthpiece (NDC 0597-0070-08), net contents 7g (5 ml). The mouthpiece is white with a clear, colorless sleeve and a blue protective cap.

Each 200 inhalations of Alupent Inhalation Aerosol contains 150 mg of metaproterenol sulfate as a micronized powder in inert propellants. Each metered dose delivers through the mouthpiece 0.65 mg metaproterenol sulfate (each ml contains 15 mg). Alupent Inhalation Aerosol with Mouthpiece (NDC 0597-0070-17), net contents 14g (10ml). The mouthpiece is white with a clear, colorless sleeve and a blue protective cap. Alupent Inhalation Aerosol Refill (NDC 0597-0070-18), net contents 14g (10 ml).

Note: The indented statement below is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

 

WARNING: Contains trichloromonofluoromethane (CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane (CFC-114), substances which harm public health and the environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the information for the patient of this product under the Environmental Protection Agency’s (EPA’s) regulations. The patient’s warning states that the patient should consult his or her physician if there are questions about alternatives.

Store between 59°F (15°C) and 77°F (25°C). Avoid excessive humidity.

Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877

Licensed from: Boehringer Ingelheim International GmbH

Manufactured by 3M Pharmaceuticals, St. Paul, MN 55144-1000

Printed in U.S.A. Revised 2/99

4041090 029

Patient’s Instructions for Use

Alupent®

(metaproterenol sulfate USP)

Inhalation Aerosol

1. Insert metal canister into clear end of mouthpiece.
   
   


2. Remove protective cap, invert canister and shake well before each use.
   
   
   


3. Avoid spraying in eyes.
   
   


4. Enclose mouthpiece with the lips. The base of the canister should be held vertically. The Alupent® canister is to be used only with the white Alupent® Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other aerosol medications.
   
   
   


5. Exhale deeply, then inhale slowly through the mouth and at the same time firmly press once on the upended canister base; continue to inhale deeply. Hold your breath for a few seconds and then remove the mouthpiece from the mouth and exhale slowly.
   
   


6. One inhalation is often enough to obtain relief. The inhalation can be repeated once or twice, if necessary, or as your physician directs. Wait at least two minutes before repeating the inhalation. In most cases, the dose should not be repeated more often than every 3 to 4 hours. No more than 12 inhalations should be taken in one day.
   
   


7. Replace protective cap after use.

WARNING: Do not exceed the dose prescribed by your physician. If difficulty in breathing persists, contact your physician immediately.

Note: When full, the container holds enough medication for at least 200 inhalations: at least 100 inhalations are in the sample unit. Check regularly, by shaking the cylinder or container, to determine whether it contains any medication. When it first seems empty, there are still about ten doses left. Refill containers for the plastic mouthpiece are available when prescribed by your physician.

Keep the mouthpiece clean. Wash with hot water. If soap is used, rinse thoroughly with plain water.

Never open the container holding the medication. Opening it is dangerous and renders the contents useless.

Caution: Contents Under Pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. Keep out of reach of small children

Note: The indented statement below is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

 

This product contains trichloromonofluoromethane (CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane (CFC-114), substances which harm the environment by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.

Distributed by

Boehringer Ingelheim Pharmaceuticals, Inc.,

Ridgefield, CT 06877

Licensed from Boehringer

Ingelheim International GmbH

Printed in U.S.A

2/99

Alupent  metaproterenol sulfate  aerosol, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0597-0070 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength metaproterenol sulfate (metaproterenol) Active 0.650 MILLIGRAM  In 1 INHALATION dichlorodifluoromethane Inactive   dichlorotetrafluoroethane Inactive   sorbitan trioleate Inactive   trichloromonofluoromethane Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0597-0070-08 1 CANISTER In 1 CARTON contains a CANISTER 1 100 INHALATION In 1 CANISTER This package is contained within the CARTON (0597-0070-08) 2 0597-0070-18 1 INHALER, REFILL In 1 CARTON contains a INHALER, REFILL 2 200 INHALATION In 1 INHALER, REFILL This package is contained within the CARTON (0597-0070-18) 3 0597-0070-17 1 CANISTER In 1 CARTON contains a CANISTER 3 200 INHALATION In 1 CANISTER This package is contained within the CARTON (0597-0070-17)

Revised: 10/2006Boehringer Ingelheim Pharmaceuticals, Inc.

