Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); valsartan, quantity: 80 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; crospovidone; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide yellow - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - amlodipine (unii: 1j444qc288) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - amlodipine 5 mg - amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine and valsartan. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detec

United States - English - NLM (National Library of Medicine)

sandoz inc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - amlodipine 5 mg - amlodipine and valsartan tablets may be used in patients whose blood pressure is not adequately controlled on either monotherapy. amlodipine and valsartan tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. the choice of amlodipine and valsartan tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of amlodipine and valsartan tablets. patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination co

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); valsartan, quantity: 320 mg - tablet, film coated - excipient ingredients: crospovidone; colloidal anhydrous silica; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; iron oxide yellow; titanium dioxide; hypromellose; purified talc; macrogol 4000 - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); valsartan, quantity: 320 mg - tablet, film coated - excipient ingredients: crospovidone; sodium starch glycollate; iron oxide yellow; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hypromellose; purified talc; iron oxide red; macrogol 4000 - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); valsartan, quantity: 160 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide red; iron oxide yellow - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 160 mg; amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; colloidal anhydrous silica; hypromellose; purified talc; iron oxide yellow; macrogol 4000; titanium dioxide - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 320 mg; hydrochlorothiazide, quantity: 25 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg) - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); hydrochlorothiazide, quantity: 25 mg; valsartan, quantity: 160 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; crospovidone; microcrystalline cellulose; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 160 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; crospovidone; magnesium stearate; hypromellose; purified talc; iron oxide red; macrogol 4000; iron oxide yellow; titanium dioxide - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).