VERMIDOL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VERMIDOL (VERMIDOL).

How it works

VERMIDOL is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis and attenuating pain, inflammation, and fever.

What the body does with it

Metabolism	Primarily metabolized by the liver via CYP2C9 and CYP3A4 isoenzymes, with minor contributions from glucuronidation and sulfation.
Excretion	Renal: ~60-70% as unchanged drug; biliary/fecal: ~20-30%; minor metabolism via hepatic CYP3A4.
Half-life	Terminal elimination half-life: 8-12 hours (mean 10 h); prolonged in renal impairment (up to 24 h) and elderly.
Protein binding	95% bound primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	1.2-1.8 L/kg (mean 1.5 L/kg); indicates extensive tissue distribution.
Bioavailability	Oral: 70-85% (first-pass metabolism ~15%); intramuscular: 90-100%.
Onset of Action	Oral: 1-2 hours; intravenous: 5-10 minutes; intramuscular: 15-30 minutes.
Duration of Action	Oral: 6-8 hours; intravenous: 4-6 hours; intramuscular: 5-7 hours; clinical effect correlates with plasma levels above 0.5 mcg/mL.

Classification & Brands

Dosing & administration

200 mg orally twice daily for 3 days; maximum 400 mg per day.

Dosage form	SYRUP
Renal impairment	GFR 30-89 mL/min: no adjustment. GFR 15-29 mL/min: 200 mg once daily. GFR <15 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: 200 mg once daily. Child-Pugh C: contraindicated.
Pediatric use	Weight ≥10 kg: 200 mg orally twice daily for 3 days. Weight <10 kg: not recommended.
Geriatric use	No dose adjustment required; monitor renal function and consider reduced dosing in frailty.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VERMIDOL (VERMIDOL).

Breastfeeding	Excreted in human milk; M/P ratio 0.8. Limited data on infant exposure; potential for adverse effects (e.g., drowsiness). Caution advised; consider alternative therapy.
Teratogenic Risk	First trimester: Evidence of increased risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and limited human data. Third trimester: Risk of premature closure of ductus arteriosus and oligohydramnios. Avoid in pregnancy unless maternal benefit outweighs fetal risk.

Warnings & precautions

■ FDA Black Box Warning

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk. VERMIDOL is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Side Effect Profile

Serious Effects

Absolute Contraindications

History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; perioperative pain in CABG surgery; advanced renal disease; active gastrointestinal bleeding; third trimester of pregnancy; known hypersensitivity to VERMIDOL or its components.

Clinical Precautions

Precautions

Cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation; renal toxicity; hepatic toxicity; hypertension; anaphylactoid reactions; skin reactions including SJS/TEN; hematologic effects; fluid retention and edema; use during pregnancy especially third trimester; avoid use with aspirin or other NSAIDs.

Clinical Tips & Counseling

Drug interactions

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VERMIDOL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VERMIDOL (VERMIDOL).

How it works

What the body does with it

Metabolism	Primarily metabolized by the liver via CYP2C9 and CYP3A4 isoenzymes, with minor contributions from glucuronidation and sulfation.
Excretion	Renal: ~60-70% as unchanged drug; biliary/fecal: ~20-30%; minor metabolism via hepatic CYP3A4.
Half-life	Terminal elimination half-life: 8-12 hours (mean 10 h); prolonged in renal impairment (up to 24 h) and elderly.
Protein binding	95% bound primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	1.2-1.8 L/kg (mean 1.5 L/kg); indicates extensive tissue distribution.
Bioavailability	Oral: 70-85% (first-pass metabolism ~15%); intramuscular: 90-100%.
Onset of Action	Oral: 1-2 hours; intravenous: 5-10 minutes; intramuscular: 15-30 minutes.
Duration of Action	Oral: 6-8 hours; intravenous: 4-6 hours; intramuscular: 5-7 hours; clinical effect correlates with plasma levels above 0.5 mcg/mL.

Classification & Brands

Dosing & administration

200 mg orally twice daily for 3 days; maximum 400 mg per day.

Dosage form	SYRUP
Renal impairment	GFR 30-89 mL/min: no adjustment. GFR 15-29 mL/min: 200 mg once daily. GFR <15 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: 200 mg once daily. Child-Pugh C: contraindicated.
Pediatric use	Weight ≥10 kg: 200 mg orally twice daily for 3 days. Weight <10 kg: not recommended.
Geriatric use	No dose adjustment required; monitor renal function and consider reduced dosing in frailty.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VERMIDOL (VERMIDOL).

Breastfeeding	Excreted in human milk; M/P ratio 0.8. Limited data on infant exposure; potential for adverse effects (e.g., drowsiness). Caution advised; consider alternative therapy.
Teratogenic Risk	First trimester: Evidence of increased risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and limited human data. Third trimester: Risk of premature closure of ductus arteriosus and oligohydramnios. Avoid in pregnancy unless maternal benefit outweighs fetal risk.