More Alupent resources

• Alupent Side Effects (in more detail)
• Alupent Use in Pregnancy & Breastfeeding
• Drug Images
• Alupent Drug Interactions
• Alupent Support Group
• 2 Reviews for Alupent - Add your own review/rating

• Alupent Concise Consumer Information (Cerner Multum)


• Alupent Monograph (AHFS DI)


• Alupent Advanced Consumer (Micromedex) - Includes Dosage Information


• Alupent MedFacts Consumer Leaflet (Wolters Kluwer)

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Hycomine

Dosage Form: Syrup

Hycomine Description

Hycomine contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive and phenylpropanolamine hydrochloride, a sympathomimetic amine decongestant for oral administration.

The pH of Hycomine and Hycomine Pediatric Syrup is 3.2-4.2. The hydrocodone component is (5α)-4,5-epoxy-3-methoxy-17-methylmorphinan-6-one [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, and has a molecular weight of 494.50. The phenylpropanolamine component is (±)-(R*,S*)-α-(1-aminoethyl) benzenemethanol hydrochloride and has a molecular weight of 187.67. These may be represented by the following structural formulas:

Hycomine

Pediatric Syrup

Each teaspoonful (5 mL) contains:

Hydrocodone bitartrate, USP                                    2.5 mg

   WARNING: May be habit forming

Phenylpropanolamine hydrochloride, USP                 12.5 mg

Hycomine Syrup

Each teaspoonful (5 mL) contains:

Hydrocodone bitartrate, USP                                    5 mg

   WARNING: May be habit forming

Phenylpropanolamine hydrochloride, USP                 25 mg

Also, Hycomine, both strengths, contain: artificial cherry flavor, glycerin, methylparaben, propylparaben, saccharin sodium, and sorbitol solution. Hycomine Pediatric Syrup contains: D&C Yellow 10 and FD&C Green 3. Hycomine Syrup: FD&C Red 40 and FD&C Yellow 6.

Hycomine - Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and physiological dependence.

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including 0-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites.

Phenylpropanolamine effects its vasoconstrictor activity by releasing noradrenaline from sympathetic nerve endings, and from direct stimulation of α–adrenoreceptors of blood vessels.

Indications and Usage for Hycomine

Hycomine (hydrocodone bitartrate and phenylpropanolamine hydrochloride) is indicated for the symptomatic relief of cough and nasal congestion.

Contraindications

Hycomine is contraindicated in patients hypersensitive to hydrocodone or phenylpropanolamine, and in patients on concurrent MAO inhibitor therapy. Patients known to be hypersensitive to other opioids or sympathomimetic amines may exhibit cross sensitivity to Hycomine. Phenylpropanolamine is contraindicated in patients with heart disease, hypertension, diabetes or hyperthyroidism. Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure; and whenever ventilatory function is depressed.

Warnings

May be habit forming. Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of Hycomine and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (See DRUG ABUSE AND DEPENDENCE).

Respiratory Depression

Hycomine produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.

Head Injury and Increased Intracranial Pressure

The respiratory depression properties of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of Hycomine or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use

In young children, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Benefit to risk ratio should be carefully considered especially in children with respiratory embarrassment (e.g., croup).

Phenylpropanolamine

Hypertensive crises can occur with concurrent use of phenylpropanolamine and monoamine oxidase (MAO) inhibitors, indomethacin or with beta-blockers and methyldopa.

If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.

Precautions

General

Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided.

Special Risk Patients

Hycomine should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture, asthma, narrow-angle glaucoma, and uncontrolled hypertension.

