Dosing and uses of Zutripro (hydrocodone/chlorpheniramine/pseudoephedrine)
Adult dosage forms and strengths
hydrocodone/chlorpheniramine/pseudoephedrine
oral solution: Schedule II
- (5mg/4mg/60mg)/5mL
Cough/Cold/Allergies
Indicated for relief of cough and nasal congestion associated with common cold or allergies in adults
5 mL PO q4-6hr PRN; not to exceed 4 doses (20 mL) in 24 hr
Renal & Hepatic Impairment
Severe renal or hepatic Impairment: Use with caution
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
Caution advised because of greater potential for renal or hepatic impairment
Consider decreasing dose and/or frequency
Zutripro (hydrocodone/chlorpheniramine/pseudoephedrine) adverse (side) effects
Frequency not defined
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
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
Cautions
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
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
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Zutripro (hydrocodone/chlorpheniramine/pseudoephedrine)
Mechanism of action
Hydrocodone: Antitussive; narcotic agonist analgesic
Chlorpheniramine: Antihistamine; histamine H1-receptor antagonist; also elicits anticholinergic effects
Pseudoephedrine: Decongestant; alpha adrenergic agonist
Absorption
Peak Plasma Time
- Hydrocodone: 1.4 hr
- Chlorpheniramine: 2-3 hr
- Pseudoephedrine: 1.97 hr
Peak Plasma Concentration
- Hydrocodone: 10.6 ng/mL
- Chlorpheniramine: 7.2 ng/mL
- Pseudoephedrine: 212 ng/mL
Distribution (Vd)
- Chlorpheniramine: 4-7 L/kg (children); 6-12 L/kg (adults)
- Pseudoephedrine: 2.5 L/kg (children); 2.64-3.51 L/kg
Metabolism
Hydrocodone: Metabolized to hydromorphone via CYP2D6
Chlorpheniramine: GI mucosa, liver
Pseudoephedrine: Liver, by N-demethylation
Elimination
Excretion
- Hydrocodone: Urine (26%)
- Chlorpheniramine: Urine
- Pseudoephedrine: Urine (43-96%)
Half-life
- Hydrocodone: 3.3-4.4 hr
- Chlorpheniramine: 10-13 hr (children); 14-24 hr (adults)
- Pseudoephedrine: 3 hr (children); 9-16 hr (adults)
Pharmacogenomics
Hydrocodone is metabolized to hydromorphone via CYP2D6; CYP2D6 poor metabolizers may not achieve adequate analgesia
Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion
