Twynsta Dosage

2.1  General Considerations

Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effective in doses of 2.5 to 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 TWYNSTA tablets 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 [see Adverse Reactions (6.1)].

TWYNSTA may be taken with or without food.

2.2  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.

2.3  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 [see Adverse Reactions (6.1)].

2.4  Initial Therapy

A patient may be initiated on TWYNSTA tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of TWYNSTA is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on TWYNSTA 80/5 mg once daily.

Initial therapy with TWYNSTA is not recommended in patients ≥75 years old or with hepatic impairment [see Dosage and Administration (2.5), Warnings and Precautions (5.4), and Use in Specific Populations (8.5, 8.6)].

Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with TWYNSTA tablets [see Warnings and Precautions (5.2)].

2.5  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.