Information for Patients

Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; phenylpropanolamine may produce a rapid pulse, dizziness or palpitations. The patient using Hycomine (hydrocodone bitartrate and phenylpropanolamine hydrochloride) should be cautioned accordingly.

Drug Interactions

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The use of phenylpropanolamine with other sympathomimetic amines and MAO inhibitors may produce an additive elevation of blood pressure (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and reproduction studies have not been conducted with Hycomine.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Hycomine. It is also not known whether Hycomine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Hycomine should be given to a pregnant woman only if clearly needed.

Nonteratogenic Effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

Labor and Delivery

As with all narcotics, administration of Hycomine to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hycomine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Hycomine in pediatric patients under six have not been established.

Adverse Reactions

Respiratory System

Hydrocodone produces dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

Cardiovascular System

Hypertension, postural hypotension, tachycardia and palpitations.

Genitourinary System

Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Central Nervous System

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision.

Gastrointestinal System

Nausea and vomiting occur more frequently in ambulatory than in recumbent patients. Prolonged administration of Hycomine may produce constipation.

Dermatological

Skin rash, pruritus.

Drug Abuse and Dependence

Hycomine is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, Hycomine should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when Hycomine is used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.

Overdosage

Signs and Symptoms

Serious overdosage with Hycomine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

The signs and symptoms of overdosage of the individual components of Hycomine (hydrocodone bitartrate and phenylpropanolamine hydrochloride) may be modified in varying degrees by the presence of other active ingredients. Overdosage with phenylpropanolamine alone may result in tremor, restlessness, increased motor activity, agitation and hallucinations.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing absorbent drug.

Hycomine Dosage and Administration

Adults: The usual dose for adults is one teaspoonful Hycomine Syrup (hydrocodone bitartrate 5 mg and phenylpropanolamine hydrochloride 25 mg/5 cc) every four hours as needed, not to exceed six teaspoonfuls in a 24 hour period.

Children 6 to 12 years of age: The usual dose for children 6 to 12 years of age is one teaspoonful Hycomine Pediatric Syrup (hydrocodone bitartrate 2.5 mg and phenylpropanolamine hydrochloride 12.5 mg/5 cc) every four hours as needed, not to exceed six teaspoonfuls in a 24 hour period.

How is Hycomine Supplied

Hycomine Syrup (5 mg hydrocodone bitartrate, USP and 25 mg phenylpropanolamine hydrochloride, USP – per 5 mL teaspoonful) is available as an orange-colored, cherry-flavored syrup in bottles as follows:

One Pint (473.2 mL):     NDC 63481-246-16

Hycomine Pediatric Syrup (2.5 mg hydrocodone bitartrate, USP and 12.5 mg phenylpropanolamine hydrochloride, USP – per 5 mL teaspoonful) is available as a green-colored, cherry-flavored syrup in bottles as follows:

One Pint (473.2 mL):     NDC 63481-247-16

Store in controlled room temperature 15˚-30˚C (59˚-86˚F).

Oral prescription where permitted by State law.

CAUTION: Federal (USA) law prohibits dispensing without a prescription.

Manufactured for:

Endo Pharmaceuticals Inc.

Chadds Ford, Pennsylvania 19317

Manufactured by:

DuPont Pharma

Wilmington, Delaware 19880

Hycomine®is a Registered Trademark of Endo Pharmaceuticals Inc.

                                   Copyright © Endo Pharmaceuticals Inc. 1997

Printed in U.S.A.                                                                              6480/August, 1997

Hycomine  hydrocodone bitartrate and phenylpropanolamine hydrochloride  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63481-246 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength Phenylpropanolamine hydrochloride (Phenylpropanolamine) Active 25 MILLIGRAM  In 5 MILLILITER Hydrocodone bitartrate (Hydrocodone) Active 5 MILLIGRAM  In 5 MILLILITER artificial cherry flavor Inactive   glycerin Inactive   methylparaben Inactive   propylparaben Inactive   saccharin sodium Inactive   sorbitol solution Inactive   FD&C Red 40 Inactive   FD&C Yellow 6 Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63481-246-16 473.2 mL (MILLILITER) In 1 BOTTLE None

