Molecule Info

Content(s) & Description

Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil INN 20mg or 40mg 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 & dosage

This combination is indicated for the treatment of hypertension, alone or with other antihypertensive agents. This may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Initial therapy:

The usual starting dose of this combination is one tablet (5/20 mg) once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of this combination is 10/40 mg once daily as needed to control blood pressure. This combination may be taken with or without food. This combination may be administered with other antihypertensive agents. Initial therapy with this combination product is not recommended in elderly patients (≥ 75 years old) or with hepatic impairment.

Replacement therapy:

This combination may be substituted for its individually titrated components. When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.

Add-on therapy:

This combination may be used to provide additional blood pressure lowering for patients not adequately controlled with Amlodipine (or another dihydropyridine calcium channel blocker) alone or with Olmesartan Medoxomil (or another angiotensin II receptor blocker) alone.

Precautions

Fetal/Neonatal morbidity and mortality: When pregnancy is detected, this combination drug should be discontinued as soon as possible. Hypotension in volume- or salt-depleted patients: Symptomatic hypotension may occur after initiation of therapy. Vasodilation: Exercise caution, when administering this combination, particularly in patients with severe aortic stenosis. Patients with Severe Obstructive Coronary Artery Disease: Patients may develop increased frequency, duration, or severity of angina or acute MI on starting calcium channel blocker therapy or at the time of dosage increase. Patients with Congestive Heart Failure: Calcium channel blocker should be used with caution.

Patients with Impaired Renal Function / Hepatic Impairment: Should be used with caution

Pregnancy/lactation

Pregnancy: When pregnancy is detected, discontinue this combination product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Lactation: 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.

Children: The safety and effectiveness in pediatric patients have not been established.

Side effects

The reported adverse reactions were generally mild and seldom led to discontinuation of treatment. The most common side effects include edema, dizziness, flushing, palpitation. Other side effects may include vomiting, diarrhoea, rhabdomyolysis, alopecia, pruritus, urticaria etc.

Contraindications

Hypersensitivity to any of the components of the formulation.

Drug interactions

The pharmacokinetics of Amlodipine and Olmesartan Medoxomil are not altered when the drugs are co-administered. No drug interaction studies have been conducted with Amlodipine and Olmesartan combination tablet and other drugs, although studies have been conducted with the individual Amlodipine and Olmesartan Medoxomil components and no significant drug interactions have been observed.

 

Brand/Product Info


Total Products : 5     
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ABECAB ACI Ltd. Amlodipine 5mg+ Olmesartan Medoxomil 20mg Tablet 30's: 240.90 MRP
BIZORAN Beximco Pharmaceuticals Ltd Amlodipine 5mg + Olmesartan Medoxomil 20 mg Tablet 30's: 240.00 MRP
CAMLOSART 14732 Square Pharmaceuticals Ltd. Amlodipine + Olmesartan Medoxomil (5mg + 40mg) Tablet 2x10's: 301.00 MRP
CAMLOSART 42510 Square Pharmaceuticals Ltd. Amlodipine + Olmesartan Medoxomil (5mg + 20mg) Tablet 3x10's: 240.90 MRP
OLMEZEST AM Sun Pharmaceutical (Bangladesh) Ltd. Amlodipine 5mg+ Olmesartan Medoxomil 40mg Tablet 30's: 255.00 MRP