Homatropine methylbromide and Hydrocodone

Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: Not indicated for pediatric patients under 18 years of age. Contraindicated in pediatric patients less than 6 years of age. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.

Hydrocodone Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known, however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration. Homatropine Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.

Adults 18 years of age and older: One tablet or 5 mL of the oral solution every 4 to 6 hours as needed, not to exceed six tablets or 30 mL in 24 hours. Measure hydrocodone bitartrate and homatropine methylbromide oral solution with an accurate milliliter measuring device. Do not increase the dose or dosing frequency. Prescribe for the shortest duration consistent with treatment goals. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. Reevaluate patient prior to refilling. Do not rapidly reduce or abruptly discontinue in a physically-dependent patient.

Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: All pediatric patients younger than 6 years of age. Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected gastrointestinal obstruction, including paralytic ileus. Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide. Children younger than 6 years of age. Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.

Boxed warning: Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. Seizures in patients with seizure disorders: Monitor during therapy. Severe hypotension: Monitor during initiation of therapy.

The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse Life-threatening respiratory depression Accidental overdose and death due to medication errors Decreased mental alertness with impaired mental and/or physical abilities Interactions with benzodiazepines and other CNS depressants Paralytic ileus, gastrointestinal adverse reactions Increased intracranial pressure Obscured clinical course in patients with head injuries Seizures Severe hypotension Neonatal Opioid Withdrawal Syndrome Adrenal insufficiency The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine.

No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide. Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. Muscle Relaxants: Avoid concomitant use. Diuretics: Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. Anticholinergic drugs: Concurrent use may cause paralytic ileus.

Store oral solution at controlled room temperature 20°C to 25°C (68°F to 77°F).