Rezira Generic Name & Formulations
Legal Class
CII
General Description
Hydrocodone bitartrate 5mg, pseudoephedrine hydrochloride 60mg; per 5mL; oral soln; grape-flavor.
Pharmacological Class
Antitussive + sympathomimetic.
How Supplied
Soln—480mL
Manufacturer
Rezira Indications
Indications
Cough and nasal congestion associated with common cold.
Rezira Dosage and Administration
Adult
Use accurate measuring device. ≥18yrs: 5mL every 4–6hrs as needed. Max: 4 doses (20mL) per 24hrs.
Children
<18yrs: not established.
Rezira Contraindications
Contraindications
During or within 14 days of MAOIs. Narrow angle glaucoma. Urinary retention. Severe hypertension. Severe coronary artery disease.
Rezira Boxed Warnings
Boxed Warning
Risks from concomitant use with benzodiazepines or other CNS depressants.
Rezira Warnings/Precautions
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.
Rezira Pharmacokinetics
See Literature
Rezira Interactions
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.
Rezira Adverse Reactions
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.
Rezira Clinical Trials
See Literature
Rezira Note
Not Applicable
Rezira Patient Counseling
See Literature