Gracid

Description

Gracid Capsule: Uses, Dosage, and Side Effects

Gracid Capsule (Omeprazole 20mg) is a proton pump inhibitor (PPI) manufactured by Gracure Pharmaceuticals Ltd. and available in Nepal. It’s used to reduce stomach acid and treat various acid-related conditions.

Key Information

• Generic Name: Omeprazole
• Strength: 20mg
• Manufacturer: Gracure Pharmaceuticals Ltd.
• Pack Size: 200 capsules
• Retail Price: 4.00 NPR (per capsule)

Indications

Gracid Capsule is prescribed for:

• Peptic Ulcer: Sores that develop on the lining of the esophagus, stomach, or small intestine.
• H. pylori Infection: A bacterial infection that can cause stomach ulcers.
• Gastro-oesophageal Reflux Disease (GERD): A condition where stomach acid frequently flows back into the esophagus, causing heartburn and other symptoms.
• Zollinger-Ellison Syndrome: A rare condition causing tumors that release large amounts of gastrin, leading to excess stomach acid.
• Oesophagitis: Inflammation of the esophagus.
• Acid-related Dyspepsia: Indigestion caused by excess stomach acid.
• NSAID-associated Ulceration: Ulcers caused by the use of non-steroidal anti-inflammatory drugs.

Dosage

Adults (Oral):

• Peptic Ulcer: 20 or 40 mg once daily for 4 weeks (duodenal ulcer) or 8 weeks (gastric ulcer).
  • Maintenance: 10-20 mg once daily.
• NSAID-associated Ulceration: 20 mg once daily in the morning.
• Gastro-oesophageal Reflux Disease (GERD): 20 mg once daily for 4 weeks; can be continued 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: Initially, 60 mg once daily in the morning; adjust as needed. Doses over 80 mg should be given in two divided doses.
• Prophylaxis of Acid Aspiration (during general anesthesia): 40 mg in the evening, and another 40 mg 2-6 hours before surgery.
• 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.
• H. pylori Infection:
  • Triple Therapy (7 or 10 days): 20 mg twice daily OR 40 mg once daily, combined with specific antibiotic regimens (e.g., amoxicillin + metronidazole, or clarithromycin + metronidazole/tinidazole, or amoxicillin + clarithromycin).
  • Dual Therapy (2 weeks): 20 mg twice daily OR 40 mg once daily, combined with either amoxicillin (750mg to 1g twice daily) or clarithromycin (500mg three times daily).

Adults (Intravenous):

• GERD, Gastric & 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 once daily; adjust according to response. Daily doses over 60 mg should be given in two divided doses.

Elderly: No dosage adjustment is typically needed.

Hepatic Impairment: 10-20 mg once daily.

Children (Oral):

• GERD:
  • 1 year and older:
    • 5-10 kg: 5 mg once daily
    • 10-20 kg: 10 mg once daily

    • 20 kg: 20 mg once daily

• Erosive Esophagitis:
  • 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)

Renal Impairment: No dosage adjustment is typically needed.

Administration

• Delayed-release Capsules: Take on an empty stomach, at least 1 hour before meals. Swallow whole; do not chew or crush. If swallowing is difficult, open the capsule and sprinkle contents onto a spoonful of applesauce. Swallow immediately without chewing; do not store the mixture.
• Powder for Oral Suspension: Take on an empty stomach, at least 1 hour before a meal.
• MUPS Tablets: Can be taken with or without food.
• Capsules (general): Should be taken with food, immediately before a meal.

Contraindications

Do not use Gracid Capsule if you have a known hypersensitivity (allergy) to omeprazole or any of its components.

Precautions

• A doctor should rule out gastric malignancy (stomach cancer) before starting treatment.
• Use with caution during pregnancy and lactation.
• Not recommended for children under 1 year of age for GERD, and under 1 month for erosive esophagitis.
• Monitor magnesium (Mg) levels before starting treatment and periodically thereafter.

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 Interactions: May decrease plasma concentrations and pharmacological effects of rilpivirine, nelfinavir, and atazanavir.

Side Effects

Common side effects (1-10% occurrence) include:

• Headache, abdominal pain, diarrhea, nausea, vomiting, flatulence.
• Dizziness, upper respiratory infection, acid regurgitation, constipation, rash, cough.

Less common or rare side effects (frequency not defined) include:

• Bone fractures (including hip), osteoporosis-related issues, hepatotoxicity (liver damage), agranulocytosis (severe drop in white blood cells), anorexia, gastric polyps, alopecia (hair loss), atrophic gastritis, interstitial nephritis (kidney inflammation), pancreatitis, rhabdomyolysis, taste perversion, abnormal dreams, and toxic epidermal necrolysis.

Potentially Fatal: Anaphylaxis (severe allergic reaction).

Mechanism of Action

Omeprazole is a proton pump inhibitor (PPI). It works by specifically inhibiting the H+/K+ ATPase enzyme system (the “proton pump”) found on the surface of the stomach’s parietal cells. By blocking this final step in acid production, it effectively reduces both basal (resting) and stimulated acid secretion in the stomach.

Important Note

The information provided here is for general knowledge and informational purposes only, and does not constitute medical advice. It is not intended to be a substitute for professional medical judgment, diagnosis, or treatment. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.