Prolok
Generic Name
Omeprazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| prolok 20 mg capsule | ৳ 5.50 | ৳ 55.00 |
Description
Overview of the medicine
Prolok 20 mg Capsule contains Omeprazole, a proton pump inhibitor (PPI) used to reduce the amount of acid produced in the stomach. It is effective in treating conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related disorders.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For GERD: 20 mg once daily for 4-8 weeks. For duodenal ulcer: 20 mg once daily for 2-4 weeks. For gastric ulcer: 20 mg once daily for 4-8 weeks. For H. pylori eradication: 20 mg twice daily with antibiotics for 7-14 days. For Zollinger-Ellison syndrome: Initial dose 60 mg once daily, adjusted based on patient response.
Elderly
No specific dose adjustment is generally required for elderly patients, but caution is advised in patients with severe hepatic impairment.
Renal_impairment
No dose adjustment is necessary for patients with impaired renal function.
How to Take
Take the capsule orally, usually once daily in the morning, before a meal. Swallow the capsule whole with water. Do not chew, crush, or open the capsule.
Mechanism of Action
Omeprazole works by irreversibly binding to and inhibiting the H+/K+-ATPase pump (proton pump) located in the gastric parietal cells. This action blocks the final step in gastric acid production, leading to a profound and long-lasting reduction in stomach acid secretion.
Pharmacokinetics
Onset
Onset of acid secretion inhibition occurs within 1 hour, with maximum effect within 2 hours. Full acid suppression may take several days.
Excretion
Approximately 77% of a dose is excreted in the urine as metabolites, and about 18% is excreted in the feces.
Half life
Plasma half-life is short, about 0.5 to 1 hour, but the duration of antisecretory effect is much longer (up to 72 hours) due to irreversible binding to the proton pump.
Absorption
Rapidly absorbed from the gastrointestinal tract. Bioavailability is approximately 30-40% due to first-pass metabolism, increasing to about 60% with repeated dosing.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 enzyme system, specifically CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to omeprazole, substituted benzimidazoles, or any component of the formulation
- Concomitant use with nelfinavir (an antiviral drug)
Drug Interactions
Digoxin
Omeprazole may increase digoxin levels, especially in elderly patients, requiring monitoring.
Warfarin
Omeprazole may increase the anticoagulant effect of warfarin, requiring monitoring of INR and dose adjustment.
Clopidogrel
Omeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19, potentially increasing the risk of cardiovascular events.
Methotrexate
Concomitant use with high-dose methotrexate may increase and prolong methotrexate serum levels and its toxic effects.
Nelfinavir/Atazanavir
Omeprazole may significantly decrease the plasma concentrations of nelfinavir and atazanavir, reducing their effectiveness. Concomitant use is contraindicated for nelfinavir.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and may include nausea, vomiting, abdominal pain, diarrhea, headache, and dizziness. There is no specific antidote. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Omeprazole is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to omeprazole, substituted benzimidazoles, or any component of the formulation
- Concomitant use with nelfinavir (an antiviral drug)
Drug Interactions
Digoxin
Omeprazole may increase digoxin levels, especially in elderly patients, requiring monitoring.
Warfarin
Omeprazole may increase the anticoagulant effect of warfarin, requiring monitoring of INR and dose adjustment.
Clopidogrel
Omeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19, potentially increasing the risk of cardiovascular events.
Methotrexate
Concomitant use with high-dose methotrexate may increase and prolong methotrexate serum levels and its toxic effects.
Nelfinavir/Atazanavir
Omeprazole may significantly decrease the plasma concentrations of nelfinavir and atazanavir, reducing their effectiveness. Concomitant use is contraindicated for nelfinavir.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and may include nausea, vomiting, abdominal pain, diarrhea, headache, and dizziness. There is no specific antidote. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Omeprazole is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Omeprazole has undergone extensive clinical trials demonstrating its efficacy and safety in various acid-related disorders. Ongoing research continues to explore its long-term effects and potential new indications.
Lab Monitoring
- Monitor serum magnesium levels periodically in patients expected to be on prolonged treatment or who take other drugs that may cause hypomagnesemia.
- Consider monitoring vitamin B12 levels in patients on long-term therapy (over 3 years) due to potential malabsorption.
Doctor Notes
- Emphasize the importance of appropriate duration of PPI therapy; avoid unnecessary prolonged use.
- Counsel patients on potential risks associated with long-term use, including bone fractures and C. difficile infection.
- Consider baseline and periodic monitoring of magnesium levels in patients on long-term therapy or concomitant interacting drugs.
- Advise patients to report any severe or persistent diarrhea.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Do not stop taking the capsule abruptly without consulting your doctor, even if symptoms improve.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Seek medical advice if symptoms persist or worsen after treatment.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Generally, omeprazole does not affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or visual disturbances, avoid such activities.
Lifestyle Advice
- Avoid foods that trigger heartburn or acid reflux, such as spicy, fatty, or acidic foods.
- Limit consumption of alcohol and caffeine.
- Quit smoking, as it can worsen acid reflux symptoms.
- Eat smaller, more frequent meals and avoid lying down immediately after eating.
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