TELMISARTAN tablet TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare US, LLC

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Telmisartan tablets 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 variety of

Product summary:

Telmisartan tablets, USP, are available as white to off-white, uncoated tablets containing telmisartan 20 mg, 40 mg, or 80 mg. Tablets are marked with “S” on one side, and on the other side, with either “511”, “512”, or “513” for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows: Telmisartan tablets, USP, 20 mg are round and packaged in bottles of 30 (NDC 43547-283-03), bottles of 90 (NDC 43547-283-09) and bottles of 500 (NDC 43547-283-50). Telmisartan tablets, USP, 40 mg are oval and packaged in bottles of 30 (NDC 43547-284-03), bottles of 90 (NDC 43547-284-09) and bottles of 500 (NDC 43547-284-50). Telmisartan tablets, USP, 80 mg are oval and packaged in bottles of 30 (NDC 43547-285-03), bottles of 90 (NDC 43547-285-09) and bottles of 500 (NDC 43547-285-50). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed. Tablets should not be removed from bottle until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TELMISARTAN- TELMISARTAN TABLET
TELMISARTAN- TELMISARTAN TABLET
Solco Healthcare US, LLC
----------
PATIENT INFORMATION
Dispense with Patient Information available at:
www.solcohealthcare.com/medguide/telmisartan-
tablets.pdf
Telmisartan Tablets, USP
(tel” mi sar’ tan)
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 tablets 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
tablets, tell your doctor right away.
What are telmisartan tablets?
Telmisartan tablets are prescription medicines 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 tablets are safe and effective in
children.
Who should not take telmisartan tablets?
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 tablets 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 "What is the most
important information I
should know about telmisartan tablets?"
•
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 breast-feed. You should
not do both. Talk with your doctor abou

Summary of Product characteristics

TELMISARTAN- TELMISARTAN TABLET
TELMISARTAN- TELMISARTAN TABLET
SOLCO HEALTHCARE US, LLC
----------
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._
•
•
INDICATIONS AND USAGE
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
• 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
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
•
When pregnancy is detected, discontinue telmisartan tablets as soon as
possible (5.1, 8.1)
Drugs that act directly on the renin-angiotensin system can cause
injury and death to the
developing fetus (5.1, 8.1)
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)
Cardiovascular (CV) risk reduction in patients unable to take ACE
inhibitors (1.2)
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)
Tablets: 20 mg, 40 mg, 80 mg (3)
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)
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 hepat