Xeldrin 40

Generic

Omeprazole

 

Indications

• Omeprazole is used to treat ulcers in the stomach and duodenum.
• Duodenal and stomach ulcers caused by NSAIDs
• In patients with a history of NSAID-related duodenal and stomach ulcers, as a preventative measure
• Gastro-esophageal reflux disease (GERD) is a type of gastro-esophageal reflux
• Acid reflux disease management over time
• Dyspepsia caused by stomach acid
• Reflux esophagitis with ulcers is a serious condition.
• Acid aspiration prevention during general anesthesia

 

Pharmacology

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking the ATPase H + / K + enzyme system in gastric parietal cells. After oral administration, the antisecretory effect takes effect in 1 hour, the maximum effect occurs in 2 hours, and the inhibition of secretion lasts up to 72 hours. After stopping the drug, secretory activity will gradually recover over 3-5 days.

 

Dosage

Oral-

• Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
• NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
• Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for 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 treatment; maintenance dose is 20 mg once daily.
• Long-term management of acid reflux disease: 10-20 mg daily.
• Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
• Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
• Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
• Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
• Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection-

• Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
• Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
• Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.

 

Administration

Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

 

Interaction

Omeprazole can prolong the elimination of diazepam, warfarin, and phenytoin. Therefore, when omeprazole is added to treatment, it may be necessary to reduce the dose of warfarin or phenytoin. There is no evidence that omeprazole interacts with theophylline, propranolol, or antacids.

 

Contraindications

Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

 

Side Effects

Omeprazole is generally well tolerated. According to reports, nausea, abdominal cramps, paresthesias, dizziness, and headaches are usually mild and short-lived and do not need to be reduced.

 

Pregnancy & Lactation

U.S. FDA omeprazole pregnancy classification is C. However, the results of three prospective epidemiological studies indicate that omeprazole has no adverse effects on pregnancy or fetal/newborn health. There is no information about omeprazole passing into breast milk or its effects on newborns. Therefore, if it is deemed necessary to use omeprazole, breastfeeding should be stopped.

 

Precautions & Warnings

When gastric ulcers are suspected, the possibility of gastric malignancies should be ruled out before starting omeprazole treatment, because treatment may reduce symptoms and delay diagnosis.

 

Therapeutic Class

Proton Pump Inhibitor

 

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

 

Pharmacetical Name

ACI Limited