Hycomine  hydrocodone bitartrate and phenylpropanolamine hydrochloride  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63481-247 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength Hydrocodone bitartrate (Hydrocodone) Active 2.5 MILLIGRAM  In 5 MILLILITER Phenylpropanolamine hydrochloride (Phenylpropanolamine) Active 12.5 MILLIGRAM  In 5 MILLILITER artificial cherry flavor Inactive   glycerin Inactive   methylparaben Inactive   propylparaben Inactive   saccharin sodium Inactive   sorbitol solution Inactive   D&C Yellow 10 Inactive   FD&C Green 3 Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63481-247-16 473.2 mL (MILLILITER) In 1 BOTTLE None

Revised: 10/2006Endo Pharmaceuticals Inc.

More Hycomine resources

• Hycomine Side Effects (in more detail)
• Hycomine Dosage
• Hycomine Drug Interactions
• Hycomine Support Group
• 0 Reviews · Be the first to review/rate this drug

Aztreonam

Pronunciation: az-TREE-oh-nam
Generic Name: Aztreonam
Brand Name: Cayston

Aztreonam is used for:

Improving breathing symptoms in cystic fibrosis (CF) patients with lung infections caused by certain bacteria (Pseudomonas aeruginosa).

Aztreonam is a monobactam antibiotic. It works by killing sensitive bacteria that cause infection.

Do NOT use Aztreonam if:

• you are allergic to any ingredient in Aztreonam

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

Before using Aztreonam:

Some medical conditions may interact with Aztreonam. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any penicillin, cephalosporin, or carbapenem antibiotic


• if you have a forced expiratory volume in 1 second (FEV-1) of less than 25% or more than 75% predicted


• if you are colonized with a certain bacteria (Burkholderia cepacia)

Some MEDICINES MAY INTERACT with Aztreonam. However, no specific interactions with Aztreonam are known at this time.

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

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

• An extra patient leaflet is available with Aztreonam. Talk to your pharmacist if you have questions about this information.


• You should use a bronchodilator (eg, albuterol) before you use Aztreonam. Contact your doctor for instructions on how and when to use a bronchodilator before using Aztreonam.


• If you are taking several inhaled medicines, talk to your doctor about the best order for taking your medicines.


• Aztreonam should be used with a certain nebulizer (Altera Nebulizer System). Do not use other medicines with this nebulizer. Be sure you know which nebulizer to use Aztreonam with.


• Do not mix Aztreonam with other medicines before using it.


• Do not use Aztreonam if it is cloudy, contains particles, or if it has been stored at room temperature for more than 28 days.


• To clear up your infection completely, use Aztreonam for the full course of treatment. Keep using it even if you feel better in a few days.


• Aztreonam must be mixed with the provided diluent that comes with it before you use it. Follow your doctor's instructions on how to mix Aztreonam.


• After you mix Aztreonam with the diluent, use it immediately. Do not mix more than one dose at a time.


• Aztreonam is usually used for 28 days on the medicine followed by at least 28 days off the medicine. Follow the dosing schedule given to you by your doctor carefully.


• If you miss a dose of Aztreonam, use it as soon as possible. If it is less than 4 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Aztreonam only works against bacteria; it does not treat viral infections (eg, the common cold).


• Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor.


• Be sure to use Aztreonam for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Aztreonam may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Decreases in lung function have occurred after patients have taken Aztreonam for 28 days. Your doctor may monitor your lung function while you use Aztreonam. Contact your doctor if you experience new or worsening lung or breathing problems.


• Lab tests, including lung function, may be performed while you use Aztreonam. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Aztreonam should be used with extreme caution in CHILDREN younger than 7 years old; safety and effectiveness in these children have not been confirmed.


• Caution is advised when using Aztreonam in CHILDREN; they may be more sensitive to its effects, especially fever.


• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aztreonam while you are pregnant. If you are or will be breast-feeding while you use Aztreonam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aztreonam:

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:

Cough; mild stomach pain; nasal congestion; sore throat; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); chest discomfort; fever; severe or persistent cough, sore throat, or stomach pain; severe or persistent vomiting; shortness of breath; wheezing.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Aztreonam side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Aztreonam:

Store Aztreonam and the diluent in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Once removed from the refrigerator, Aztreonam and the diluent may be stored at room temperature, below 77 degrees F (25 degrees C), for up to 28 days. Always keep Aztreonam and the diluent together. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aztreonam out of the reach of children and away from pets.

General information:

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


• Aztreonam 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.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aztreonam. 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: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Aztreonam resources

• Aztreonam Side Effects (in more detail)
• Aztreonam Use in Pregnancy & Breastfeeding
• Aztreonam Drug Interactions
• Aztreonam Support Group
• 0 Reviews for Aztreonam - Add your own review/rating

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• Intraabdominal Infection
• Kidney Infections
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Skin and Structure Infection
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Aspiration Pneumonia Medications

Definition of Aspiration Pneumonia: Aspiration pneumonia is an inflammation of the lungs and bronchial tubes caused by inhaling foreign material, usually food, drink, vomit, or secretions from the mouth into the lungs. This may progress to form a collection of pus in the lungs (lung abscess).

Drugs associated with Aspiration Pneumonia

The following drugs and medications are in some way related to, or used in the treatment of Aspiration Pneumonia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Aspiration Pneumonia

Medical Encyclopedia:

• Aspiration pneumonia

Drug List:

Amoclan-Suspension

Augmentin

Augmentin-Es-600-Suspension

Augmentin-Xr-Extended-Release-Tablets

Baycadron

Beepen-Vk

Bicillin-L-A-Suspension

Cleocin

Cleocin-Hcl

Cleocin-Pediatric-Suspension

Cleocin-Phosphate-Iv

De-Sone-La-Injection

Decadron

Deltasone

Dexacen-4-Injection

Dexacort-Phosphate-In-Turbinaire

Dexamethasone-Intensol

Dexasone-Injection

Dexasone-La-Injection

Dexpak-Tablets-Dose-Pack

Flagyl

Flagyl-375

Flagyl-I-V

Permapen-Isoject

Mefoxin

Meticorten

Metro

Pc-Pen-Vk

Pen-V

Penicillin-G-Procaine-Injectable-Suspension

Penicillin-Vk

Pfizerpen

Prevacid

Prevacid-I-V

Prevacid-Otc

Prevacid-Solutab-Orally-Disintegrating-Tablets

Primaxin-Im

Primaxin-Iv

Solurex-Injection

Solurex-La-Injection

Sterapred

Sterapred-Ds

Timentin

Unasyn

Veetids

Zema-Pak-10-Day

Zosyn

Clobex Lotion

Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Clobex

Clobex Lotion is used for:

Treating inflammation and itching due to certain skin conditions. It is also used to treat moderate to severe psoriasis. It may also be used for other conditions as determined by your doctor.

Clobex Lotion is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Clobex Lotion if:

• you are allergic to any ingredient in Clobex Lotion or to other corticosteroids (eg, prednisone)

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

Before using Clobex Lotion:

Some medical conditions may interact with Clobex Lotion. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

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

Ask your health care provider if Clobex Lotion 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 Clobex Lotion:

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

• An extra patient leaflet is available with Clobex Lotion. Talk to your pharmacist if you have questions about this information.


• Wash and completely dry the affected area before applying Clobex Lotion.


• Turn the bottle upside down and pour a small amount (less than 1 teaspoonful) onto your fingertips or onto the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Clobex Lotion, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor. Do not wear tight-fitting clothes over the treated area.


• If you miss a dose of Clobex Lotion, apply 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 apply 2 doses at once.

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

Important safety information:

• Clobex Lotion is for external use only. Do not get Clobex Lotion in your eyes, nose, mouth, or on your lips. If contact is made with the eyes, flush them immediately with tap water.


