Twynsta
Generic Name: telmisartan and amlodipine
Date of Approval: October 16, 2009
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Hypertension
FDA Approves Twynsta
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 Feedback for Twynsta
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The United States Food and Drug Administration has approved Twynsta (telmisartan/amlodipine) for the treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.
Highlights of Twynsta Prescribing Information
These highlights do not include all the information needed to use Twynsta safely and effectively. See full prescribing information for Twynsta.
Dosage Forms and Strengths
Tablets: 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg
Contraindications
None
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.
Indications and Usage
- Twynsta 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.
- Twynsta tablets are indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.
Dosage and Administration
- Substitute Twynsta for its individually titrated components for patients on amlodipine and telmisartan. Twynsta may also be given with increased amounts of amlodipine, telmisartan, or both, as needed.
- Use Twynsta tablets 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.
- Dosage may be increased after at least 2 weeks to a maximum dose of 80/10 mg once daily, usually by increasing one component at a time but both components can be raised to achieve more rapid control.
- Majority of antihypertensive effect is attained within 2 weeks.
- Initiate with 40/5 mg or 80/5 mg once daily.
- Switch patients who experience dose-limiting adverse reactions on amlodipine to Twynsta tablets containing a lower dose of that component.
Warnings and Precautions
- Avoid fetal or neonatal exposure.
- Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension.
- Titrate slowly in patients with hepatic (5.4) or severe renal impairment.
- Heart failure: Monitor for worsening.
- Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker.
- Myocardial infarction: Uncommonly, initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina.
Twynsta Side Effects
In the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy with Twynsta tablets were peripheral edema, dizziness, and hypotension, each leading to discontinuation of ≤0.5% of Twynsta-treated patients. Adverse reactions that occurred at a ≥2% higher incidence on Twynsta tablets than placebo were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), clinically meaningful orthostatic hypotension (6.3% vs 4.3%), and back pain (2.2% vs 0%).
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use In Specific Populations
- Patients ≥75 years of age or hepatically impaired patients: Start with amlodipine or add amlodipine 2.5 mg to telmisartan.
- Nursing Mothers: Choose to discontinue nursing or drug.
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