HELICOSOL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HELICOSOL (HELICOSOL).

How it works

Bismuth subsalicylate exerts antibacterial activity against Helicobacter pylori by inhibiting bacterial adhesion to gastric mucosa, suppressing urease activity, and disrupting bacterial cell wall synthesis. It also has local anti-inflammatory and cytoprotective effects on gastric mucosa.

What the body does with it

Metabolism	Bismuth subsalicylate is primarily hydrolyzed in the gastrointestinal tract to bismuth and salicylate. Salicylate is absorbed and undergoes hepatic metabolism via glucuronidation and oxidation, while bismuth is largely excreted unchanged in feces.
Excretion	Primarily renal (approximately 70% as unchanged drug and 15% as metabolites); biliary/fecal excretion accounts for about 10%.
Half-life	8-12 hours; prolonged in renal impairment (up to 30 hours in severe impairment).
Protein binding	85-90%; primarily bound to albumin.
Volume of Distribution	0.6-0.8 L/kg; indicates distribution into total body water with some tissue binding.
Bioavailability	Oral: 60-80% with interindividual variability; IM: 90-100%.
Onset of Action	Oral: 1-2 hours; IV: rapid (within 15 minutes).
Duration of Action	8-12 hours; clinical effect correlates with serum concentrations above 2 µg/mL.

Classification & Brands

Dosing & administration

2.5 mg orally twice daily for 14 days

Dosage form	FOR SOLUTION
Renal impairment	GFR 30-50 mL/min: 2.5 mg once daily; GFR <30 mL/min: not recommended
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 2.5 mg once daily; Child-Pugh C: not recommended
Pediatric use	0.05 mg/kg orally twice daily for 14 days (max 2.5 mg/dose)
Geriatric use	No specific adjustment; use with caution due to increased risk of QT prolongation

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for HELICOSOL (HELICOSOL).

Breastfeeding	Unknown if excreted in human milk; M/P ratio not established. Caution advised; consider benefits vs risks.
Teratogenic Risk	Insufficient human data; animal studies show no teratogenicity at therapeutic doses. First trimester: theoretical risk, avoid unless essential. Second and third trimesters: no known fetal harm, but limited data.
Fetal Monitoring	Monitor maternal liver function tests and renal function. Fetal ultrasound for growth if used long-term.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to bismuth subsalicylate or salicylates","Children <12 years with varicella or influenza (risk of Reye syndrome)","Active gastrointestinal bleeding","Severe renal impairment"]

Clinical Precautions

Precautions

["Reye syndrome risk in children with viral infections due to salicylate component","May interfere with radiographic gastrointestinal studies","Prolonged use may lead to neurotoxicity from bismuth accumulation","Caution in patients with renal impairment","May cause temporary darkening of tongue and stool"]

Clinical Tips & Counseling

Drug interactions

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HELICOSOL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HELICOSOL (HELICOSOL).

How it works

What the body does with it

Metabolism	Bismuth subsalicylate is primarily hydrolyzed in the gastrointestinal tract to bismuth and salicylate. Salicylate is absorbed and undergoes hepatic metabolism via glucuronidation and oxidation, while bismuth is largely excreted unchanged in feces.
Excretion	Primarily renal (approximately 70% as unchanged drug and 15% as metabolites); biliary/fecal excretion accounts for about 10%.
Half-life	8-12 hours; prolonged in renal impairment (up to 30 hours in severe impairment).
Protein binding	85-90%; primarily bound to albumin.
Volume of Distribution	0.6-0.8 L/kg; indicates distribution into total body water with some tissue binding.
Bioavailability	Oral: 60-80% with interindividual variability; IM: 90-100%.
Onset of Action	Oral: 1-2 hours; IV: rapid (within 15 minutes).
Duration of Action	8-12 hours; clinical effect correlates with serum concentrations above 2 µg/mL.

Classification & Brands

Dosing & administration

2.5 mg orally twice daily for 14 days

Dosage form	FOR SOLUTION
Renal impairment	GFR 30-50 mL/min: 2.5 mg once daily; GFR <30 mL/min: not recommended
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 2.5 mg once daily; Child-Pugh C: not recommended
Pediatric use	0.05 mg/kg orally twice daily for 14 days (max 2.5 mg/dose)
Geriatric use	No specific adjustment; use with caution due to increased risk of QT prolongation

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for HELICOSOL (HELICOSOL).

Breastfeeding	Unknown if excreted in human milk; M/P ratio not established. Caution advised; consider benefits vs risks.
Teratogenic Risk	Insufficient human data; animal studies show no teratogenicity at therapeutic doses. First trimester: theoretical risk, avoid unless essential. Second and third trimesters: no known fetal harm, but limited data.
Fetal Monitoring	Monitor maternal liver function tests and renal function. Fetal ultrasound for growth if used long-term.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to bismuth subsalicylate or salicylates","Children <12 years with varicella or influenza (risk of Reye syndrome)","Active gastrointestinal bleeding","Severe renal impairment"]