País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
REMEDYREPACK INC.
VALSARTAN
VALSARTAN 160 mg
ORAL
PRESCRIPTION DRUG
Valsartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. 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 hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide 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 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 Progra
Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. Strengths are available as follows. 80/12.5 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “345” on one side and “HH” on the other side. Bottles of 30 ........................................................................................NDC 43547-311-03 Bottles of 90 ........................................................................................NDC 43547-311-09 Bottles of 500.......................................................................................NDC 43547-311-50 160/12.5 mg Tablet - Pink, capsule-shaped, biconvex, film-coated tablets debossed with “347” on one side and “HH” on the other side. Bottles of 30 .........................................................................................NDC 43547-312-03 Bottles of 90 .........................................................................................NDC 43547-312-09 Bottles of 500........................................................................................NDC 43547-312-50 160/25 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “346” on one side and “HH” on the other side. Bottles of 30 .........................................................................................NDC 43547-313-03 Bottles of 90 .........................................................................................NDC 43547-313-09 Bottles of 500........................................................................................NDC 43547-313-50 320/12.5 mg Tablet - Pink, capsule-shaped, biconvex, film-coated tablets debossed with “351” on one side and “HH” on the other side. Bottles of 30 .........................................................................................NDC 43547-314-03 Bottles of 90 .........................................................................................NDC 43547-314-09 Bottles of 500........................................................................................NDC 43547-314-50 320/25 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “349” on one side and “HH” on the other side. Bottles of 30 ..........................................................................................NDC 43547-315-03 Bottles of 90 ..........................................................................................NDC 43547-315-09 Bottles of 500 ........................................................................................NDC 43547-315-50 Store at 20-25 o C (68-77 o F); excursions permitted to 15-30 o C (59-86 o F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- PATIENT INFORMATION FDA-Approved Patient Labeling Valsartan and Hydrochlorothiazide Tablets, USP (val sar’ tan and hye’’ droe klor’’ oh thye’ azide) Read the Patient Information that comes with valsartan and hydrochlorothiazide tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment. If you have any questions about valsartan and hydrochlorothiazide tablets, ask your doctor or pharmacist. What is the most important information I should know about valsartan and hydrochlorothiazide tablets? Valsartan and hydrochlorothiazide tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking valsartan and hydrochlorothiazide tablets, tell your doctor right away. What are valsartan and hydrochlorothiazide tablets? Valsartan and hydrochlorothiazide tablets contain 2 prescription medicines: 1. valsartan, an angiotensin receptor blocker (ARB) 2. hydrochlorothiazide (HCTZ), a water pill (diuretic) Valsartan and hydrochlorothiazide tablets may be used to lower high blood pressure (hypertension) in adults- • when 1 medicine to lower your high blood pressure is not enough. • as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than 1 medicine. Valsartan and hydrochlorothiazide tablets have not been studied in children under 18 years of age. Who should not take valsartan and hydrochlorothiazide tablets? Do not take valsartan and hydrochlorothiazide tablets if you: • are allergic to any of the ingredients in valsartan and hydrochlorothiazide tablets. See the end of this leaflet for a complete list of ingredients in valsartan and hydrochlorothiazide tablets. • make less urine due to kidney problems. • are allergic to medicines that contain sulfonamides. What should I tell my doct Leer el documento completo
VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALSARTAN AND HYDROCHLOROTHIAZIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN AND HYDROCHLOROTHIAZIDE. VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED FOR ORAL USE. INITIAL U.S. APPROVAL: 1998 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN AND HYDROCHLOROTHIAZIDE 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) INDICATIONS AND USAGE Valsartan and hydrochlorothiazide tablets are the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled with monotherapy ( 1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions . DOSAGE AND ADMINISTRATION Dose once daily. Titrate as needed to a maximum dose of 320/25mg ( 2) May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ) ( 2) May be substituted for titrated components ( 2.3) DOSAGE FORMS AND STRENGTHS Tablets (valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 ( 3) CONTRAINDICATIONS Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component; Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes ( 4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to Leer el documento completo