Exforge
Generic Name
Amlodipine + Valsartan
Manufacturer
Novartis
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| exforge 10 mg tablet | ৳ 79.09 | ৳ 1,107.26 |
Description
Overview of the medicine
Exforge 10 mg tablet is a fixed-dose combination medication containing Amlodipine (a calcium channel blocker) and Valsartan (an angiotensin II receptor blocker). It is used to treat high blood pressure (hypertension) in adults when blood pressure is not adequately controlled by either monotherapy. This combination works by relaxing blood vessels and making it easier for the heart to pump blood, thereby lowering blood pressure.
Uses & Indications
Dosage
Adults
One tablet daily, typically starting with lower strengths and titrating up as needed. Maximum dose of Amlodipine 10mg/Valsartan 320mg once daily.
Elderly
No initial dose adjustment generally required, but caution due to potential decreased renal function.
Renal_impairment
No initial dose adjustment for mild to moderate renal impairment. Avoid in severe renal impairment (CrCl < 30 mL/min).
How to Take
Take orally, with or without food. It is recommended to take it at the same time each day, preferably in the morning. Swallow the tablet whole with water.
Mechanism of Action
Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, resulting in peripheral arterial vasodilation and a reduction in peripheral vascular resistance. Valsartan selectively blocks the binding of angiotensin II to the AT1 receptor, inhibiting the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation and decreased blood pressure.
Pharmacokinetics
Onset
Amlodipine: Gradual onset, full effect within hours. Valsartan: Within 2 hours, maximum effect within 4-6 weeks of continuous treatment.
Excretion
Amlodipine: Primarily via urine (inactive metabolites). Valsartan: Primarily via feces (unmetabolized drug), 13% via urine.
Half life
Amlodipine: 30-50 hours. Valsartan: ~6 hours.
Absorption
Amlodipine: Well absorbed orally, peak plasma concentrations 6-12 hours. Bioavailability 64-90%. Valsartan: Rapidly absorbed orally, peak plasma concentrations 2-4 hours. Bioavailability ~25%. Food decreases absorption.
Metabolism
Amlodipine: Extensively metabolized in the liver to inactive metabolites. Valsartan: Minimally metabolized (~20%) by the liver, no significant metabolism by CYP450 enzymes.
Side Effects
Contraindications
- Known hypersensitivity to amlodipine, valsartan, or any component of the formulation
- Pregnancy (especially second and third trimesters)
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (CrCl < 60 mL/min)
- Severe hepatic impairment or biliary cirrhosis
- Severe hypotension
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity.
Aliskiren
Contraindicated in diabetic or renally impaired patients (CrCl < 60 mL/min) due to increased risk of hyperkalemia, hypotension, and renal impairment.
Simvastatin
Increased exposure to simvastatin; limit simvastatin dose to 20 mg daily.
NSAIDs (including COX-2 inhibitors)
Decreased antihypertensive effect, increased risk of renal impairment.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
Increased serum potassium.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to excessive hypotension and possibly reflex tachycardia. Symptomatic and supportive treatment should be initiated. If ingestion is recent, gastric lavage or induced emesis may be considered. Amlodipine is not dialyzable, valsartan is minimally dialyzable.
Pregnancy & Lactation
Contraindicated in pregnancy due to fetal toxicity (Valsartan). Avoid during lactation; it is unknown if amlodipine or valsartan are excreted in human milk.
Side Effects
Contraindications
- Known hypersensitivity to amlodipine, valsartan, or any component of the formulation
- Pregnancy (especially second and third trimesters)
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (CrCl < 60 mL/min)
- Severe hepatic impairment or biliary cirrhosis
- Severe hypotension
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity.
Aliskiren
Contraindicated in diabetic or renally impaired patients (CrCl < 60 mL/min) due to increased risk of hyperkalemia, hypotension, and renal impairment.
Simvastatin
Increased exposure to simvastatin; limit simvastatin dose to 20 mg daily.
NSAIDs (including COX-2 inhibitors)
Decreased antihypertensive effect, increased risk of renal impairment.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
Increased serum potassium.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to excessive hypotension and possibly reflex tachycardia. Symptomatic and supportive treatment should be initiated. If ingestion is recent, gastric lavage or induced emesis may be considered. Amlodipine is not dialyzable, valsartan is minimally dialyzable.
Pregnancy & Lactation
Contraindicated in pregnancy due to fetal toxicity (Valsartan). Avoid during lactation; it is unknown if amlodipine or valsartan are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years (refer to specific product packaging)
Availability
Worldwide, in pharmacies and hospitals
Approval Status
Approved by FDA and various regulatory bodies globally.
Patent Status
Patent expired for original formulation; generic versions available.
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Exforge in reducing blood pressure in patients with hypertension, including those inadequately controlled by monotherapy. Key studies include randomized, double-blind, placebo-controlled trials showing superior efficacy of the combination compared to monotherapies.
Lab Monitoring
- Blood pressure monitoring
- Serum potassium levels (especially in patients with renal impairment or on potassium-sparing drugs)
- Renal function (BUN, creatinine)
- Liver function tests (LFTs) periodically
Doctor Notes
- Monitor blood pressure regularly and assess for signs of hypotension or fluid retention.
- Educate patients on the importance of adherence and lifestyle modifications.
- Caution in patients with severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
- Regularly check kidney function and serum potassium levels.
Patient Guidelines
- Take Exforge regularly as prescribed, even if you feel well.
- Do not stop taking the medication without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any signs of swelling, dizziness, or unusual symptoms to your doctor immediately.
- Avoid excessive salt intake and consult about potassium-rich foods.
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
May cause dizziness, fatigue, or visual disturbances. Patients should be cautious when driving or operating machinery until they know how Exforge affects them.
Lifestyle Advice
- Adopt a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking.
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