Hydrocodone Bitartrate/Homatropine Methylbromide Associates

Hydrocodone Bitartrate/Homatropine Methylbromide Associates is indicated for the symptomatic relief of cough.

Adult

One (1) tablet every 4 to 6 hours as needed; do not exceed six (6) tablets in 24 hours.

Children 6 To 12 Years Of Age

One-half (1/2) tablet every 4 to 6 hours as needed; do not exceed three (3) tablets in 24 hours.

Hydrocodone Bitartrate/Homatropine Methylbromide Associates should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

WARNINGS

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/Homatropine Methylbromide Associates 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/Homatropine Methylbromide Associates 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/Homatropine Methylbromide Associates 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).

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/Homatropine Methylbromide Associates 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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies of Hydrocodone Bitartrate/Homatropine Methylbromide Associates in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Hydrocodone Bitartrate/Homatropine Methylbromide Associates. It is also not known whether Hydrocodone Bitartrate/Homatropine Methylbromide Associates can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydrocodone Bitartrate/Homatropine Methylbromide Associates 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/Homatropine Methylbromide Associates 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/Homatropine Methylbromide Associates, 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/Homatropine Methylbromide Associates in children under six have not been established.

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/Homatropine Methylbromide Associates may produce constipation.

Genitourinary System

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

Respiratory Depression

Hydrocodone Bitartrate/Homatropine Methylbromide Associates may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSE).

Dermatological

Skin rash, pruritus.

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/Homatropine Methylbromide Associates 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.