Apzole

Description

Apzole Capsule (Omeprazole)

Overview

Apzole Capsule, containing the active ingredient Omeprazole, is a proton pump inhibitor (PPI) that significantly reduces stomach acid production. It works by blocking the H+/K+ ATPase enzyme system in the stomach’s parietal cells, inhibiting both basal and stimulated acid secretion.

Indications

Apzole Capsule is used to treat and manage various acid-related conditions, including:

• Peptic Ulcers (duodenal and gastric)
• H. pylori infection (in combination with antibiotics)
• Gastro-oesophageal Reflux Disease (GERD)
• Zollinger-Ellison Syndrome
• Oesophagitis (inflammation of the esophagus)
• Acid-related Dyspepsia (indigestion)
• NSAID-associated Ulceration (ulcers caused by non-steroidal anti-inflammatory drugs)

Dosage

Adult Dose (Oral)

• Peptic Ulcer:
  • 20 or 40 mg once daily, typically for 4 weeks (duodenal ulcer) or 8 weeks (gastric ulcer).
  • Maintenance: 10-20 mg once daily.
  • All doses taken once in the morning.
• NSAID-associated Ulceration: 20 mg once in the morning.
• Gastro-oesophageal Reflux Disease (GERD):
  • 20 mg once daily for 4 weeks; may extend for another 4-8 weeks if needed.
  • Refractory Oesophagitis: 40 mg once daily.
  • Maintenance: 20 mg once daily (after oesophagitis healing); 10 mg once daily (for acid reflux).
  • All doses taken once in the morning.
• Zollinger-Ellison Syndrome:
  • Initially, 60 mg once in the morning, adjusted as needed (range: 20-120 mg/day).
  • Doses >80 mg/day are given in two divided doses.
• Prophylaxis of Acid Aspiration (General Anesthesia): 40 mg in the evening, and another 40 mg 2-6 hours pre-operation.
• Acid-related Dyspepsia: 10 or 20 mg once 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 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
      • 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.

Adult Dose (Intravenous)

• GERD; Gastric and Duodenal Ulcers; NSAID-associated Ulceration: 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: Initially, 60 mg/day, adjusted based on response. Daily doses >60 mg are given in two divided doses.

Elderly Dose

No dosage adjustment is typically needed.

Hepatic Impairment Dose

10-20 mg once daily.

Child Dose (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 & maintenance of healing):
  • <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.

Renal Impairment Dose

No dosage adjustment is 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, the capsule can be opened and its contents sprinkled into a spoonful of applesauce. Swallow this mixture immediately without chewing; do not store for later use.
• Powder for Oral Suspension: Take on an empty stomach, at least 1 hour before a meal.
• MUPS Tablets: May be taken with or without food.
• Capsules: Take with food, immediately before a meal.

Contraindications

Known hypersensitivity to omeprazole or any of its components.

Precautions

• Before starting treatment, gastric malignancy should be ruled out, as omeprazole may mask symptoms.
• Use with caution in pregnant or lactating women, and in children under 1 year of age.
• Monitoring: Magnesium concentrations should be monitored before starting treatment and periodically thereafter.
• Lactation: Omeprazole distributes into human breast milk; use caution.

Interactions

• Increased Risk of: Hypomagnesemia (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.
• Prolonged Elimination of: Diazepam, cilostazol, phenytoin, and ciclosporin.
• Reduced Effect of: Clopidogrel (antiplatelet effect).
• Potentially Fatal Interactions: 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.

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.

Important Note

Apzole 20mg Capsule is manufactured by Apple International Pharmaceuticals Pvt. Ltd. Its generic name is Omeprazole, and it is available in Nepal. This information from Farmaco Nepal drug index is for informational purposes only and is not intended for diagnosis, medical advice, or treatment, nor is it a substitute for professional medical judgment