TUZISTRA XR CIII
Generic Name and Formulations:
Codeine polistirex 14.7 mg (equivalent to codeine phosphate 20mg), chlorpheniramine polistirex 2.8 mg (equivalent to chlorpheniramine maleate 4mg); per 5mL; ext-rel susp; cherry flavor.
Vernalis Therapeutics, Inc.
Indications for TUZISTRA XR:
Cough and symptoms associated with upper-respiratory allergies or common cold.
Use lowest effective dose for shortest duration. Use accurate measuring device. ≥18yrs: 10mL every 12hrs; max 20mL/24hrs.
<18yrs: not established.
Children <12yrs. Post-op pain management in children <18yrs following tonsillectomy and/or adenoidectomy.
Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children. Risk from concomitant use with benzodiazepines or other CNS depressants.
Risk of respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. children in post-op following tonsillectomy and/or adenoidectomy). Obstructive sleep apnea. Discontinue if respiratory depression occurs. Post-operatively. Compromised respiratory function (eg, pulmonary disease, depressed ventilator function). Abuse potential (monitor). Avoid in head injury, other intracranial lesions or pre-existing increase in intracranial pressure. Underlying intestinal motility disorders. Acute abdomen. Asthma. Persistent or chronic cough. Hypothyroidism. Addison’s disease. Prostatic hypertrophy. Urethral stricture. Severe hepatic or renal impairment. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
Antitussive + antihistamine.
Increased risk of respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, opioids, antihistamines, antipsychotics, anxiolytics, alcohol); avoid. During or within 14 days of MAOIs, concomitant TCAs: not recommended. Paralytic ileus may occur with anticholinergics. May potentiate phenytoin; monitor. May be affected by CYP2D6 and CYP3A4 inhibitors or inducers.
Nausea, vomiting, constipation, abdominal distension/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, insomina, dyskinesia, irritability, tremor; respiratory depression.