The combination of Amlodipine Besilate + Valsartan is used for the management of hypertension (high blood pressure). This fixed-dose combination is not recommended as the first-line treatment for patients newly diagnosed with hypertension.

Amlodipine is a dihydropyridine calcium channel blocker that prevents calcium ions from entering vascular smooth muscle and cardiac muscle cells, leading to relaxation of blood vessels. Valsartan works by selectively blocking the Angiotensin II type 1 (AT1) receptor, thereby inhibiting the vasoconstrictive and aldosterone-releasing effects of Angiotensin II. This action is independent of how Angiotensin II is formed. Together, Amlodipine and Valsartan effectively reduce blood pressure. They act through complementary mechanisms—Amlodipine by blocking calcium influx and Valsartan by preventing Angiotensin II-mediated vasoconstriction—resulting in decreased peripheral resistance.

Treatment of hypertension: Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan, using amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as needed to control blood pressure. This combination may be administered with or without food. This combination may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to this combination therapy.

Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.

Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

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

No formal drug interaction studies have been performed specifically with the combination of Amlodipine Besilate + Valsartan. However, interaction studies are available for each individual component.

This combination should not be used in patients with known hypersensitivity to Amlodipine, Valsartan, or any other component of the formulation.

Side effects are generally mild and temporary. Commonly reported effects include peripheral edema (swelling), nasal congestion, throat irritation or pain during swallowing, upper respiratory tract infections, and dizziness.

Pregnancy Category D. The excretion of Amlodipine or Valsartan into human breast milk is not clearly known. Due to the potential risk to the nursing infant, a decision should be made whether to stop breastfeeding or discontinue the medication, considering the importance of the treatment for the mother.

Avoid exposure during pregnancy, especially to prevent fetal or neonatal harm. Monitor for hypotension. Patients with severe obstructive coronary artery disease should be cautioned about the risk of myocardial infarction or worsening angina. Dose adjustment should be done carefully in patients with liver impairment or severe kidney dysfunction.

The safety and efficacy of this combination in pediatric patients have not yet been established.

Combination antihypertensive agent.

Store below 30°C in a cool, dry place, protected from light and moisture. Keep out of reach of children.