Hycid

Description

Hycid Capsule (Omeprazole)

Indications: Hycid Capsule is a proton pump inhibitor (PPI) used for the treatment and management of conditions associated with excessive stomach acid production, including:

• Peptic Ulcers (duodenal and gastric ulcers)
• Helicobacter pylori (H. pylori) Infection (as part of 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 anesthesia

Dosage and Administration:

Oral Dosing:

• Peptic Ulcer:

  • Adult: 20 or 40 mg once daily in the morning.
    • Duodenal ulcer: for 4 weeks.
    • Gastric ulcer: for 8 weeks.
  • Maintenance: 10-20 mg once daily.

• NSAID-associated Ulceration:

  • Adult: 20 mg once daily in the morning.

• Gastro-oesophageal Reflux Disease (GERD):

  • Adult: 20 mg once daily for 4 weeks; may continue for another 4-8 weeks if needed.
  • Refractory Oesophagitis: 40 mg once daily.
  • Maintenance: 20 mg once daily (after healing of oesophagitis); 10 mg once daily (for acid reflux).

• Zollinger-Ellison Syndrome:

  • Adult: Initially, 60 mg once daily in the morning, adjusted as required (Dose Range: 20-120 mg/day). Doses >80 mg should be given in two divided doses.

• Prophylaxis of Acid Aspiration during General Anesthesia:

  • Adult: 40 mg the evening before surgery and another 40 mg 2-6 hours pre-operatively.

• Acid-related Dyspepsia:

  • Adult: 10 or 20 mg once daily in the morning for 2-4 weeks.

• Erosive Oesophagitis:

  • Adult: 20 mg once daily for 4-8 weeks.
  • Maintenance of healing: 20 mg once daily for up to 12 months.

• H. pylori Infection (Eradication Therapy):

  • Adult (as part of combination therapy):
    • Triple Therapy (7 or 10 days):
      • 20 mg twice daily OR 40 mg once daily, combined with:
        • Amoxicillin 500 mg three times daily AND Metronidazole 400 mg three times daily; OR
        • Clarithromycin 250 mg twice daily AND Metronidazole 400 mg (or Tinidazole 500 mg) twice daily; OR
        • Amoxicillin 1 g twice daily AND Clarithromycin 500 mg 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.

• Pediatric Dosing (Oral):

  • GERD:
    • <1 year: Safety and efficacy not established.

    • 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):
    • <1 month: Safety and efficacy not established.
    • 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.

Intravenous (IV) Dosing:

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

Special Populations:

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

Method of Administration:

• Delayed-release Capsule: Take on an empty stomach, at least 1 hour before meals. Swallow whole; do not chew or crush. For patients with difficulty swallowing, the capsule may be opened and contents sprinkled on a spoonful of applesauce. Swallow the mixture immediately without chewing. Do not store for future use.
• Powder for Oral Suspension: Take on an empty stomach, at least 1 hour before a meal.
• MUPS Tablet: May be taken with or without food.
• Capsule: Should be taken with food, immediately before a meal.

Contraindications: Known hypersensitivity to omeprazole or any of its components.

Precautions:

• Gastric malignancy should be ruled out before initiating treatment.
• Use with caution in pregnant or lactating women, and in children under 1 year of age.
• Monitor magnesium concentrations before and periodically during treatment.

Interactions:

• Increased risk of hypomagnesaemia with diuretics.
• May increase INR and prothrombin time with warfarin.
• Increased risk of digoxin-induced cardiotoxic effects.
• May increase plasma concentrations of benzodiazepines (e.g., diazepam), clarithromycin, and methotrexate.
• Decreased absorption of itraconazole, ketoconazole, posaconazole, dasatinib, and 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 (Omeprazole):

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

Mechanism of Action: Omeprazole is a substituted benzimidazole, classified as a Proton Pump Inhibitor (PPI). It acts by specifically inhibiting the H+/K+ ATPase enzyme system (the proton pump) located on the secretory surface of the gastric parietal cells. This action blocks the final step in gastric acid secretion, thereby inhibiting both basal and stimulated acid production.

Note: Hycid 20mg Capsule is manufactured by XL. Its generic name is Omeprazole. Hycid 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