Perizol
Generic Name
omeprazole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Omeprazole (Perizol) is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. It is used to treat conditions like heartburn, acid reflux, and stomach ulcers.
Uses & Indications
Dosage
Adults
Typical dosage ranges from 20 mg to 40 mg once daily, depending on the condition being treated. For GERD, 20-40 mg once daily for 4-8 weeks. For duodenal ulcers, 20 mg once daily for 2-4 weeks. For gastric ulcers, 20 mg once daily for 4-8 weeks. For H. pylori eradication, typically 20 mg twice daily with antibiotics.
Elderly
No specific dose adjustment is generally required, but caution should be exercised in very elderly patients with significant hepatic impairment.
Renal_impairment
No dose adjustment is necessary for patients with impaired renal function.
Hepatic_impairment
Dose reduction may be considered in patients with severe hepatic impairment, as plasma half-life can be increased.
How to Take
Take orally, typically once daily in the morning, at least 30-60 minutes before a meal. Swallow the capsule whole with water; do not chew, crush, or open the capsule.
Mechanism of Action
Omeprazole irreversibly blocks the H+/K+ ATPase enzyme system (the 'proton pump') in the secretory surface of the gastric parietal cells. This action inhibits the final step of acid production in the stomach, leading to a significant and prolonged reduction in gastric acid secretion.
Pharmacokinetics
Onset
Within 1 hour; maximum acid suppression within 2 hours. Full therapeutic effect within 4 days.
Excretion
Approximately 80% of metabolites are excreted in the urine and the remainder in the feces.
Half life
Plasma half-life is approximately 0.5-1 hour, but its acid-suppressing effect lasts much longer due to irreversible binding to the proton pump.
Absorption
Rapidly absorbed from the gastrointestinal tract after oral administration, but absorption can be delayed. Bioavailability is about 30-40% after a single dose and increases to about 60% with repeated dosing.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 system (CYP2C19 and CYP3A4), to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to omeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Digoxin
Increased absorption and plasma levels of digoxin.
Diazepam
Delayed elimination of diazepam.
Warfarin
Increased INR and risk of bleeding.
Tacrolimus
Increased serum concentration of tacrolimus.
Clopidogrel
Decreased antiplatelet effect of clopidogrel due to inhibition of CYP2C19.
Methotrexate
Increased and prolonged serum levels of methotrexate.
HIV Antivirals (e.g., Atazanavir, Nelfinavir)
Reduced absorption and efficacy of these drugs.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and may include nausea, vomiting, abdominal pain, diarrhea, headache, lethargy, or confusion. Treatment is symptomatic and supportive. Omeprazole is not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category C (old system). Use only if clearly needed and potential benefits outweigh risks. Omeprazole is excreted in 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.
Drug Interactions
Digoxin
Increased absorption and plasma levels of digoxin.
Diazepam
Delayed elimination of diazepam.
Warfarin
Increased INR and risk of bleeding.
Tacrolimus
Increased serum concentration of tacrolimus.
Clopidogrel
Decreased antiplatelet effect of clopidogrel due to inhibition of CYP2C19.
Methotrexate
Increased and prolonged serum levels of methotrexate.
HIV Antivirals (e.g., Atazanavir, Nelfinavir)
Reduced absorption and efficacy of these drugs.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and may include nausea, vomiting, abdominal pain, diarrhea, headache, lethargy, or confusion. Treatment is symptomatic and supportive. Omeprazole is not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category C (old system). Use only if clearly needed and potential benefits outweigh risks. Omeprazole is excreted in 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 24-36 months from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established omeprazole's efficacy and safety for various acid-related disorders. Ongoing research explores long-term effects and new indications.
Lab Monitoring
- Magnesium levels (for long-term use)
- Liver function tests (if hepatic impairment is suspected)
- Vitamin B12 levels (for very long-term use)
Doctor Notes
- Counsel patients on potential long-term risks of PPIs and consider periodic reassessment for continued necessity.
- Be mindful of drug interactions, especially with clopidogrel and HIV antivirals.
- Assess for symptoms that might mask serious underlying conditions (e.g., dysphagia, weight loss).
Patient Guidelines
- Take as directed by your doctor, usually before the first meal of the day.
- Do not chew, crush, or open the capsule; swallow it whole.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double doses.
Driving Precautions
Omeprazole is generally not expected to affect the ability to drive or operate machinery. However, side effects such as dizziness or visual disturbances may occur rarely. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Avoid trigger foods and beverages that worsen acid reflux (e.g., fatty foods, spicy foods, caffeine, alcohol).
- Eat smaller, more frequent meals.
- Avoid lying down for at least 2-3 hours after eating.
- Elevate the head of your bed.
- Maintain a healthy weight and stop smoking.
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