Bismuth Subsalicylate

Mechanism :

Causes reabsorption of fluid and electrolytes across the intestine. It also results in the inhibition of synthesis of prostaglandins which reduces intestinal inflammation and hypermotility. Possesses topical mucosal effects, reduces secretions binds bacterial toxins; possesses antimicrobial effects for Bismuth Subsalicylate.

Indication :

Acute diarrhea
Chronic infantile diarrhea
Travellers Diarrhoea
Flatulence
Indigestion
Heartburn
Nausea

Contraindications :

• Hypersensitivity

• G6PD deficiency

• Coagulation disorders

• Bleeding from GIT

• Viral febrile infections

• Severe renal/hepatic impairment

• Caution in case of mild to moderate hepatic/renal impairment, gout, pregnancy <20 weeks of gestation (risk of renal dysfunction, oligohydramnios, premature closure of ductus arteriosus), lactation as salicylates can transfer via breast milk

• Influenza (patients < 20 years)

• Varicella (patients < 20 years)

Dosing :

Dosage forms:

Chewable tablet: 262 mg

Oral suspension:

262 mg/15 ml.

525 mg/15 mL.

525 mg/30 mL.

1050 mg/30 mL.

For acute diarrhea/gas/indigestion/heartburn/nausea:

<3 years: not established safe or efficacious or 2.5 mL (extra strength)

3-6 years: 1/3rd tablet or 5 ml (regular strength) or 5 mL (extra strength) suspension per oral every ½-1 hour as required

6-9 years: 2/3rd tablet or 10 ml (regular strength) or 7.5 mL (extra strength) suspension per oral every ½-1 hour as required

9-12 years: 1 tablet or 15ml (regular strength) or 15 mL (extra strength) suspension per oral every ½-1 hour as required

>12 years: 2 tablets or 30ml suspension per oral every ½-1 hour as required (maximum daily dose to not exceed more than 4200mg/24 hours. Give upto 3 weeks as prophylaxis for Travelers diarrhoea - during period of risk.)

For chronic infantile diarrhea:

<2 years: 2.5ml suspension every 4 hours.

2-4 years: 5ml suspension every 4 hours.

4-6 years: 10ml suspension every 4 hours.

For H Pylori infection:

<10 years: Part of multidrug regimen. 1 tablet or 15 ml suspension per oral every 6 hours/4 times a day for 14 days.

>10 years: Part of multidrug regimen. 2 tablets or 30 ml suspension per oral evert 6 hours/4 times a day for 14 days.

Adverse Effect :

• Common: nausea, diarrhea, abdominal pain

• Uncommon: upper respiratory tract infections, blood in stools, asthenia ,constipation, anorexia, vomiting, dyspepsia, stool abnormality, duodenal ulcer, flatulence, GI hemorrhage, anal discomfort, headache, dizziness, sinusitis, insomnia, paresthesia, pain (1%)

• Rare: anxiety, confusion, depression, weakness, muscle spasm, neurotoxicity, tinnitus

Interaction :

• Contraindicated: dichlorphenamide

• Serious: warfarin, tetracycline, demeclocycline, minocycline, oxytetracycline, doxycycline

• Requiring close monitoring: intranasal metoclopramide, beta-blockers (propranolol, acebutolol, carvedilol, atenolol, betaxolol, esmolol, labetalol, pindolol)

• Minor: omeprazole, esomeprazole, aspirin

Hepatic Dose :

• Not defined for pediatric population - refer to hepatic adjustments in adults