Logo

Indications - Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.

Dosage & Administration - 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.

Side Effects - 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.

Others - Pregnancy & Lactation Pregnancy Category D. 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.