Ezium™
[Esomeprazole]
Description / Properties
Esomeprazole is S-isomer of omeprazole & markedly differs from omeprazole in pharmacokinetic & pharmacodynamic properties.
Indications
Treatment of Gastroesophageal Reflux Disease (GERD), Healing of Erosive Esophagitis, Maintenance of Healing of Erosive Esophagitis, Symptomatic Gastroesophageal Reflux Disease, H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence.
Drug Interactions
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin). Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine did not seem to change the pharmacokinetic profile of esomeprazole.
Side Effects
Common: Headache, abdominal pain, diarrhea, flatulence, nausea, vomiting, dermatitis, dry mouth.
Gastrointestinal: Stomatitis & GI candidiasis. Hematological: Leucopenia, thrombocytopenia & pancytopenia.
Hepatic: Increased liver enzymes, encephalopathy in patients with existing liver disease. CNS & PNS. Paraesthesia, somnolence, insomnia, vertigo, reversible confusion, agitation, aggression, hallucinations.
Skin: Rashes, Steven Johnson syndrome & alopecia.
Others: Malaise, increased sweating, fever, bronchospasm.
Warning and Precautions
General: Symptomatic response to therapy with Ezium does not preclude the presence of gastric malignancy.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Esomeprazole was negative in the Ames mutation test, in the in vivo rat bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test. Esomeprazole, however, was positive in the in vitro human lymphocyte chromosome aberration test.
Dosage
GERD: 20 or 40 mg once daily for 4 to 8 weeks, Maintenance of healing of erosive esophagitis 20 mg once daily, For symptomatic reflux disease 20 mg once daily for 4 weeks, H.pylori eradication to reduce risk of duodenal ulcer 40 mg daily for 10 days along with Amoxicillin 1000 mg twice daily for 10 days & Clarithromycin 500 mg twice daily for 10 days.
Presentations Available
Ezium™ 20mg Capsules: available in alu-alu blister pack of 2x7 capsules
Ezium™ 40mg Capsules: available in alu-alu blister pack of 2x7 capsules
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