Olmefast-AM
Generic Name
Olmesartan Medoxomil + Amlodipine Besylate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| olmefast am 5 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Olmefast-AM 5 mg tablet is a combination medicine used to treat high blood pressure (hypertension). It contains Olmesartan (an Angiotensin Receptor Blocker) and Amlodipine (a Calcium Channel Blocker) which work together to relax blood vessels and lower blood pressure.
Uses & Indications
Dosage
Adults
The usual starting dose is Olmesartan 20 mg/Amlodipine 5 mg once daily. The dose may be increased after 1-2 weeks if necessary, to a maximum of Olmesartan 40 mg/Amlodipine 10 mg once daily.
Elderly
No dosage adjustment is generally required for elderly patients, but caution is advised. Initiate at the lower end of the dosing range.
Renal_impairment
No dosage adjustment is usually required for mild to moderate renal impairment. For severe renal impairment, lower initial doses and careful monitoring are recommended.
How to Take
Take the tablet orally, once daily, with or without food. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Olmesartan Medoxomil selectively blocks the binding of angiotensin II to the AT1 receptor, inhibiting the vasoconstrictive and aldosterone-secreting effects of angiotensin II. Amlodipine Besylate is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to vasodilation and reduced peripheral vascular resistance.
Pharmacokinetics
Onset
Antihypertensive effects of Amlodipine begin within 6-12 hours. For Olmesartan, maximum blood pressure reduction is achieved within 2 weeks.
Excretion
Olmesartan is excreted renally (35-50%) and hepatobiliary (50-65%). Amlodipine is primarily excreted in the urine (60% as metabolites, 10% as unchanged drug).
Half life
Olmesartan has an elimination half-life of approximately 13-15 hours. Amlodipine has a prolonged elimination half-life of 30-50 hours.
Absorption
Olmesartan is rapidly absorbed, with a bioavailability of approximately 26%. Amlodipine is well absorbed after oral administration, with peak plasma concentrations occurring 6-12 hours post-dose, and bioavailability of 64-90%.
Metabolism
Olmesartan is largely eliminated unmetabolized, with a small fraction metabolized to inactive metabolites. Amlodipine is extensively metabolized in the liver 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.
- Bilateral renal artery stenosis.
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).
- Cardiogenic shock, clinically significant aortic stenosis, unstable angina.
- Severe hypotension.
Drug Interactions
NSAIDs
May reduce the antihypertensive effect of Olmesartan and impair renal function, especially in elderly, volume-depleted, or renally impaired patients.
Lithium
Increased serum lithium concentrations and toxicity have been reported with concomitant use of ARBs.
Simvastatin
Amlodipine may increase systemic exposure to simvastatin. Limit simvastatin dose to 20 mg daily.
Potassium-sparing diuretics/Potassium supplements
May increase serum potassium levels due to Olmesartan's effect.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
May increase systemic exposure to Amlodipine, requiring dose reduction.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include marked hypotension (low blood pressure) with possible reflex tachycardia (rapid heartbeat) and peripheral vasodilation. Amlodipine overdose can lead to excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension. Management involves symptomatic treatment and supportive measures. If ingestion is recent, gastric lavage may be considered. Intravenous calcium gluconate may be beneficial for reversing calcium channel blockade effects. Vasopressors may be needed for hypotension.
Pregnancy & Lactation
Olmefast-AM is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with Olmesartan. Amlodipine is Category C. It is not known whether Olmesartan or Amlodipine are excreted in human milk, therefore, caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to olmesartan, amlodipine, or any component of the formulation.
- Second and third trimesters of pregnancy.
- Severe hepatic impairment.
- Bilateral renal artery stenosis.
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).
- Cardiogenic shock, clinically significant aortic stenosis, unstable angina.
- Severe hypotension.
Drug Interactions
NSAIDs
May reduce the antihypertensive effect of Olmesartan and impair renal function, especially in elderly, volume-depleted, or renally impaired patients.
Lithium
Increased serum lithium concentrations and toxicity have been reported with concomitant use of ARBs.
Simvastatin
Amlodipine may increase systemic exposure to simvastatin. Limit simvastatin dose to 20 mg daily.
Potassium-sparing diuretics/Potassium supplements
May increase serum potassium levels due to Olmesartan's effect.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
May increase systemic exposure to Amlodipine, requiring dose reduction.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include marked hypotension (low blood pressure) with possible reflex tachycardia (rapid heartbeat) and peripheral vasodilation. Amlodipine overdose can lead to excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension. Management involves symptomatic treatment and supportive measures. If ingestion is recent, gastric lavage may be considered. Intravenous calcium gluconate may be beneficial for reversing calcium channel blockade effects. Vasopressors may be needed for hypotension.
Pregnancy & Lactation
Olmefast-AM is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with Olmesartan. Amlodipine is Category C. It is not known whether Olmesartan or Amlodipine are excreted in human milk, therefore, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved
Patent Status
Off-patent (generic versions available)
Clinical Trials
The combination of olmesartan and amlodipine has been extensively studied in clinical trials demonstrating its efficacy and safety in reducing blood pressure in patients with hypertension. These trials have shown superior blood pressure reduction compared to monotherapy with either agent.
Lab Monitoring
- Monitor blood pressure regularly.
- Monitor renal function (serum creatinine, BUN) periodically, especially in patients with pre-existing renal impairment.
- Monitor serum potassium levels, especially in patients with renal impairment or those receiving potassium-sparing diuretics/supplements.
Doctor Notes
- Monitor blood pressure, renal function, and serum potassium levels regularly.
- Caution in patients with severe aortic stenosis or severe obstructive coronary artery disease due to the potential for excessive vasodilation.
- Advise patients on lifestyle modifications to complement drug therapy.
Patient Guidelines
- Take this medicine regularly as prescribed by your doctor, even if you feel well.
- Do not stop taking this medicine abruptly without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regularly monitor your blood pressure at home if 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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, headache, or fatigue, especially at the beginning of treatment. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Adopt a healthy lifestyle including a balanced diet rich in fruits and vegetables, and low in salt.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit or avoid alcohol consumption.
- Quit smoking.
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