Label: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- hydrocodone bitartrate and homatropine methylbromide syrup 

  • NDC Code(s): 50383-043-16
  • Packager: Hi-Tech Pharmacal Co., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 04/12

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  • DESCRIPTION

    This product contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

    Each teaspoonful (5 mL) for oral administration contains:

    Hydrocodone Bitartrate, USP 5 mg

    WARNING: May be habit forming.

    Homatropine Methylbromide, USP 1.5 mg

    Hydrocodone Bitartrate and Homatropine Methylbromide Syrup also contains: Caramel color, cherry flavor, citric acid, FD&C Red #40, methylparaben, propylparaben, purified water, sorbitol solution and sucrose syrup. Citric acid and/or sodium citrate may be added to adjust pH.

    The hydrocodone component is a 4,5α- epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50) and may be represented by the following structural formula:

    Structural Formula for hydrocodone bitartrate

    Structural Formula for homatropine methylbromide

    Homatropine methylbromide is 8- Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenylacetyl) oxy]-8,8-dimethyl-,bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

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  • 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 O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxymetabolites.

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  • INDICATIONS AND USAGE

    Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough.

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  • CONTRAINDICATIONS

    Hydrocodone bitartrate and homatropine methylbromide syrup should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

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  • 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 hydrocodone bitartrate and homatropine methylbromide 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

    Hydrocodone bitartrate and homatropine methylbromide 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 pre-existing 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 hydrocodone bitartrate and homatropine methylbromide or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

    Pediatric Use

    In young pediatric patients, 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 the pediatric population with respiratory embarrassment (e.g., croup).

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  • 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 physiological complications, and that appropriate therapy for the primary disease is provided.

    Special Risk Patients

    Hydrocodone bitartrate and homatropine methylbromide 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, and narrow-angle glaucoma.

    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. The patient using hydrocodone bitartrate and homatropine methylbromide should be cautioned accordingly.

    Drug Interactions

    Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and homatropine methylbromide may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

    Carcinogenesis, mutagenesis, impairment of fertility

    Studies of hydrocodone bitartrate and homatropine methylbromide in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C: Animal reproduction studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide. It is also not known whether hydrocodone bitartrate and homatropine methylbromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydrocodone bitartrate and homatropine methylbromide 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 hydrocodone bitartrate and homatropine methylbromide 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 hydrocodone bitartrate and homatropine methylbromide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

    Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide in pediatric patients under six have not been established.

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  • ADVERSE REACTIONS

    To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.

    Central Nervous System

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

    Gastrointestinal System

    Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of hydrocodone bitartrate and homatropine methylbromide may produce constipation.

    Genitourinary System

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

    Respiratory System

    Hydrocodone bitartrate and homatropine methylbromide may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

    Dermatological

    Skin rash, pruritus.

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  • DRUG ABUSE AND DEPENDENCE

    Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, hydrocodone bitartrate and homatropine methylbromide should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and homatropine methylbromide 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.

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  • OVERDOSAGE

    Signs and Symptoms

    Serious overdosage with hydrocodone 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 ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide may, in addition, result in acute homatropine intoxication.

    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 unabsorbed drug.

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  • DOSAGE AND ADMINISTRATION

    Adults

    One (1) teaspoonful (5 mL) of the syrup every 4 to 6 hours as needed; do not exceed six (6) teaspoonfuls in 24 hours.

    Children 6 to 12 Years of Age

    One-half (1/2) teaspoonful (2.5 mL) of the syrup every 4 to 6 hours as needed; do not exceed three (3) teaspoonfuls in 24 hours.

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  • HOW SUPPLIED

    Hydrocodone Bitartrate and Homatropine Methylbromide Syrup is available as a clear red colored, cherry flavored syrup in:

    Bottles of 16 fl. oz. (one pint)

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

    Dispense in a tight, light-resistant container, as defined in the USP.

    Oral prescription where permitted by state law.


    Manufactured By:

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701


    Rev. 043:00 3/09

    MG #21271


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  • PRINCIPAL DISPLAY PANEL

    Image of Container Label

    NDC 50383-043-16

    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP

    5 mg/1.5 mg per 5 mL

    Each 5 mL (teaspoonful) contains:

    Hydrocodone Bitartrate, USP....................................5 mg

    Homatropine Methylbromide, USP..........................1.5 mg

    Usual Dosage: Read accompanying product information.

    Dispense in a tight, light-resistant container as defined in the USP.

    KEEPT TIGHTLY CLOSED.

    Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

    Oral prescription where permitted by state law.

    Rx only

    16 fl oz (473 mL)

    HI-TECH PHARMACAL CO., INC.

    Amityville, NY 11701

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  • INGREDIENTS AND APPEARANCE
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 
    hydrocodone bitartrate and homatropine methylbromide syrup
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50383-043
    Route of Administration ORAL DEA Schedule CIII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg  in 5 mL
    HOMATROPINE METHYLBROMIDE (METHYLHOMATROPINE) HOMATROPINE METHYLBROMIDE 1.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    CARAMEL  
    CHERRY  
    FD&C RED NO. 40  
    METHYLPARABEN  
    PROPYLPARABEN  
    SODIUM CITRATE  
    SORBITOL  
    SUCROSE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50383-043-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040613 02/08/2008
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-043)
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