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TWYNSTA 40mg/5mg

Last Updated: December 03, 2009

TWYNSTA (telmisartan/amlodipine) tablets by Boehringer Ingelheim

Manufacturer:

Boehringer Ingelheim Pharmaceuticals

Pharmacological Class:

Antihypertensive (angiotensin II receptor blocker + calcium channel blocker)

Active Ingredient(s):

Telmisartan 40mg, amlodipine 5mg; tabs.

Also:

TWYNSTA 40mg/10mg
Telmisartan 40mg, amlodipine 10mg; tabs.

TWYNSTA 80mg/5mg
Telmisartan 80mg, amlodipine 5mg; tabs.

TWYNSTA 80mg/10mg
Telmisartan 80mg, amlodipine 10mg; tabs.

Indication(s):

Hypertension, as monotherapy or with other antihypertensives. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Pharmacology:

Telmisartan blocks the vasoconstriction and aldosterone-secreting effects of angiotensin II, the main pressor agent of the renin-angiotensin system. Amlodipine inhibits the influx of calcium ions into vascular smooth muscle and, to a lesser extent, cardiac muscle. By inhibiting this process, amlodipine causes a reduction in peripheral resistance and a reduction in blood pressure.

Clinical Trials:

An 8-week randomized, double-blind, placebo controlled study in 1461 patients with mild to severe hypertension compared Twynsta to either monotherapy component across 16 treatment arms. The four key treatment combinations, including telmisartan 40mg or 80mg and amlodipine 5mg or 10mg, had statistically significant reductions in in-clinic seated trough cuff systolic and diastolic blood pressure (SBP and DBP) compared to the respective individual monotherapies.

In an active-controlled study, 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5mg were randomized to either Twynsta (40/5 or 80/5) or amlodipine (5mg or 10mg). In a second active-controlled study, 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10mg were randomized to Twynsta (40/10 or 80/10) or amlodipine 10mg. Each of the combination treatments was statistically significantly superior to the respective amlodipine monotherapy doses in the reduction of DBP and SBP after 8-weeks of treatment in both studies.

Legal Classification:

Adults:

Take once daily. Initial therapy: 40/5mg or 80/5mg; may titrate at 2-week intervals to max 80/10mg. Add-on therapy: may be used if not controlled on monotherapy; if dose-limiting adverse reactions with amlodipine 10mg, switch to 40/5mg tab. Replacement therapy: may be substituted for the titrated components. Renal and/or hepatic impairment: titrate slower. ≥75 years, or hepatic impairment: not for initial use (initially use amlodipine alone, or add amlodipine 2.5mg to telmisartan).

Children:

Not recommended.

Precaution(s):

Correct hypovolemia before starting therapy or monitor closely. CHF. Biliary obstruction. Hepatic or severe renal dysfunction. Renal artery stenosis. Severe obstructive coronary disease. Pregnancy (Cat.D in 2^nd and 3^rd trimester; Cat.C in 1^st trimester); discontinue ASAP when pregnancy detected. Nursing mothers: not recommended.

Interaction(s):

Concomitant ramipril: not recommended. Hyperkalemia with K⁺ supplements, K⁺ sparing diuretics, K⁺ containing salt supplements. May potentiate digoxin, lithium.