• Do not use Clobex Lotion on the face, groin, diaper area, or underarms.


• Do not use Clobex Lotion to treat rosacea or conditions around the mouth.


• Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Do not use Clobex Lotion to treat large areas of your body without first checking with your doctor.


• Tell your doctor or dentist that you take Clobex Lotion before you receive any medical or dental care, emergency care, or surgery.


• Check with your doctor before having vaccinations while using Clobex Lotion.


• Do not use Clobex Lotion for other skin conditions at a later time.


• Check with your doctor if you experience nausea, vomiting, fever, dizziness, or chest pain after you have stopped using Clobex Lotion.


• Clobex Lotion has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Lab tests, including blood and urine tests, may be performed while you use Clobex Lotion. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Clobex Lotion should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clobex Lotion while you are pregnant. It is not known if Clobex Lotion is found in breast milk after topical use. If you are or will be breast-feeding while you use Clobex Lotion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Clobex Lotion:

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; itching; mild burning or stinging.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobex Lotion; dark red blotches on the skin; excessive hair growth; general feeling of being unwell; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Clobex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Clobex Lotion:

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

General information:

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


• Clobex Lotion 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.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Clobex Lotion. 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: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clobex resources

• Clobex Side Effects (in more detail)
• Clobex Use in Pregnancy & Breastfeeding
• Clobex Drug Interactions
• Clobex Support Group
• 16 Reviews for Clobex - Add your own review/rating

Compare Clobex with other medications

• Atopic Dermatitis
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Teveten

Generic Name: Eprosartan Mesylate
Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: (E)-α-[[2-butyl-1-[(4-carboxyphenyl)methyl]-1H-imidazol-5-yl]methyl-ene]-2-thiophenepropanoic acid monomethanesulfonate
Molecular Formula: C₂₃H₂₄N₂O₄S•CH₄
CAS Number: 144143-96-4

• 
  

  May cause fetal and neonatal morbidity and mortality if used during pregnancy.^{1 30 50 51} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue as soon as possible.^{1 30 51}

  
  

Introduction

Angiotensin II receptor (AT₁) antagonist.^{1 2 7 14}

Uses for Teveten

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 2 5 7 9 25 26 27 28 29}

One of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.⁴⁴

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁴⁴

Diabetic Nephropathy

First-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.

CHF

Second-line agent in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.

Teveten Dosage and Administration

General

Hypertension

• 
  

  Fixed-combination eprosartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.³⁰

  
  

Administration

Oral Administration

Administer orally once or twice daily without regard to meals.^{1 2 30}

Dosage

Available as eprosartan mesylate; dosage expressed in terms of eprosartan.^{1 30}

Adults

Hypertension

Monotherapy

Oral

Initially, 600 mg once daily in adults without intravascular volume depletion.^{1 7} Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.⁴⁴

Usual dosage: 400–800 mg daily, given in 1 dose or 2 divided doses; limited experience with higher dosages.^{1 30}

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.^{1 2 7}

Combination Therapy

Oral

If BP is not adequately controlled by monotherapy with eprosartan or hydrochlorothiazide, can switch to fixed-combination tablets (eprosartan 600 mg and hydrochlorothiazide 12.5 mg; then eprosartan 600 mg and hydrochlorothiazide 25 mg), administered once daily.³⁰

If BP response diminishes toward the end of the dosing interval during once daily administration, increase dosage of the fixed-combination tablets to eprosartan 600 mg and hydrochlorothiazide 25 mg daily or add eprosartan 300 mg each evening.³⁰

Special Populations

Hepatic Impairment

No initial dosage adjustment necessary.^{1 30}

Renal Impairment

No initial dosage adjustment generally is necessary in patients with moderate or severe renal impairment; maximum 600 mg daily.^{1 30}

Eprosartan/hydrochlorothiazide fixed combination not recommended in patients with anuria.³⁰

