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Esomeprazole Sodium for Injection 40mg
Composition:
Each vial contains:
- Esomeprazole Sodium (equivalent to 40 mg of Esomeprazole)
Description:
Esomeprazole is a proton pump inhibitor (PPI) that inhibits gastric acid secretion by targeting the H+/K+-ATPase enzyme system in the gastric parietal cells. It is the S-isomer of omeprazole and has improved pharmacokinetics for longer acid suppression.
Indications:
Esomeprazole Sodium for Injection is indicated for:
- Gastroesophageal Reflux Disease (GERD) with erosive esophagitis
- Peptic Ulcer Disease (gastric and duodenal ulcers)
- Prevention of rebleeding in patients with gastric or duodenal ulcers
- Zollinger-Ellison Syndrome and other pathological hypersecretory conditions
- Stress ulcer prophylaxis in critically ill patients
Dosage & Administration:
Recommended Dosage (Adults Only):
- GERD with Erosive Esophagitis: 40 mg IV once daily for 7-10 days, followed by oral therapy
- Peptic Ulcer Disease: 40 mg IV once daily for 7-10 days
- Prevention of Rebleeding in Upper GI Bleeding: 80 mg IV bolus, followed by continuous infusion of 8 mg/hour for 72 hours, then switch to oral therapy
- Zollinger-Ellison Syndrome: Initial dose: 80 mg IV daily, then adjust based on acid output
Administration:
- Reconstitution:
- Add 10 mL of 0.9% sodium chloride (NaCl) injection to the 40 mg vial
- Shake gently until fully dissolved
- Further dilute in 100 mL of 0.9% NaCl or 5% dextrose before infusion
- Administration Method:
- IV infusion over 20-30 minutes
- Do not administer as IV push or bolus
Dose Adjustments:
- Hepatic Impairment: Maximum 20 mg/day in severe liver disease
- Renal Impairment: No dosage adjustment required
- Elderly Patients: No specific dose adjustment needed
Contraindications:
- Hypersensitivity to Esomeprazole, PPIs, or any excipients
- Coadministration with atazanavir or rilpivirine (reduces antiviral efficacy)
Precautions:
- Long-term use may increase the risk of:
- Clostridium difficile-associated diarrhea
- Osteoporosis-related fractures
- Vitamin B12 deficiency
- Hypomagnesemia
- Monitor liver function in patients with hepatic impairment
Adverse Reactions:
- Common: Headache, nausea, diarrhea, abdominal pain, dizziness
- Serious: Hypomagnesemia, interstitial nephritis, Clostridium difficile infection
Drug Interactions:
- Warfarin: Monitor INR for increased bleeding risk
- Methotrexate: May increase methotrexate toxicity
- Clopidogrel: May reduce antiplatelet effect-use alternative PPI if necessary
Overdose & Management:
- Symptoms: Dizziness, confusion, tachycardia
- Treatment: Symptomatic and supportive care (no specific antidote)
Storage Conditions:
- Store below 25°C, protect from light
- Use within 12 hours after reconstitution
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