FDA approved Tuxarin Er (codeine/chlorpheniramine) for Cough and Upper Respiratory SymptomsFDA approved new cough medicine Tuxarin Er for adults only.

Codeine is an opioid agonist that acts on mu-opioid receptors in the cough center of the medulla to suppress cough. Chlorpheniramine is a histamine-1 (H1) receptor antagonist that reduces upper respiratory symptoms.

Tuxarin Er is indicated for temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years and older. It is not indicated for pediatric patients under 18 years. Contraindicated in children under 12 years and in children 12-18 years after tonsillectomy/adenoidectomy.

Adults 18 years and older: one tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. Do not increase dose or frequency. Prescribe for shortest duration consistent with treatment goals. Reevaluate unresponsive cough in 5 days or sooner. Taper dose gradually (25-50% every 2-4 days) when discontinuing in physically dependent patients.

Trial data not available in label.

Contraindicated in children under 12 years, postoperative management in children under 18 years after tonsillectomy/adenoidectomy, significant respiratory depression, acute/severe bronchial asthma in unmonitored setting, known/suspected GI obstruction, concurrent MAOI use or within 14 days, and hypersensitivity to codeine, chlorpheniramine, or other opioids. Warnings include addiction, abuse, misuse, respiratory depression, and risks in specific populations.

Tuxarin Er is a second-line option for adult patients with cough and upper respiratory symptoms from allergy or cold when non-opioid treatments are inadequate. Due to opioid risks, it should be reserved for patients where cough suppression benefits outweigh risks, and used for the shortest duration needed.