TELMISARTAN tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)

Prieinama:

Hisun Pharmaceuticals USA, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Telmisartan 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 the class to which this drug principally belongs. 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 variet

Produkto santrauka:

Telmisartan tablets USP are available as white or off-white tablets containing 20 mg, 40 mg, or 80 mg of telmisartan USP. Tablets are marked with the HU on one side, and on the other side, with either 20, 40, or 80 for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows: Telmisartan tablets USP 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-135-51). Telmisartan tablets USP 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-136-51). Telmisartan tablets USP 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-137-51). Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)  [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TELMISARTAN- TELMISARTAN TABLET
HISUN PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TELMISARTAN TABLETS.
TELMISARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN 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)
INDICATIONS AND USAGE
Telmisartan tablets USP are an angiotensin II receptor blocker (ARB)
indicated for:
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)
DOSAGE AND ADMINISTRATION
May be administered with or without food ( 2.1)
INDIC ATIO N
STARTING DOSE
DOSE RANGE
Hypertension ( 2.1) 40 mg once daily 40 to 80 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg, 80 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity (e.g., anaphylaxis or angioedema) to
telmisartan or any other component of this product ( 4)
Do not co-administer aliskiren with telmisartan in patients with
diabetes ( 4)
WARNINGS AND PRECAUTIONS
Avoid fetal or neonatal exposure ( 5.1)
Hypotension: Correct any volume or salt depletion before initiating
therapy. Observe for signs and symptoms of
hypotension ( 5.2)
Monitor carefully in patients with impaired hepatic ( 5.4) or renal
function ( 5.5)
Avoid concomitant use of an ACE inhibitor and angiotensin receptor
blocker ( 5.6)
ADVERSE REACTIONS
Hypertension: The most common adverse events (≥1%) reported in
hypertension trials are back pain, sinusitis, and
diarrhea ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HISUN PHARMACEUTICALS
USA, INC. AT 1-855-554-4786, OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG IN