Pylosec

Description

Pylosec Capsule: Omeprazole 20mg

Pylosec Capsule is a medication containing Omeprazole 20mg, manufactured by Curex Pharmaceuticals Pvt. Ltd. It’s an acid-reducing drug known as a Proton Pump Inhibitor (PPI) that works by blocking acid production in the stomach.

Availability: Pylosec is available in Nepal in packs of 10 capsules, with a retail price of NPR 7.00.

Uses (Indication

Pylosec Capsule is used to treat conditions related to excessive stomach acid, including:

• Peptic ulcers (stomach and duodenal ulcers)
• 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 pain relievers)
• Prophylaxis of acid aspiration during general anesthesia
• Erosive oesophagitis

Dosage Information

Important: Always take Pylosec Capsule on an empty stomach, at least one hour before meals. Swallow the capsule whole; do not chew or crush it. If you have difficulty swallowing, you can open the capsule and sprinkle the contents onto a spoonful of applesauce. Consume immediately; do not store the mixture.

Adult Dosin

• Peptic Ulcer:
  • Treatment: 20 mg or 40 mg once daily (for severe cases) for 4 weeks (duodenal ulcer) or 8 weeks (gastric ulcer).
  • Maintenance: 10-20 mg once daily.
• NSAID-Associated Ulceration: 20 mg once daily.
• Gastro-Oesophageal Reflux Disease (GERD):
  • Treatment: 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 healing); 10 mg once daily (for acid reflux).
• Zollinger-Ellison Syndrome:
  • Initial: 60 mg once daily. Doses over 80 mg should be divided into two doses.
  • Range: 20-120 mg daily.
• Prophylaxis of Acid Aspiration (General Anesthesia): 40 mg the evening before surgery and another 40 mg 2-6 hours prior to surgery.
• Acid-Related Dyspepsia: 10 or 20 mg once daily for 2-4 weeks.
• Erosive Oesophagitis:
  • Treatment: 20 mg once daily for 4-8 weeks.
  • Maintenance: 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: 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).
  • Dual Therapy (2 weeks):
    • 20 mg twice daily OR 40 mg once daily
    • Combined with: Amoxicillin 750 mg to 1 g twice daily OR
    • Combined with: Clarithromycin 500 mg three times daily.

Child 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: (May treat for up to 6 weeks)
    • 3 to <5 kg: 2.5 mg once daily
    • 5 to <10 kg: 5 mg once daily

    • 10 kg: 10 mg once daily

  • 1-16 years: (May treat for 4-8 weeks)
    • 5 to <10 kg: 5 mg once daily
    • 10 to <20 kg: 10 mg once daily

    • 20 kg: 20 mg once daily

Intravenous (IV) Dosing

Pylosec can be administered intravenously when oral administration isn’t possible.

• GERD, Gastric and Duodenal Ulcers, NSAID-Associated Ulceration: 40 mg once daily, infused over 20-30 minutes or given as a slow injection over 5 minutes.
• Zollinger-Ellison Syndrome:
  • Initial: 60 mg once daily, adjusted based on response.
  • Daily doses over 60 mg should be given in two divided doses.

Special Population

• Elderly: No dosage adjustment is typically needed.
• Hepatic Impairment (Liver Problems): 10-20 mg once daily.
• Renal Impairment (Kidney Problems): No dosage adjustment is typically needed.

Important Considerations

• Contraindications: Do not use Pylosec if you have a known hypersensitivity (allergy) to omeprazole or any of its components.
• Precautions:
  • Your doctor should rule out gastric malignancy (stomach cancer) before starting treatment.
  • Use with caution during pregnancy and lactation (breastfeeding), and in children under 1 year.
  • Monitoring: Magnesium levels may need to be monitored before and periodically during treatment. Omeprazole distributes into breast milk, so caution is advised if breastfeeding.
• Drug Interactions: Pylosec can interact with other medications, potentially leading to increased side effects or reduced effectiveness of either drug.
  • Increased risk of hypomagnesemia (low magnesium) 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 effects of rilpivirine, nelfinavir, and atazanavir. Always inform your doctor about all medications you are taking.

Possible Side Effects

Common side effects (1-10%):

• Headache (7%)
• Abdominal pain (5%)
• Diarrhea (4%)
• Nausea (4%)
• Vomiting (3%)
• Flatulence (3%)
• Dizziness (2%)
• Upper respiratory infection (2%)
• Acid regurgitation (2%)
• Constipation (2%)
• Rash (2%)
• Cough (1%)

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

• Bone fractures (osteoporosis-related), Hip fracture
• Hepatotoxicity (liver damage)
• Agranulocytosis (severe drop in white blood cells)
• Anorexia
• Gastric polyps
• Alopecia (hair loss)
• Atrophic gastritis
• Interstitial nephritis (kidney inflammation)
• Pancreatitis (pancreas inflammation)
• Rhabdomyolysis (muscle breakdown)
• Taste perversion
• Abnormal dreams
• Toxic epidermal necrolysis (severe skin reaction)
• Potentially Fatal: Anaphylaxis (severe allergic reaction).

How it Works (Mechanism of Action

Omeprazole is a Proton Pump Inhibitor (PPI). It works by specifically blocking the H+/K+ ATPase enzyme system, which is located on the surface of the stomach’s parietal cells. This enzyme is responsible for the final step in producing stomach acid. By inhibiting it, omeprazole effectively reduces both normal (basal) and stimulated acid secretion.

Disclaimer: This information about Pylosec 20mg Capsule is for general knowledge and is not intended as medical advice, diagnosis, or treatment. It should not replace the professional judgment of a healthcare provider. Always consult with a doctor or pharmacist for any health concerns or before starting a new medication.