Losectil Capsule (Omeprazole)

Description

Losectil Capsule (Omeprazole)

Indications:

• Peptic Ulcer (duodenal and gastric)
• Helicobacter pylori (H. pylori) infection (in combination therapy)
• Gastro-oesophageal Reflux Disease (GERD)
• Zollinger-Ellison Syndrome
• Oesophagitis (including erosive oesophagitis)
• Acid-Related Dyspepsia
• NSAID-Associated Ulceration
• Prophylaxis of acid aspiration during general anaesthesia

Dosage:

• Adults (Oral):

  • Peptic Ulcer: 20 or 40 mg once daily for 4-8 weeks (duodenal: 4 weeks; gastric: 8 weeks). Maintenance: 10-20 mg once daily.
  • NSAID-Associated Ulceration: 20 mg once daily.
  • Gastro-oesophageal Reflux Disease (GERD): 20 mg once daily for 4 weeks; may extend for another 4-8 weeks. Refractory oesophagitis: 40 mg once daily. Maintenance: 20 mg once daily (after healing), or 10 mg once daily (for acid reflux).
  • Zollinger-Ellison Syndrome: Initial: 60 mg once daily, adjusted as required (range: 20-120 mg/day). Doses >80 mg are given in two divided doses.
  • Prophylaxis of Acid Aspiration during General Anaesthesia: 40 mg the evening before and another 40 mg 2-6 hours pre-operation.
  • Acid-Related Dyspepsia: 10 or 20 mg once daily for 2-4 weeks.
  • Erosive Oesophagitis: 20 mg once daily for 4-8 weeks. Maintenance: 20 mg once daily for up to 12 months.
  • H. pylori Infection (Eradication Therapy):
    • Triple Therapy (7 or 10 days): 20 mg twice daily OR 40 mg once daily, combined with:
      • Amoxicillin 500 mg and Metronidazole 400 mg (both three times daily) OR
      • Clarithromycin 250 mg and Metronidazole 400 mg (or Tinidazole 500 mg) (both twice daily) OR
      • Amoxicillin 1 g and Clarithromycin 500 mg (both twice daily).
    • Dual Therapy (2 weeks): 20 mg twice daily OR 40 mg once daily, combined with:
      • Amoxicillin 750 mg to 1 g twice daily OR
      • Clarithromycin 500 mg three times daily.

• Adults (Intravenous – IV):

  • GERD, Gastric & Duodenal Ulcers, NSAID-Associated Ulceration: 40 mg once daily (infused over 20-30 min or slow injection over 5 min) until oral administration is possible.
  • Zollinger-Ellison Syndrome: Initial: 60 mg/day, adjusted based on response. Daily doses >60 mg should be given in two divided doses.

• Children (Oral):

  • GERD:
    • <1 year: Safety and efficacy not established.
    • $\ge$1 year:
      • 5-10 kg: 5 mg once daily.
      • 10-20 kg: 10 mg once daily.

      • 20 kg: 20 mg once daily.

  • Erosive Esophagitis (Treatment and Maintenance of Healing):
    • 1 month to <1 year:
      • 3 to <5 kg: 2.5 mg once daily.
      • 5 to <10 kg: 5 mg once daily.

      • 10 kg: 10 mg once daily. (May treat for up to 6 weeks).

    • 1-16 years:
      • 5 to <10 kg: 5 mg once daily.
      • 10 to <20 kg: 10 mg once daily.

      • 20 kg: 20 mg once daily. (May treat for 4-8 weeks).

Special Populations:

• Elderly: No dosage adjustment needed.
• Hepatic Impairment: 10-20 mg/day.
• Renal Impairment: No dosage adjustment needed.

Administration:

• Delayed-Release Capsules/Powder for Oral Suspension: Take on an empty stomach, at least 1 hour before meals. Swallow capsules whole; do not chew/crush. For swallowing difficulties, capsules may be opened and contents sprinkled on a spoonful of applesauce; swallow immediately without chewing or storing.
• MUPS Tablet: May be taken with or without food.
• Capsule (General): Take with food, immediately before a meal.

Contraindications:

• Known hypersensitivity to omeprazole or any of its components.
• Concomitant use with rilpivirine, nelfinavir, or atazanavir.

Precautions:

• Gastric malignancy should be ruled out before initiating treatment.
• Use with caution in pregnancy, lactation, and children <1 year (except where specifically indicated).
• Monitoring: Monitor magnesium concentrations before and periodically during treatment.

Interactions:

• Increased Risk of: Hypomagnesaemia (with diuretics), increased INR and prothrombin time (with warfarin), digoxin-induced cardiotoxic effects, plasma concentration of benzodiazepines (e.g., diazepam), clarithromycin, and methotrexate.
• Decreased Absorption of: Itraconazole, ketoconazole, posaconazole, dasatinib, iron salts.
• Prolonged Elimination of: Diazepam, cilostazol, phenytoin, ciclosporin.
• Reduced Antiplatelet Effect of: Clopidogrel.
• Potentially Fatal: May significantly decrease plasma concentrations and pharmacological effects of rilpivirine, nelfinavir, and atazanavir.

Adverse Effects:

• Common (1-10%): Headache, abdominal pain, diarrhea, nausea, vomiting, flatulence, dizziness, upper respiratory infection, acid regurgitation, constipation, rash, cough.
• Less Common (Frequency Not Defined): Bone fracture (osteoporosis-related), hepatotoxicity (rare), agranulocytosis, anorexia, gastric polyps, hip fracture, alopecia, atrophic gastritis, interstitial nephritis (rare), pancreatitis (rare), rhabdomyolysis, taste perversion, abnormal dreams, toxic epidermal necrolysis (rare).
• Potentially Fatal: Anaphylaxis.

Mechanism of Action: Omeprazole is a substituted benzimidazole, belonging to the class of Proton Pump Inhibitors (PPIs). It works by specifically inhibiting the H+/K+ ATPase enzyme system (the proton pump) on the secretory surface of gastric parietal cells. This action effectively blocks the final step in gastric acid secretion, inhibiting both basal and stimulated acid production.

Note: Losectil 20mg Capsule is manufactured by Eskayef Bangladesh Ltd. Its generic name is Omeprazole. Losectil is available in Nepal. This information is not intended for diagnosis, medical advice, or treatment, nor is it a substitute for the exercise of professional judgment