COLD CAPSULE V
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COLD CAPSULE V (COLD CAPSULE V).
Combination of acetaminophen (analgesic/antipyretic via COX inhibition in CNS), phenylephrine (alpha-1 adrenergic agonist causing vasoconstriction), and dextromethorphan (NMDA receptor antagonist and sigma-1 agonist suppressing cough).
| Metabolism | Acetaminophen: hepatic via CYP450 (primarily CYP2E1, also CYP1A2, CYP3A4) and glucuronidation/sulfation. Phenylephrine: hepatic via MAO-A. Dextromethorphan: hepatic via CYP2D6. |
| Excretion | Renal: 70% (inactive metabolites), Fecal: 25% (unabsorbed drug), Biliary: 5%. |
| Half-life | 4-6 hours; prolonged to 8-12 hours in hepatic impairment; no accumulation with q6h dosing in normal renal function. |
| Protein binding | 85% bound to albumin; 15% unbound (active fraction). |
| Volume of Distribution | 0.8-1.2 L/kg; indicates distribution into total body water; higher Vd in elderly due to increased fat tissue. |
| Bioavailability | Oral: 70-80% (first-pass metabolism reduces absorption); Rectal: 60-70% (irregular absorption); IM: 90-100%. |
| Onset of Action | Oral: 30-60 minutes; Peak effect at 1-2 hours. |
| Duration of Action | 4-6 hours; extended-release formulation up to 12 hours; clinical effect declines as serum concentration falls below therapeutic threshold. |
Chlorpheniramine 4 mg orally every 4-6 hours, not to exceed 24 mg/day; Dextromethorphan 15-30 mg orally every 6-8 hours, not to exceed 120 mg/day; Phenylephrine 10 mg orally every 4 hours, not to exceed 60 mg/day.
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Renal impairment | eGFR 30-59 mL/min: Reduce dose to 75% of normal; eGFR 15-29 mL/min: Reduce dose to 50% of normal; eGFR <15 mL/min: Use maximum 50% of normal dose, extend interval to every 12 hours. |
| Liver impairment | Child-Pugh A: No adjustment; Child-Pugh B: Reduce dose to 75% of normal; Child-Pugh C: Contraindicated or use 50% of normal dose with caution. |
| Pediatric use | Children 6-12 years: Chlorpheniramine 2 mg, Dextromethorphan 7.5 mg, Phenylephrine 5 mg orally every 4-6 hours, not to exceed 4 doses/day; Children 2-5 years: Chlorpheniramine 1 mg, Dextromethorphan 3.75 mg, Phenylephrine 2.5 mg orally every 6 hours, not to exceed 4 doses/day. |
| Geriatric use | Initial dose at 50% of normal adult dose; maximum Chlorpheniramine 12 mg/day, Dextromethorphan 60 mg/day, Phenylephrine 30 mg/day; monitor for anticholinergic effects, hypotension, and sedation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COLD CAPSULE V (COLD CAPSULE V).
| Breastfeeding | Acetaminophen: Compatible; excreted in breast milk with M/P ratio ~0.91. Chlorpheniramine: Excreted in breast milk; may cause drowsiness in infant; avoid due to anticholinergic effects. Phenylephrine: Excreted in breast milk; limited data; avoid due to potential cardiovascular effects. Pump and discard for 4 hours after dose. M/P ratio not well defined. |
| Teratogenic Risk | COLD CAPSULE V typically contains acetaminophen, chlorpheniramine, and phenylephrine. Acetaminophen: Low risk at therapeutic doses; no increased malformation rate. Chlorpheniramine: No clear teratogenic risk; avoid near term due to potential neonatal respiratory depression. Phenylephrine: Avoid in first trimester; possible association with gastroschisis. Pregnancy category C for phenylephrine. First trimester: Caution advised. Second/third trimester: Generally safe at recommended doses. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any component; concurrent use or within 14 days of MAO inhibitors; severe hypertension or coronary artery disease; pregnancy (phenylephrine may cause fetal hypoxia).
| Precautions | Do not exceed recommended dose due to risk of acetaminophen hepatotoxicity; avoid in patients with severe hypertension or coronary artery disease due to phenylephrine; caution in patients with asthma or chronic cough with excessive phlegm. |
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| Fetal Monitoring | Monitor maternal blood pressure and heart rate due to phenylephrine. Fetal ultrasound for development if used in first trimester. Assess neonatal respiratory status if chlorpheniramine used near term. Monitor liver function with prolonged acetaminophen use. |
| Fertility Effects | No significant effects reported for male or female fertility at therapeutic doses. Acetaminophen: Possible reduced sperm quality at high doses but not established. Chlorpheniramine and phenylephrine: No known impact on fertility. |