Presec 20 mg (Capsule (Enteric Coated))
Medicine Details
Category | Details |
---|---|
Generic | Omeprazole |
Company | Unimed unihealth pharmaceuticals ltd |
Also available as |
Indications
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- Prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer
Pharmacology
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
Dosage
- 20 mg once daily for 4 weeks in duodenal ulceration
- 8 weeks in gastric ulceration
- 20 mg once daily for 4 weeks in NSAID-associated duodenal or gastric ulcer
- 20 mg once daily for 4 weeks in gastro-esophageal reflux disease
- 40 mg once daily for 8 weeks in refractory gastro-esophageal reflux disease
- 10-20 mg daily for long-term management of acid reflux disease
- 20 mg once daily for 2-4 weeks in acid-related dyspepsia
- 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery for prophylaxis of acid aspiration
- Initially 60 mg once daily for Zollinger-Ellison syndrome
- Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents for Helicobacter pylori eradication regimen
Administration
- Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
- Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Interaction
Due to the decreased intragastric acidity the absorption of ketoconazole may be reduced during Presec treatment as it is during treatment with other acid secretion inhibitors. As Presec is metabolised in the liver through cytochrome P450 it can delay the elimination of diazepam, phenytoin and warfarin. Monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary.
Contraindications
Omeprazole is contraindicated in patients with known hypersensitivity to it. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis.
Side Effects
- Skin rash, urticaria and pruritus
- Photosensitivity, bullous eruption, erythema multiforme, angioedema and alopecia
- Diarrhoea and headache
- Constipation, nausea/vomiting, flatulence and abdominal pain
- Dry mouth, stomatitis and candidiasis
- Paraesthesia
- Dizziness, light headedness and feeling faint
- Somnolence, insomnia and vertigo
- Reversible mental confusion, agitation, depression and hallucinations
- Arthritic and myalgic symptoms
- Blurred vision, taste disturbance, peripheral oedema, increased sweating, gynaecomastia
- Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, anaphylactic shock, malaise, fever, bronchospasm, encephalopathy, hepatitis with or without jaundice, interstitial nephritis and hepatic failure
- Increases in liver enzymes
Pregnancy & Lactation
- Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy.
- There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
Precautions & Warnings
Avoid concomitant use of clopidogrel and Presec as the pharmacological activity of clopidogrel is reduced if given concomitantly. Observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Presec. Concomitant use of PPIs with methotrexate may lead to methotrexate toxicities.
Therapeutic Class
Proton Pump Inhibitor
Storage Conditions
Keep in a dry place away from light and heat. Keep out of the reach of children.
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