Ometid Capsule 20mg
10 capsules
Ometid
Omeprazole
Description Omeprazole (Omend") is a statuted benzimidazole, a compound that his gas secretion The stability of Omeprsace is Mode of action: Omeprazie (Ometid") press gastrie act secretion by speche webton of the HK stability under alkaline condos The hall te in teghty pr deperstars ATPase enzyme system at the secretory surface of the gastric parietal cel Decause this enzyme system regarded as the acid proton pump within the gastre mucosa, Omeprazole has been characterized as a gestric
acid-pung in that blacks the final step of acid production Pharmacokinetics: Abopon & Boevalability Absorption of Omeprazole begins only wher the granules leave the stomach Absorption is rapid, with peak plasma levels occurring within 0.5 to 35 hours. Absolute boevalability (compared with incavenous administration) is about 30-40% at doses of 20-40 mg in healthy subjects the plasma half-in 0.5 hour and the tal body clearance is 500-600 min Based on a relative bovalability study, the AUC and Cmax of Omeprazole Oral Suspension were 87% and 80% of those for Omeprazole Capsules respectively Disebuton Protein binding is approximately 95% Metabolism and Elimination Extensively metabokret by the cytochrome P450 enzyme aystem The majority of the dose (about (77%) is eliminated through urine
Composition Ometid 20 mg
Capsule: Each capsule (as enteric coated 23.5% Omeprazole peels contains Omeprazole P
20 mg Ometi 40 mg Capsule: Each capsule (as entenc coated 23.5% Omeprazole pellets) contains Omeprazole BP
Ometid 40 mg IV bjection: Each vial contains Omeprazole 40 mg as a sterte lyophilized Omeprazole Sodium BP indications with dosage & administration: Omeprazole Capsules or Oral Suspension should be taken before 30 minutes of meal
40m
Short-Term Treatment of Active Duodenal Ulcer: The recommended adult oral dose is 20 mg once daily. Most patients heal within four weeks Some patients may require an additional four weeks of therapy H pylon Eradication for the Reduction of the Risk of Duodenal Ulcer fiecurrence Triple Therapy The recommended adult oral regimen is Omeprazole 20 mg plus Clarithromycin 500 mg plus Amoxicillin 1000 mg each given twice daily for 10 days in patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole 20 mg once daily is recommended for ulcer healing and symptom relet. Dual Therapy The recommended adult oral regimen is Omeprazole 40 mg once daily plys Clarithromycin 500 mg three times daily for 14 days in patients with an ulcer present at the time of intiation of therapy, an additional 14
days of Omeprazole 20 mg once daily is recommended for uicer healing and symptom reliet
Gastric Ulcer: The recommended adult oral dose is 40 mg once daily for 4-8 weeks
Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose for the treatment of patients with
symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks
Maintenance of Healing of Erosive Esophagits: The recommended adult oral dose is 20 mg daily
Pathological Hypersecretory Conditions: The dosage of Omeprazole in patients with pathological hypersecretory conditions varies with the individual patent The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses Zollinger-Ellison Syndrome: Initially 60 mg once daily, usual range 20-120 mg. The dose above 80 mg should be administered in divided doses.
Pediatric Dose
700 mcg/kg once daily increased if necessary after 7-14 days to 1.4 mg/kg
Neonate
Child 1 years 700 micrograms/kg once daily, increased if necessary to 3 mg/kg once daily
Body weight 10-20 kg
Body weight over 20 kg
10 mg once daily increased it necessary to 20 mg once daily (in severe
ulcerating reflux oesophagitis, max. 12 weeks at higher dose)
20mg once daily increased if necessary to 40 mg once daily (in severe
ulcerating reflux oesophagitis max. 12 weeks at higher dose)
Contraindications: In patients with known hypersensitivity to any component of the formulation.
morgame, pomoce day 2x 40 mg once daily way C Hoche zyri raddanao with anatik Child 1-12 years h by Char 32-18 years
mg once daily Chad 1318 years
Omet IV Injection Indication
Dose
Prophylaxis of acid angination
40mg once daily
40 mg once daly 1 hour belo
petents with duodenal en gedhe excchagits where oral medication is inappropriate
Zollinger-Ellison syndrome
Recommended estal dose is 60 mg daily Highly doses may be required and the dose should be Austed individualy When doses exceed 50 mg day the dose should be divided and given twice daily
Method
40 mg once daily up to 5 days
administration:
The solution for Ometi IV injection is obtained by adding to the vial 10 me of the solvers provided Aher the injection should be given slowly over a period of 5 minutes Reconstituted solution should be preferably within 4 hours Side effects Nausea, vomiting headache, dry mouth, abdominal pain, danhea et may resina rarely
Use in pregnancy & lactation: Different expert review of published data on experiences with Omeprazole use during pregnancy concluded that therapeutic doses during pregnancy are unlikely to Dose & substant Omeprazole is excreted in human mak, because of the potential for serious adverse reactions in nursing infants from Omeprazole, a deosion should be made whether to disconnue nursing or to discontinue the drug taking eratogenic risk
Use in children: Use of Omeprazole in pediatric & adolescent patents 1 month to 16 years of age is supported into account the importance of the drug to the mother in offferent extrapolated results Geriatric use: Omeprazole in the US individuals (a65 years of age) in clinical trials
and Europe. There were no differences in safety and effectiveness between the elderly and younger Precautions: Omeprazole should be used with caution in patients with liver disease, pregnancy & lactation was administered to over 2000 elderly Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy reduce the rate of metabolism of Diazepam, Phenylon, Carbamazepre
subjects
Drug Interactions: Omeprazole may Over dosage: Reports have been received of over dosage with Omeprazole in humans. Doses ranged up to etc. but this is not clinically important
2400 mg (120 times the usual recommended clinical dose). were vanable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. Storage: Store in a cool & dry place, protected from light
Packaging
Ometid 20 mg Capsule: Each contains 10X9 capsules in alu-alu blister pack Ometid 40 mg Capsule: Each carton contains 10X3 capsules in alu-alu bilister pack
Ometi 40 mg IV injection: Each carton contains one vial of 40 mg powder with one ampoule of 10 mi
water and a 10 mi disposable syringe.
Opsonin Pharma
by Optonin Pharma Limited
Rupatali, Barshal, Bangladesh
Registered Trade Mark