TELMISARTAN AND HYDROCHLOROTHIAZIDE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

थमां उपलब्ध:

Hikma Pharmaceuticals USA Inc.

INN (इंटरनेशनल नाम):

TELMISARTAN

रचना:

TELMISARTAN 40 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Telmisartan and hydrochlorothiazide 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 the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide. 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,

उत्पाद समीक्षा:

Telmisartan and hydrochlorothiazide is available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets containing telmisartan and hydrochlorothiazide: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

प्राधिकरण का दर्जा:

New Drug Application Authorized Generic

उत्पाद विशेषताएं

TELMISARTAN AND HYDROCHLOROTHIAZIDE- TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLET
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS.
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥2% of patients) were upper
respiratory tract infection, dizziness,
sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BOEHRINGER INGELHEIM
PHARMACEUTICALS,
INC. AT [phone] OR [phone] TTY, OR FDA AT 1-800-FDA-1088
OR
WWW.FDA.GOV/MEDWATCH.
When pregnancy is detected, discontinue telmisartan and
hydrochlorothiazide 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)
Telmisartan and hydrochlorothiazide is a combination of an angiotensin
II receptor blocker (ARB) and
a thiazide diuretic indicated for the treatment of hypertension, alone
or with other antihypertensive
agents, to lower blood pressure. Lowering blood pressure reduces the
risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
(1)
Telmisartan and hydrochlorothiazide is not indicated for initial
therapy (1)
Usual starting dose is 80 mg/12.5 mg once daily (2.1)
Titrate up to 160 mg/25 mg as needed (2.1)
Initiate patients with biliary obstructive disorders or hepatic
insufficiency at 40 mg/12.5 mg (2.2)
Hypersensiti