Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Camber Pharmaceuticals, Inc.
TELMISARTAN
TELMISARTAN 20 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Preberite celoten dokument