Olmefast-AM
Generic Name
Olmesartan Medoxomil + Amlodipine Besilate
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 is a combination medication containing Olmesartan Medoxomil, an Angiotensin Receptor Blocker (ARB), and Amlodipine Besilate, a Dihydropyridine Calcium Channel Blocker (CCB). It is primarily used to treat essential hypertension in adults when monotherapy is not sufficient.
Uses & Indications
Dosage
Adults
Usually one tablet daily (e.g., Olmesartan 20 mg/Amlodipine 5 mg) or as directed by physician. Dosage may be adjusted based on response.
Elderly
No special dosage adjustment is generally required, but caution is advised, especially in patients over 75 years, due to reduced renal function.
Renal_impairment
Caution required. Initial dosage may need adjustment for severe renal impairment. Regular monitoring is essential.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Olmesartan blocks the binding of angiotensin II to the AT1 receptor, leading to vasodilation and reduced blood pressure. Amlodipine inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle, resulting in peripheral vasodilation and reduced blood pressure.
Pharmacokinetics
Onset
Olmesartan: within 2 hours; Amlodipine: within 6-12 hours (peak effect).
Excretion
Olmesartan: primarily excreted unchanged via bile and urine. Amlodipine: primarily excreted via urine as inactive metabolites.
Half life
Olmesartan: 13 hours; Amlodipine: 30-50 hours.
Absorption
Olmesartan Medoxomil is rapidly and completely absorbed from the gastrointestinal tract and rapidly converted to olmesartan. Amlodipine is well absorbed from the GI tract.
Metabolism
Olmesartan is not metabolized by the cytochrome P450 system. Amlodipine is extensively metabolized in the liver to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Olmesartan, Amlodipine, or any component of the formulation
- Pregnancy (especially 2nd and 3rd trimesters)
- Severe hepatic impairment
- Obstructive biliary disorders
- Severe hypotension
- Shock (including cardiogenic shock)
- Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis)
- Hemodynamically unstable heart failure after acute myocardial infarction
- Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m2)
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect and increase the risk of renal function deterioration.
CYP3A4 inducers (e.g., Rifampicin, St. John's Wort)
May decrease amlodipine exposure.
CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May increase amlodipine exposure, leading to increased risk of hypotension.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia).
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 profound hypotension, bradycardia, and tachycardia. Management involves symptomatic and supportive treatment. Amlodipine overdose may lead to excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy: Contraindicated during the 2nd and 3rd trimesters due to fetal toxicity. Use of ARBs is not recommended during the first trimester. Lactation: Not recommended. It is unknown if olmesartan is excreted in human milk. Amlodipine is excreted in human milk. Consider alternatives.
Side Effects
Contraindications
- Hypersensitivity to Olmesartan, Amlodipine, or any component of the formulation
- Pregnancy (especially 2nd and 3rd trimesters)
- Severe hepatic impairment
- Obstructive biliary disorders
- Severe hypotension
- Shock (including cardiogenic shock)
- Obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis)
- Hemodynamically unstable heart failure after acute myocardial infarction
- Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m2)
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect and increase the risk of renal function deterioration.
CYP3A4 inducers (e.g., Rifampicin, St. John's Wort)
May decrease amlodipine exposure.
CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May increase amlodipine exposure, leading to increased risk of hypotension.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia).
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 profound hypotension, bradycardia, and tachycardia. Management involves symptomatic and supportive treatment. Amlodipine overdose may lead to excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy: Contraindicated during the 2nd and 3rd trimesters due to fetal toxicity. Use of ARBs is not recommended during the first trimester. Lactation: Not recommended. It is unknown if olmesartan is excreted in human milk. Amlodipine is excreted in human milk. Consider alternatives.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Available in pharmacies nationwide
Approval Status
Approved by FDA (USA) and DGDA (Bangladesh)
Patent Status
Generic available (likely off-patent for the combination)
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of the Olmesartan/Amlodipine combination in reducing blood pressure in hypertensive patients.
Lab Monitoring
- Serum creatinine and potassium levels (especially in renal impairment)
- Liver function tests periodically
Doctor Notes
- Monitor blood pressure regularly. Check renal function and serum potassium periodically.
- Counsel patients on potential for dizziness and importance of adherence.
- Adjust dosage based on individual patient response and tolerability.
Patient Guidelines
- Take consistently at the same time each day.
- Do not stop taking the medicine abruptly without consulting your doctor.
- Report any swelling, especially in the ankles or face, or any unusual symptoms.
- Avoid potassium-rich foods or supplements unless 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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, fatigue, or headache. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet low in sodium.
- Engage in regular physical activity.
- Avoid smoking and limit alcohol intake.
- Monitor blood pressure regularly at home as advised by your doctor.
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