TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medsource Pharmaceuticals

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
MEDSOURCE PHARMACEUTICALS
----------
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 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 AS SOON AS
POSSIBLE ( 5.1)
DRUGS THAT ACT DIRECTLY ON THE RENNIN-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 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 coadminister 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 ZYDUS PHARMACEUTICALS
USA IN