OMEPRAZOLE oral

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.*

10 mg tablet**

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

* In a syringe, dissolve a ½ dispersible tablet (5 mg) in 5 ml of water to obtain a solution of 1 mg/ml.
** Dissolve 1 dispersible tablet in half a glass of water.

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.