onsiderations
2.2 Add-on Therapy
2.3 Replacement Therapy
2.4 Initial Therapy
3DOSAGE FORMS AND STRENGTHS
5WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
5.2 Hypotension
5.3 Risk of Myocardial Infarction or Increased Angina5.4 Impaired Hepatic Function
5.5 Impaired Renal Function - Hypertension
5.6 Congestive Heart Failure
6ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7DRUG INTERACTIONS
7.1 Drug/Drug Interactions
7.2 CYP 450 Interactions
7.3 Transporters
7.4 Clinical Laboratory Findings
8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.3 Developmental Toxicity Studies
14CLINICAL STUDIES
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
WARNING: AVOID USE IN PREGNANCY
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. [SeeWarningsand Precautions(5.1)]
1INDICATIONS AND USAGE
1.1 Hypertension
Exforge (amlodipine and valsartan) is indicated for the treatment of hypertension.
Exforge may be used in patients whose blood pressure is not adequately controlled on either monotherapy.
Exforge may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of Exforge as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of Exforge.
Patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Data from the high-dose multifactorial study [see Clinical Studies (14)] provide estimates of the probability of reaching a blood pressure goal with Exforge compared to amlodipine or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Exforge10/320 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.
Figure 1:Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8
Figure 2:Probability of Achieving Diastolic Blood Pressure<90 mmHg at Week 8
Figure 3:Probability of Achieving Systolic Blood Pr
