Omcid

Ocid QRS 20 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 (in severe cases) for 4 weeks (duodenal ulcer) or 8 weeks (gastric ulcer). Maintenance: 10-20 mg once daily. All doses to be taken once in the morning.
  • NSAID-Associated Ulceration: 20 mg once daily in the morning.
  • Gastro-oesophageal Reflux Disease (GERD): 20 mg once daily for 4 weeks; may continue for another 4-8 weeks if necessary. Refractory oesophagitis: 40 mg once daily. Maintenance: 20 mg once daily (after healing of oesophagitis); 10 mg once daily (acid reflux). All doses to be taken once in the morning.
  • Zollinger-Ellison Syndrome: Initially, 60 mg once daily in the morning, adjusted as required. Dose range: 20-120 mg/day. Doses >80 mg are administered in 2 divided doses.
  • Prophylaxis of Acid Aspiration during General Anaesthesia: 40 mg given in the evening and another 40 mg 2-6 hours pre-operation.
  • Acid-Related Dyspepsia: 10 or 20 mg once daily in the morning for 2-4 weeks.
  • Erosive Oesophagitis: 20 mg once daily for 4-8 weeks. Maintenance of healing: 20 mg once daily for up to 12 months. All doses to be taken once in the morning.
  • H. pylori Infection:
    • 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 combined with clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) (both twice daily); OR combined with amoxicillin 1 g and clarithromycin 500 mg (both twice daily).
    • 2-week Dual Therapy: 20 mg twice daily OR 40 mg once daily, combined with either amoxicillin 750 mg to 1 g twice daily OR with clarithromycin 500 mg three times daily.

• Adults (Intravenous – IV):

  • Gastro-oesophageal Reflux Disease; Gastric and Duodenal Ulcers; NSAID-associated Ulceration: 40 mg once daily infused over 20-30 minutes or slow injection over 5 minutes until oral administration is possible.
  • Zollinger-Ellison Syndrome: Initially, 60 mg/day, adjusted according to response. Daily doses >60 mg/day should be given in 2 divided doses.

• Children (Oral):

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

      • 20 kg: 20 mg orally once daily.

  • Erosive Oesophagitis (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 orally once daily.
      • 10 to <20 kg: 10 mg orally once daily.

      • 20 kg: 20 mg orally 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: Should be taken on an empty stomach, at least 1 hour before meals. Swallow capsules whole; do not chew/crush. For patients with difficulty swallowing, capsules may be carefully opened and entire contents sprinkled in a spoonful of applesauce. Swallow drug/food mixture without chewing immediately after preparation. Drug/food mixture should not be stored for future use.
• MUPS tablet: May be taken with or without food.
• Capsule (general): Should be taken with food, immediately before a meal.

Contraindications:

• Known hypersensitivity to omeprazole or any of its components.
• Concomitant use with rilpivirine, nelfinavir, and atazanavir due to potentially fatal interactions.

Precautions:

• Gastric malignancy should be ruled out before initiating treatment.
• Pregnancy and Lactation: Use caution; omeprazole distributes into human breast milk.
• Children: Use with caution in children <1 year unless specifically indicated.
• Monitoring Parameters: Monitor magnesium concentrations prior to initiation and periodically thereafter.

Interactions:

• Increased Risk of: Hypomagnesaemia (with diuretics); increased INR and prothrombin time (with warfarin); digoxin-induced cardiotoxic effects; increased plasma concentration of benzodiazepines (e.g., diazepam), clarithromycin, and methotrexate.
• Decreased Absorption of: Itraconazole, ketoconazole, posaconazole, dasatinib, iron salts.
• May Prolong Elimination of: Diazepam, cilostazol, phenytoin, and ciclosporin.
• May Reduce the Antiplatelet Effect of: Clopidogrel.
• Potentially Fatal: May 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.
• 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 gastric antisecretory agent, also known as a Proton Pump Inhibitor (PPI). It blocks the final step in gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system present on the secretory surface of the gastric parietal cell. Both basal and stimulated acid production are inhibited.

Note: Ocid QRS 20 20mg Capsule is manufactured by Zydus Pharmaceuticals. Its generic name is Omeprazole. Ocid QRS 20 is available in Nepal. This information is not intended for diagnosis, medical advice, or treatment; neither is it intended to be a substitute for the exercise of professional judgment.