LL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
WARNING: AVOID USE IN PREGNANCY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Considerations
2.2 Add-on / Switch Therapy
2.3 Replacement Therapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
5.2 Hypotension in Volume- or Salt-Depleted Patients5.3 Increased Angina and/or Myocardial Infarction
5.4 Impaired Hepatic Function
5.5 Impaired Renal Function5.6 Heart Failure
5.7 Hypersensitivity Reaction
5.8 Systemic Lupus Erythematosus
5.9 Lithium Interaction
5.10 Electrolytes and Metabolic Imbalances
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Clinical Laboratory Test Findings
7.3 Drug/Food Interactions
8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.3 Developmental Toxicity
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
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 [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is indicated for the treatment of hypertension.
This fixed combination drug is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].
2 DOSAGE AND ADMINISTRATION
2.1 General Considerations
Dose once-daily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT. The maximum recommended dose of Exforge HCT is 10/320/25 mg.
Exforge HCT may be administered with or without food.
No initial dosage adjustment is required for elderly patients.
Renal impairment: The usual regimens of therapy with Exforge HCT may be followed if the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Exforge HCT [see Impaired Renal Function (5.5)].
Hepatic impairment: Avoid Exforge HCT in patients with severe hepatic impairment. In patients with lesser degrees of hepatic impairment, monitor for worsening of hepatic or renal function and adverse reactions [see Impaired Hepatic Function (5.4)].
2.2 Add-on / Switch Therapy
Exforge HCT may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Exforge HCT may be switched to Exforge HCT contai |
