TWYNSTA®

Dosing and administration

General Considerations

Telmisartan is an effective treatment of hypertension in once daily doses of 20-80 mg while amlodipine is effective in doses of 2.5-10 mg.

Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan/amlodipine is 80/10 mg once daily.

The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter.

Replacement Therapy

Patients receiving amlodipine and telmisartan from separate tablets may instead receive TWYNSTA® tablets containing the same component doses once daily. When substituting for individual components, increase the dose of TWYNSTA® if blood pressure control has not been satisfactory.

Add-on therapy for patients with hypertension not adequately controlled on antihypertensive monotherapy

TWYNSTA® tablets may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone.

Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to TWYNSTA® 40/5 mg tablets once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.

Dosing in Specific Populations

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

In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients with hepatic impairment.

Patients 75 Years of Age and Older

In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients 75 years of age and older.

Tablet for oral administration

TWYNSTA® may be taken with or without food.

The telmisartan/amlodipine non-scored, multilayer tablets are of oval, biconvex shape. Tablets are white to off-white on one side and blue on the other side. The white side is debossed with the BOEHRINGER INGELHEIM symbol and with A3 for the 80/5 mg strengths, respectively.