BANCAP HC
Clinical safety rating
cautionComprehensive clinical and safety monograph for BANCAP HC (BANCAP HC).
BANCAP HC contains hydrocodone, a mu-opioid receptor agonist, and acetaminophen, which inhibits cyclooxygenase (COX) enzymes, primarily in the CNS, to reduce pain and fever.
| Metabolism | Hydrocodone is metabolized by CYP2D6 and CYP3A4 to hydromorphone (active) and norhydrocodone; acetaminophen is primarily metabolized by glucuronidation and sulfation, with minor CYP2E1 oxidation to NAPQI. |
| Excretion | Renal elimination of unchanged drug and metabolites: 90% (60% as glucuronide conjugates, 10% as unchanged drug, 5% as cysteine and mercapturic acid conjugates); biliary/fecal: 5%; the remainder as other metabolites. Renal clearance of hydrocodone is dose-dependent. |
| Half-life | Terminal elimination half-life: 3.8 hours (range 3.3–4.4 h) for hydrocodone; clinical context: requires dosing every 4–6 hours to maintain analgesic effect, with potential accumulation in renal impairment. |
| Protein binding | 20–30% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Vd: 3.5–4.0 L/kg; indicates extensive tissue distribution with high penetration into central nervous system. |
| Bioavailability | Oral: 70% (first-pass metabolism reduces bioavailability; range 60–80%). |
| Onset of Action | Oral: 10–20 minutes for analgesic effect; peak plasma concentrations at 1.3 hours. |
| Duration of Action | 4–6 hours for analgesia; clinical notes: duration is dose-dependent and may be shorter with lower doses; extended use may lead to tolerance. |
| Molecular Weight | Hydrocodone: 299.4 Da; Acetaminophen: 151.2 Da |
Each 5 mL contains hydrocodone bitartrate 5 mg and acetaminophen 500 mg. For moderate to moderately severe pain: 1 tablet (or 5 mL suspension) every 4 to 6 hours as needed; maximum single dose: 2 tablets (10 mL); maximum daily dose: 8 tablets (40 mL) due to acetaminophen limit.
| Dosage form | CAPSULE |
| Renal impairment | For GFR 30-50 mL/min: reduce dose to 75% of normal, extend interval to every 6 hours. For GFR <30 mL/min: avoid use; if necessary, use 50% of normal dose every 8 hours with careful monitoring. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: start at 50% of normal dose, titrate cautiously, maximum daily acetaminophen 2000 mg. Child-Pugh Class C: contraindicated. |
| Pediatric use | Weight-based: hydrocodone 0.1-0.2 mg/kg/dose (max 10 mg/dose) every 4-6 hours as needed; acetaminophen 10-15 mg/kg/dose (max 75 mg/kg/day). For BANCAP HC 5-500: 0.1-0.2 mL/kg/dose (max 10 mL/dose) every 4-6 hours. |
| Geriatric use | Initiate at 50% of adult dose (e.g., half tablet or 2.5 mL) every 6 hours; maximum daily acetaminophen 3000 mg; monitor renal function and avoid in frailty with GFR <30. |
| 1st trimester | Avoid if possible; contains hydrocodone (teratogenic risk) and acetaminophen (safe at therapeutic doses). |
| 2nd trimester | Use only if benefit outweighs risk; hydrocodone may cause fetal dependence and respiratory depression. |
| 3rd trimester | Avoid near term; hydrocodone can cause neonatal opioid withdrawal syndrome and respiratory depression. |
Clinical note
Comprehensive clinical and safety monograph for BANCAP HC (BANCAP HC).
| Placental transfer | Hydrocodone crosses the placenta (fetal/maternal ratio ~0.5-1.0). Acetaminophen crosses but no known adverse effects at therapeutic doses. |
| Breastfeeding | Hydrocodone is excreted into breast milk in small amounts; monitor infant for sedation and respiratory depression. Acetaminophen is considered safe. Consider alternative analgesia if prolonged use. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | BANCAP HC contains hydrocodone and acetaminophen. Hydrocodone: Risk not fully established; first trimester: potential association with congenital malformations (limited data); second and third trimesters: prolonged use may cause neonatal opioid withdrawal syndrome and respiratory depression at delivery. Acetaminophen: Generally considered low risk at therapeutic doses; prolonged high-dose use may be associated with fetal adverse effects. |
| Fetal Monitoring | Maternal: Assess pain control, respiratory status, liver function (acetaminophen toxicity risk), opioid tolerance/dependence. Fetal/Neonatal: Ultrasound for structural anomalies if exposed in first trimester; monitor for neonatal opioid withdrawal syndrome after prolonged third-trimester exposure; support respiratory function at delivery. |
| Fertility Effects | Hydrocodone may disrupt menstrual cycle via opioid-mediated hypothalamic-pituitary-gonadal axis suppression, potentially reducing fertility. Acetaminophen: No known significant effect on fertility. |
■ FDA Black Box Warning
Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; hepatotoxicity (acetaminophen).
| Serious Effects |
Hypersensitivity to hydrocodone, acetaminophen, or any componentSignificant respiratory depressionAcute or severe bronchial asthmaParalytic ileusKnown or suspected gastrointestinal obstructionConcurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping
| Precautions | Respiratory depression, drug interaction with CNS depressants, risk of hypotension, risk of serotonin syndrome, adrenal insufficiency, severe hypotension, seizures, hepatotoxicity (acetaminophen), opioid-induced hyperalgesia, dependency/tolerance. |
| Food/Dietary | Avoid alcohol completely. Grapefruit juice may increase hydrocodone levels; caution advised. High-fat meals may delay absorption of hydrocodone, but no specific food restrictions. |
| Clinical Pearls | BANCAP HC is a combination of hydrocodone (an opioid) and acetaminophen. Monitor for acetaminophen hepatotoxicity; maximum daily acetaminophen dose should not exceed 4 g in adults. Hydrocodone is a prodrug metabolized by CYP2D6 to hydromorphone; poor metabolizers may have reduced effect. Avoid concurrent use with other CNS depressants, including alcohol. Use with caution in patients with respiratory compromise, head injury, or biliary tract disorders. |
| Patient Advice | Take this medication exactly as prescribed; do not increase dose or frequency without consulting your doctor. · Acetaminophen is also present in many over-the-counter products; check labels to avoid exceeding 4000 mg per day. · Do not consume alcohol while taking this medication; risk of liver damage and increased sedation. · Avoid driving or operating heavy machinery until you know how this medication affects you. · Do not stop abruptly; withdrawal symptoms may occur. Consult your doctor for a tapering schedule. · Store securely away from children; accidental ingestion can be fatal. |
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