TELMISARTAN tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Chartwell RX, LLC.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Telmisartan 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 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 variety of

Podsumowanie produktu:

Telmisartan Tablets USP are available as follows: 20 mg, white to off-white colored, circular, biconvex, uncoated tablets debossed with ‘ 20 ’ on one side and plain on other side. NDC 62135-535-30 HDPE bottle of 30 tablets with a child resistant closure and desiccant 40 mg, white to off-white colored, capsule shaped, uncoated tablets debossed with ‘ 40 ’ on one side and plain on other side. NDC 62135-536-30 HDPE bottle of 30 tablets with a child resistant closure and desiccant 80 mg, white to off-white colored, capsule shaped, uncoated tablets debossed with ‘ 80 ’ on one side and plain on other side. NDC 62135-537-30 HDPE bottle of 30 tablets with a child resistant closure and desiccant 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 the bottle until immediately before administration.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TELMISARTAN- TELMISARTAN TABLET
CHARTWELL RX, LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TELMISARTAN TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TELMISARTAN TABLETS, USP.
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 TABLETS 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 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)
INDICATION
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 tablets 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 CHARTWELL RX, LLC. AT
1-845-232-1683
OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWAT