BANCAP HC

Clinical safety rating: caution

Comprehensive clinical and safety monograph for BANCAP HC (BANCAP HC).

How it works

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.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for BANCAP HC (BANCAP HC).

Breastfeeding

Hydrocodone: Excreted in breast milk; relative infant dose estimated <5% of maternal weight-adjusted dose; M/P ratio not well characterized. Monitor infant for sedation, respiratory depression, and poor feeding. Acetaminophen: Compatible with breastfeeding; minimal excretion.

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.

Warnings & precautions

■ 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).

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to hydrocodone or acetaminophen, significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction (including paralytic ileus), severe hepatic impairment (acetaminophen).

Clinical Precautions

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 Tips & Counseling

Drug interactions

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BANCAP HC

Clinical safety rating: caution

Comprehensive clinical and safety monograph for BANCAP HC (BANCAP HC).

How it works

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.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for BANCAP HC (BANCAP HC).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Clinical Precautions

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 Tips & Counseling

Drug interactions

Loading safety data…