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Losectil 40
Indications
Omeprazole is indicated for the treatment of:
- Gastric and duodenal ulcers
- NSAID-associated gastric and duodenal ulcers
- Prophylaxis in patients with a history of NSAID-associated ulcers
- Gastroesophageal reflux disease (GERD)
- Long-term management of erosive reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis against acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcers
Pharmacology
Omeprazole, a substituted benzimidazole, inhibits gastric acid secretion by blocking the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in gastric parietal cells. After oral administration, the antisecretory effect begins within one hour, reaches maximum effectiveness in two hours, and can last up to 72 hours. Once the medication is discontinued, normal acid secretion gradually resumes over 3 to 5 days.
Dosage and Administration
Oral Dosage:
- Benign Gastric and Duodenal Ulcer: 20 mg once daily for 4 weeks for duodenal ulcers and 8 weeks for gastric ulcers; for severe or recurrent cases, increase to 40 mg daily. For recurrent duodenal ulcers, a maintenance dose of 20 mg daily is recommended, with 10-20 mg daily for relapse prevention.
- NSAID-Associated Ulcer: 20 mg once daily for 4 weeks, with an additional 4 weeks if not fully healed. Prophylaxis is 20 mg once daily for patients with a history of NSAID-associated ulcers.
- Gastroesophageal Reflux Disease: 20 mg once daily for 4 weeks; extend for an additional 4-8 weeks if symptoms persist. For refractory GERD, a dose of 40 mg once daily for 8 weeks may be prescribed; maintenance dose is 20 mg daily.
- Long-term Acid Reflux Management: 10-20 mg daily.
- Acid-Related Dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of Acid Aspiration: 40 mg the evening before surgery, then 40 mg 2-6 hours prior to surgery.
- Zollinger-Ellison Syndrome: Initial dose of 60 mg once daily; usual dosage ranges from 20-120 mg daily (if exceeding 80 mg, split into two doses).
- Helicobacter Pylori Eradication: 20 mg twice daily in combination with antimicrobial agents for one week (options include Amoxicillin and Metronidazole or Clarithromycin).
- Pediatric Use (for severe ulcerating reflux esophagitis): For children over 1 year, 10-20 mg once daily for 4-12 weeks if body weight is 10-20 kg; 20-40 mg once daily for 4-12 weeks if body weight exceeds 20 kg.
IV Injection:
- Prophylaxis of Acid Aspiration: 40 mg administered slowly (over 5 minutes) as an intravenous infusion one hour before surgery.
- Duodenal or Gastric Ulcer/Reflux Esophagitis: 40 mg IV once daily if oral administration is inappropriate.
- Zollinger-Ellison Syndrome: Initial intravenous dose of 60 mg daily, with higher doses as needed and adjusted individually. If doses exceed 60 mg daily, they should be divided into two doses.
Interaction
Omeprazole may prolong the elimination of diazepam, warfarin, and phenytoin, necessitating potential dose adjustments for these medications. There is no significant interaction reported with theophylline, propranolol, or antacids.
Contraindications
Omeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
Side Effects
Omeprazole is generally well tolerated. Reported side effects may include mild nausea, abdominal pain, dizziness, paresthesia, and headaches, which are usually transient and do not require dosage adjustments.
Pregnancy & Lactation
The FDA classifies Omeprazole as Category C during pregnancy. Although studies indicate no adverse effects on pregnancy or fetal health, there is limited information on its transfer into breast milk. Breastfeeding should be discontinued if Omeprazole is deemed necessary.
Precautions & Warnings
Before initiating treatment for suspected gastric ulcers, exclude the possibility of gastric malignancy, as treatment may alleviate symptoms and delay diagnosis.
Therapeutic Class
Proton Pump Inhibitor
Storage Conditions
Store in a dry place away from light and heat, and keep out of reach of children.
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