Molecule Info

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WARNING

FETAL TOXICITY
ï‚· When pregnancy is detected, discontinue Amlodipine+Valsartan combination as soon as possible.
ï‚· Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

RECENT MAJOR CHANGES

RECENT MAJOR CHANGES OF Amlodipine+Valsartan Brand with US FDA:

Boxed Warning: Fetal Toxicity 01/2012
Indications and Usage: Benefits of lowering blood pressure (1) 12/2011
Contraindications: Known hypersensitivity (4) 09/2012
Contraindications: Dual RAS Blockade in Diabetics (4) 11/2012
Warnings and Precautions: Fetal Toxicity (5.1) 01/2012
Drug Interactions: Dual Blockade of the Renin-Angiotensin System (7) 11/2012

Find details with Brand Manufacturer's Prescribing Information.

Content(s) & Description

Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Valsartan USP 80mg or 160mg Tablet and Amlodipine Besilate BP equivalent to Amlodipine 10 mg and Valsartan USP 160mg Tablet.

This product is a combination of two antihypertensive drugs: a dihydropyridine calcium antagonist, Amlodipine Besilate and an angiotensin II receptor blocker, Olmesartan Medoxomil. The Amlodipine component inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle and the Olmesartan Medoxomil component blocks the vasoconstrictor effects of angiotensin II.

Indication(s), dosage & administration

This product is a combination of Amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and Valsartan, an angiotensin II receptor blocker (ARB). This combination is indicated for the treatment of hypertension, to lower blood pressure:
ï‚· In patients not adequately controlled on monotherapy.
ï‚· As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. 
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

This combination is indicated for the treatment of hypertension.

General Considerations
Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.

This combination may be administered with or without food and also with other antihypertensive agents.

Add-on Therapy
A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another angiotensin II receptor blocker) alone may be switched to combination therapy with This combination.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to This combination containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to This combination should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg.

Replacement Therapy
For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of This combination containing the same component doses.

Initial Therapy
A patient may be initiated on This combination if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is This combination 5/160 mg once daily in patients who are not volume-depleted.

Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Precautions

Avoid fetal or neonatal exposure, assess for hypotension, warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina, titrate slowly in patients with impaired hepatic or severely impaired renal function.

Pregnancy Category (FDA) and use in Specific Population

Pregnancy: Category D.

Lactation: It is not known whether Amlodipine or Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Use in children: Safety and effectiveness in paediatric patients have not been established.

Adverse Drug Reaction(s)

Generally been mild and transient in nature. The most common side effects include peripheral edema, nasal congestion, sore throat and discomfort when swallowing, upper respiratory tract infection, dizziness etc.

Contraindications

This combination product is contraindicated in patients who are hypersensitive to any components of this product.

Drug interactions

No drug interaction studies have been conducted with Amlodipine and Valsartan combination, although studies have been conducted with the individual components.

 

Brand/Product Info


Total Products : 19                   
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
Amlosartan 10/160 Incepta Pharmaceuticals Limited Amlodipine Besilate BP equivalent to Amlodipine 10mg + Valsartan USP 160mg Tablet 10x3's:MRP 480 Tk
Amlosartan 5/160 Incepta Pharmaceuticals Limited Amlodipine Besilate BP equivalent to Amlodipine 5mg + Valsartan USP 160mg Tablet 10x3's:MRP 480 Tk
Amlosartan 5/80 Incepta Pharmaceuticals Limited Amlodipine Besilate BP equivalent to Amlodipine 5mg + Valsartan USP 80mg Tablet 10x3's:MRP 270 Tk
AMLOVAS VS 160/10 Popular Pharmaceuticals Ltd. Valsartan INN USP 160mg+ Amlodipine BP 10mg Tablet (film-coated) 30's: 481.80 MRP
AMLOVAS VS 160/5 Popular Pharmaceuticals Ltd. Valsartan INN USP 160mg+ Amlodipine BP 5mg Tablet (film-coated) 30's: 481.80 MRP
AMLOVAS VS 80/5 Popular Pharmaceuticals Ltd. Valsartan INN USP 80mg+ Amlodipine BP 5mg Tablet (film-coated) 30's: 270.90 MRP
AV-10 Drug International Ltd Valsartan INN USP 160mg+ Amlodipine BP 10mg Tablet (film-coated) 20's: 200.00 MRP
AV-5 Drug International Ltd Valsartan INN USP 80mg+ Amlodipine BP 5mg Tablet (film-coated) 20's: 160.00 MRP
AVODIL VL 10/320 Opsonin Pharma Limited Valsartan INN USP 320mg+ Amlodipine BP 10mg Tablet (film-coated) 20's: 640.00 MRP
AVODIL VL 5/160 Opsonin Pharma Limited Valsartan INN USP 160mg+ Amlodipine BP 5mg Tablet (film-coated) 20's: 320.00 MRP
AVODIL VL 5/320 Opsonin Pharma Limited Valsartan INN USP 320mg+ Amlodipine BP 5mg Tablet (film-coated) 20's: 440.00 MRP
AVODIL VL 5/80 Opsonin Pharma Limited Valsartan INN USP 80mg+ Amlodipine BP 5mg Tablet (film-coated) 30's: 270.00 MRP
CAMOVAL 29342 Square Pharmaceuticals Ltd. Amlodipine + Valsartan (5mg + 80mg) Tablet 3x10's: 271.80 MRP
CAMOVAL 5/160 Square Pharmaceuticals Ltd. Amlodipine + Valsartan (5mg + 160mg) Tablet 2x10's: 322.20 MRP
Co-Disys 160/10 Healthcare Pharmacuticals Ltd. Amlodipine Besilate BP equivalent to Amlodipine 10mg + Valsartan USP 160mg Tablet 30's MRP 570 Tk
Co-Disys 160/5 Healthcare Pharmacuticals Ltd. Amlodipine Besilate BP equivalent to Amlodipine 5mg + Valsartan USP 160mg Tablet 30's MRP 540 Tk
Co-Disys 80/5 Healthcare Pharmacuticals Ltd. Amlodipine Besilate BP equivalent to Amlodipine 5mg + Valsartan USP 80mg Tablet 30's MRP 300 Tk
REOVAN A 160/5 R A K Pharmaceuticals Pvt. Ltd. Valsartan INN USP 160mg+ Amlodipine BP 5mg Tablet (film-coated) 30's: 450.00 MRP
REOVAN A 80/5 R A K Pharmaceuticals Pvt. Ltd. Valsartan INN USP 80mg+ Amlodipine BP 5mg Tablet (film-coated) 30's: 270.00 MRP
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