Chlorpheniramine and Codeine

TUXARIN ER 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. TUXARIN ER is a combination of codeine, an opioid agonist, and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, 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. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve TUXARIN ER for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Codeine Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic and antitussive properties of codeine have been speculated to come from its conversion to morphine. The precise mechanism of action of codeine and other opiates is not known, however, codeine is believed to act centrally on the cough center. In excessive doses, codeine 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: 1 tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. 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.

TUXARIN ER is contraindicated for: All children younger than 12 years of age. Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. TUXARIN ER 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. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within 14 days. Hypersensitivity to codeine, chlorpheniramine, or any of the inactive ingredients in TUXARIN ER.

Boxed warning: exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor closely for these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. 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.

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse Life-threatening respiratory depression Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children 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 Interactions with MAOI Severe hypotension Neonatal Opioid Withdrawal Syndrome Adrenal insufficiency The following adverse reactions have been identified during clinical studies, or during post-approval use of codeine and/or chlorpheniramine.

No specific drug interaction studies have been conducted with TUXARIN ER. Phenytoin: Avoid concomitant use, may increase phenytoin levels. Serotonergic drugs: Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. Muscle relaxants: Avoid concomitant use. Diuretics: Codeine may reduce the efficacy of diuretics. Monitor for reduced effect. Anticholinergic drugs: Concurrent use may cause paralytic ileus.

Store at 20 to 25°C (68 to 77°F).