TELMISARTAN tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Aurobindo Pharma Limited

INN (Διεθνής Όνομα):

TELMISARTAN

Σύνθεση:

TELMISARTAN 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Telmisartan Tablets USP, 20 mg are white to off-white, round, flat faced beveled edged uncoated tablets, debossed with ‘H’ on one side and ‘74’ on the other side. Bottles of 30                            NDC 65862-867-30 3 x 10 Unit-dose Tablets          NDC 65862-867-03 Telmisartan Tablets USP, 40 mg are white to off-white, oval, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘75’ on the other side. Bottles of 30                            NDC 65862-868-30 3 x 10 Unit-dose Tablets          NDC 65862-868-03 Telmisartan Tablets USP, 80 mg are white to off-white, oval, biconvex uncoated tablets, debossed with ‘H’ on one side and ‘73’ on the other side. Bottles of 30                            NDC 65862-869-30 3 x 10 Unit-dose Tablets          NDC 65862-869-03 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Tablets should not be removed from bottles and blisters until immediately before administration.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TELMISARTAN - TELMISARTAN TABLET
AUROBINDO PHARMA LIMITED
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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 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)
INDICATIONS AND USAGE
Telmisartan tablets are an 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)
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 co-administer aliskiren with telmisartan tablets 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 recep