Classes
DEA Class; Rx
Common Brand Names; Zutripro
- Antitussives, Narcotic Combos
Description
Oral sedating antihistamine, opiate agonist antitussive, and decongestant combination
Used to relieve cough and congestion due to allergies, acute or chronic bronchitis, colds, and other acute respiratory infections
Not indicated in pediatric patients under 18 years of age; contraindicated in neonates, infants and children less than 6 years of age
Indications
Indicated for relief of cough and nasal congestion associated with common cold or allergies in adults
Contraindications
Hypersensitivity
Coadministration with MAOIs or within 14 ays of discontinuing MAOIs; may increase risk of hypertensive crisis
Narrow angle glaucoma
Urinary retention
Severe hypertension or severe coronary artery disease
Adverse Effects
Hydrocodone, an opioid, may result in respiratory depression, drug dependence, increased ICP, decreased mental alertness, or paralytic ileus
Pseudoephedrine, a sympathomimetic, may result in CNS effects (eg, insomnia, dizziness, weakness, tremor, convulsions or cardiovascular effects (eg, arrhythmias, increased blood pressure)
Chlorpheniramine, an antihistamine, may result in decreased mental alertness or anticholinergic effects (urinary retention, ileus)
Common adverse effects include sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, and tremor
Warnings
May cause dose-related respiratory depression; use with caution
Hydrocodone can cause drug dependence; prescribe with caution that is appropriate to the use of other opioids
Avoid use in patients with head injury or elevated ICP; opioids decrease respiratory depression and may increase ICP
May cause drowsiness; avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery
Elicits CNS depressant effects; avoid concurrent use of alcohol or other central nervous system depressants
Use with caution with acute abdominal conditions; opioids may obscure diagnosis and anticholinergics may increase risk of paralytic ileus
Coexisting conditions: Use with caution with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy or urethral stricture, or asthma
Use with TCAs may increase effects of hydrocodone or TCAs
Pseudoephedrine component may increase risk for hypertension
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone; because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol
Pregnancy and Lactation
Pregnancy Category: C
Lactation: Hydrocodone, chlorpheniramine, and pseudoephedrine are distributed in breast milk; caution advised, chlorpheniramine may suppress lactation is used prior to nursing
Maximum Dosage
NOTE: Do not exceed recommended dosage limits for the specific product prescribed.
Chlorpheniramine 16 mg/day PO; hydrocodone 20 mg/day PO; pseudoephedrine 240 mg/day PO.
Chlorpheniramine 16 mg/day PO; hydrocodone 20 mg/day PO; pseudoephedrine 240 mg/day PO.
Safety and efficacy have not been established.
6 years and older: Safety and efficacy have not been established.
Less than 6 years: Use is contraindicated.
Use is contraindicated.
How supplied
Hydrocodone/chlorpheniramine/pseudoephedrine
oral solution: Schedule II
- (5mg/4mg/60mg)/5mL