Olmesafe-AM
Generic Name
Olmesartan Medoxomil + Amlodipine Besylate
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| olmesafe am 5 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Olmesafe-AM is a combination medication containing Olmesartan medoxomil, an angiotensin II receptor blocker (ARB), and Amlodipine besylate, a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) when monotherapy is not sufficient.
Uses & Indications
Dosage
Adults
Usually one tablet (Olmesartan 20 mg/Amlodipine 5 mg) once daily. Dosage may be increased after 2 weeks if blood pressure is not adequately controlled. Maximum recommended daily dose is Olmesartan 40 mg/Amlodipine 10 mg.
Elderly
No dosage adjustment is generally required, but caution is advised. Initiate with the lowest available dose.
Renal_impairment
For severe renal impairment (creatinine clearance <20 mL/min), use with caution. No initial dose adjustment is typically needed for mild to moderate impairment.
Hepatic_impairment
Use with caution in patients with hepatic impairment, especially severe impairment. A lower starting dose of amlodipine may be considered.
How to Take
Take orally, once daily, with or without food. Swallow the tablet whole with water. It is recommended to take the medicine at the same time each day.
Mechanism of Action
Olmesartan medoxomil selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, leading to vasodilation and reduced blood pressure. Amlodipine besylate inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, resulting in peripheral arterial vasodilation and reduction in blood pressure.
Pharmacokinetics
Onset
Onset of action for Amlodipine is gradual, typically 6-12 hours. For Olmesartan, blood pressure reduction starts within 2 weeks, with maximum effect by 8 weeks.
Excretion
Olmesartan is excreted renally (35-50%) and hepatically/biliary (50-65%). Amlodipine is primarily excreted in urine as inactive metabolites (60%) and feces (25%).
Half life
Olmesartan has an elimination half-life of approximately 13 hours. Amlodipine has a prolonged elimination half-life of 30-50 hours.
Absorption
Olmesartan medoxomil is rapidly absorbed and completely hydrolyzed to active olmesartan during absorption from the gastrointestinal tract. Amlodipine is well-absorbed orally, with peak plasma concentrations occurring 6-12 hours post-dose. Bioavailability of amlodipine is approximately 60-64%.
Metabolism
Olmesartan is not extensively metabolized. Amlodipine is extensively metabolized in the liver to inactive metabolites (approximately 90%).
Side Effects
Contraindications
- Hypersensitivity to olmesartan, amlodipine, or any component of the formulation
- Second and third trimesters of pregnancy
- Severe hepatic impairment
- Biliary obstruction
- Cardiogenic shock, unstable angina pectoris, severe aortic stenosis
Drug Interactions
NSAIDs
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in dehydrated or elderly patients.
Lithium
Concurrent use may increase serum lithium concentrations and lead to lithium toxicity.
Simvastatin
Amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg daily.
CYP3A4 Inducers (e.g., rifampicin)
May decrease amlodipine exposure.
CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir)
May increase amlodipine exposure, requiring dose adjustment.
Potassium-sparing diuretics, potassium supplements
May increase serum potassium levels (due to olmesartan).
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include marked hypotension with possible reflex tachycardia or, less commonly, profound bradycardia. Peripheral vasodilation and shock may occur. Treatment should be symptomatic and supportive, including monitoring of cardiac and respiratory function, elevation of extremities, and management of fluid volume and electrolyte balance. If ingestion is recent, gastric lavage may be considered. Vasopressors may be useful for refractory hypotension. Intravenous calcium gluconate may reverse the effects of calcium channel blockade.
Pregnancy & Lactation
Olmesafe-AM is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury or death associated with olmesartan. It is not recommended during the first trimester. Amlodipine is pregnancy category C, Olmesartan is pregnancy category D. It is not known whether Olmesartan is excreted in human milk, and Amlodipine is excreted in human milk; therefore, use is not recommended during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to olmesartan, amlodipine, or any component of the formulation
- Second and third trimesters of pregnancy
- Severe hepatic impairment
- Biliary obstruction
- Cardiogenic shock, unstable angina pectoris, severe aortic stenosis
Drug Interactions
NSAIDs
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in dehydrated or elderly patients.
Lithium
Concurrent use may increase serum lithium concentrations and lead to lithium toxicity.
Simvastatin
Amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg daily.
CYP3A4 Inducers (e.g., rifampicin)
May decrease amlodipine exposure.
CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir)
May increase amlodipine exposure, requiring dose adjustment.
Potassium-sparing diuretics, potassium supplements
May increase serum potassium levels (due to olmesartan).
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include marked hypotension with possible reflex tachycardia or, less commonly, profound bradycardia. Peripheral vasodilation and shock may occur. Treatment should be symptomatic and supportive, including monitoring of cardiac and respiratory function, elevation of extremities, and management of fluid volume and electrolyte balance. If ingestion is recent, gastric lavage may be considered. Vasopressors may be useful for refractory hypotension. Intravenous calcium gluconate may reverse the effects of calcium channel blockade.
Pregnancy & Lactation
Olmesafe-AM is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury or death associated with olmesartan. It is not recommended during the first trimester. Amlodipine is pregnancy category C, Olmesartan is pregnancy category D. It is not known whether Olmesartan is excreted in human milk, and Amlodipine is excreted in human milk; therefore, use is not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved in many countries
Patent Status
Generic available
Clinical Trials
Clinical trials have demonstrated the superior efficacy of olmesartan/amlodipine combination therapy in blood pressure reduction compared to monotherapy with either agent, with a good tolerability profile.
Lab Monitoring
- Serum creatinine and BUN (to monitor renal function)
- Serum potassium (due to risk of hyperkalemia with olmesartan)
- Liver function tests (periodically)
Doctor Notes
- Emphasize the importance of consistent medication adherence to patients.
- Advise regular blood pressure monitoring and reporting of symptoms.
- Caution against abrupt discontinuation of therapy.
- Monitor renal function, electrolytes, and hepatic enzymes periodically.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Monitor your blood pressure regularly as advised by your doctor.
- Report any unusual or severe side effects to your doctor immediately.
- Inform your doctor if you become pregnant or plan to become pregnant.
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-AM may cause dizziness, lightheadedness, or fatigue, especially at the start of treatment or when changing doses. Avoid driving or operating heavy machinery until you know how the medicine affects you.
Lifestyle Advice
- Adopt a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as approved by your doctor.
- Maintain a healthy body weight.
- Limit alcohol consumption.
- Quit smoking.
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