OMEPRAZOLE oral

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    Prescription under medical supervision

     

    Therapeutic action

    • Antiulcer and gastric antisecretory agent (proton pump inhibitor)

    Indications

    • Gastro-oesophageal reflux
    • Gastric and duodenal ulcers in adult

    Forms and strengths

    • 10 mg dispersible gastro-resistant tablet
    • 20 mg gastro-resistant capsule

    Dosage

    Gastro-oesophageal reflux

    • Child under 5 kg: 0.7 to 1.4 mg/kg (max. 2.8 mg/kg daily) once daily in the morning
    • Child 5 to 10 kg: 5 mg once daily in the morning
    • Child 10 to 20 kg: 10 mg once daily in the morning
    • Child over 20 kg and adult: 20 mg once daily in the morning

     

    Age

    Weight

    1 mg/ml sol. (a) Citation a. In a syringe, dissolve one 10 mg dispersible tablet in 10 ml of water to obtain a solution of 1 mg/ml.

    10 mg tablet (b) Citation b. Dissolve 1 dispersible tablet in half a glass of water.

    20 mg capsule

    < 2 months

    < 5 kg

    3 ml

    –

    –

    2 months to < 1 year

    5 to < 10 kg

    5 ml

    –

    –

    1 to < 6 years

    10 to < 20 kg

    –

    1 tab

    –

    ≥ 6 years and adult

    ≥ 20 kg

    –

    –

    1 cap

    Gastric and duodenal ulcers

    • Adult: 20 mg once daily in the morning
      In severe or recurrent cases, dose can be increased if necessary to 40 mg once daily.

    Duration

    • Gastro-oesophageal reflux: 3 days (short-term relief of symptoms) or 4 to 8 weeks (long-term treatment)
    • Gastric and duodenal ulcers: 7 to 10 days or up to 8 weeks (severe or recurrent cases)

    Contra-indications, adverse effects, precautions

    • Do not exceed 0.7 mg/kg daily (max. 20 mg daily) in patients with severe hepatic impairment.
    • May cause: headache, diarrhoea, constipation, nausea, vomiting, abdominal pain, dizziness, skin rash, fatigue.
    • Monitor combination with:
      • atazanavir, itraconazole (decreased efficacy of these drugs);
      • diazepam, phenytoin, digoxin, raltegravir (increased toxicity of these drugs).
    • Pregnancy: no contra-indication
    • Breast-feeding: no contra-indication

    Remarks

    • Do not open capsules.
    • Omeprazole is also used in combination with 2 antibacterial drugs for cure of Helicobacter pylori infection, at a dosage of 20 mg 2 times daily for 7 days.

    Storage

     
    –  Below 25 °C   

    Once dissolved, dispersible tablets should be administered within 30 minutes.

    • (a)In a syringe, dissolve one 10 mg dispersible tablet in 10 ml of water to obtain a solution of 1 mg/ml.
    • (b)Dissolve 1 dispersible tablet in half a glass of water.
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