TELMISARTAN AND HYDROCHLOROTHIAZIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Solco Healthcare LLC

INN (Tarptautinis Pavadinimas):

TELMISARTAN

Sudėtis:

TELMISARTAN 40 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Telmisartan and hydrochlorothiazide tablets, USP are available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets containing telmisartan, USP and hydrochlorothiazide, USP: 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]. Keep bottle tightly closed and do not remove tablets from bottle until immediately before administration.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TELMISARTAN AND HYDROCHLOROTHIAZIDE- TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLET
SOLCO HEALTHCARE LLC
----------
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_.
•
•
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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 SOLCO HEALTHCARE US,
LLC, AT 1-866-257-
2597 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 tablets are 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 tablets are 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)
Hypersensitivity to telmisartan or any compo