Antiulcerant (Proton pump Inhibitor)
Brand Name: SB-Omec 20
Generic Name with Specification: Omeprazole BP
Strength: 20 mg & 40 mg
SB-Omec 20 Capsule: Each Capsule contains Omeprazole BP 20 mg as enteric coated pellets.
SB-Omec 40 Capsule: Each Capsule contains Omeprazole BP 40 mg as enteric coated pellets.
SB-Omec capsule is indicated for Gastroesophageal Reflux Disease (GERD) including Reflux Esophagitis, Acid Reflux Disease, Duodenal and Gastric Ulcer, Helicobacter pylori eradication in Peptic Ulcer Disease, Prophylaxis of Acid Aspiration,
Zollinger-Ellison Syndrome and for the treatment of NSAIDs associated Gastric Ulcer, Duodenal Ulcer or Gastroduodenal Erosions, relief of Reflux like symptoms (e.g. heartburn) or Ulcer like symptoms(e.g. epigastric pain), associated with Acid Related Dyspepsia.
Dosage & Administration:
Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration, in severe or recurrent cases increase to 40 mg daily. Maintenance for recurrent duodenal ulcer: 20 mg once daily, prevention of relapse in duodenal ulcer, 10 mg daily increasing to 20 mg once daily if symptoms return. NSAIDs associated duodenal or gastric ulcer and gastroduodenal erosions: 20 mg once daily for 4 weeks, followed by a further 4 weeks if not fully healed, prophylaxis in patients with a history of NSAIDs associated duodenal or gastric ulcer, gastro duodenal lesions or dyspeptic symptoms who require continued NSAIDs treatment, 20 mg once daily. Duodenal ulcer associated with Helicobacter pylori: 20 mg twice daily. Benign gastric ulcer associated with H. pylori: 40 mg daily in 1-2 divided doses for 2 weeks. Zollinger-Ellison syndrome: Initially 60 mg once daily, usual range 20-120 mg daily (above 880 mg in 2 divided doses).
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, followed by a further 4-8 weeks if not fully healed, 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease refractory to other treatments, may be continued at 20 mg once daily. Acid reflux disease (long-term management): 10 mg daily increasing to 20 mg once daily if symptoms return.
Acid related dyspepsia: 10-20 mg once daily for 2-4 weeks according to response.
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows: 5 to less than 10 kg patient weight is 5 mg,10 to less than 20 kg is 10 mg, 20 kg or greater than 20 kg is 20 mg.
Omeprazole is well tolerated. Nausea, diarrhea, abdominal colic, paresthesia, dizziness, constipation, flatulence and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
Omeprazole is contraindicated for patients known to have hypersensitivity to this product or any of its components. Symptomatic treatment to therapy with Omeprazole does not preclude the presence of gastric malignancy.
Use in Pregnancy & Lactation:
FDA approved pregnancy Category C.
Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.
Before taking this medicine, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take this medicine during this time.
Your doctor will decide whether you can take this medicine if you are breast feeding.
SB-Omec 20 Capsule: Each box contains 100 Capsules in Alu-Alu blister pack.
SB-Omec 40 Capsule: Each box contains 50 Capsules in Alu-Alu blister.