Olmesafe
Generic Name
Olmesafe
Manufacturer
Square Pharmaceuticals Ltd.
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 |
| olmesafe 40 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Olmesafe (Olmesartan Medoxomil) is an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) in adults and children 6 years and older. It helps to lower blood pressure, which can reduce the risk of strokes, heart attacks, and kidney problems.
Uses & Indications
Dosage
Adults
Initial dose: 20 mg orally once daily. May be increased to 40 mg once daily if needed. Doses above 40 mg generally do not provide additional benefit.
Elderly
No initial dosage adjustment is typically required, but caution is advised in elderly patients, especially those with renal impairment.
Renal_impairment
No initial dosage adjustment is needed for mild to moderate renal impairment. For severe renal impairment (creatinine clearance < 20 mL/min), a lower starting dose (e.g., 10 mg) may be considered, and careful monitoring is recommended.
How to Take
Olmesafe can be taken orally once daily with or without food. It should be swallowed whole with a glass of water. Try to take it at the same time each day.
Mechanism of Action
Olmesartan Medoxomil is a prodrug that is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective antagonist of the angiotensin II type 1 (AT1) receptor. It blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT1 receptor, thereby lowering blood pressure.
Pharmacokinetics
Onset
Antihypertensive effect generally appears within 2 weeks, with maximum reduction achieved after about 8 weeks.
Excretion
Eliminated via urine (35-50%) and bile/feces (50-65%).
Half life
Approximately 13 hours.
Absorption
Rapidly and completely converted to olmesartan during absorption from the gastrointestinal tract. Absolute bioavailability of olmesartan is approximately 26%. Peak plasma concentration (Cmax) is reached 1-2 hours after oral dosing.
Metabolism
Olmesartan does not undergo significant metabolism by the cytochrome P450 system. It is primarily eliminated unchanged.
Side Effects
Contraindications
- Hypersensitivity to any component of the product.
- Pregnancy (especially second and third trimesters).
- Concomitant use with aliskiren in patients with diabetes or moderate to severe renal impairment.
Drug Interactions
Lithium
Concurrent use may increase serum lithium concentrations and lead to lithium toxicity.
Aliskiren
Concomitant use in diabetic patients or patients with renal impairment (GFR < 60 mL/min/1.73m2) is contraindicated due to increased risk of hypotension, hyperkalemia, and renal function deterioration.
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, or salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia).
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 tachycardia; bradycardia could occur from parasympathetic stimulation. Treatment should be symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Activated charcoal may reduce absorption. Olmesartan is not dialyzable.
Pregnancy & Lactation
Olmesafe is contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury or death. Discontinue as soon as pregnancy is detected. It is not recommended during lactation as it is unknown if olmesartan is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to any component of the product.
- Pregnancy (especially second and third trimesters).
- Concomitant use with aliskiren in patients with diabetes or moderate to severe renal impairment.
Drug Interactions
Lithium
Concurrent use may increase serum lithium concentrations and lead to lithium toxicity.
Aliskiren
Concomitant use in diabetic patients or patients with renal impairment (GFR < 60 mL/min/1.73m2) is contraindicated due to increased risk of hypotension, hyperkalemia, and renal function deterioration.
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, or salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia).
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 tachycardia; bradycardia could occur from parasympathetic stimulation. Treatment should be symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Activated charcoal may reduce absorption. Olmesartan is not dialyzable.
Pregnancy & Lactation
Olmesafe is contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury or death. Discontinue as soon as pregnancy is detected. It is not recommended during lactation as it is unknown if olmesartan is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific details on packaging.
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved by FDA and DGDA
Patent Status
Generic versions available, original patent expired
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Olmesartan Medoxomil in reducing blood pressure and associated cardiovascular risks. Studies like the ROADMAP trial have explored its effects in specific patient populations.
Lab Monitoring
- Monitor serum creatinine and potassium levels periodically, especially in patients with renal impairment or those taking other medications that can affect potassium levels.
- Liver function tests may be considered.
Doctor Notes
- Counsel patients on the importance of adherence to therapy and lifestyle modifications.
- Monitor blood pressure, renal function, and serum potassium regularly.
- Advise patients to report symptoms of angioedema or severe enteropathy immediately.
Patient Guidelines
- Take Olmesafe exactly as prescribed by your doctor.
- Do not stop taking Olmesafe without consulting your doctor, even if you feel well.
- Report any unusual symptoms or side effects to your doctor immediately.
- Monitor your blood pressure regularly as advised by your healthcare provider.
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 lightheadedness, especially when starting treatment or increasing the dose. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Adopt a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity, such as brisk walking, for at least 30 minutes most days of the week.
- Maintain a healthy weight.
- Limit alcohol consumption.
- Quit smoking.
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