Cough and cold:

Indications for: TUZISTRA XR

Cough and symptoms associated with upper-respiratory allergies or common cold.

Adult Dosage:

Use lowest effective dose for shortest duration. Use accurate measuring device. ≥18yrs: 10mL every 12hrs; max 20mL/24hrs.

Children Dosage:

<18yrs: not established.

TUZISTRA XR Contraindications:

Children <12yrs. Post-op pain management in children <18yrs following tonsillectomy and/or adenoidectomy.

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:

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 Classification:

Antitussive + antihistamine.

TUZISTRA XR 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.

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.

Generic Drug Availability:

NO

How Supplied:

Susp—473mL