📋 Indications & Clinical Dosage
*Reflux oesophagitis:*
Adults: 20 mg once daily for 4 wk, extend for a further 4-8 weeks if not fully healed.
*Refractory cases:*
Adults: 40 mg once daily.
*Acid-reflux disease:*
Adults: Long-term management, 10 mg once daily, increased to 20 mg once daily if symptoms return.
*Benign Duodenal ulceration:*
Adults: 20 mg once daily for 4 weeks. Severe cases; increased to 40 mg once daily.
*Prevention of relapse:*
Adults:10 mg once daily, increasing to 20 mg once daily if symptoms return.
*Duodenal ulceration with Helicobacter pylori:*
Adults: 40 mg daily with amoxicillin 1.5-2 gm daily for 2 weeks.
*Benign Gastric ulceration:*
Adults: 20 mg once daily for 8 wk. Severe cases: increase to 40 mg once daily.
*Zollinger-Ellison syndrome:*
Adults: 60 mg once daily adjusted to response. Usual maintenance: 20-120 mg daily. Doses over 80 mg daily are given in two divided doses
*Acid aspiration:*
Adults: 40 mg in the evening of day before surgery, then 40 mg 1-4 hour prior to surgery.
Children: Not recommended.
⚠️ Precautions & Warnings
Exclude malignancy before treatment, hepatic impairment. Monitor serum B12 in severely ill patients on long term treatment.
🔄 Drug Interactions
Phenytoin, warfarin, digoxin Diazepam, ketoconazole, itraconazole.
⚠️ Adverse Reactions / Side Effects
Headache, somnolence, insomnia, arthralgia, GI upset, skin rashes, paraesthesia, dizziness, myalgia, increased risk of GI infections. Increase in liver enzymes.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Risk cannot be ruled out.
Lactation / Breastfeeding:
Not recommended.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.