HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Exforgesafely and effectively. See full prescribing information for Exforge.
Exforge (amlodipine and valsartan) Tablets
Initial U.S. Approval: 2007
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)
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).
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)
DOSAGE FORMS AND STRENGTHS
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 (3)
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
ADVERSE REACTIONS
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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
NSAIDS use may lead to increased risk of renal impairment and loss of anti-hypertensive effect (7)
USE IN SPECIFIC POPULATIONS
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 COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 04/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: AVOID USE IN PREGNANCY
1INDICATIONS AND USAGE
1.1 Hypertension
2DOSAGE AND ADMINISTRATION
2.1 General C |
