Dozole

Description

Dozole Capsule, which contains Omeprazole, is a medication used to treat conditions caused by excessive stomach acid. It belongs to a group of drugs called Proton Pump Inhibitors (PPIs) and works by reducing the amount of acid your stomach produces. Dozole is manufactured by Everest Pharmaceuticals Pvt. Ltd. and is available in Nepal.

What Dozole Capsule Treats

Dozole is prescribed for various acid-related conditions, including:

• Peptic Ulcers: Both duodenal ulcers (in the small intestine) and gastric ulcers (in the stomach).
• H. pylori Infection: Used as part of a combination therapy to eradicate Helicobacter pylori, a bacterium that can cause ulcers.
• Gastro-oesophageal Reflux Disease (GERD): Also known as acid reflux, this condition causes heartburn and regurgitation.
• Zollinger-Ellison Syndrome: A rare condition where the stomach produces too much acid.
• Oesophagitis: Inflammation of the esophagus, often due to acid reflux (including erosive oesophagitis).
• Acid-related Dyspepsia: General discomfort or pain in the upper abdomen due to acid.
• NSAID-associated Ulceration: Ulcers caused by the use of non-steroidal anti-inflammatory drugs.
• Prophylaxis of Acid Aspiration: Used before general anesthesia to preDosage Information

Dozole can be taken orally (by mouth) or administered intravenously (IV).

Oral Dosing for Adults:

• Peptic Ulcer:
  • 20 mg daily; in severe cases, 40 mg daily.
  • Treatment duration: 4 weeks for duodenal ulcers, 8 weeks for gastric ulcers.
  • Maintenance: 10-20 mg daily.
  • Take all doses in the morning.
• NSAID-associated Ulceration: 20 mg once daily in the morning.
• Gastro-oesophageal Reflux Disease (GERD):
  • 20 mg daily for 4 weeks; may continue for another 4-8 weeks if needed.
  • For refractory oesophagitis (difficult to treat inflammation of the esophagus): 40 mg daily.
  • Maintenance after healing: 20 mg daily for oesophagitis; 10 mg daily for acid reflux.
  • Take all doses in the morning.
• Zollinger-Ellison Syndrome:
  • Start with 60 mg once daily in the morning, adjusting the dose as needed.
  • Typical dose range: 20-120 mg daily.
  • If the dose is over 80 mg daily, it should be divided into two doses.
• Prophylaxis of Acid Aspiration (before 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 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.
  • Take all doses in the morning.
• H. pylori Infection (always in combination with antibiotics):
  • 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.

Intravenous (IV) Dosing for Adults:

• 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. IV administration continues until oral medication is possible.
• Zollinger-Ellison Syndrome: Start with 60 mg daily, adjusting based on response. Daily doses over 60 mg should be given in two divided doses.

Dosing for Children (Oral):

• GERD:
  • Under 1 year: Safety and efficacy not established.
  • 1 year and older:
    • 5-10 kg: 5 mg once daily.
    • 10-20 kg: 10 mg once daily.
    • Over 20 kg: 20 mg once daily.
• Erosive Oesophagitis (treatment and maintenance):
  • Under 1 month: Safety and efficacy not established.
  • 1 month to under 1 year:
    • 3 to under 5 kg: 2.5 mg once daily.
    • 5 to under 10 kg: 5 mg once daily.
    • Over 10 kg: 10 mg once daily.
    • May be treated for up to 6 weeks.
  • 1-16 years:
    • 5 to under 10 kg: 5 mg once daily.
    • 10 to under 20 kg: 10 mg once daily.
    • Over 20 kg: 20 mg once daily.
    • May be treated for 4-8 weeks.

Special Populations:

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

How to Take Dozole Capsule

For 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 the entire contents into a spoonful of applesauce. Swallow this mixture immediately without chewing. Do not store the mixture for later use.

For Powder for Oral Suspension:

• Take on an empty stomach, at least 1 hour before a meal.

For MUPS (Multiple Unit Pellet System) Tablets:

• Can be taken with or without food.

For Capsules (standard, not delayed-release if available):

• Take with food, immediately before a meal.

Important Precautions and Warnings

Do not use Dozole if you have a known hypersensitivity (severe allergic reaction) to omeprazole or any of its components.

Before starting treatment, your doctor should rule out any serious conditions like gastric malignancy (stomach cancer), as symptoms can be similar.

Special Populations:

• Pregnancy and Lactation: Omeprazole distributes into human breast milk. Use caution if you are pregnant or breastfeeding. Consult your doctor.
• Children: Safety and efficacy are not established for children under 1 year for GERD, and under 1 month for erosive esophagitis.

Monitoring:

• Your doctor may monitor your magnesium levels before and periodically during treatment, especially with long-term use or if you’re taking diuretics.

Potential Drug Interactions

Dozole can interact with other medications, potentially affecting their effectiveness or increasing side effects:

• Increased risk of low magnesium (hypomagnesaemia) with diuretics.
• May increase the effect of blood thinners like warfarin, potentially increasing bleeding risk (monitor INR and prothrombin time).
• Increased risk of heart problems with digoxin.
• May increase blood levels of certain benzodiazepines (like diazepam), clarithromycin, and methotrexate.
• Decreased absorption of certain antifungal medications (e.g., itraconazole, ketoconazole, posaconazole), dasatinib, and iron salts.
• May prolong the elimination of diazepam, cilostazol, phenytoin, and ciclosporin.
• May reduce the antiplatelet effect of clopidogrel, which is used to prevent blood clots.
• Potentially Fatal Interactions: May significantly decrease the plasma concentrations and effectiveness of certain antiviral drugs used for HIV (rilpivirine, nelfinavir, and atazanavir).

Possible Side Effects

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

• Headache
• Abdominal pain
• Diarrhea
• Nausea
• Vomiting
• Flatulence (gas)
• Dizziness
• Upper respiratory infection
• Acid regurgitation
• Constipation
• Rash
• Cough

Less common but serious side effects can include:

• Bone fractures (especially with long-term use)
• Hepatotoxicity (liver damage – rare)
• Agranulocytosis (severe drop in white blood cells)
• Anorexia (loss of appetite)
• Gastric polyps
• Alopecia (hair loss)
• Atrophic gastritis (inflammation of the stomach lining)
• Interstitial nephritis (kidney inflammation – rare)
• Pancreatitis (inflammation of the pancreas – rare)
• Rhabdomyolysis (muscle breakdown)
• Taste perversion
• Abnormal dreams
• Toxic epidermal necrolysis (a severe skin reaction – rare)

Potentially Fatal:

• Anaphylaxis: A severe, life-threatening allergic reaction.

Important Note: This information about Dozole Capsule is provided for general knowledge and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.