(Codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII
The lead programme in Vernalis' cough cold pipeline, Tuzistra® XR, was approved by the US FDA in April 2015 for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
To access the Tuzistra® XR product website please click here.
Tuzistra® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII, is the first product from Vernalis' development and licensing deal with Tris to be approved by FDA.
Proof-of-concept was achieved in March 2013, with the pivotal single dose and multi dose bioavailability studies completed by February 2014. The NDA was submitted to FDA in June 2014 and approval granted on 30 April 2015.
Tris supplies the product to Vernalis and Vernalis is promoting the product in the US prescription cough cold market.
Tuzistra® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension is a Schedule III (CIII) DEA controlled drug that has been approved by the FDA:
• for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older;
• Important Limitations of Use: Not indicated for pediatric patients under 18 years of age.
Tuzistra® XR is administered as an oral dose of 10mL every 12 hours and may be taken with or without food.
Like other codeine-containing products, Tuzistra® XR has a Boxed Warning relating to the use of codeine in children.
IMPORTANT SAFETY INFORMATION
WARNING: DEATH RELATED TO ULTRA RAPID METABOLISM OF CODEINE TO MORPHINE
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
Concomitant Use with Benzodiazepines, CNS Depressants
- Postoperative pain management of children undergoing 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. Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype, which prevalence varies widely, and is estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs.
- 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.
- Dose-related respiratory depression: Use with caution, including when used postoperatively, in patients with pulmonary disease or shortness of breath, or whenever ventilator function is depressed. Overdose of codeine in adults has been associated with fatal respiratory depression, and the use of codeine in children has been associated with fatal respiratory depression. If respiratory depression occurs, discontinue the drug and use naloxone or other supportive measures as necessary.
- 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.
- Obstructive Bowel Disease Caution: Chronic use may result in constipation or chronic obstructive bowel disease, especially in patients with underlying intestinal motility disorders.
- Acute abdominal conditions: Use with caution in patients with acute abdominal conditions.
- Dosing Caution: Measure dose with an accurate milliliter measuring device; a household teaspoon is not accurate and could lead to overdosage, resulting in serious adverse reactions.
- Special risk patients: Caution in elderly patients and those with asthma, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture.
- 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 Vernalis Therapeutics, Inc. at 1-855-705-9546 and email@example.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.