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

  • NDC Code(s): 60432-455-16, 60432-455-28
  • Packager: Morton Grove Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 09/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Close
  • 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 5 mL (teaspoonful) contains:
    Hydrocodone Bitartrate, USP . . . . . . . . . 5 mg
    WARNING: May be habit forming.
    Homatropine Methylbromide, USP . . . . 1.5 mg
    Alcohol . . . . . . . . . . . . . . . . . . less than 0.1%
                    (contributed by flavorings)

    Also contains: Caramel, NF; Cherry Flavor; D&C Red No. 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. Citric Acid, USP or Sodium Citrate, USP may be added for pH adjustment.

    The hydrocodone component is 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, and has the following structural formula:

    Chemical Structure 1

    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, and has the following structural formula:

    Chemical Structure 2
    Close
  • 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.

    Close
  • INDICATIONS AND USAGE

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

    Close
  • CONTRAINDICATIONS

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

    Close
  • 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 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 syrup 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 syrup 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 pediatric population with respiratory embarrassment (e.g., croup).

    Close
  • 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 complication, and that appropriate therapy for the primary disease is provided.

    Special Risk Patients

    Hydrocodone bitartrate and homatropine methylbromide syrup 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 syrup should be cautioned accordingly.

    Drug Interactions

    Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents or other Central Nervous System (CNS) depressants (including alcohol) concomitantly with hydrocodone bitartrate and homatropine methylbromide syrup 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 years of age have not been established.

    Close
  • ADVERSE REACTIONS

    To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA, LLC at 1-800-445-4290 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 Depression

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

    Dermatological

    Skin rash, pruritus.

    Close
  • DRUG ABUSE AND DEPENDENCE

    Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule II narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, hydrocodone bitartrate and homatropine methylbromide syrup 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.

    Close
  • 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 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.

    Close
  • DOSAGE AND ADMINISTRATION

    Adults and children 12 years of age and over: 5 mL (teaspoonful) of the syrup every four to six hours as needed; do not exceed 6 teaspoonfuls in 24 hours.

    Children 6 to 12 years of age: 2.5 mL (½ teaspoonful) of the syrup every four to six hours as needed; do not exceed 3 teaspoonfuls in 24 hours.

    Close
  • HOW SUPPLIED

    Hydrocodone bitartrate and homatropine methylbromide syrup is a red-colored, cherry-flavored syrup in 16 fl oz (473 mL) and gallon (3785 mL) bottles.

    RECOMMENDED STORAGE

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

    AVOID FREEZING

    KEEP TIGHTLY CLOSED

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

    Close
  • SPL UNCLASSIFIED SECTION

    Rx Only

    Oral prescription where permitted by state law.

    Product No.: 8455

    Manufactured For:
    Wockhardt USA, LLC
    Parsippany, NJ 07054

    Manufactured By:
    Morton Grove Pharmaceuticals, Inc.
    Morton Grove, IL 60053

    A50-8455-16
    REV. 08-14

    Close
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    MGP

    NDC 60432-455-16

    HYDROCODONE
    AND HOMATROPINE
    SYRUP

    (Hydrocodone Bitartrate and
    Homatropine Methylbromide Syrup)

    CII

    DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED
    FOR YOUR PROTECTION" IS BROKEN OR MISSING.

    BULK CONTAINER —
    NOT FOR HOUSEHOLD USE

    Oral prescription where permitted by state law.

    Rx Only

    NET: 1 Pint (473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
    Close
  • 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:60432-455
    Route of Administration ORAL DEA Schedule CII    
    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
    Water  
    SUCROSE  
    GLYCERIN  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Sorbitol  
    D&C RED NO. 33  
    CARAMEL  
    ANHYDROUS CITRIC ACID  
    TRISODIUM CITRATE DIHYDRATE  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60432-455-16 473 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
    2 NDC:60432-455-28 3785 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA088008 03/03/1983
    Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)
    Close