Pylosec

Description

Pylosec Capsule, containing Omeprazole, is a medication used to treat various conditions caused by excessive stomach acid. As a Proton Pump Inhibitor (PPI), it effectively reduces the amount of acid your stomach produces. Pylosec is manufactured by Curex Pharmaceuticals Pvt. Ltd. and is available in Nepal.

What Pylosec Capsule Treats

Pylosec is prescribed for a range of acid-related problems in your digestive system, including:

• Peptic Ulcers: This includes ulcers found in the small intestine (duodenal ulcer) and the stomach (gastric ulcer).
• H. pylori Infection: It’s used as part of a combination therapy to eliminate Helicobacter pylori, a common bacteria that can lead to ulcers.
• Gastro-oesophageal Reflux Disease (GERD): Often called acid reflux, this condition causes symptoms like heartburn and regurgitation.
• Zollinger-Ellison Syndrome: A rare condition where the stomach produces abnormally high levels of acid.
• Oesophagitis: Inflammation of the esophagus, frequently caused by acid reflux, including more severe forms like erosive oesophagitis.
• Acid-related Dyspepsia: General discomfort, pain, or indigestion in your upper abdomen due to stomach acid.
• NSAID-associated Ulceration: Ulcers that develop as a side effect of taking non-steroidal anti-inflammatory drugs (NSAIDs).
• Prophylaxis of Acid Aspiration: It’s used before general anesthesia to prevent stomach acid from entering the lungs.

Dosage Guidelines

Pylosec (Omeprazole) can be taken orally (by mouth) or, in some cases, administered intravenously (into a vein) in clinical settings.

Oral Dosing for Adults:

• Peptic Ulcer:
  • Typically 20 mg daily, or 40 mg daily for severe cases.
  • Treatment usually lasts 4 weeks for duodenal ulcers and 8 weeks for gastric ulcers.
  • For long-term prevention (maintenance), the dose is usually 10-20 mg daily.
  • All doses should be taken once in the morning.
• NSAID-associated Ulceration: 20 mg once in the morning.
• Gastro-oesophageal Reflux Disease (GERD):
  • 20 mg daily for 4 weeks; can be extended for another 4-8 weeks if necessary.
  • For severe or unresponsive oesophagitis (refractory oesophagitis): 40 mg daily.
  • Maintenance after healing: 20 mg daily for oesophagitis; 10 mg daily for acid reflux.
  • All doses should be taken once in the morning.
• Zollinger-Ellison Syndrome:
  • Initial dose is 60 mg once in the morning, adjusted based on your response.
  • The typical daily dose range is 20-120 mg.
  • If your daily dose is more than 80 mg, it should be given in two divided doses.
• Prophylaxis of Acid Aspiration (before general anesthesia): 40 mg given the evening before surgery, and another 40 mg 2-6 hours pre-op.
• Acid-related Dyspepsia: 10 or 20 mg once in the morning for 2-4 weeks.
• Erosive Oesophagitis:
  • 20 mg daily for 4-8 weeks.
  • Maintenance to prevent recurrence: 20 mg daily for up to 12 months.
  • All doses should be taken once in the morning.
• H. pylori Infection (always combined with antibiotics):
  • Triple Therapy (for 7 or 10 days):
    • 20 mg twice daily (bid) OR 40 mg once daily.
    • Combined with: Amoxicillin (500 mg) and Metronidazole (400 mg) (both taken three times daily, tid), OR Clarithromycin (250 mg) and Metronidazole (400 mg or Tinidazole 500 mg) (both taken twice daily, bid), OR Amoxicillin (1 g) and Clarithromycin (500 mg) (both taken twice daily, bid).
  • Dual Therapy (for 2 weeks):
    • 20 mg twice daily (bid) OR 40 mg once daily.
    • Combined with: Amoxicillin (750 mg to 1 g) twice daily (bid), OR Clarithromycin (500 mg) three times daily (tid).

Intravenous (IV) Dosing for Adults:

• Gastro-oesophageal Reflux Disease; Gastric and Duodenal Ulcers; NSAID-associated Ulceration: 40 mg once daily, typically infused over 20-30 minutes or given as a slow injection over 5 minutes. This method is used until oral medication can be resumed.
• Zollinger-Ellison Syndrome: Initial dose is 60 mg daily, adjusted based on your body’s response. If the total daily dose is greater than 60 mg, it should be given in two divided doses.

