SERAX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SERAX (SERAX).

How it works

SERAX (oxazepam) is a benzodiazepine that modulates GABA-A receptors, enhancing the inhibitory effect of GABA, leading to anxiolytic, sedative, and anticonvulsant effects.

What the body does with it

Metabolism	Primarily hepatic via glucuronide conjugation (glucuronidation) mediated by UDP-glucuronosyltransferases; not significantly metabolized by CYP450 enzymes.
Excretion	Primarily renal (urinary) as unchanged drug (60-80%) and metabolites (20-40%); less than 5% fecal elimination.
Half-life	Terminal elimination half-life is 8-15 hours (mean 12 hours) in adults; prolonged in renal impairment.
Protein binding	Approximately 85-95% bound to serum albumin.
Volume of Distribution	Vd ~0.7-1.1 L/kg (mean 0.9 L/kg), indicating extensive tissue distribution.
Bioavailability	Oral: 80-90%; IM: 95-100%.
Onset of Action	Oral: 30-60 minutes; IV: 1-3 minutes; IM: 10-15 minutes.
Duration of Action	Oral: 6-8 hours; IV: 3-4 hours; IM: 4-6 hours.

Classification & Brands

Action Class	Proteolytic Enzymes
Brand Substitutes	Serowel Tablet, Basebard 10mg Tablet, Serperite 10mg Tablet, Seridase 10mg Tablet, Serdase 10mg Tablet, Mucozen Forte 20mg Tablet, Exudase 20mg Tablet, Seriflam DS 20mg Tablet, Synotrip 20mg Tablet, Espidase 20mg Tablet, Zinase 20mg Tablet

Dosing & administration

Oral: 5-10 mg twice daily; maximum 20 mg/day. Intravenous: 2-5 mg slow IV push, may repeat after 2 hours.

Dosage form	TABLET
Renal impairment	GFR <30 mL/min: reduce dose by 50% or extend interval to every 12-24 hours. Not dialyzable.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: avoid use.
Pediatric use	Children <6 years: not recommended. 6-12 years: 1.25-2.5 mg orally 2-3 times daily; maximum 10 mg/day.
Geriatric use	Initial dose 2.5 mg once or twice daily; increase cautiously. Avoid use in elderly with hepatic impairment or CYP2C19 poor metabolizers.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SERAX (SERAX).

Breastfeeding	Serax (oxazepam) is excreted into breast milk in small amounts; M/P ratio approximately 0.3-0.5. Limited data suggest low risk of adverse effects in breastfed infants, but monitoring for sedation and feeding difficulties is advised. Consider alternative benzodiazepines with shorter half-lives and no active metabolites.
Teratogenic Risk	First trimester: Increased risk of major malformations, particularly orofacial clefts and neural tube defects, with exposure during weeks 4-10. Second and third trimesters: Risk of fetal neurobehavioral effects, including potential for neonatal withdrawal syndrome and persistent pulmonary hypertension of the newborn (PPHN). Avoid use throughout pregnancy unless absolutely necessary.

Warnings & precautions

■ FDA Black Box Warning

Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to benzodiazepines","Acute narrow-angle glaucoma","Severe respiratory insufficiency","Myasthenia gravis","Concurrent use with opioids (except in specific circumstances)"]

Clinical Precautions

Precautions

["Risk of respiratory depression, especially when used with opioids or other CNS depressants","Dependence and withdrawal reactions","Abuse potential","Paradoxical reactions (e.g., hostility, insomnia)","Impaired cognition and psychomotor function","Use with caution in hepatic impairment"]

Clinical Tips & Counseling

Drug interactions

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SERAX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SERAX (SERAX).

How it works

SERAX (oxazepam) is a benzodiazepine that modulates GABA-A receptors, enhancing the inhibitory effect of GABA, leading to anxiolytic, sedative, and anticonvulsant effects.

What the body does with it

Metabolism	Primarily hepatic via glucuronide conjugation (glucuronidation) mediated by UDP-glucuronosyltransferases; not significantly metabolized by CYP450 enzymes.
Excretion	Primarily renal (urinary) as unchanged drug (60-80%) and metabolites (20-40%); less than 5% fecal elimination.
Half-life	Terminal elimination half-life is 8-15 hours (mean 12 hours) in adults; prolonged in renal impairment.
Protein binding	Approximately 85-95% bound to serum albumin.
Volume of Distribution	Vd ~0.7-1.1 L/kg (mean 0.9 L/kg), indicating extensive tissue distribution.
Bioavailability	Oral: 80-90%; IM: 95-100%.
Onset of Action	Oral: 30-60 minutes; IV: 1-3 minutes; IM: 10-15 minutes.
Duration of Action	Oral: 6-8 hours; IV: 3-4 hours; IM: 4-6 hours.

Classification & Brands

Action Class	Proteolytic Enzymes
Brand Substitutes	Serowel Tablet, Basebard 10mg Tablet, Serperite 10mg Tablet, Seridase 10mg Tablet, Serdase 10mg Tablet, Mucozen Forte 20mg Tablet, Exudase 20mg Tablet, Seriflam DS 20mg Tablet, Synotrip 20mg Tablet, Espidase 20mg Tablet, Zinase 20mg Tablet

Dosing & administration

Oral: 5-10 mg twice daily; maximum 20 mg/day. Intravenous: 2-5 mg slow IV push, may repeat after 2 hours.

Dosage form	TABLET
Renal impairment	GFR <30 mL/min: reduce dose by 50% or extend interval to every 12-24 hours. Not dialyzable.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: avoid use.
Pediatric use	Children <6 years: not recommended. 6-12 years: 1.25-2.5 mg orally 2-3 times daily; maximum 10 mg/day.
Geriatric use	Initial dose 2.5 mg once or twice daily; increase cautiously. Avoid use in elderly with hepatic impairment or CYP2C19 poor metabolizers.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SERAX (SERAX).

Breastfeeding	Serax (oxazepam) is excreted into breast milk in small amounts; M/P ratio approximately 0.3-0.5. Limited data suggest low risk of adverse effects in breastfed infants, but monitoring for sedation and feeding difficulties is advised. Consider alternative benzodiazepines with shorter half-lives and no active metabolites.
Teratogenic Risk	First trimester: Increased risk of major malformations, particularly orofacial clefts and neural tube defects, with exposure during weeks 4-10. Second and third trimesters: Risk of fetal neurobehavioral effects, including potential for neonatal withdrawal syndrome and persistent pulmonary hypertension of the newborn (PPHN). Avoid use throughout pregnancy unless absolutely necessary.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to benzodiazepines","Acute narrow-angle glaucoma","Severe respiratory insufficiency","Myasthenia gravis","Concurrent use with opioids (except in specific circumstances)"]