HYCODAN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HYCODAN (HYCODAN).

How it works

Hydrocodone is a full mu-opioid receptor agonist; homatropine is an anticholinergic agent that reduces excessive respiratory tract secretions.

What the body does with it

Metabolism	Hydrocodone: CYP3A4 and CYP2D6 to hydromorphone; homatropine: not extensively metabolized.
Excretion	Renal elimination of unchanged drug (hydrocodone: ~26%; homatropine: negligible) and glucuronide conjugates (hydrocodone: ~40% as hydromorphone and norhydrocodone). Biliary/fecal excretion accounts for ~20-30%.
Half-life	Terminal elimination half-life of hydrocodone is 3.8-5.7 hours (mean 4.5 h) in adults; clinical duration of analgesia is 4-6 hours. Half-life may be prolonged in hepatic or renal impairment.
Protein binding	Hydrocodone: ~30-40% bound to plasma proteins (primarily albumin). Homatropine: minimal binding.
Volume of Distribution	Hydrocodone: Vd ~2.5-3.0 L/kg (range 2.0-3.5 L/kg), indicating extensive tissue distribution.
Bioavailability	Oral bioavailability of hydrocodone: ~50-70% (first-pass metabolism reduces bioavailability).
Onset of Action	Oral: 10-20 minutes for analgesia; peak effect at 30-60 minutes.
Duration of Action	Analgesic duration: 4-6 hours (immediate-release). Antitussive effect may persist up to 6 hours.

Classification & Brands

Dosing & administration

1 tablet (5 mg hydrocodone/1.5 mg homatropine) orally every 4 to 6 hours as needed for cough; maximum 6 tablets per 24 hours.

Dosage form	SYRUP
Renal impairment	eGFR 30-89 mL/min: No adjustment necessary. eGFR 15-29 mL/min: Initiate with 50% of usual dose and monitor for adverse effects. eGFR <15 mL/min or dialysis: Not recommended due to risk of toxicity.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50% or extend dosing interval. Child-Pugh Class C: Avoid use.
Pediatric use	Children ≥6 years: 0.2 mL/kg (0.1 mg/kg hydrocodone) orally every 4-6 hours as needed; maximum 6 doses per 24 hours. Children <6 years: Not recommended.
Geriatric use	Initiate with 50% of adult dose (0.5 tablet) every 6 hours; titrate cautiously due to increased risk of respiratory depression, falls, and cognitive impairment.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for HYCODAN (HYCODAN).

Breastfeeding	Hydrocodone (active metabolite) is excreted in breast milk; M/P ratio approximately 2.0. Relative infant dose estimated 2-4% of weight-adjusted maternal dose. Caution: CNS depression in infants, especially with high maternal doses or poor metabolizers (CYP2D6). AAP considers hydrocodone compatible with breastfeeding but with monitoring.
Teratogenic Risk	First trimester: Limited data; opioid use associated with neural tube defects and congenital heart defects (odds ratio ~1.5-2.0). Second trimester: No specific malformation risk, but prolonged use may lead to fetal opioid dependence. Third trimester: Risk of neonatal opioid withdrawal syndrome (NOWS) in up to 60% of exposed neonates; also associated with preterm birth and low birth weight.

Warnings & precautions

■ FDA Black Box Warning

Risk of opioid addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion of even one dose may be fatal in children; neonatal opioid withdrawal syndrome; interaction with alcohol or CNS depressants; risks from concomitant use with benzodiazepines or other CNS depressants; additive effects when used with CNS depressants.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to hydrocodone or homatropine","Significant respiratory depression","Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment","Known or suspected gastrointestinal obstruction","Paralytic ileus","Use in children less than 18 years of age for post-tonsillectomy/adenoidectomy pain management"]

Clinical Precautions

Precautions

["Respiratory depression","Drug dependence","Risk of abuse and addiction","Concomitant use with CYP3A4 inhibitors or inducers may alter effects","Risks in patients with head injury or increased intracranial pressure","Severe hypotension","Avoid in patients with known or suspected gastrointestinal obstruction"]

Clinical Tips & Counseling

Drug interactions

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HYCODAN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HYCODAN (HYCODAN).

How it works

Hydrocodone is a full mu-opioid receptor agonist; homatropine is an anticholinergic agent that reduces excessive respiratory tract secretions.

What the body does with it

Metabolism	Hydrocodone: CYP3A4 and CYP2D6 to hydromorphone; homatropine: not extensively metabolized.
Excretion	Renal elimination of unchanged drug (hydrocodone: ~26%; homatropine: negligible) and glucuronide conjugates (hydrocodone: ~40% as hydromorphone and norhydrocodone). Biliary/fecal excretion accounts for ~20-30%.
Half-life	Terminal elimination half-life of hydrocodone is 3.8-5.7 hours (mean 4.5 h) in adults; clinical duration of analgesia is 4-6 hours. Half-life may be prolonged in hepatic or renal impairment.
Protein binding	Hydrocodone: ~30-40% bound to plasma proteins (primarily albumin). Homatropine: minimal binding.
Volume of Distribution	Hydrocodone: Vd ~2.5-3.0 L/kg (range 2.0-3.5 L/kg), indicating extensive tissue distribution.
Bioavailability	Oral bioavailability of hydrocodone: ~50-70% (first-pass metabolism reduces bioavailability).
Onset of Action	Oral: 10-20 minutes for analgesia; peak effect at 30-60 minutes.
Duration of Action	Analgesic duration: 4-6 hours (immediate-release). Antitussive effect may persist up to 6 hours.

Classification & Brands

Dosing & administration

1 tablet (5 mg hydrocodone/1.5 mg homatropine) orally every 4 to 6 hours as needed for cough; maximum 6 tablets per 24 hours.

Dosage form	SYRUP
Renal impairment	eGFR 30-89 mL/min: No adjustment necessary. eGFR 15-29 mL/min: Initiate with 50% of usual dose and monitor for adverse effects. eGFR <15 mL/min or dialysis: Not recommended due to risk of toxicity.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50% or extend dosing interval. Child-Pugh Class C: Avoid use.
Pediatric use	Children ≥6 years: 0.2 mL/kg (0.1 mg/kg hydrocodone) orally every 4-6 hours as needed; maximum 6 doses per 24 hours. Children <6 years: Not recommended.
Geriatric use	Initiate with 50% of adult dose (0.5 tablet) every 6 hours; titrate cautiously due to increased risk of respiratory depression, falls, and cognitive impairment.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for HYCODAN (HYCODAN).

Breastfeeding	Hydrocodone (active metabolite) is excreted in breast milk; M/P ratio approximately 2.0. Relative infant dose estimated 2-4% of weight-adjusted maternal dose. Caution: CNS depression in infants, especially with high maternal doses or poor metabolizers (CYP2D6). AAP considers hydrocodone compatible with breastfeeding but with monitoring.
Teratogenic Risk	First trimester: Limited data; opioid use associated with neural tube defects and congenital heart defects (odds ratio ~1.5-2.0). Second trimester: No specific malformation risk, but prolonged use may lead to fetal opioid dependence. Third trimester: Risk of neonatal opioid withdrawal syndrome (NOWS) in up to 60% of exposed neonates; also associated with preterm birth and low birth weight.