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Tuzistra Xr Generic Name & Formulations
Legal Class
CIII
General Description
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.
Pharmacological Class
Antitussive + antihistamine.
How Supplied
Susp—473mL
Manufacturer
Generic Availability
NO
Tuzistra Xr Indications
Indications
Cough and symptoms associated with upper-respiratory allergies or common cold.
Tuzistra Xr Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Use accurate measuring device. ≥18yrs: 10mL every 12hrs; max 20mL/24hrs.
Children
<18yrs: not established.
Tuzistra Xr Contraindications
Contraindications
Children <12yrs. Post-op pain management in children <18yrs following tonsillectomy and/or adenoidectomy.
Tuzistra Xr Boxed Warnings
Boxed Warning
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.
Tuzistra Xr Warnings/Precautions
Warnings/Precautions
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.
Tuzistra Xr Pharmacokinetics
See Literature
Tuzistra Xr Interactions
Interactions
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.
Tuzistra Xr Adverse Reactions
Adverse Reactions
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.
Tuzistra Xr Clinical Trials
See Literature
Tuzistra Xr Note
Not Applicable
Tuzistra Xr Patient Counseling
See Literature