Dosing for Children (Oral):

• GERD:
  • Under 1 year: Safety and effectiveness haven’t been established.
  • 1 year and older:
    • 5-10 kg: 5 mg PO qDay
    • 10-20 kg: 10 mg PO qDay
    • Over 20 kg: 20 mg PO qDay
• Erosive Oesophagitis (treatment and maintenance):
  • Under 1 month: Safety and effectiveness haven’t been established.
  • 1 month to under 1 year:
    • 3 to less than 5 kg: 2.5 mg qDay
    • 5 to less than 10 kg: 5 mg qDay
    • Over 10 kg: 10 mg qDay
    • May be treated for up to 6 weeks.
  • 1-16 years:
    • 5 to less than 10 kg: 5 mg PO qDay
    • 10 to less than 20 kg: 10 mg PO qDay
    • Over 20 kg: 20 mg PO qDay
    • May be treated for 4-8 weeks.

Dosing Adjustments for Specific Conditions:

• Elderly: No dosage adjustment is usually needed.
• Hepatic Impairment (liver problems): A lower dose of 10-20 mg daily is typically recommended.
• Renal Impairment (kidney problems): No dosage adjustment is usually needed.

How to Take Pylosec Capsule (Administration)

Pylosec is an oral capsule. Follow these guidelines for administration:

• Delayed-release Capsules:
  • Take on an empty stomach, at least 1 hour before a meal.
  • Swallow the capsule whole; do not chew or crush it.
  • If you have trouble swallowing, you can carefully open the capsule and sprinkle its entire contents onto a spoonful of applesauce. Swallow this mixture immediately without chewing. Do not prepare and store the mixture for later use.
• Powder for Oral Suspension (if applicable):
  • Take on an empty stomach, at least 1 hour before a meal.
• MUPS (Multiple Unit Pellet System) Tablets (if applicable):
  • Can be taken with or without food.
• Standard Capsules (if applicable):
  • Take with food, immediately before a meal.

Important Warnings and Precautions

• Do not use Pylosec if you have a known hypersensitivity (severe allergic reaction) to omeprazole or any of its ingredients.
• Your doctor should rule out serious conditions like stomach cancer (gastric malignancy) before you start treatment, as some symptoms can be similar.
• Pregnancy and Lactation: Omeprazole passes into breast milk. Use caution if you are pregnant, planning to become pregnant, or breastfeeding. Always consult your doctor.
• Children: Safety and effectiveness are not established for children under 1 year for GERD, and under 1 month for erosive oesophagitis.
• Monitoring: Your doctor might monitor your magnesium levels prior to initiation and periodically thereafter, especially with long-term use or if you are taking diuretics.

Potential Drug Interactions

Pylosec can interact with other medications, potentially affecting their efficacy or increasing side effects. It’s crucial to inform your doctor about all medications you’re taking, including over-the-counter drugs, supplements, and herbal remedies.

Key interactions include:

• Diuretics: Increased risk of low magnesium levels (hypomagnesaemia).
• Warfarin: May increase the effect of this blood thinner, potentially raising bleeding risk. Your doctor might need to monitor your INR and prothrombin time.
• Digoxin: Increased risk of digoxin-induced heart effects.
• Certain Benzodiazepines (e.g., diazepam), Clarithromycin, Methotrexate: May increase their levels in your blood.
• Itraconazole, Ketoconazole, Posaconazole, Dasatinib, Iron Salts: Pylosec can decrease the absorption of these medications.
• Diazepam, Cilostazol, Phenytoin, Ciclosporin: Pylosec may slow down their elimination from your body.
• Clopidogrel: May reduce the antiplatelet (blood-thinning) effect of clopidogrel.
• Potentially Fatal Interactions: Pylosec may significantly decrease the blood levels and effectiveness of certain HIV medications (e.g., rilpivirine, nelfinavir, atazanavir).

Possible Side Effects

While generally well-tolerated, Omeprazole can cause side effects. Common ones (occurring in 1-10% of users) include:

• 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 but serious side effects (frequency not defined) can include:

• Bone fracture, osteoporosis-related
• Liver damage (hepatotoxicity – rare)
• Agranulocytosis (severe decrease in white blood cells)
• Anorexia (loss of appetite)
• Gastric polyps
• Hip fracture
• Alopecia (hair loss)
• Atrophic gastritis (inflammation of the stomach lining)
• Interstitial nephritis (rare kidney inflammation)
• Pancreatitis (rare inflammation of the pancreas)
• Rhabdomyolysis (muscle breakdown)
• Taste perversion (altered taste)
• Abnormal dreams
• Toxic epidermal necrolysis (rare, severe skin reaction)

Potentially Fatal Side Effect:

• Anaphylaxis: A severe, life-threatening allergic reaction. Seek immediate medical attention if you experience symptoms like sudden swelling, difficulty breathing, or severe rash.

Important Note: This information about Pylosec Capsule is for general knowledge only and should not replace professional medical advice. Always consult a qualified healthcare professional for any health concerns, diagnosis, or treatment decisions.