Empraz

Empraz

omeprazole

Manufacturer:

Stallion Labs

Distributor:

Geo Pharma

Marketer:

Ambica
Full Prescribing Info
Contents
Omeprazole sodium.
Description
Each vial of Empraz contains omeprazole sodium equivalent to omeprazole 40 mg.
Each ampule of diluent contains sterile water for injection 10 mL.
Action
Pharmacology: Mechanism of Action: Omeprazole inhibits secretion of gastric acid is irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase (H+/K+ATPase), the 'proton pump' of the gastric parietal cell.
Pharmacokinetics: Omeprazole is rapidly but variably absorbed after oral doses. Absorption is not affected by food. Omeprazole is acid-labile and pharmacokinetics may vary between the various formulations developed to improve oral bioavailability. The absorption of omeprazole also appears to be dose-dependent; increasing the dosage >40 mg has been reported to increase the plasma concentrations in a nonlinear fashion because of saturable first-pass hepatic metabolism. In addition, absorption is higher after long-term use.
Bioavailability of omeprazole may be increased in elderly patients, in some ethnic groups eg, Chinese and in patients with hepatic impairment, but is not markedly affected in patients with renal impairment.
Following absorption, omeprazole is almost completely metabolized in the liver, primarily by the cytochrome P-450 isoenzyme CYP2C19 to hydroxyomeprazole and to a small extent by CYP3A from omeprazole sulfone. The metabolites are inactive and are excreted mostly in the urine and to a lesser extent in bile. The elimination t½ from plasma is reported to be about 0.5-3 hrs. Omeprazole is about 95% bound to plasma proteins.
Indications/Uses
Used in benign gastric and duodenal ulcers, Zollinger-Ellison syndrome, gastric acid reduction, gastroesophageal reflux disease, acid reflux disease, acid-related dyspepsia.
Dosage/Direction for Use
Omeprazole may be given by mouth as the base or magnesium salt or IV as the sodium salt.
Relief of Acid-Related Dyspepsia: Usual Doses: 10 or 20 mg daily by mouth for 2-4 weeks.
Gastroesophageal Reflux Disease: 20 mg once daily by mouth for 4 weeks, followed by 4-8 weeks if not fully healed.
Refractory Esophagitis: Adults: 40 mg daily. Children >1 yr Weighing >20 kg: Oral doses are 20 mg daily; 10-20 kg: Oral doses are 10 mg daily.
Management of Peptic Ulcer Disease: 20 mg daily by mouth; 40 mg in severe cases. Treatment is continued for 4 weeks for duodenal ulcer and 8 weeks of gastric ulcer.
Eradication of Helicobacter pylori in Peptic Ulcer: Omeprazole may be combined with antibacterials in dual or triple therapy.
Effective Triple Therapy Regimens: Omeprazole 20 mg twice daily combined with amoxicillin 500 mg and metronidazole 400 mg, both 3 times daily; clarithromycin 500 mg and metronidazole 400 mg or (tinidazole 500 mg) both twice daily; or with amoxicillin 1 g and clarithromycin 500 mg both twice daily. These regimens are given for 1 week.
Dual Therapy Regimens: Omeprazole 40 mg daily with either amoxicillin 750 mg to 1 g twice daily; or clarithromycin 500 mg 3 times daily are less effective. It must be given for 2 weeks. Omeprazole alone may be continued further for 4-8 weeks.
NSAID-Associated Ulceration and Prophylaxis in Patients with History of Gastroduodenal Lesions Requiring Continued NSAID-Treatment: 20 mg daily.
Zollinger-Ellison syndrome: Recommended Initial Dose: 60 mg once by mouth daily, adjusted as required. Majority of patients are effectively controlled by doses in the range 20-120 mg daily, but doses up to 120 mg, 3 times daily have been used. Daily dose >80 mg should be given as divided dose (usually 2).
Overdosage
The major clinical features were drowsiness headache (possibly due to metabolite) and tachycardia.
Special Precautions
Before giving omeprazole or other proton-pump inhibitors to patients with gastric ulcers, the possibility of malignancy should be considered since these drug may mask symptoms and delay diagnosis. Omeprazole and other proton-pump inhibitor should be used with caution in hepatic impairment.
Adverse Reactions
The adverse effects reported most frequently with omeprazole and other proton-pump inhibitors have been headache, diarrhea and skin rashes; sometimes it is severe enough to require discontinuation of treatment. Other effects include pruritus, dizziness, fatigue, constipations, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria and dry mouth. Isolated cases of photosensitivity, bullous eruption, erythema multiforme, angioedema, and anaphylaxis have been reported. Effects on the CNS include occasional insomnia, somnolence and vertigo; reversible confusional states, agitation, depression and hallucinations have occurred in severely ill patients. Raised liver enzymes and isolated cases of hepatitis, jaundice and hepatic encephalopathy, have been reported. Other adverse effects reported rarely or in isolated cases include paresthesia, blurred vision, alopecia, stomatitis, sweating, taste disturbances, peripheral edema, malaise, hyponatremia, blood disorders (including agranulocytosis, leukopenia and thrombocytopenia) and interstitial nephritis.
Drug Interactions
Omeprazole and other proton-pump inhibitors are metabolized by the cytochromes P-450 system primarily by isoenzyme CYP2C19 and may alter the metabolism of some drugs metabolized by these enzymes. Omeprazole may prolong the elimination of diazepam, phenytoin and warfarin.
Omeprazole and other proton-pump inhibitors can reduce the absorption of drugs eg, ketoconazole and possibly itraconazole, whose absorption is dependent on acid gastric pH. With voriconazole, the plasma concentration of both drugs may be increased and a reduced dose of omeprazole is recommended.
Storage
Store at temperature not exceeding 30°C. Protect from light.
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).
Presentation/Packing
Powd for inj 40 mg (vial + 10 mL amp diluent) x 1's.
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