Telmisartan EfficacyReview clinical study results for telmisartan—A component of TWYNSTA, a fixed-dose ARB/CCB combining telmisartan and amlodipine for the treatment of hypertensionReview clinical study results for telmisartan—a component of TWYNSTA, the only |
The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension.
Visit the MICARDIS for Healthcare Professionals Web site to access tools and resources designed to help you create individualized treatment plans for your hypertensive patients.
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INDICATION
Twynsta® (telmisartan/amlodipine) tablets is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
Base the choice of TWYNSTA tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of TWYNSTA tablets. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use TWYNSTA tablets as initial therapy.
IMPORTANT SAFETY INFORMATION
WARNING: AVOID USE IN PREGNANCY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue TWYNSTA as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
TWYNSTA is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or amlodipine or any other components of this product.
Symptomatic hypotension may occur in patients with an activated renin-angiotensin system. Correct volume and/or salt depletion in patients before initiating TWYNSTA or start treatment under close supervision with a reduced dose.
Patients taking TWYNSTA should be told not to use potassium supplements or salt substitutes that contain potassium without consulting their physician. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.
Titrate slowly in patients with hepatic or severe renal impairment and closely monitor. Initial therapy with TWYNSTA is not recommended in hepatically impaired patients.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system such as patients with severe congestive heart failure or renal dysfunction, treatment with ACE inhibitors and an ARB such as TWYNSTA has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur. When adding an ACE inhibitor to an ARB, monitor renal function closely. Use of TWYNSTA with ramipril is not recommended.
Uncommonly, patients starting or increasing their dose of a CCB have developed increased frequency, duration, or severity of angina or acute myocardial infarction.
Monitor patients with heart failure for worsening of their condition.
In clinical trials, the most common reasons for discontinuation of therapy with TWYNSTA were peripheral edema, dizziness, and hypotension. Adverse events that occurred at a ≥2% higher incidence with TWYNSTA than with placebo were peripheral edema, dizziness, and back pain.
Please see full Prescribing Information, including boxed WARNING, for TWYNSTA.
