Olmesafe
Generic Name
Olmesartan Medoxomil
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| olmesafe 20 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Olmesafe 20 mg tablet is an Angiotensin II Receptor Blocker (ARB) used to treat high blood pressure (hypertension). It helps to relax blood vessels, allowing blood to flow more easily and thereby lowering blood pressure.
Uses & Indications
Dosage
Adults
The usual starting dose is 20 mg once daily. The dose may be increased to 40 mg once daily if blood pressure is not adequately controlled. Doses above 40 mg generally do not provide further benefit.
Elderly
No initial dose adjustment is generally required for elderly patients, but close monitoring is advised.
Renal_impairment
For patients with moderate to severe renal impairment (creatinine clearance <40 mL/min), a starting dose of 10 mg once daily is recommended. Avoid use in severe renal impairment in diabetic patients also taking aliskiren.
How to Take
Take Olmesafe 20 mg tablet orally once daily, with or without food. Swallow the tablet whole with a glass of water.
Mechanism of Action
Olmesartan medoxomil is a prodrug that is rapidly converted to its active metabolite, olmesartan, during absorption from the gastrointestinal tract. Olmesartan selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, adrenal glands, and other tissues. This inhibition prevents the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased blood pressure, and reduced sodium and water retention.
Pharmacokinetics
Onset
Onset of antihypertensive effect is within 1-2 hours; maximal blood pressure reduction is usually achieved within 2 weeks, with full effect observed within 4 weeks.
Excretion
Approximately 35-50% of the absorbed dose is excreted renally (urine) and the remainder is eliminated via the hepatobiliary route (feces).
Half life
The elimination half-life of olmesartan is approximately 13 hours.
Absorption
Olmesartan medoxomil is rapidly and completely converted to olmesartan during absorption. The absolute bioavailability of olmesartan is approximately 26%. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Olmesartan is not metabolized by the cytochrome P450 system and undergoes little or no metabolism in the liver. It is primarily excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to olmesartan or any component of the formulation.
- Pregnancy (especially second and third trimesters).
- Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m²).
- Biliary obstruction.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity have been reported. Monitor lithium levels.
Aliskiren
Concomitant use is contraindicated in patients with diabetes or renal impairment due to increased risk of renal dysfunction, hyperkalemia, and hypotension.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of olmesartan and increase the risk of renal impairment, especially in elderly or dehydrated patients.
Potassium-sparing diuretics/Potassium supplements
May lead to increased serum potassium levels (hyperkalemia).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hypotension (low blood pressure) and possibly tachycardia; bradycardia could occur. Treatment should be symptomatic and supportive, including close monitoring of vital signs and intravenous fluid administration.
Pregnancy & Lactation
Olmesafe is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury or death. It is not recommended during the first trimester. It is unknown whether olmesartan is excreted in human milk, so caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to olmesartan or any component of the formulation.
- Pregnancy (especially second and third trimesters).
- Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m²).
- Biliary obstruction.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity have been reported. Monitor lithium levels.
Aliskiren
Concomitant use is contraindicated in patients with diabetes or renal impairment due to increased risk of renal dysfunction, hyperkalemia, and hypotension.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of olmesartan and increase the risk of renal impairment, especially in elderly or dehydrated patients.
Potassium-sparing diuretics/Potassium supplements
May lead to increased serum potassium levels (hyperkalemia).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hypotension (low blood pressure) and possibly tachycardia; bradycardia could occur. Treatment should be symptomatic and supportive, including close monitoring of vital signs and intravenous fluid administration.
Pregnancy & Lactation
Olmesafe is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury or death. It is not recommended during the first trimester. It is unknown whether olmesartan is excreted in human milk, so caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from the date of manufacture, specific details on packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved (e.g., FDA, DGDA)
Patent Status
Patent expired; generic versions available
Clinical Trials
Olmesartan has undergone extensive clinical trials demonstrating its efficacy and safety in the management of hypertension, including trials comparing it with other antihypertensive agents.
Lab Monitoring
- Serum creatinine and potassium levels should be monitored periodically, especially in patients with renal impairment or those taking potassium-sparing diuretics.
- Blood pressure should be regularly monitored.
Doctor Notes
- Counsel patients on the importance of regular blood pressure monitoring and adherence to therapy.
- Warn pregnant women about the risk of fetal toxicity and discontinue if pregnancy is detected.
- Monitor renal function and serum potassium, especially in patients with pre-existing renal impairment or those on concomitant medications affecting potassium levels.
- Be aware of the rare risk of sprue-like enteropathy; evaluate patients presenting with unexplained, chronic, severe diarrhea and weight loss.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Olmesafe suddenly without consulting your doctor, even if you feel well.
- Inform your doctor if you experience severe diarrhea or significant weight loss.
- Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Olmesafe may cause dizziness or fatigue, especially at the beginning of treatment or when the dose is increased. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Adopt a low-sodium diet and limit processed foods.
- Engage in regular physical activity as recommended by your doctor.
- Avoid smoking and limit alcohol consumption.
- Maintain a healthy weight.
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