REZIRA ORAL SOLUTION CII

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REZIRA ORAL SOLUTION

Cough and cold
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Generic Name and Formulations:

Hydrocodone bitartrate 5mg, pseudoephedrine hydrochloride 60mg; per 5mL; grape-flavor.

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Indications for REZIRA ORAL SOLUTION:

Cough and nasal congestion associated with common cold.

Adult:

Use accurate measuring device. ≥18yrs: 5mL every 4–6hrs as needed. Max: 4 doses (20mL) per 24hrs.

Children:

<18yrs: not established.

Contraindications:

During or within 14 days of MAOIs. Narrow angle glaucoma. Urinary retention. Severe hypertension. Severe coronary artery disease.

Warnings/Precautions:

Risks from concomitant benzodiazepines or other CNS depressants (see Interactions). Discontinue if respiratory depression occurs. Abuse potential (monitor). Avoid in head injury, other intracranial lesions or pre-existing increase in intracranial pressure. Acute abdomen. Cardiovascular disorders. Diabetes. Thyroid disorders. Addison's disease. Prostatic hypertrophy. Urethral stricture. Asthma. Severe hepatic or renal impairment. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. Increased risk of respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, opioids, antihistamines, antipsychotics, anxiolytics, alcohol); avoid. Hypertensive crisis with MAOIs. May affect or be affected by TCAs. Paralytic ileus may occur with anticholinergics.

Pharmacological Class:

Antitussive + sympathomimetic.

Adverse Reactions:

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness or sleeplessness, tremor, arrhythmia; respiratory depression, cardiovascular effects.

How Supplied:

Soln—480mL