TELMISARTAN tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Proficient Rx LP

INN (Kansainvälinen yleisnimi):

TELMISARTAN

Koostumus:

TELMISARTAN 80 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Telmisartan 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 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 pharmacol

Tuoteyhteenveto:

Telmisartan Tablets, USP are supplied as below: 80 mg, white to off-white uncoated oval shaped tablets, biconvex with beveled edges, plain on one side and debossed “038”on other side. NDC 63187-951-30 bottle of 30 units NDC 63187-951-60 bottle of 60 units NDC 63187-951-90 bottle of 90 units Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration. Dispense in a tightly closed container.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

TELMISARTAN- TELMISARTAN TABLET
PROFICIENT RX LP
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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._
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RECENT MAJOR CHANGES
Warnings and Precautions
Dual Blockade of the Renin-Angiotensin-Aldosterone System (5.6)
12/2014
INDICATIONS AND USAGE
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for:
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DOSAGE AND ADMINISTRATION
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INDIC ATIO N
STARTING DOSE
DOSE RANGE
Hypertension (2.1)
40 mg once once daily
40 to 80 mg once daily
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASCEND LABORATORIES,
LLC, PARSIPPANY, NJ 07054 AT 1-
877-272-7901 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AS SOON AS
POSSIBLE (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS (5.1)
Treatment of hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infractions.
(1.1)
May be administered with or without food (2.1)
Tablets: 20mg, 40mg, 80mg (3)
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)
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