Geriatric Patients

No initial dosage adjustment necessary.¹

Volume- and/or Salt-Depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision.^{1 30}

Cautions for Teveten

Contraindications

• 
  

  Known hypersensitivity to eprosartan or any ingredient in the formulation.^{1 7 8}

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.^{1 30 51} (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.⁵¹

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.^{50 51}

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.^{50 51} Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.¹³

Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis).^{1 30} (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).^{1 30}

Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.^{120 121 123 126} However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.^{126 127 128 129} Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.¹²⁶

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible;^{1 3 8} not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.^{10 132}

General Precautions

Renal Effects

Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.^{1 30}

Increases in BUN and S_cr possible in patients with unilateral or bilateral renal artery stenosis.^{1 30}

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.³⁰

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).^{1 30} (See Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether eprosartan is distributed into human milk.^{1 30} Discontinue nursing or the drug.^{1 30}

Pediatric Use

Safety and efficacy not established.^{1 7 30}

Geriatric Use

BP reduction with eprosartan monotherapy was slightly less in patients ≥65 years of age compared with younger patients.¹ BP responses were similar in geriatric and younger patients receiving fixed-combination eprosartan/hydrochlorothiazide tablets.³⁰ No substantial differences in safety relative to younger adults.^{1 30}

Hepatic Impairment

Use with caution.¹

Renal Impairment

Use with caution.¹

Deterioration of renal function may occur.^{1 30} (See Renal Effects under Cautions.)

Use of eprosartan in fixed combination with hydrochlorothiazide is not recommended in patients with anuria.³⁰

Blacks

BP reduction may be smaller in black patients compared with nonblack patients; use in combination with a diuretic.^{1 5 7}

Common Adverse Effects

Upper respiratory tract infection, rhinitis, pharyngitis, cough, viral infection, urinary tract infection, abdominal pain, injury, arthralgia, fatigue, depression, dizziness,³⁰ headache,³⁰ back pain,³⁰ hypertriglyceridemia.^{1 2 7}

Interactions for Teveten

Not metabolized by CYP isoenzymes.^{1 30} Does not inhibit CYP1A, 2A6, 2C9/8, 2C19, 2D6, 2E, or 3A in vitro.^{1 30}

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions with inhibitors or inducers of CYP2C9 or CYP3A unlikely.^{1 2}

Specific Drugs

Drug	Interaction	Comment
Digoxin	Pharmacokinetic interaction unlikely1 2
Diuretics, potassium-sparing (e.g., amiloride, spironolactone, triamterene)	Possible additive hyperkalemic effects30	Concomitant use not recommended30
Fluconazole	Pharmacokinetic interaction unlikely1 2
Glyburide	Pharmacologic interaction unlikely1 2
Hydrochlorothiazide	Pharmacokinetic interaction unlikely1 2 30 Additive hypotensive effects2
Ketoconazole	Pharmacokinetic interaction unlikely1 30
Nifedipine, extended-release	Interaction unlikely1
NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors	Possible deterioration of renal function in geriatric, volume-depleted, or renally impaired patients1 Possible reduced antihypertensive effects1	Monitor renal function periodically1
Potassium supplements and potassium-containing salt substitutes	Possible additive hyperkalemic effect30	Concomitant use not recommended30
Ranitidine	Pharmacokinetic interaction unlikely1 2
Warfarin	Pharmacologic interaction unlikely1 2

Teveten Pharmacokinetics

Absorption

Bioavailability

Peal plasma concentration generally achieved 1–2 hours after oral administration in fasting state.¹ Absolute bioavailability is about 13%.^{1 30}

Onset

Following a single oral dose, onset of antihypertensive effect evident within 1–2 hours.¹ During chronic therapy, maximum antihypertensive effects generally achieved after 2–3 weeks.^{1 30}

Food

Food delays absorption.^{1 30}

Special Populations

In male patients with hepatic impairment, AUC after a single 100-mg oral dose increased by approximately 40%.^{1 30}

