Ometac
Generic Name
Omeprazole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ometac 40 mg capsule | ৳ 7.00 | ৳ 28.00 |
Description
Overview of the medicine
Omeprazole is a proton pump inhibitor (PPI) used to reduce the amount of acid produced in the stomach. It is commonly prescribed for conditions such as ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.
Uses & Indications
Dosage
Adults
For most conditions, 20-40 mg once daily. For severe cases like Zollinger-Ellison syndrome, doses may range from 60 mg to 120 mg daily, typically divided into two doses.
Elderly
No general dose adjustment is needed based solely on age, but caution is advised in elderly patients with hepatic impairment.
Renal_impairment
No dosage adjustment is required for patients with impaired renal function.
How to Take
Ometac capsules should be swallowed whole with a glass of water, usually in the morning at least 30 minutes before a meal. Do not chew or crush the capsules, as this may affect the delayed-release properties.
Mechanism of Action
Omeprazole irreversibly blocks the H+/K+-ATPase (proton pump) in the secretory surface of gastric parietal cells. This action inhibits the final step in gastric acid production, leading to a sustained decrease in gastric acid secretion.
Pharmacokinetics
Onset
Within 1 hour, with maximal acid suppression achieved within 2 hours. Full therapeutic effect is typically seen within 2-4 days of continuous daily dosing.
Excretion
Approximately 77% of the dose is excreted in the urine as metabolites, and about 20% is excreted in the feces.
Half life
Approximately 0.5 to 1 hour (plasma half-life), but the duration of acid suppression is much longer due to irreversible binding to the proton pump.
Absorption
Rapidly absorbed from the small intestine after oral administration, with peak plasma concentrations occurring within 0.5 to 3.5 hours. Bioavailability is about 30-40% after the first dose and increases slightly with repeated administration.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 enzyme system, specifically CYP2C19 and CYP3A4. Its metabolites are largely inactive.
Side Effects
Contraindications
- Known hypersensitivity to omeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir (an antiretroviral drug).
Drug Interactions
Digoxin
May increase the bioavailability of digoxin, especially in patients on long-term therapy.
Diazepam
May prolong the elimination of diazepam, increasing its plasma levels.
Warfarin
Omeprazole can increase INR and prothrombin time in patients taking warfarin. Close monitoring is recommended.
Clopidogrel
Omeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19. Concomitant use should be avoided.
Methotrexate
Omeprazole may increase methotrexate plasma levels and prolong its elimination, potentially leading to toxicity. Dose adjustments or temporary discontinuation of omeprazole may be necessary.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of omeprazole overdose are generally mild and self-limiting, including nausea, vomiting, abdominal pain, diarrhea, headache, lethargy, confusion, and tachycardia. There is no specific antidote; treatment should be symptomatic and supportive.
Pregnancy & Lactation
Omeprazole is categorized as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Small amounts of omeprazole may be excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother.
Side Effects
Contraindications
- Known hypersensitivity to omeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir (an antiretroviral drug).
Drug Interactions
Digoxin
May increase the bioavailability of digoxin, especially in patients on long-term therapy.
Diazepam
May prolong the elimination of diazepam, increasing its plasma levels.
Warfarin
Omeprazole can increase INR and prothrombin time in patients taking warfarin. Close monitoring is recommended.
Clopidogrel
Omeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19. Concomitant use should be avoided.
Methotrexate
Omeprazole may increase methotrexate plasma levels and prolong its elimination, potentially leading to toxicity. Dose adjustments or temporary discontinuation of omeprazole may be necessary.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of omeprazole overdose are generally mild and self-limiting, including nausea, vomiting, abdominal pain, diarrhea, headache, lethargy, confusion, and tachycardia. There is no specific antidote; treatment should be symptomatic and supportive.
Pregnancy & Lactation
Omeprazole is categorized as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Small amounts of omeprazole may be excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, depending on the specific product and manufacturer.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Omeprazole has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in various acid-related disorders, including peptic ulcers, GERD, and Zollinger-Ellison syndrome. Studies have also confirmed its role in H. pylori eradication regimens.
Lab Monitoring
- Magnesium levels (for patients on long-term therapy, especially with diuretics or other drugs that can cause hypomagnesemia).
- Vitamin B12 levels (for long-term use exceeding 3 years, due to potential malabsorption).
- INR/prothrombin time (for patients on concomitant warfarin therapy).
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration consistent with the patient's condition.
- Consider testing for H. pylori infection in patients with recurrent ulcers.
- Advise patients on long-term therapy about potential risks like hypomagnesemia and vitamin B12 deficiency and monitor accordingly.
- Avoid concomitant use with clopidogrel due to reduced antiplatelet efficacy.
- Be aware of potential drug interactions with warfarin, methotrexate, and other drugs metabolized by CYP2C19 and CYP3A4.
Patient Guidelines
- Take Ometac exactly as prescribed by your doctor. Do not alter the dose or stop the medication without consulting your healthcare provider.
- Swallow the capsules whole with water. Do not chew, crush, or open them.
- Take your dose at least 30 minutes before your first meal of the day.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any new or worsening symptoms, especially severe diarrhea, persistent abdominal pain, or unusual bruising/bleeding.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Omeprazole may cause dizziness, visual disturbances, or somnolence in some individuals. If you experience these side effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid trigger foods and beverages that may worsen acid reflux symptoms, such as spicy foods, fatty foods, caffeine, chocolate, and alcohol.
- Maintain a healthy weight, as obesity can exacerbate GERD.
- Elevate the head of your bed by 6-8 inches if you experience nighttime heartburn.
- Avoid lying down immediately after meals; wait at least 2-3 hours.
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