OZG

Description

Omeprazole, marketed as OZG Capsule, is a medication used to treat conditions caused by excessive stomach acid. As a Proton Pump Inhibitor (PPI), it works by reducing the amount of acid produced in your stomach. OZG is manufactured by G.D. Laboratories Pvt. Ltd. and is available in Nepal.

What OZG Capsule Treats

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

• Peptic Ulcers: This includes ulcers in the small intestine (duodenal ulcer) and the stomach (gastric ulcer).
• H. pylori Infection: It’s used as part of a combination therapy to eradicate Helicobacter pylori, a bacterium commonly associated with ulcers.
• Gastro-oesophageal Reflux Disease (GERD): Also known as acid reflux, causing symptoms like heartburn and regurgitation.
• Zollinger-Ellison Syndrome: A rare condition characterized by the stomach producing abnormally high levels of acid.
• Oesophagitis: Inflammation of the esophagus, often 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: Used before general anesthesia to prevent stomach acid from entering the lungs.

Dosage Guidelines

OZG (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:
  • 20 mg or 40 mg/day in severe cases for 4 weeks (duodenal ulcer) or for 8 weeks (gastric ulcer).
  • Maintenance: 10-20 mg/day.
  • All doses to be taken once in the morning.
• NSAID-associated Ulceration: 20 mg once in the morning.
• Gastro-oesophageal Reflux Disease (GERD):
  • 20 mg/day for 4 weeks; may continue for another 4-8 weeks if necessary.
  • Refractory oesophagitis: 40 mg/day.
  • Maintenance: 20 mg/day (after healing of oesophagitis); 10 mg/day (acid reflux).
  • All doses to be taken once in the morning.
• Zollinger-Ellison Syndrome:
  • Initially, 60 mg once in the morning, adjust as required.
  • Dose Range: 20-120 mg/day.
  • Doses >80 mg are administered in 2 divided doses.
• Prophylaxis of acid aspiration during general anaesthesia: 40 mg given in the evening 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/day for 4-8 weeks.
  • Maintenance of healing: 20 mg/day for up to 12 months.
  • All doses to be taken once in the morning.
• H. pylori Infection (always combined with antibiotics):
  • As triple therapy: 20 mg twice daily (bid) or 40 mg once daily, combined with:
    • Amoxicillin 500 mg and Metronidazole 400 mg (both three times daily, tid), OR
    • Clarithromycin 250 mg and Metronidazole 400 mg (or Tinidazole 500 mg) (both twice daily, bid), OR
    • Amoxicillin 1 g and Clarithromycin 500 mg (both twice daily, bid).
    • Duration: 7 or 10 days.
  • As 2-week dual therapy: 20 mg bid or 40 mg/day, combined with either:
    • Amoxicillin 750 mg to 1 g bid, OR
    • Clarithromycin 500 mg tid.

Intravenous (IV) Dosing for Adults:

• Gastro-oesophageal reflux disease; Gastric and duodenal ulcers; NSAID-associated ulceration: 40 mg once daily infused over 20-30 min or slow injection over 5 min until oral administration is possible.
• Zollinger-Ellison syndrome: Initially, 60 mg/day, adjust according to response. Daily doses >60 mg/day should be given in 2 divided doses.

Dosing for Children (Oral):

• GERD:
  • <1 year: Safety and efficacy not established.
  • >1 year:
    • 5-10 kg: 5 mg PO qDay
    • 10-20 kg: 10 mg PO qDay
    • >20 kg: 20 mg PO qDay
• Erosive Esophagitis:
  • <1 month: Safety and efficacy not established.
  • Aged 1 month to <1 year:
    • 3 to <5 kg: 2.5 mg qDay
    • 5 to <10 kg: 5 mg qDay
    • >10 kg: 10 mg qDay
    • May treat for up to 6 weeks.
  • Aged 1-16 years:
    • 5 to <10 kg: 5 mg PO qDay
    • 10 to <20 kg: 10 mg PO qDay
    • >20 kg: 20 mg PO qDay
    • May treat for 4-8 weeks.

Dosing Adjustments for Specific Conditions:

• Elderly: No dosage adjustment needed.
• Hepatic impairment (liver problems): 10-20 mg/day.
• Renal impairment (kidney problems): No dosage adjustment needed.

How to Take OZG Capsule (Administration)

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

• Delayed-release Capsules:
  • Should be taken on an empty stomach, at least 1 hour before meals.
  • Swallow whole, do not chew or crush.
  • For patients with difficulty swallowing, the capsule may be carefully opened & its entire contents sprinkled in a spoonful of applesauce. Swallow the drug/food mixture without chewing immediately after preparation. The drug/food mixture should not be stored for future use.
• Powder for Oral Suspension (if applicable):
  • Should be taken on an empty stomach, at least 1 hour before a meal.
• MUPS (Multiple Unit Pellet System) Tablets (if applicable):
  • May be taken with or without food.
• Standard Capsules (if applicable):
  • Should be taken with food. Take immediately before a meal.

Important Warnings and Precautions

• Contraindications: Do not use OZG if you have a known hypersensitivity (severe allergic reaction) to omeprazole or any of its components.
• Gastric Malignancy: Gastric malignancy (stomach cancer) should be ruled out before starting treatment, as symptoms can be masked.
• Pregnancy and Lactation: Omeprazole distributes into human breast milk. Use caution if you are pregnant, planning to become pregnant, or breastfeeding. Always consult your doctor.
• Children: Not indicated for children under 1 year.
• Monitoring Parameters: Your doctor may monitor Magnesium concentrations prior to initiation and periodically thereafter, especially with long-term use or if you are taking diuretics.

Potential Drug Interactions

OZG 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 hypomagnesaemia (low magnesium levels).
• Warfarin: May increase INR and prothrombin time, increasing bleeding risk.
• Digoxin: Increased risk of digoxin-induced cardiotoxic effects.
• May increase plasma concentration of: benzodiazepines (e.g., diazepam), clarithromycin, and methotrexate.
• Decreased absorption of: itraconazole, ketoconazole, posaconazole, dasatinib, 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.

Possible Side Effects

While generally well-tolerated, Omeprazole can cause side effects.

Common (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%)

Frequency Not Defined (Less Common but Potentially Serious):

• Fracture of bone, osteoporosis-related
• Hepatotoxicity (rare liver damage)
• Agranulocytosis (rare, severe drop in white blood cells)
• Anorexia (loss of appetite)
• Gastric polyps
• Hip fracture
• Alopecia (hair loss)
• Atrophic gastritis (inflammation of 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 OZG 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.