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These highlights do not include all the information needed to use Exforge safely and effectively . See full prescribing information for Exforge .
Exforge (amlodipine and valsartan) Tablets
Initial U.S. Approval: 2007 |
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WARNING: AVOID USE IN PREGNANCY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Exforge as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1) |
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RECENT MAJOR CHANGES |
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Indications and Usage (1) 7/2008 Dosage and Administration, Initial Therapy (2.4) 7/2008 |
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INDICATIONS AND USAGE |
Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge is indicated for the treatment of hypertension: - In patients not adequately controlled on monotherapy (1)
- As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).
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DOSAGE AND ADMINISTRATION |
General Considerations: - Majority of effect attained within 2 weeks (2.1)
- May be administered with other antihypertensive agents (2.1)
Hypertension - May be used as add-on therapy for patients not controlled on monotherapy (2.2)
- Patients who experience dose-limiting adverse reactions on monotherapy may be switched to Exforge containing a lower dose of that component (2.2)
- May be substituted for titrated components (2.3)
- When used as initial therapy: Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily (2.4)
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DOSAGE FORMS AND STRENGTHS |
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Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 (3) |
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WARNINGS AND PRECAUTIONS |
- Avoid fetal or neonatal exposure (5.1)
- Assess for hypotension. (5.2)
- Warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina (5.3)
- Titrate slowly in patients with impaired hepatic (5.4) or severely impaired renal (5.5) function
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ADVERSE REACTIONS |
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In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Exforge-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Exforge were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (≥2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact N ovartis Pharmaceuticals C orporation at 1 - 888 - 669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch |
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USE IN SPECIFIC POPULATIONS |
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Start amlodipine or add amlodipine at 2.5 mg in patients ≥75 years old or in patients with hepatic impairment. (8.5) Nursing Mothers: Choose breastfeeding or Exforge therapy, but not both. (8.3) |
See 17 for PATIENT |
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