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 40 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Olmesafe 40mg Tablet contains Olmesartan Medoxomil, an angiotensin II receptor blocker (ARB) used to treat high blood pressure. It helps relax blood vessels, allowing blood to flow more easily and lowering blood pressure, thereby reducing the risk of stroke, heart attack, and kidney problems.
Uses & Indications
Dosage
Adults
Usually 20 mg once daily. May be increased to 40 mg once daily if blood pressure is not adequately controlled. Doses above 40 mg daily are not typically recommended.
Elderly
No initial dosage adjustment usually required unless severe renal impairment. Careful monitoring is advised.
Renal_impairment
For moderate to severe renal impairment (CrCl < 40 mL/min), starting dose 10 mg once daily, maximum 20 mg once daily. Not recommended for patients on dialysis.
How to Take
For oral administration. Olmesafe tablets can be taken with or without food, preferably at about the same time each day.
Mechanism of Action
Olmesartan selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues (vascular smooth muscle, adrenal glands, kidneys, heart). This blockade prevents the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation and reduced blood pressure.
Pharmacokinetics
Onset
Initial blood pressure reduction within 1 week, maximal effect typically within 2 weeks.
Excretion
Primarily excreted unchanged, about 35-50% renally and 50-65% hepatobiliary (feces).
Half life
Terminal elimination half-life is approximately 13 hours.
Absorption
Rapidly and completely absorbed from the GI tract after oral administration, converted to active olmesartan. Absolute bioavailability approx. 26%. Peak plasma concentration (Tmax) in 1-2 hours. Food does not significantly affect bioavailability.
Metabolism
Olmesartan medoxomil is a prodrug and is rapidly and completely hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan itself is not further metabolized.
Side Effects
Contraindications
- Hypersensitivity to olmesartan or any other component of the formulation.
- Pregnancy (second and third trimesters) due to fetal toxicity.
- 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; monitor lithium levels carefully.
Aliskiren
Increased risk of hypotension, hyperkalemia, and renal impairment (contraindicated in patients with diabetes or renal impairment).
NSAIDs (Non-Steroidal Anti-inflammatory Drugs)
Reduced antihypertensive effect; increased risk of worsening renal function and hyperkalemia, especially in dehydrated or elderly patients.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia; monitor serum potassium levels.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose would be hypotension and possibly tachycardia; bradycardia could occur. Treatment is symptomatic and supportive, including monitoring vital signs and managing fluid and electrolyte balance.
Pregnancy & Lactation
Pregnancy Category D (second and third trimesters) due to risk of fetal injury and death. Discontinue immediately if pregnancy is detected. Not recommended during breastfeeding, as olmesartan is excreted in rat milk and potential for adverse effects on nursing infant.
Side Effects
Contraindications
- Hypersensitivity to olmesartan or any other component of the formulation.
- Pregnancy (second and third trimesters) due to fetal toxicity.
- 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; monitor lithium levels carefully.
Aliskiren
Increased risk of hypotension, hyperkalemia, and renal impairment (contraindicated in patients with diabetes or renal impairment).
NSAIDs (Non-Steroidal Anti-inflammatory Drugs)
Reduced antihypertensive effect; increased risk of worsening renal function and hyperkalemia, especially in dehydrated or elderly patients.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia; monitor serum potassium levels.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose would be hypotension and possibly tachycardia; bradycardia could occur. Treatment is symptomatic and supportive, including monitoring vital signs and managing fluid and electrolyte balance.
Pregnancy & Lactation
Pregnancy Category D (second and third trimesters) due to risk of fetal injury and death. Discontinue immediately if pregnancy is detected. Not recommended during breastfeeding, as olmesartan is excreted in rat milk and potential for adverse effects on nursing infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have established olmesartan's efficacy and safety in managing hypertension, including its role in reducing cardiovascular morbidity and mortality. Notable studies include the ROADMAP study and various trials evaluating its use in combination therapies.
Lab Monitoring
- Monitor serum electrolytes (especially potassium) regularly, particularly in patients with renal impairment, on diuretics, or elderly.
- Monitor renal function (serum creatinine, BUN) periodically.
- Liver function tests if clinically indicated or if symptoms suggest hepatic dysfunction.
Doctor Notes
- Initiate therapy with 20mg once daily; may increase to 40mg if needed for blood pressure control.
- Caution in patients with bilateral renal artery stenosis or severe heart failure, as ARBs may precipitate acute renal failure.
- Monitor serum potassium and renal function (creatinine) periodically, especially in elderly patients and those on concomitant medications that affect potassium levels.
- Educate patients on the importance of adherence to therapy and potential signs of adverse effects like angioedema or hyperkalemia.
Patient Guidelines
- Take Olmesafe exactly as prescribed by your doctor, usually once daily.
- Do not stop taking the medicine abruptly, even if you feel well, without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual side effects like swelling of the face, lips, or tongue immediately.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
Driving Precautions
Olmesafe may cause dizziness or lightheadedness, especially at the start of treatment or when changing dose. Avoid driving or operating machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain a healthy diet low in sodium and rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol consumption.
- Quit smoking to significantly improve cardiovascular health.
- Manage stress effectively.
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