البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ALISKIREN HEMIFUMARATE (UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Noden Pharma USA, Inc.
ALISKIREN HEMIFUMARATE
ALISKIREN 150 mg
ORAL
PRESCRIPTION DRUG
Tekturna HCT is 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 (HCTZ). There are no controlled trials demonstrating risk reduction with Tekturna HCT. 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, Evaluation, and Treatment of High Blood Pressure (JNC). Nume
Tekturna HCT is supplied as biconvex, ovaloid film-coated tablets. All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below. Storage Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in original container.
New Drug Application
TEKTURNA HCT- ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED NODEN PHARMA USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TEKTURNA HCT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TEKTURNA HCT. TEKTURNA HCT (ALISKIREN AND HYDROCHLOROTHIAZIDE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2008 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE TEKTURNA HCT AS SOON AS POSSIBLE. ( 5.1, 8.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. ( 5.1, 8.1) RECENT MAJOR CHANGES Contraindications ( 4) 3/2015 Warnings and Precautions ( 5.1, 5.2, 5.5, 5.8) 3/2015 INDICATIONS AND USAGE Tekturna HCT is a combination of aliskiren, a renin inhibitor, and hydrochlorothiazide (HCTZ), a thiazide diuretic, 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 infarction. DOSAGE AND ADMINISTRATION Initiate with 150/12.5mg daily. Titrate as needed up to a maximum of 300/25 mg ( 2.2) Order of increasing mean effect: 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg ( 2.1) Replacement therapy: May be substituted for titrated components ( 2.4) DOSAGE FORMS AND STRENGTHS Tablets (mg aliskiren/mg HCTZ): 150/12.5, 150/25, 300/12.5, 300/25 ( 3) CONTRAINDICATIONS Do not use with angiotensin receptor blockers (ARBs) or angiotensin- converting enzyme inhibitors (ACEIs) in patients with diabetes. ( 4) Anuria ( 4) Hypersensitivity to sulfonamide-derived drugs or to any of the components. ( 4) WARNINGS AND PRECAUTIONS Avoid concomitant use with ARBs or ACEIs particularly in patients with renal impairment [cr اقرأ الوثيقة كاملة