Chlorpheniramine and Hydrocodone

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important 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, and misuse with opioids, even at recommended doses, reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made.

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. Chlorpheniramine Chlorpheniramine is a propylamine derivative antihistamine (H 1 -receptor antagonist) of the alkylamine class that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Adults 18 years of age and older: 5 mL every 12 hours as needed, not to exceed 2 doses (10 mL) in 24 hours. Measure Hydrocodone Polistirex and Chlorpheniramine Polistirex 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.

Hydrocodone Polistirex and Chlorpheniramine Polistirex is contraindicated for: All children younger than 6 years of age. Hydrocodone Polistirex and Chlorpheniramine Polistirex is also contraindicated in patients with: 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, chlorpheniramine, or any of the inactive ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex. Children younger than 6 years of age. Significant respiratory depression.

Boxed warning: Addiction, Abuse, and Misuse Hydrocodone Polistirex and Chlorpheniramine Polistirex exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. See Boxed WARNINGS 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.

The following serious adverse reactions are described, or described in greater detail, in other sections: • 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 chlorpheniramine.

No specific drug interaction studies have been conducted with Hydrocodone Polistirex and Chlorpheniramine Polistirex. Phenytoin: Avoid concomitant use, may increase phenytoin levels. 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: Concomitant use may cause paralytic ileus.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Store away from direct sunlight.