G: FETAL TOXICITY
1 INDICATIONS AND USAGE
1.1 Hypertension 1.2 Hypertensive Patients with Left Ventricular Hypertrophy 1.3 Nephropathy in Type 2 Diabetic Patients 2 DOSAGE AND ADMINISTRATION
2.1 Hypertension 2.2 Hypertensive Patients with Left Ventricular Hypertrophy 2.3 Nephropathy in Type 2 Diabetic Patients 2.4 Dosage Modifications in Patients with Hepatic Impairment 2.5 Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension) 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal Toxicity 5.2 Hypotension in Volume- or Salt-Depleted Patients 5.3 Renal Function Deterioration 5.4 Hyperkalemia 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 Agents Increasing Serum Potassium 7.2 Lithium 7.3 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) 7.4 Dual Blockade of the Renin-Angiotensin System (RAS) 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Race 8.7 Renal Impairment 8.8 Hepatic Impairment 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 14 CLINICAL STUDIES
14.1 Hypertension 14.2 Hypertensive Patients with Left Ventricular Hypertrophy 14.3 Nephropathy in Type 2 Diabetic Patients 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 HypertensionLosartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, eva luation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pr |
