TELMISARTAN tablet
Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Fachinformation
(SPC)
17-08-2017
Anfrage senden.
Wirkstoff:
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Verfügbar ab:
Camber Pharmaceuticals, Inc.
INN (Internationale Bezeichnung):
TELMISARTAN
Zusammensetzung:
TELMISARTAN 20 mg
Verabreichungsweg:
ORAL
Verschreibungstyp:
PRESCRIPTION DRUG
Anwendungsgebiete:
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 infractions. 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 guidlines, 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 var
Produktbesonderheiten:
Telmisartan Tablets USP, 20 mg are white to off white, round, flat bevel edged tablets, debossed with 'H' on one side and '162' on the other side. They supplied as follows: Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-802-31 Blister Pack of 250 (25x10) unit dose tablets NDC 31722-802-32 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-802-36 Blister Card of 10 unit dose tablets (Alu-Peel-Push) NDC 31722-802-33 Blister Pack of 250 (25x10) unit dose tablets NDC 31722-802-34 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-802-35 Telmisartan Tablets USP, 40 mg are white to off white, oval shaped, biconvex tablets, debossed with 'H' on one side and '163' on the other side. They supplied as follows: Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-803-31 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-803-32 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-803-37 Blister Card of 10 unit dose tablets (Alu-Peel-Push) NDC 31722-803-33 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-803-34 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-803-35 Blister Pack of 10 (1x10) unit dose tablets NDC 31722-803-36 Telmisartan Tablets USP, 80 mg are white to off white, oval shaped, biconvex tablets, debossed with 'H' on one side and '164' on the other side. They supplied as follows: Blister Card of 10 unit dose tablets (Alu-Alu) NDC 31722-804-31 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-804-32 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-804-37 Blister Card of 10 unit dose tablets (Alu-Peel-Push) NDC 31722-804-33 Blister Pack of 150 (15x10) unit dose tablets NDC 31722-804-34 Blister Pack of 30 (3x10) unit dose tablets NDC 31722-804-35 Blister Pack of 10 (1x10) unit dose tablets NDC 31722-804-36 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.
Berechtigungsstatus:
Abbreviated New Drug Application
Fachinformation
TELMISARTAN - TELMISARTAN TABLET
CAMBER PHARMACEUTICALS, 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 USP, 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)
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions
Dual Blockade of the Renin-Angiotensin-Aldosterone System (5.6)
12/2014
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)
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 R
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