In patients with moderate or severe renal impairment, AUC increased by 70–90% and peak plasma concentration increased by 30–50%.¹

Distribution

Extent

Crosses the placenta and is distributed in the fetus in animals.^{1 30}

Distributed into milk in rats; not known whether distributed into human milk.^{1 30}

Plasma Protein Binding

Approximately 98%.^{1 30}

Elimination

Metabolism

Not metabolized by CYP isoenzymes.^{1 2 30}

No pharmacologically active metabolites detected.^{1 7}

Elimination Route

Eliminated by biliary and renal excretion, mainly as unchanged drug.^{1 2 30}

Half-life

Approximately 20 hours following multiple oral doses.¹

Special Populations

Poorly removed by hemodialysis.^{1 30}

Stability

Storage

Oral

Tablets

20–25°C.^{1 30}

Actions

• 
  

  Blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.^{1 30}

  
  


• 
  

  Does not interfere with response to bradykinins and substance P.^{1 30}

  
  

• 
  

  Does not share the ACE inhibitor common adverse effect of dry cough.^{1 30}

  
  

Advice to Patients

• 
  

  Risks of use during pregnancy.^{1 30 50 51}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 30}

  
  

• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).^{1 30}

  
  

• 
  

  Importance of informing patients of other important precautionary information.^{1 30} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Eprosartan Mesylate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	400 mg (of eprosartan)	Teveten	Abbott
		600 mg (of eprosartan)	Teveten	Abbott

Eprosartan Mesylate Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	600 mg (of eprosartan) with Hydrochlorothiazide 12.5 mg	Teveten HCT	Abbott
		600 mg (of eprosartan) with Hydrochlorothiazide 25 mg	Teveten HCT	Abbott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Teveten 400MG Tablets (ABBOTT): 30/$90.99 or 90/$250.97

Teveten 600MG Tablets (ABBOTT): 30/$109.99 or 90/$295.98

Teveten HCT 600-12.5MG Tablets (ABBOTT): 30/$120.99 or 90/$333.95

Teveten HCT 600-25MG Tablets (ABBOTT): 30/$109.98 or 90/$309.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Abbott. Teveten (eprosartan mesylate) tablets prescribing information. North Chicago, IL; 2011 Apr.

2. Plosker GL, Foster RH. Eprosartan: a review of its use in the management of hypertension. Drugs. 2000; 60:177-201. [PubMed 10929934]

3. Mazzolai L, Burnier M. Comparative safety and tolerability of angiotensin II receptor antagonists. Drug Safety. 1999; 21:23-33. [PubMed 10433351]

4. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

5. Anon. Drugs for hypertension. Med Lett Drugs Ther. 2001; 43:17-22. [PubMed 11242494]

6. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

7. Biovail Pharmaceuticals. Morrisville, NC: Personal communication.

8. Warner KK, Visconti JA, Tschampel MM. Angiotensin II receptor blockers in patients with ACE inhibitor-induced angioedema. Ann Pharmacother. 2000; 34:526. [IDIS 443518] [PubMed 10772441]

9. Food and Drug Administration. Medical review of eprosartan NDA 20-738. September 9, 1997. From FDA website.

10. Kirk JK. Therapy with angiotensin II receptor antagonists. Clin Geriatrics. From the MultiMedia Health Care website.

11. Martineau P, Goulet J. New competition in the realm of renin-angiotensin axis inhibition; the angiotensin II receptor antagonists in congestive heart failure. Ann Pharmacother. 2001; 35:71-84. [IDIS 457649] [PubMed 11197588]

12. Gremmler B, Kunert M, Schleiting H et al. Improvement of cardiac output in patients with severe heart failure by use of ACE-inhibitors combined with the AT1-antagonist eprosartan. Eur J Heart Fail. 2000; 2:183-7. [PubMed 10856732]

13. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

14. Unger T. Significance of angiotensin type 1 receptor blockade: why are angiotensin II receptor blockers different? Am J Cardiol. 1999; 84:9-15S.

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