OP-40

Indication:

OP-40 is indicated for the treatment of duodenal and benign gastric ulcers.Prophylaxis of acid aspiration during general anesthesia.Gastroesophageal reflux disease (GORD/GERD) and acid-related dyspepsia.Zollinger-Ellison syndrome (excessive acid production).Eradication of Helicobacter pylori (in combination with antibiotics).Prevention and treatment of NSAID-associated ulcers.

Dogase & Adminstration:

OP-40 should be taken before meal.

Gastroesophageal reflux disease including reflux esophagitis:The usual dosage is 20 mg Omeprazole 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. Omeprazole 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 Omeprazole 10 mg once daily is recommended, increasing to 20 mg if symptoms return.

Duodenal and benign gastric ulcers : The usual dose is 20 mg Omeprazole 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 Omeprazole daily. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg Omeprazole once daily. For prevention of relapse in patients with duodenal ulcer the recommended dose is Omeprazole 10 mg once daily, increasing to 20 mg once daily, if symptoms return.

Helicobacter pylori eradication regimens in peptic ulcer disease: Omeprazole 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 Omeprazole 40 mg on the evening before surgery followed by Omeprazole 40 mg 2-6 hours prior to surgery.

Zollinger-Ellison syndrome : The recommended initial dosage is 60 mg Omeprazole 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 Omeprazole 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 Omeprazole is 20 mg once daily.

Children (Oral):

• GORD (1 month to 18 years): Dose is weight-dependent:
  • • 5–10 kg: 5 mg once daily.
    • 10–20 kg: 10 mg once daily.
    • Over 20 kg: 20 mg once daily.

IV Injection:

• Duodenal ulcer, gastric ulcer or reflux esophagitis: In patients where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.

• Zollinger-Ellison Syndrome (ZES): Recommended initial dose is 60 mg daily intravenously. The dose should be adjusted individually. Doses exceeding 60 mg should be divided and given twice daily.

Pharmacology:

• Mechanism of Action: Omeprazole is a substituted benzimidazole that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme system (the “proton pump”) at the secretory surface of the gastric parietal cell.
• Pharmacodynamics: By blocking the final step of acid production, it reduces both basal and stimulated acid secretion, regardless of the stimulus.
• Pharmacokinetics: It is acid-labile (hence gastro-resistant coating). Absorption occurs in the small intestine. It is highly protein-bound and extensively metabolized by the hepatic cytochrome P450 system (mainly CYP2C19).

Side Effects:

• May decrease the absorption of drugs requiring low gastric pH (e.g., Ketoconazole).Increases plasma concentration of Diazepam, Phenytoin, and Warfarin.Avoid concomitant use with Clopidogrel due to reduced antiplatelet efficacy.

Pregnancy & Lactation:

• Pregnancy: Generally considered safe; however, use only when clearly needed.
• Lactation: Excreted in breast milk, but unlikely to affect the infant at therapeutic doses.

Over Dosage:

Symptoms: Nausea, vomiting, dizziness, abdominal pain, and headache.Management: Symptomatic and supportive care.

Therapeutic Class:

Proton Pump Inhibitor (PPI); Anti-ulcerant.

Storage Conditions:

Store in a cool, dry place at room temperature below 30°C as per manufacturer. Keep out of reach of children. Keep Away fron from direct sunlight and heat.