Codeine and Promethazine

Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs 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 under 12 years of age. Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine HCl and Codeine Phosphate Oral Solution 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. Promethazine Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Promethazine possesses antihistamine (H 1 receptor antagonist), antiemetic, sedative, and anticholinergic effects. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Adults 18 years of age and older: 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours. Measure Promethazine HCl and Codeine Phosphate 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.

Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for: All children younger than 12 years of age. Postoperative pain management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Promethazine HCl and Codeine Phosphate Oral Solution 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. A history of an idiosyncratic reaction to promethazine or to other phenothiazines.

Boxed warning: Addiction, Abuse, and Misuse Promethazine HCl and Codeine Phosphate Oral Solution 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. Neuroleptic Malignant Syndrome: Monitor during therapy. Paradoxical Reactions: 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 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 Neuroleptic Malignant Syndrome Paradoxical reactions, including dystonias Seizures Interactions with MAOI Bone marrow suppression Severe hypotension Neonatal Opioid Withdrawal Syndrome Adrenal insufficiency The following adverse reactions have been identified during clinical studies, in the literature, or during postapproval use of codeine and/or promethazine.

No specific drug interaction studies have been conducted with Promethazine HCl and Codeine Phosphate Oral Solution. 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), excursions permitted from 15° to 30°C (59° to 86°F). Protect from light.