๐ Indications & Clinical Dosage
*NSAID-associated gastric ulcer:*
Adult: 20 mg once daily for 4-8 weeks
BY IV INJ, OR BY INF: Adult: 20 mg daily continue until oral administration possible, injection to be given over at least 3 minutes.
*Prophylaxis of NSAID-associated gastric or duodenal ulcer:*
BY IV INJ, OR BY INF: Adult: 20 mg daily continue until oral administration possible, injection to be given over at least 3 minutes.
*Gastro-oesophageal reflux disease (in the presence of erosive reflux oesophagitis):*
Child 1-11 years (body-weight 10 kg and above): 10 mg once dailyfor 8 weeks. Child above 12yrs and adults: Initially 40 mg once daily for 4 weeks,continued for further 4 weeks if symptoms persist; maintenance 20 mg daily.
BY IV INJ, OR BY INF: Adult: 40 mg daily continue until oral administration possible, injection over at least 3 minutes.
*Symptomatic treatment of Gastro-Oesophageal Reflux Disease GORD (in the absence of oesophagitis):*
Child 1-11 years (body-weight 10 kg and above): 10 mg once daily for up to 8 weeks
Children above 12yrs and adults: 20 mg once daily for up to 4 weeks, continue for further 4 wks if required.
BY IV INJ, OR BY INF: Adult: 20 mg once daily continue until oral administration is possible, injection to be given over at least 3 minutes.
*Zollinger-Ellison syndrome:*
Adult: 40 mg twice daily, adjusted according to response; usual dose 80-160 mg daily.
*Severe peptic ulcer bleeding (following endoscopic treatment):*
BY INF: Adult: 80 mg, to be given over 30 minutes, then (by continuous intravenous INF) 8 mg/hour for 72 hours, then (by mouth) 40 mg once daily for 4 wks.
*Helicobacter pylori eradication in combination with clarithromycin and amoxicillin or metronidazole:*
Adult: 20 mg twice daily
Children: Not recommended.
๐ Mode of Administration
Continuous or intermittent IV infusion in NaCI 0.9%. Reconstitute 40-80 mg with up to 100 ml infusion fluid; For Intermittent infusion, give requisite dose over 10-30 min. For IV injection: Adults: Reconstitute powder with 5 ml NS. For IV infusion: Children: Initially reconstitute powder with 5 ml of NS, then further dilute to a final volume of 50 ml. Adults:
Initially reconstitute powder with 5 ml of NS, LR, D5W, then further dilute to a final volume of 50 ml. Reconstituted solution in NS or LR should be used in 12 hours.
โ ๏ธ Precautions & Warnings
Exclude malignancy prior to treatment, prolong use, renal impairment, severe hepatic impairment; in adults in severe hepatic impairment max. 20mg daily, in children 1-11years max 10 mg daily in severe impairment.
๐ Drug Interactions
Diazepam, citalopram, ketoconazole, itraconazole, imipramine, clomipramine, phenytoin, other drugs metabolized by CYP2C19, warfarin
โ ๏ธ Adverse Reactions / Side Effects
Headache, GI upset, skin reaction, dry mouth, rarely angioedema, anaphylaxis.
๐คฐ Pregnancy & Lactation Safety
Pregnancy Risk:
Use only if clearly needed
Lactation / Breastfeeding:
Contraindicated
๐งช Compatibility & Storage Stability
Stability & Storage: Store vials at 25C; excursions permitted to 15C-30C. Protect from light. Reconstituted solution for infusion prepared in D5W should be used in 6 hours.