Seclo MUPS 20

Generic

Omeprazole

 

Indications

Omeprazole is used to treat the following conditions:

• Duodenal and gastric ulcers
• Duodenal and stomach ulcers caused by NSAIDs
• As a preventative measure in individuals with a history of NSAID-related duodenal and stomach ulcers.
• GERD is an abbreviation for gastroesophageal reflux disease.
• Long-term acid reflux disease management
• Dyspepsia caused by acid
• Esophagitis with severe ulcerating reflux
• Acid aspiration prevention during general anesthesia
• Zollinger-Ellison syndrome is a condition in which there is a buildup of toxins in
• Peptic ulcer caused by Helicobacter pylori.

 

Pharmacology

Omeprazole, a substituted benzimidazole, is a stomach acid secretion inhibitor. It reduces stomach acid secretion by inhibiting the enzyme system of hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) in the gastric parietal cell. The antisecretory action begins within one hour of oral administration, with the greatest impact happening within two hours and secretion suppression lasting up to 72 hours. When the medication is stopped, secretory activity gradually recovers over 3 to 5 days.

 

Dosage & Administration

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.

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 cause diazepam, warfarin, and phenytoin to be eliminated more slowly. When Omeprazole is added to the therapy, the amount of warfarin or phenytoin may need to be reduced. Omeprazole does not appear to interact with theophylline, propranolol, or antacids.

 

Contraindications

Omeprazole is not recommended for people who have a history of hypersensitivity to any of the formulation's components.

 

Side Effects

Omeprazole is well tolerated in most people. Nausea, stomach colic, paresthesia, dizziness, and headache have all been reported to be minor and transitory, with no dosage decrease.

 

Pregnancy & Lactation

Omeprazole is classified as pregnancy category C by the US Food and Drug Administration. However, the findings of three prospective epidemiological studies show that Omeprazole has no negative effects on pregnancy or the health of the fetus/newborn child. There is no information on Omeprazole's entry into breast milk or its effects on the newborn. If the usage of Omeprazole is deemed necessary, breast-feeding should be terminated.

 

Precautions & Warnings

When a stomach ulcer is suspected, the potential of gastric cancer should be ruled out before starting Omeprazole treatment, as the medication may relieve symptoms while delaying detection.

 

Therapeutic Class

Inhibitor of the Proton Pump

 

Storage Conditions

Keep away from light and heat in a dry area. Keep out of children's reach.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.