Hydromet

Actavis Mid Atlantic LLC
Actavis Mid Atlantic LLC

FORM NO. 1030 Rev. 3/08 VC3089

FULL PRESCRIBING INFORMATION

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 (one teaspoonful) contains:

Hydrocodone Bitartrate ........................ 5 mg

Homatropine Methylbromide ............... 1.5 mg

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, has a molecular weight of 494.490, and may be represented by the following structural formula:

Inactive Ingredients: Artificial Cherry Flavor, Citric Acid, D&C Red #33, FD&C Blue #1, FD&C Red #40, Methylparaben, Propylene Glycol, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Citrate, Sucrose.

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 psychological 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-ß-hydroxymetabolites.

For the symptomatic relief of cough.

Should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

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).

Hydrocodone 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.

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.

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

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 pediatric patients with respiratory embarrassment (e.g., croup).

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.

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 function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.

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 this product should be cautioned accordingly.

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.

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.

Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide. It is also not known whether this product 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.

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.

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 discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide in pediatric patients 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 and homatropine methylbromide may produce constipation.

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

Respiratory Depression: Hydrocodone may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

Dermatological: Skin rash, pruritus.

Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III controlled substance. 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.

Signs And Symptoms: Serious overdose 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 this product 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 against 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, including treatment for anticholinergic drug intoxication. Gastric emptying may be useful in removing unabsorbed drug.

Adults: One (1) teaspoonful (5 mL) every four to six hours as needed; do not exceed six (6) teaspoonfuls in 24 hours.

Children 6 To 12 Years Of Age: One-half (½) teaspoonful (2.5 mL) every four to six hours as needed; do not exceed three (3) teaspoonfuls in 24 hours.

This preparation is a red colored, cherry flavored syrup containing 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide per 5 mL, and is available in one pint (473 mL).

Store at controlled room temperature 15°-30°C (59°-86°F).

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

Oral prescription where permitted by State Law.

Manufactured by

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

FORM NO. 1030

Rev. 3/08

VC3089