TUZISTRA® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII
WARNING
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN
Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism.
TUZISTRA XR is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of TUZISTRA XR in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
INDICATIONS AND USAGE
TUZISTRA XR is a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H1) receptor antagonist indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Children less than 12 years of age
- Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
- Patients with known hypersensitivity to codeine, chlorpheniramine, or any of the product components of TUZISTRA XR.
WARNINGS AND PRECAUTIONS
- Risk of death in ultra-rapid metabolizers: Conversion of codeine into its active metabolite, morphine, may occur more rapidly and completely resulting in higher than expected morphine levels and respiratory depression or death.
- Risks from concomitant use with benzodiazepines or other CNS depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
- Dose-related respiratory depression: Use with caution.
- Drug dependence: Prescribe with caution that is appropriate to the use of other opioids.
- Head injury and increased intracranial pressure: Avoid in patients with head injury, intra-cranial lesions, or increased intracranial pressure.
- Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating heavy machinery. Avoid concurrent use of alcohol or other central nervous system depressants.
- Acute abdominal conditions: Use with caution in patients with acute abdominal conditions.
- Special risk patients: Caution in elderly patients and those with asthma, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture.
ADVERSE REACTIONS:
- Common adverse reactions of TUZISTRA XR include: nausea and vomiting, constipation, abdominal distension, abdominal pain, blurred vision, diplopia, visual disturbances, confusion, dizziness, depression, drowsiness, sedation, headache, euphoria, facial dyskinesia, feeling faint, light-headedness, general feeling of discomfort or illness, excitability, nervousness, agitation, restlessness, somnolence, insomnia, dyskinesia, irritability, tremor.
- To report SUSPECTED ADVERSE REACTIONS, contact Aytu BioPharma, Inc. at 1-855-AYTU BIO (1-855-298-8246) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning.
