TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Limited

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 20 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN - TELMISARTAN TABLET
ALEMBIC PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TELMISARTAN.
TELMISARTAN TABLETS, USP
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNINGS._
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 EVEN DEATH TO THE
DEVELOPING FETUS (5.1)
RECENT MAJOR CHANGES
Boxed Warning 1/2012
Indications and Usage
Hypertension (1.1) 9/2012
Contraindications (4) 10/2012
Warnings and Precautions
Fetal Toxicity (5.1) 1/2012
INDICATIONS AND USAGE
Telmisartanis an angiotensin II receptor blocker (ARB) indicated for:
(1)
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
DOSERANGE
Hypertenstion (2.1)40 mg once daily40 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 FD