VALSARTAN tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

Disponible desde:

Mylan Pharmaceuticals Inc.

Designación común internacional (DCI):

VALSARTAN

Composición:

VALSARTAN 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. 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 one 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, Evaluation, 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 pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Valsartan tablets may be used alone or in combination with other antihypertensive agents. Valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in patients with heart failure (NYHA class II-IV). There is no evidence that valsartan tablets provide added benefits when they are used with an adequate dose of an ACE inhibitor [see Clinical Studies (14.2)] . In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see Clinical Studies (14.3)] . Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [see Drug Interactions (7)]. Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations). When pregnancy is detected, consider alternative drug treatment and discontinue valsartan tablets as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking valsartan tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. No teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the MRHD on a mg/m2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day. In rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. In rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. There is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan tablets. Valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. The antihypertensive effects of valsartan tablets have been evaluated in two randomized, double-blind clinical studies in pediatric patients from 1-5 and 6-16 years of age [see Clinical Studies (14.1)] . The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology (12.3)] . Valsartan tablets were generally well tolerated in children 6 to 16 years and the adverse experience profile was similar to that described for adults. In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. Valsartan tablets are not recommended for pediatric patients under 6 years of age due to safety findings for which a relationship to treatment could not be excluded [see Adverse Reactions (6.1)] . No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate < 30 mL/min/1.73 m2 . There is limited clinical experience with valsartan tablets in pediatric patients with mild-to-moderate hepatic impairment [see Warnings and Precautions (5.3)] . In the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years. No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. Exposure (measured by AUC) to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary [see Clinical Pharmacology (12.3)] . Of the 2,511 patients with heart failure randomized to valsartan in the Valsartan Heart Failure Trial, 45% (1,141) were 65 years of age or older. In the VALsartan In Acute myocardial iNfarcTion trial (VALIANT), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. There were no notable differences in efficacy or safety between older and younger patients in either trial. Safety and effectiveness of valsartan tablets in patients with severe renal impairment (CrCl ≤ 30 mL/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60 to 90 mL/min) or moderate (CrCl 30 to 60 mL/min) renal impairment. No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease.

Resumen del producto:

Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with M on one side of the tablet and V above the score and 7 below the score on the other side. They are available as follows: NDC 0378-5807-93 bottles of 30 tablets The 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with M on one side of the tablet and V13 on the other side. They are available as follows: NDC 0378-5813-77 bottles of 90 tablets The 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with M on one side of the tablet and V14 on the other side. They are available as follows: NDC 0378-5814-77 bottles of 90 tablets The 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with M on one side of the tablet and V15 on the other side. They are available as follows: NDC 0378-5815-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

VALSARTAN- VALSARTAN TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN
TABLETS.
VALSARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
Valsartan tablets are an angiotensin II receptor blocker (ARB)
indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
*
INDICATION
STARTING DOSE
DOSE RANGE
TARGET MAINTENANCE
DOSE
Adult Hypertension
(2.1)
80 or 160 mg once daily 80-320 mg once daily
---
Pediatric Hypertension
(6-16 years) (2.2)
1.3 mg/kg once daily (up
to 40 mg total)
1.3-2.7 mg/kg once daily (up
to 40-160 mg total)
---
Heart Failure (2.3)
40 mg twice daily
40-160 mg twice daily
160 mg twice daily
Post-Myocardial
Infarction (2.4)
20 mg twice daily
20-160 mg twice daily
160 mg twice daily
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320
CONTRAINDICATIONS
Known hypersensitivity to any component.
Do not coadminister aliskiren with valsartan tablets in patients with
diabetes (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
_Hypertension:_ Most common adverse reactions are headache, dizziness,
viral infection, fatigue and
abdominal pain (6.1)
_Heart Failure:_ Most common adverse reactions are dizziness,
hypotension, diarrhea, arthralgia, back pain,
fatigue and hyperkalemia (6.1)
WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN TABLETS AS SOON AS
POSSIBLE.
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. (5.1)
Treatment of hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal
and nonfatal cardiovascular events, primarily strokes and myocardial
infarctions (1.1)
Treatment of heart failure (NYHA class II-IV); valsartan tablets
significantly reduced hospitalization for
heart failure (1