Olmepres-AM
Generic Name
Olmesartan Medoxomil 20 mg + Amlodipine Besylate 5 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
olmepres am 5 mg tablet | ৳ 17.00 | ৳ 170.00 |
Description
Overview of the medicine
Olmepres-AM is a combination medication used to treat high blood pressure (hypertension). It contains Olmesartan Medoxomil, an angiotensin II receptor blocker (ARB), and Amlodipine Besylate, a calcium channel blocker (CCB). This combination effectively lowers blood pressure by relaxing blood vessels and reducing the workload on the heart.
Uses & Indications
Dosage
Adults
Usually one tablet once daily. Dosage may be adjusted after 1-2 weeks of therapy.
Elderly
No dosage adjustment is generally required, but caution is advised due to potential age-related decrease in renal clearance.
Renal_impairment
Mild to moderate renal impairment: No initial dosage adjustment. Severe renal impairment: Not recommended.
How to Take
Take orally, once daily, with or without food. Swallow the tablet whole with water.
Mechanism of Action
Olmesartan Medoxomil blocks the binding of angiotensin II to the AT1 receptor, preventing vasoconstriction and aldosterone secretion, leading to vasodilation and reduced blood pressure. Amlodipine Besylate inhibits the influx of calcium ions into vascular smooth muscle and myocardial cells, causing peripheral arterial vasodilation and reduced peripheral vascular resistance, thus lowering blood pressure.
Pharmacokinetics
Onset
Amlodipine: Gradual, usually within 6-12 hours. Olmesartan: Within 2 weeks for maximal effect.
Excretion
Olmesartan: Primarily renal (35-50%) and biliary/fecal (50-65%). Amlodipine: Primarily renal (approx. 60% as inactive metabolites, 10% as unchanged drug).
Half life
Olmesartan: 10-15 hours. Amlodipine: 30-50 hours.
Absorption
Olmesartan medoxomil is rapidly and completely converted to olmesartan during absorption from the gastrointestinal tract. Amlodipine is well absorbed after oral administration, with peak plasma concentrations occurring 6-12 hours post-dose. Bioavailability of amlodipine is 64-90%.
Metabolism
Olmesartan is not metabolized by the cytochrome P450 system and is primarily eliminated 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 hepatic impairment.
- Bilateral renal artery stenosis.
- Obstructive biliary disorders.
- Cardiogenic shock, clinically significant aortic stenosis, unstable angina.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity. Monitor lithium levels.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of olmesartan. Concurrent use may worsen renal function in patients with impaired renal function.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase amlodipine exposure. Monitor for symptoms of hypotension.
Potassium-sparing diuretics, potassium supplements
May increase serum potassium levels (due to olmesartan). Monitor serum potassium.
CYP3A4 inducers (e.g., rifampicin, St. John's Wort)
May decrease amlodipine exposure. Monitor blood pressure.
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 excessive hypotension and reflex tachycardia. Management involves symptomatic and supportive care. If ingestion is recent, gastric lavage may be considered. Intravenous fluids and vasopressors may be used to support blood pressure. Amlodipine is highly protein-bound, so dialysis is unlikely to be beneficial.
Pregnancy & Lactation
Pregnancy: Contraindicated in the second and third trimesters due to fetal toxicity. Discontinue as soon as pregnancy is detected. Lactation: Unknown whether olmesartan or amlodipine are excreted in human milk. 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.
- Pregnancy (especially second and third trimesters).
- Severe hepatic impairment.
- Bilateral renal artery stenosis.
- Obstructive biliary disorders.
- Cardiogenic shock, clinically significant aortic stenosis, unstable angina.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity. Monitor lithium levels.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of olmesartan. Concurrent use may worsen renal function in patients with impaired renal function.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase amlodipine exposure. Monitor for symptoms of hypotension.
Potassium-sparing diuretics, potassium supplements
May increase serum potassium levels (due to olmesartan). Monitor serum potassium.
CYP3A4 inducers (e.g., rifampicin, St. John's Wort)
May decrease amlodipine exposure. Monitor blood pressure.
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 excessive hypotension and reflex tachycardia. Management involves symptomatic and supportive care. If ingestion is recent, gastric lavage may be considered. Intravenous fluids and vasopressors may be used to support blood pressure. Amlodipine is highly protein-bound, so dialysis is unlikely to be beneficial.
Pregnancy & Lactation
Pregnancy: Contraindicated in the second and third trimesters due to fetal toxicity. Discontinue as soon as pregnancy is detected. Lactation: Unknown whether olmesartan or amlodipine are excreted in human milk. 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 manufacturing date.
Availability
Pharmacies nationwide
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of olmesartan/amlodipine combination in reducing blood pressure in patients with hypertension.
Lab Monitoring
- Serum potassium levels (especially in renal impairment or with potassium-sparing drugs).
- Renal function (creatinine, BUN) periodically.
- Liver function tests (if symptoms of hepatic dysfunction occur).
Doctor Notes
- Emphasize the importance of patient adherence for optimal blood pressure control.
- Counsel patients on lifestyle modifications in conjunction with medication.
- Be mindful of potential interactions, especially with potassium-sparing diuretics or NSAIDs.
Patient Guidelines
- Take the medication consistently at the same time each day.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Report any swelling in the ankles, feet, or face to your doctor.
- Avoid grapefruit products during treatment.
Missed Dose Advice
If a dose is missed, 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
May cause dizziness, fatigue, or headache. Avoid driving or operating heavy machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet, low in salt and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Quit smoking if you smoke.
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