Olmevas-AM
Generic Name
Olmesartan Medoxomil + Amlodipine (as Besylate)
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| olmevas am 5 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Olmevas-AM 5 mg Tablet is a fixed-dose combination medicine used to treat high blood pressure (hypertension). It contains Olmesartan Medoxomil, an Angiotensin Receptor Blocker (ARB), and Amlodipine, a Calcium Channel Blocker (CCB). This combination helps to relax blood vessels, making it easier for the heart to pump blood, thereby lowering blood pressure.
Uses & Indications
Dosage
Adults
The usual starting dose is Olmesartan Medoxomil 20 mg + Amlodipine 5 mg orally once daily. Dosage may be increased after 1-2 weeks as needed, up to a maximum of Olmesartan Medoxomil 40 mg + Amlodipine 10 mg once daily.
Elderly
No specific dose adjustment is required, but caution is advised. Start with the lowest effective dose.
Renal_impairment
No initial dose adjustment for mild to moderate renal impairment. For severe renal impairment, lower doses and careful monitoring are recommended. Not recommended in patients undergoing dialysis.
How to Take
Take the tablet whole with a glass of water, with or without food, at approximately the same time each day.
Mechanism of Action
Olmesartan Medoxomil is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, preventing vasoconstriction and aldosterone release. Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to peripheral arterial vasodilation and a reduction in peripheral vascular resistance.
Pharmacokinetics
Onset
Olmesartan: 1-2 hours. Amlodipine: 6-12 hours (for peak effect).
Excretion
Olmesartan: Biliary/fecal (50-65%) and renal (35-50%). Amlodipine: Primarily renal (60% as metabolites).
Half life
Olmesartan: ~13 hours. Amlodipine: 30-50 hours.
Absorption
Olmesartan: Rapid conversion to active olmesartan, bioavailability ~26%. Amlodipine: Well absorbed, bioavailability 64-90%.
Metabolism
Olmesartan: Minimal hepatic metabolism. Amlodipine: Extensive hepatic metabolism to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Olmesartan, Amlodipine, or any component of the formulation
- Second and third trimesters of pregnancy
- Severe hepatic impairment
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²)
Drug Interactions
NSAIDs
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
Lithium
Increased serum lithium concentrations and toxicity reported. Monitor lithium levels.
Aliskiren
Contraindicated in diabetic patients or those with renal impairment (GFR <60 mL/min/1.73 m²) due to increased risk of hyperkalemia, hypotension, and renal impairment.
Simvastatin
Amlodipine may increase simvastatin exposure. Limit simvastatin dose to 20 mg/day.
CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir)
May increase amlodipine exposure, leading to increased risk of hypotension and edema. Dose reduction of amlodipine may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include marked hypotension with possible reflex tachycardia, or excessive peripheral vasodilation leading to shock with fatal outcome. Management involves symptomatic and supportive care, including close monitoring of blood pressure, fluid status, and electrolyte balance. Intravenous fluids and vasopressors may be necessary for hypotension. Amlodipine is highly protein-bound, so hemodialysis is unlikely to be beneficial.
Pregnancy & Lactation
Pregnancy: Contraindicated during the second and third trimesters due to potential fetal harm (renal dysfunction, oligohydramnios, fetal death). Discontinue if pregnancy is detected. Lactation: Not recommended. It is unknown if olmesartan is excreted in human milk, and amlodipine is known to be excreted. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Olmesartan, Amlodipine, or any component of the formulation
- Second and third trimesters of pregnancy
- Severe hepatic impairment
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²)
Drug Interactions
NSAIDs
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
Lithium
Increased serum lithium concentrations and toxicity reported. Monitor lithium levels.
Aliskiren
Contraindicated in diabetic patients or those with renal impairment (GFR <60 mL/min/1.73 m²) due to increased risk of hyperkalemia, hypotension, and renal impairment.
Simvastatin
Amlodipine may increase simvastatin exposure. Limit simvastatin dose to 20 mg/day.
CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir)
May increase amlodipine exposure, leading to increased risk of hypotension and edema. Dose reduction of amlodipine may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include marked hypotension with possible reflex tachycardia, or excessive peripheral vasodilation leading to shock with fatal outcome. Management involves symptomatic and supportive care, including close monitoring of blood pressure, fluid status, and electrolyte balance. Intravenous fluids and vasopressors may be necessary for hypotension. Amlodipine is highly protein-bound, so hemodialysis is unlikely to be beneficial.
Pregnancy & Lactation
Pregnancy: Contraindicated during the second and third trimesters due to potential fetal harm (renal dysfunction, oligohydramnios, fetal death). Discontinue if pregnancy is detected. Lactation: Not recommended. It is unknown if olmesartan is excreted in human milk, and amlodipine is known to be excreted. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities for hypertension
Patent Status
Active ingredients are generic
Clinical Trials
The efficacy and safety of Olmesartan Medoxomil and Amlodipine Besylate fixed-dose combination have been demonstrated in multiple clinical trials for the treatment of hypertension, showing superior blood pressure reduction compared to monotherapy.
Lab Monitoring
- Blood pressure regularly
- Renal function (serum creatinine, BUN)
- Serum electrolytes (especially potassium)
- Liver function tests periodically
Doctor Notes
- Emphasize the importance of consistent daily dosing and not discontinuing therapy abruptly.
- Monitor blood pressure, renal function, and electrolytes regularly, especially in elderly or high-risk patients.
- Counsel patients on potential side effects, particularly dizziness and peripheral edema, and strategies for management.
- Advise lifestyle modifications (diet, exercise, smoking cessation) for optimal blood pressure control.
Patient Guidelines
- Take medicine exactly as prescribed by your doctor, even if you feel well.
- Do not stop taking this medicine abruptly without consulting your doctor, as it may lead to a sudden increase in blood pressure.
- Inform your doctor if you experience severe side effects or if you become pregnant.
- Maintain a healthy lifestyle, including a balanced diet low in salt, regular exercise, and avoiding smoking and excessive alcohol consumption.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
This medicine may cause dizziness or fatigue. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Follow a low-sodium diet and limit processed foods.
- Engage in regular physical activity as advised by your doctor.
- Avoid smoking and limit alcohol intake.
- Manage stress effectively through relaxation techniques.
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