Omepesino 20

Description

💊 Omepesino 20 – Omeprazole 

Manufacturer: SinoHealth Pharmaceuticals LTD

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1. Presentation:

Tablet: 10 mg / 20 mg / 40 mg (as marketed)

Capsule: 10 mg / 20 mg / 40 mg delayed-release formulation

IV Injection: 40 mg vial (for reconstitution)

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2. Description / Pharmacology:

Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by blocking the H⁺/K⁺-ATPase enzyme system in the gastric parietal cells — the final step in acid production.

It is a substituted benzimidazole derivative that effectively reduces both basal and stimulated gastric acid secretion, regardless of the stimulus.

Pharmacological actions:

• Inhibits gastric acid secretion at the final step of acid production

• Promotes healing of gastric and duodenal ulcers

• Provides symptom relief in acid reflux and dyspepsia

• Prevents recurrence of peptic ulcers

• Reduces risk of acid aspiration during anesthesia

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3. Indications:

Omepesino 20 is indicated in —

• Gastric and duodenal ulcers

• NSAID-associated ulcers (treatment and prophylaxis)

• Gastroesophageal reflux disease (GERD)

• Long-term management of acid reflux disease

• Acid-related dyspepsia

• Severe ulcerating reflux esophagitis

• Zollinger–Ellison syndrome

• Helicobacter pylori–induced peptic ulcer (in combination with antibiotics)

• Prophylaxis of acid aspiration during general anesthesia

⚠️ রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

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4. Dosage & Administration:

Oral administration:

• Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks (duodenal) or 8 weeks (gastric). May increase to 40 mg daily in severe cases.

• NSAID-associated ulcer: 20 mg once daily for 4–8 weeks; for prophylaxis, 20 mg daily.

• GERD / Reflux esophagitis: 20 mg once daily for 4–8 weeks. Maintenance dose: 20 mg once daily.

• Acid-related dyspepsia: 10–20 mg once daily for 2–4 weeks.

• Prophylaxis of acid aspiration: 40 mg the night before and 40 mg 2–6 hours before surgery.

• Zollinger–Ellison Syndrome: Initially 60 mg once daily; adjust individually (may require 20–120 mg daily).

• H. pylori eradication:

  • Omeprazole 20 mg twice daily

  • Amoxicillin 1000 mg twice daily

  • Clarithromycin 500 mg twice daily for 7–10 days

IV administration:

• 40 mg IV once daily (for patients unable to take orally).

• For acid aspiration prophylaxis: 40 mg slow IV injection over 5 minutes, 1 hour before surgery.

💡 Tablets or capsules should be swallowed whole, one hour before a meal.

⚠️ রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

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5. Drug Interactions:

• CYP2C19 substrates (e.g., diazepam, phenytoin, warfarin): elimination may be delayed.

• Drugs requiring acidic pH (e.g., ketoconazole, iron salts, digoxin): absorption may decrease.

• Clarithromycin + Omeprazole: increases plasma concentration (useful in H. pylori eradication).

• Clopidogrel: concurrent use may reduce its antiplatelet activity.

• No interaction with food, alcohol, or most NSAIDs.

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6. Contraindications:

• Known hypersensitivity to omeprazole or substituted benzimidazoles.

• Suspected gastric malignancy must be excluded before treatment.

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7. Side Effects:

Generally well tolerated.
Common:

• Headache

• Nausea, vomiting

• Abdominal pain, flatulence

• Diarrhea or constipation

• Dizziness

Rare:

• Skin rash, urticaria

• Photosensitivity

• Hepatitis (reversible)

• Hypomagnesemia (with long-term use)

• Bone fracture (prolonged high-dose use)

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8. Pregnancy & Lactation:

• Pregnancy: Studies show no adverse effects; can be used if clearly indicated.

• Lactation: Unknown if excreted in breast milk — use caution.

Use only when potential benefits justify the risks.

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9. Precautions & Warnings:

• Rule out gastric cancer before starting therapy.

• Use caution in patients with hepatic impairment.

• Avoid long-term therapy unless necessary.

• May slightly increase risk of osteoporosis-related fracture.

• Discontinue gradually to prevent rebound acid hypersecretion.

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10. Use in Special Populations:

• Children: Limited data below 1 year.

• Elderly: No dose adjustment needed.

• Hepatic impairment: Reduce dose to 10–20 mg/day.

• Renal impairment: No adjustment necessary.

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11. Overdose Effects:

Symptoms: Drowsiness, confusion, tachycardia.
Treatment: Symptomatic and supportive. No specific antidote; omeprazole is not dialyzable.

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12. Therapeutic Class:

Proton Pump Inhibitors (PPIs) / Antiulcer Agents

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13. Storage Conditions:

Store below 30°C, in a dry place, protected from light and moisture.
Keep out of reach of children.