Esotid Capsule 40mg

Esotid

Esomeprazole

Description: Esomeprazole (Esetid is the S-isomer of omeprazole, which is a

Risomers

mature of the 5-and

Composition

Esotid 20 mg Tabiet: Each enteric-coated 22.21 mg equivalent to Esomeprazole 20 mg tablet contains Esomeprazole Magresum Trihydrate USP Esotid 40 mg Tablet: Each enteric-coated tablet contains Esomeprazole Magresium Trihydrate USP Each capsule contains Esomeprazole Magnesium Three

42 mg equivalent to Esomeprazole 40 mg Esolid 20 equivalent to Esomeprazole 20 mg in enteric coated pellets mg Capsule:

USP 22.21 mg

equivalent to Esomeprazole 40 mg in enteric coated pellets

Esotid 40 mg Capsule: Each capsule contains Esomeprazole Magnesium The USP 44.42 mg Mechanism of action: Esomeprazole is a proton pump inhibitor that suppresses genc acid secretion by specific inhibition of the HK-ATPase in the gastric parietal cell. The Sand R-isomers are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidy This effect is dose-related upto a daily dose of 20 to 40 mg and leads to inhibition

of gastric acid secretion

Pharmacokinetics: After oral administration peak plasma levels (Cmax) occur approximately 15 hours (Tmax) The Cmax increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated

once daily dosing with 40 mg, the systemic bioavailability is approximately 90% compared to 64% after a

single dose of 40 mg Esomeprazole should be taken at least one hour before meals Esomeprazole is

P450 (cyp) enzyme system

97% bound to plasma proteins Esomeprazole is extensively metabolized in the Wer by the cytochrome Indications: Treatment of Gastro-esophageal Reflux Disease (GERD) Healing of erosive esophagitis. maintenance of healing of erosive esophagitis, symptomatic gastro-esophageal reflux disease. H. pylon to reduce the risk of duodenal ulcer recurrence.

Dosage & administration Recommended Adult Dosage Schedule of Esomeprazole

Indications

Gastro-esophageal Reflux Disease (GERD)

Healing of erosive esophagitis

Maintenance of healing of erosive esophagitis Symptomatic gastro-esophageal reflux disease

Triple Therapy:

Esotid (Esomeprazole)

Moxin (Amoxicillin)

Clarithromycin

Dose

20 mg or 40 mg

20 mg 20 mg

Frequency

Once Daly for 40 8 Weeks

Once Daly"

Once Daily for 4 Weeks"

Hpylori eradication to reduce the risk of duodenal ulcer recurrence

40 mg 1000 mg

500 mg

Once Daily for 10 Days Twice Daily for 10 Days Twice Daly for 10 Days

"The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks for treatment may be considered. "Controlled studies dd not extend beyond six months. ***If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be.

Side effects: Esomepraze frequently occurring soverse events are headache, diarrhoea, nausea fatulence, constipation, and dry mouth. abdominal ser is well tolerated in both short and long term clinical trials. The s Esomeprazole is contraindicated in patients with known hypersensitivity to my component of the formulation or to substituted benzimidazoles Clarithromycin is contraindicated w Contraindications:

patients with a known hypersensitivity to any macrolide antibiotic Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant w Nursing mothers: The excretion of esomeprazole in milk has not been studied. A decision shou made whether to discontinue nursing or to discontinue the drug, taking into account the importance drug to the mother

Precautions: Proton pump inhibitors should be used with caution in liver disease, pregnancy and breas feeding. These may mask symptoms of gastric cancer, particular care is required in those who symptoms change and in those over 45 years of age, the presence of gastric malignancy should excluded before treatment. For patients with severe liver impairment, a dose of 20 mg should not be exceeded.

Overdosage: No specific antidote for esomeprazole is known. Since esomeprazole is extensively pre bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive

Drug Interactions: Esomeprazole is extensively metabolized in the liver. Co-administration of esomeprazole 30 mg and diazepam resulted in a 45% decrease in clearance of diazan Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absoon of drugs where gastric pH is an important determinant of bioavailability (eg ketoconazole, iron sahne digoxin) Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine did not som o change the pharmacokinetic profile of esomeprazole.

Storage: Store in a cool and dry place, protected from light.

Packaging

Esotid 20 mg Tablet: Each carton contains 14X7 tablets in blister with alu-alu sachet pack Esotid 40 mg Tablet: Each carton contains 14X3 tablets in blister with alu-alu sachet pack

Esotid 20 mg Capsule: Each carton contains 10X9 capsules in blister pack.

Esotid 40 mg Capsule: Each carton contains 10X6 capsules in blister pack.

Opsonin Pharma

Manufactured by

Opsonin Pharma Limited

Rupatali, Barishal, Bangladesh

Registered Trade Mark