HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Exforge HCT safely and effectively. See full prescribing information for Exforge HCT.
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) Tablets
Initial U.S. Approval: 2009
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue Exforge HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus. (5.1)
INDICATIONS AND USAGE
Exforge HCT is for the treatment of hypertension (1)
Not indicated for initial therapy
DOSAGE AND ADMINISTRATION
Dose once-daily
Exforge HCT may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
Exforge HCT may be substituted for its individually titrated components for patients on amlodipine, valsartan and hydrochlorothiazide (2).
The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/valsartan/hydrochlorothiazide mg)
5/160/12.5
10/160/12.5
5/160/25
10/160/25
10/320/25(3)
CONTRAINDICATIONS
Anuria; Hypersensitivity to sulfonamide-derived drugs (4)
WARNINGS AND PRECAUTIONS
Avoid fetal or neonatal exposure (5.1)
Symptomatic hypotension with volume- or salt-depletion. Correct volume-depletion prior to administration (5.2)
Increased angina and/or myocardial infarction (5.3)
Avoid in patients with severely impaired hepatic (2.1, 5.4) or renal function (creatinine clearance ≤30 mL/min) (2.1, 5.5)
Observe for signs of fluid or electrolyte imbalance (5.10)
Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus (5.8)
ADVERSE REACTIONS
Most common adverse events (≥2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea and nasopharyngitis.
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
Hydrochlorothiazide(7):
Alcohol, barbiturates, narcotics: Potentiation of orthostatic hypotension
Antidiabetic drugs: Dosage adjustment of antidiabetic may be required
Cholestyramine and colestipol: Reduced absorption of thiazides
Corticosteroids, ACTH: Hypokalemia, electrolyte depletion
Lithium: Reduced renal clearance and high risk of lithium toxicity when used with diuretics. Should not be given with diuretics.
NSAIDs: Can reduce diuretic, natriuretic and antihypertensive effects of diuretics.
USE IN SPECIFIC POPULATIONS
Pregnancy: Avoid use in pregnancy (5.1)
Nursing Mothers: Avoid use while nursing – discontinue either nursing or drug (8.3)
Geriatric Patients: No overall differences in the efficacy or safety of Exforge HCT was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 12/2009
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