Co-Disys® is a fixed combination of amlodipine and valsartan. Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle depend on the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. It is a peripheral arterial vasodilator that acts directly on vascular smooth muscle, reducing peripheral vascular resistance and lowering blood pressure.

Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking its binding to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is independent of the pathways for angiotensin II synthesis. By blocking angiotensin II, valsartan dilates blood vessels and reduces blood pressure. Valsartan has a much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor.

Co-Disys® is indicated for the treatment of hypertension. It may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Co-Disys® may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Amlodipine is an effective treatment for hypertension in once-daily doses of 2.5 mg to 10 mg, while valsartan is effective in doses of 80 mg to 320 mg. The majority of the antihypertensive effect is attained within two weeks after therapy initiation or a dose change. The dosage can be increased after one to two weeks of therapy to a maximum of 10 mg amlodipine and 320 mg valsartan daily as needed to control blood pressure.

Co-Disys® may be administered with or without food and may also be used in combination with other antihypertensive agents.

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. Dosages should be titrated 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.

Co-Disys® is contraindicated in patients with:

Hypersensitivity to the active substances, dihydropyridine derivatives, or any excipients
Severe hepatic impairment, biliary cirrhosis, or cholestasis
Severe renal impairment and those undergoing dialysis
Pregnancy (second and third trimesters)