TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 vari

Product summary:

Telmisartan Tablets USP, 20 mg are mottled light brown to mottled brown-colored, round-shaped, flat face beveled edge, uncoated tablets debossed with '471' on one side and plain on the other side and are supplied as follows: NDC 68382-471-06 in bottle of 30 tablets with child-resistant closure NDC 68382-471-16 in bottle of 90 tablets with child-resistant closure NDC 68382-471-01 in bottle of 100 tablets NDC 68382-471-05 in bottle of 500 tablets NDC 68382-471-10 in bottle of 1000 tablets NDC 68382-471-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 40 mg are mottled light brown to mottled brown-colored, oblong-shaped, biconvex, uncoated tablets debossed with '472' on one side and plain on the other side and are supplied as follows: NDC 68382-472-06 in bottle of 30 tablets with child-resistant closure NDC 68382-472-16 in bottle of 90 tablets with child-resistant closure NDC 68382-472-01 in bottle of 100 tablets NDC 68382-472-05 in bottle of 500 tablets NDC 68382-472-10 in bottle of 1000 tablets NDC 68382-472-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 80 mg are mottled light brown to mottled-brown colored, oblong-shaped, biconvex, uncoated tablets debossed with '473' on one side and plain on the other side and are supplied as follows: NDC 68382-473-06 in bottle of 30 tablets with child-resistant closure NDC 68382-473-16 in bottle of 90 tablets with child-resistant closure NDC 68382-473-01 in bottle of 100 tablets NDC 68382-473-05 in bottle of 500 tablets NDC 68382-473-10 in bottle of 1000 tablets NDC 68382-473-78 in cartons of 30 tablets (3 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Tablets should not be removed from blisters or bottles until immediately before administration. Dispense in a tightly closed container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TELMISARTAN- TELMISARTAN TABLET
Zydus Pharmaceuticals USA Inc.
----------
Patient Information
Telmisartan
(tel″ mi sar′ tan)
Tablets, USP
Read this Patient Information before you start taking telmisartan
tablets and each time you get a refill.
There may be new information. This information does not take the place
of talking to your doctor about
your medical condition or your treatment.
What is the most important information I should know about telmisartan
tablets?
Telmisartan can cause harm or death to an unborn baby. Talk to your
doctor about other ways to lower
your blood pressure if you plan to become pregnant. If you get
pregnant while taking telmisartan, tell
your doctor right away.
What is telmisartan?
Telmisartan is a prescription medicine used:
•
to treat high blood pressure (hypertension)
•
in certain high risk people aged 55 years and older to help lower
their risk of having certain
cardiovascular problems such as stroke, heart attack, or death
It is not known if telmisartan is safe and effective in children.
Who should not take telmisartan?
You should not take telmisartan tablets if you are allergic
(hypersensitive) to the active ingredient
(telmisartan) or any of the other ingredients listed at the end of
this leaflet.
For patients with diabetes, if you are taking telmisartan you should
not take aliskiren.
What should I tell my doctor before taking telmisartan tablets?
Before you take telmisartan tablets, tell your doctor if you:
•
are pregnant or are planning to become pregnant. See
"WhatisthemostimportantinformationIshouldknowabouttelmisartantablets?"
•
are breast-feeding or plan to breast-feed. It is not known if
telmisartan passes into your breast
milk. You and your doctor should decide if you will take telmisartan
tablets or breastfeed. You
should not do both. Talk with your doctor about the best way to feed
your baby if you take
telmisartan tablets.
•
have liver problems
•
have kidney problems
•
have heart problems
•
have any other medical conditions
Tell your doctor about al

Summary of Product characteristics

TELMISARTAN- TELMISARTAN TABLET
ZYDUS PHARMACEUTICALS USA 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, 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) _,_
_(8.1)_
DRUGS THAT ACT DIRECTLY ON THE RENNIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS (5.1) _, (8.1)_
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)
Cardiovascular (CV) risk reduction in patients unable to take ACE
inhibitors (1.2)
DOSAGE AND ADMINISTRATION
May be administered with or without food (2.1)
When used for cardiovascular risk reduction, monitoring of blood
pressure is recommended, and if
appropriate, adjustment of medications that lower blood pressure may
be necessary (2.2)
HEADER$
INDICATION
STARTING DOSE DOSE RANGE
Hypertension
(2.1)
40 mg once daily 40 to 80 mg
once daily
Cardiovascular Risk Reduction (2.2)80 mg once daily
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 angioten