. Omeprazole

.

Indication

Omeprazole Capsule and tablet is indicated for gastroesophageal reflux disease including reflux esophagitis, acid reflux disease, duodenal and benign gastric ulcers, Helicobacter pylori eradication regimens in peptic ulcer disease, prophylaxis of acid aspiration, Zollinger-Ellison Syndrome and for the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions. Omeprazole IV is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis.

Dosage & Administration

 Omeprazole Capsule and tablet:  should be taken before meal.

Disease Dosage and administration

Gastroesophageal reflux disease including reflux esophagitis	The usual dosage is 20 mg  once daily. The majority of Patients are healed after 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment.  has also been used in a dose of 40 mg once daily in patients with reflux esophagitis refractory to other therapy. Healing usually occurred within 8 weeks. Patients can be continued at a dosage of 20 mg once daily.
Acid reflux disease	For long-term management  10 mg once daily is recommended, increasing to 20 mg if symptoms return.
Duodenal and benign gastric ulcers	The usual dose is 20 mg  once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40 mg daily. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg once daily. For prevention of relapse in patients with duodenal ulcer the recommended dose is  10 mg once daily, increasing to 20 mg once daily, if symptoms return.
Helicobacter pylori eradication regimens in peptic ulcer disease	is recommended at a dose of 40 mg once daily or 20 mg twice daily in association with antimicrobial agents Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for 7 to 14 days.
Prophylaxis of acid aspiration	For patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is  40 mg on the evening before surgery followed by 40 mg 2-6 hours prior to surgery.
Zollinger-Ellison syndrome	The recommended initial dosage is 60 mg  once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given Twice daily.
For the treatment of NSAIDassociated gastric ulcers, duodenal ulcers or gastroduodenal erosions	The recommended dosage of  is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs Within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 Weeks treatment. For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment, the recommended dosage of  is 20 mg once daily.
Children GERD or other acid-related disorders	The recommended dose for pediatric patients 1 years of age and older is as follows: Age Body Weight Dose > 1 year 10 - 20 kg 10 mg once daily, if needed, 20 mg once daily > 2 year > 20 kg 20 mg once daily, if needed, 40 mg once daily
IV Injection Duodenal ulcer, gastric ulcer or reflux esophagitis	In patients with duodenal ulcer, gastric ulcer or reflux esophagitis where oral medication is inappropriate, IV 40 mg once daily is recommended.
Zollinger-Ellison Syndrome (ZES)	In patients with Zollinger-Ellison syndrome the recommended initial dose of  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 and given twice daily.

Direction For Use Of IV Injection

lyophilized powder and water for injection is for intravenous administration

only and must not be given by any other route.  injection 40 mg 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 2-5 minutes at a maximum rate of 4 ml per minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction For Use Of IV Infusion

 IV infusion 40 mg 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  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.

Contraindication And Precaution

There are no known contraindications to the use of .When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with  is instituted as treatment may alleviate symptoms and delay diagnosis.

Side-Effect

Omeprazole Is well tolerated. Nausea, diarrhoea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

Use in Pregnancy & Lactation

Omeprazole Can be used during pregnancy. is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Preparation

 Omeprazole 20 mg Capsule & DR Tablet, 40 mg Capsule & 40 mg IV Injection.