Camlosart 5/20

Generic

Amlodipine Besilate + Olmesartan Medoxomil

 

Indications

CamlosartTM is indicated for the treatment of hypertension, alone or with other antihypertensive agents.

CamlosartTM may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

 

Pharmacology

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the flow of calcium ions through the membrane to vascular smooth muscle and myocardium. The effect of amlodipine on vascular smooth muscle cells is greater than that of cardiomyocytes. Amlodipine is a peripheral arterial vasodilator, which acts directly on vascular smooth muscle, causing a decrease in peripheral vascular resistance and blood pressure. 

 Angiotensin II is formed by angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE). It is an effective vasoconstrictor and the main vasoactive hormone of the renin-angiotensin system. It is also a high blood pressure An important part of pathophysiology. It also stimulates the adrenal cortex to secrete aldosterone. 

Olmesartan medoxomil blocks the vasoconstriction and aldosterone secretion of angiotensin II by selectively blocking the binding of angiotensin II to AT1 receptors found in many tissues (such as vascular smooth muscle, adrenal glands). In vitro binding studies have shown that Olmesartan Medoxomil is a competitive and reversible AT1 receptor inhibitor. Olmesartan medoxomil does not inhibit ACE (kinase II, an enzyme that converts angiotensin I into angiotensin II and breaks down bradykinin).

 

Dosage & Administration

Initial Therapy The usual starting dose of CamlosartTM 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 10/40 mg once daily as needed to control blood pressure. CamlosartTM may be taken with or without food. CamlosartTM may be administered with other antihypertensive agents. Initial therapy with this combination product is not recommended in patients > 75 years old or with hepatic impairment. Replacement Therapy

CamlosartTM 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

CamlosartTM 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.

 

Interaction

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.

 

Contraindications

Hypersensitivity to any of the component of this combination product.

 

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.

 

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.

Nursing Mothers: 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. 

 

Precautions & Warnings

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.

 

Therapeutic Class

Combined antihypertensive preparations

 

Storage Conditions

Store in a cool and dry place, protect from light and moisture. Store at 250 C. Keep out of the reach of children

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.

 

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