D & G Pharma


D & G Pharma
Concise Prescribing Info
Omeprazole (Omexac-40 powd for inj: Na)
Omexac-20 Severe erosive esophagitis (grade 2 or above), diagnosed by endoscopy & short-term treatment of symptomatic GERD; PUD, gastric ulcer therapy. Maintenance of healing erosive esophagitis; approved for combination use in the eradication of H. pylori in patients w/ active duodenal ulcer. Omexac-40 Benign gastric & duodenal ulcers, Zollinger-Ellison syndrome, gastric acid reduction, GERD, acid reflux disease, acid-related dyspepsia.
Dosage/Direction for Use
Tab Adult GERD or erosive esophagitis 20 mg/day for 4-8 wk. Pathologically hypersecretory conditions Initially 60 mg once daily. Doses up to 120 mg tid or >80 mg daily in divided doses. H. pylori in combination w/ bismuth subsalicylate, tetracycline & clarithromycin or w/ clarithromycin alone 20 mg bid. Gastric ulcers 40 mg/day for 4-8 wk. IV Slowly over a period of at least 2.5 min at max rate of 4 mL/min. Alternative to oral therapy 40 mg IV once daily. Zollinger-Ellison syndrome Initially 60 mg daily. When dose is >60 mg daily, dose should be divided & given bid. Impaired hepatic function 10-20 mg daily dose.
Should be taken on an empty stomach: Omexac-20 Take at least 1 hr before meals. Swallow whole, do not chew/crush. For patients w/ difficulty swallowing, cap may be carefully opened & entire contents sprinkled in a spoonful of applesauce. Swallow drug/food mixt w/o chewing immediately after prep. Drug/food mixt should not be stored for future use.
Hypersensitivity. Omexac-40 Hypersensitivity to substituted benzimidazoles. Nelfinavir.
Special Precautions
Omexac-20 Elderly. Omexac-40 Exclude the possibility of malignancy prior to treatment in patients w/ gastric ulcers. Co-administration is not recommended w/ atazanivir. Patients w/ reduced body stores or risk factors for reduced vit B12 absorption on long-term therapy. Hepatic impairment.
Adverse Reactions
Headache, diarrhea. Omexac-20 Skin rashes. Omexac-40 Abdominal pain, constipation, flatulence, nausea & vomiting.
Drug Interactions
Omexac-40 May decrease plasma levels of nelfinavir & atazanavir. May increase bioavailability of digoxin. May decrease exposure to the active metabolite of clopidogrel & decrease max inhibition of platelet aggregation. May reduce absorption of posaconazole, erlotinib, ketoconazole & itraconazole thus may impair clinical efficacy.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Omexac-20 DR cap 20 mg
Omexac-40 powd for inj 40 mg
(vial + 10 mL diluent) 10 mL x 1's
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