Registered Rwanda · Rwanda FDA

6 mg of omeprazole sodium, corresponding to 40 mg of omeprazole

42.6 mg of omeprazole sodium, corresponding to 40 mg of omeprazole

Rwanda FDA-HMP-MA-0974 Powder for Solution for Injection 40 mg INN generic

What it does

Corresponding is used to treat various health conditions.

Commonly used for: general health issues, specific diseases

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0974
Registration date
26/02/2024
Expiry date
25/02/2029
Status
Registered
Active ingredient
42.6 mg of omeprazole sodium, corresponding to 40 mg of omeprazole
Strength
40 mg
Pack size
12 ml Vial and 10 ml Ampoule
Therapeutic class
-
Manufacturer / MAH
Anfarm Hellas
Applicant / LTR
DAFRA PHARMA GMbH
Country of origin
GREECE
Manufacturer location
Achaias 4, Kifisia 145 64, Greece

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:20 · updated 2026-09-21 02:30:20

Drug Interactions

4
Check interactions

Moderate (2)

Omeprazole - increases exposure

Cenobamate moderately increases the exposure to proton pump inhibitors (omeprazole). Adjust dose.

Moderate Study

Omeprazole - increases exposure

Fedratinib moderately increases the exposure to proton pump inhibitors (omeprazole). Monitor and adjust dose.

Moderate Study

Unknown (2)

Cilostazol - increases exposure

Omeprazole is predicted to increase the exposure to cilostazol. Adjust cilostazol dose, p. 253.

Unknown Study

Omeprazole - decreases exposure

Apalutamide markedly decreases the exposure to proton pump inhibitors (omeprazole). Avoid or monitor.

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About corresponding

Corresponding is used to treat various health conditions.

What it treats

  • general health issues
  • specific diseases

How it works

It works by addressing the underlying causes of health problems.

Who it's for

This medication is suitable for individuals needing treatment for specific health conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About omeprazole

Omeprazole is a medication that reduces stomach acid. It helps relieve symptoms associated with acid-related conditions.

What it treats

  • stomach ulcers
  • gastroesophageal reflux disease (GERD)
  • excessive stomach acid

How it works

Omeprazole works by blocking the production of stomach acid, which helps heal ulcers and reduce heartburn.

Who it's for

Omeprazole is for adults and children over a certain age who have problems with too much stomach acid.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: corresponding

Corresponding is a term that does not refer to a specific medication or drug. In pharmacology, it could be a placeholder for various agents used in different therapeutic contexts. Without specific information or a known substance, it remains undefined. In clinical practice, precise drug identification is crucial for effective treatment.

Dosage

Children: Refer to specific drug information for paediatric dosing.

Adults: Refer to specific drug information for adult dosing.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Omeprazole

BNF-referenced

Omeprazole is a proton pump inhibitor (PPI) that reduces gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cells. It is primarily used for the treatment of conditions associated with excessive gastric acid production, such as peptic ulcers and gastro-oesophageal reflux disease (GERD).

Indications

  • Gastric ulcer
  • Duodenal ulcer
  • Gastro-oesophageal reflux disease (GERD)
  • Severe oesophagitis
  • Helicobacter pylori eradication (in combination therapy)
  • Prevention of NSAID-associated gastric and duodenal ulcers
  • Zollinger-Ellison syndrome

Dosage

Adults: The usual dose for adults is 20 mg once daily for 4 weeks for duodenal ulcer and GERD. For gastric ulcer, the dose may be 20 mg to 40 mg once daily

Mechanism of action

Omeprazole works by specifically binding to the proton pump (H+/K+ ATPase) in the gastric parietal cells, leading to irreversible inhibition of acid secretion. This binding prevents the exchange of hydrogen ions for potassium ions, effectively reducing the production of gastric acid and promoting healing of acid-related conditions.

Pharmacodynamics

The pharmacodynamic effects of omeprazole manifest as a significant decrease in gastric acidity, which improves symptoms related to excessive acid secretion. The onset of action typically occurs within an hour of administration, with maximum effect seen within 2 to 4 days of continuous use. The duration of action allows for once-daily dosing in most indications.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 0.5 to 3.5 hours after oral administration. It is extensively metabolized in the liver via the cytochrome P450 system, primarily CYP2C19 and CYP3A4, leading to the formation of inactive metabolites. The elimination half-life is approximately 0.5 to 1 hour, but the effects on gastric acid secretion last much longer due to the irreversible nature of proton pump inhibition. Omeprazole is excreted mainly in the urine as metabolites, with less than 1% of the drug excreted unchanged.

Contra-indications

  • Hypersensitivity to omeprazole or any component of the formulation
  • Use with caution in patients with severe liver impairment

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Headache
  • Abdominal pain
  • Flatulence
  • Constipation
  • Dizziness
  • Fatigue
  • Rash
  • Muscle weakness
  • Gastrointestinal candidiasis
  • Aggression
  • Agitation
  • Bronchospasm
  • Encephalopathy

Interactions

  • Cenobamate may increase exposure to omeprazole
  • Fedratinib may increase exposure to omeprazole
  • Apalutamide may decrease exposure to omeprazole
  • Cilostazol may increase exposure to omeprazole

Precautions

  • Monitor patients for gastrointestinal symptoms
  • Use caution in patients with a history of liver disease
  • Consider potential for vitamin B12 deficiency with long-term use
  • Monitor for signs of Clostridium difficile infection in the colon

Pregnancy

Not known to be harmful during pregnancy, but should be used only if clearly needed.

Breast-feeding

Excreted in breast milk, caution is advised when administered to nursing mothers.

Storage

Store below 25 degrees Celsius. Protect from moisture. Keep out of reach of children.

Formulations

  • Orodispersible tablets
  • Gastro-resistant capsules
  • Intravenous injection
  • Oral suspension
BNF 85 (British National Formulary) p.105 BNF for Children 2019-2020 p.82 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Omeprazole

PubChem CID 4594

Molecular formula: C17H19N3O3S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.