Olpres-A
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 |
|---|---|---|
| olpres a 5 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Olpres-A 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). This combination helps to relax blood vessels, allowing blood to flow more easily and reducing the workload on the heart.
Uses & Indications
Dosage
Adults
Initially, one tablet of Olmesartan Medoxomil 20 mg/Amlodipine Besilate 5 mg once daily. Dosage may be increased after 1-2 weeks if needed, up to a maximum of Olmesartan 40 mg/Amlodipine 10 mg once daily.
Elderly
No special dosage adjustment is generally required, but caution should be exercised, and lower starting doses may be considered, especially with amlodipine.
Renal_impairment
No initial dose adjustment for mild to moderate renal impairment. For severe renal impairment, careful monitoring is advised, and lower doses may be considered.
How to Take
Oral. Take one tablet once daily with or without food, preferably at the same time each day.
Mechanism of Action
Olmesartan selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, leading to vasodilation, reduced aldosterone secretion, and decreased blood pressure. Amlodipine is a dihydropyridine calcium channel blocker that 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
Olmesartan: within 2 hours. Amlodipine: 6-12 hours for peak effect.
Excretion
Olmesartan is primarily eliminated via bile and urine. Amlodipine is primarily excreted via the kidneys as inactive metabolites, with about 10% excreted as unchanged drug.
Half life
Olmesartan: 13-15 hours. Amlodipine: 30-50 hours.
Absorption
Olmesartan medoxomil is rapidly and completely converted to olmesartan during absorption from the gastrointestinal tract. Absolute bioavailability of olmesartan is approximately 26%. Amlodipine is well absorbed after oral administration with peak plasma concentrations reached 6-12 hours after dosing. Absolute bioavailability is estimated to be 64-90%.
Metabolism
Olmesartan is not metabolized by the cytochrome P450 system and is primarily excreted unchanged. 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 second and third trimesters)
- Severe renal impairment
- Biliary obstruction
- Severe hepatic impairment
- Obstructive outflow tract lesion of the left ventricle (e.g., severe aortic stenosis)
- Cardiogenic shock
- Unstable angina pectoris (within one month of a myocardial infarction)
Drug Interactions
NSAIDs
May reduce the antihypertensive effect of olmesartan and increase the risk of renal impairment.
Lithium
Increased serum lithium concentrations and lithium toxicity have been reported with ARBs.
Simvastatin
Amlodipine increases simvastatin exposure; limit simvastatin dose to 20 mg/day.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
May increase amlodipine exposure, requiring dose reduction.
Potassium-sparing diuretics/Potassium supplements
May lead to hyperkalemia.
CYP3A4 Inducers (e.g., Rifampicin, St. John's Wort)
May decrease amlodipine exposure.
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 and possibly reflex tachycardia. Management involves symptomatic and supportive measures. If recently ingested, gastric lavage may be considered. Intravenous fluids and vasopressors may be needed for hypotension. Amlodipine overdose may also lead to prolonged systemic hypotension and bradycardia.
Pregnancy & Lactation
Not recommended during pregnancy due to fetal toxicity risk (Category D in 2nd and 3rd trimesters). Avoid during lactation as it is unknown if components are excreted in breast milk; a safer alternative should be considered.
Side Effects
Contraindications
- Hypersensitivity to Olmesartan, Amlodipine, or any component of the formulation
- Pregnancy (especially second and third trimesters)
- Severe renal impairment
- Biliary obstruction
- Severe hepatic impairment
- Obstructive outflow tract lesion of the left ventricle (e.g., severe aortic stenosis)
- Cardiogenic shock
- Unstable angina pectoris (within one month of a myocardial infarction)
Drug Interactions
NSAIDs
May reduce the antihypertensive effect of olmesartan and increase the risk of renal impairment.
Lithium
Increased serum lithium concentrations and lithium toxicity have been reported with ARBs.
Simvastatin
Amlodipine increases simvastatin exposure; limit simvastatin dose to 20 mg/day.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
May increase amlodipine exposure, requiring dose reduction.
Potassium-sparing diuretics/Potassium supplements
May lead to hyperkalemia.
CYP3A4 Inducers (e.g., Rifampicin, St. John's Wort)
May decrease amlodipine exposure.
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 and possibly reflex tachycardia. Management involves symptomatic and supportive measures. If recently ingested, gastric lavage may be considered. Intravenous fluids and vasopressors may be needed for hypotension. Amlodipine overdose may also lead to prolonged systemic hypotension and bradycardia.
Pregnancy & Lactation
Not recommended during pregnancy due to fetal toxicity risk (Category D in 2nd and 3rd trimesters). Avoid during lactation as it is unknown if components are excreted in breast milk; a safer alternative should be considered.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved for prescription use
Patent Status
Off-patent (generic available)
Clinical Trials
Various clinical trials have demonstrated the efficacy and safety of Olmesartan/Amlodipine combination in reducing blood pressure and improving cardiovascular outcomes. Studies like the TRINITY trial evaluated the efficacy of triple therapy including olmesartan and amlodipine.
Lab Monitoring
- Serum electrolytes (especially potassium)
- Renal function (BUN, creatinine)
- Liver function tests
- Blood pressure monitoring
Doctor Notes
- Counsel patients on the importance of adherence to therapy for optimal blood pressure control.
- Monitor renal function and serum potassium, especially in patients with pre-existing renal impairment or those on potassium-sparing diuretics.
- Advise patients on lifestyle modifications to complement drug therapy.
Patient Guidelines
- Take medicine regularly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor.
- Inform your doctor if you experience any unusual symptoms or side effects.
- Avoid grapefruit juice while on this medication.
- Stand up slowly from a sitting or lying position to prevent dizziness.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, 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
May cause dizziness or fatigue, especially at the start of treatment or when changing dose. Exercise caution when driving or operating 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.
- Maintain a healthy weight.
- Limit alcohol consumption.
- Quit smoking.
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