TELMISARTAN tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

Telmisartan tablets, USP 80 mg, are available as white to off-white, uncoated tablets, marked with “S” on one side, and on the other side, with “513”. NDC: 71335-2191-1: 90 Tablets in a BOTTLE NDC: 71335-2191-2: 30 Tablets in a BOTTLE Storage Store at 20°Cto 25°C (68°F to 77°F); excursions permitted to 15°Cto 30°C (59°Fto 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed. Tablets should not be removed from bottle until immediately before administration. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

TELMISARTAN- TELMISARTAN TABLET
Bryant Ranch Prepack
----------
PATIENT INFORMATION
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 aretelmisartan tablets?
Telmisartan tablets are prescription medicines used:
•
to treat high blood pressure (hypertension)
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 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 all the medicines you take, including
prescription and non-prescription
medicines, vitamins, and herbal s

製品の特徴

TELMISARTAN- TELMISARTAN TABLET
BRYANT RANCH PREPACK
----------
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
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
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE. AT
1-866-257-2597 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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)
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 hepatic (5.4) or renal
function (5.5)
Avoid concomitant use of an ACE inhibitor and angiotensin receptor
blocker (5.6)
Hypertension: The most common adverse events (≥1%) reported in
hypertension trials are back pain,
sinusitis, and