TELMISARTAN AND AMLODIPINE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Disponible desde:

Mylan Pharmaceuticals Inc.

Designación común internacional (DCI):

TELMISARTAN

Composición:

TELMISARTAN 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Telmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents 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 angiotensin II receptor blockers and dihydropyridine calcium channel blockers. There are no controlled trials demonstrating risk reduction with telmisartan and amlodipine tablets. 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 Bloo

Resumen del producto:

Telmisartan and Amlodipine Tablets, USP are available containing 40 mg or 80 mg of telmisartan, USP and 5 mg or 10 mg of amlodipine (present as 6.935 mg or 13.87 mg amlodipine besylate, USP respectively), providing for the following combinations: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg or 80 mg/10 mg. The 40 mg/5 mg tablets are bi-layered, mottled light blue and white to off-white, capsule shaped, unscored tablets with TA1M debossed on the white to off-white side of the tablet and blank on the mottled light blue side. The white to off-white layer may have a blue tinge or blue specks. They are available as follows: NDC 0378-1075-93 bottles of 30 tablets The 40 mg/10 mg tablets are bi-layered, mottled blue and white to off-white, capsule shaped, unscored tablets with TA2M debossed on the white to off-white side of the tablet and blank on the mottled blue side. The white to off-white layer may have a blue tinge or blue specks. They are available as follows: NDC 0378-1076-93 bottles of 30 tablets The 80 mg/5 mg tablets are bi-layered, mottled light blue and white to off-white, capsule shaped, unscored tablets with TA3M debossed on the white to off-white side of the tablet and blank on the mottled light blue side. The white to off-white layer may have a blue tinge or blue specks. They are available as follows: NDC 0378-1077-93 bottles of 30 tablets The 80 mg/10 mg tablets are bi-layered, mottled blue and white to off-white, capsule shaped, unscored tablets with TA4M debossed on the white to off-white side of the tablet and blank on the mottled blue side. The white to off-white layer may have a blue tinge or blue specks. They are available as follows: NDC 0378-1078-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TELMISARTAN AND AMLODIPINE- TELMISARTAN AND AMLODIPINE TABLET
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN AND AMLODIPINE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TELMISARTAN AND AMLODIPINE
TABLETS.
TELMISARTAN AND AMLODIPINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AND AMLODIPINE
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)
Telmisartan and amlodipine tablets are an angiotensin II receptor
blocker (ARB) and a dihydropyridine calcium
channel blocker (DHP-CCB) combination product indicated for the
treatment of hypertension alone or with other
antihypertensive agents to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
(1)
Telmisartan and amlodipine tablets are indicated as initial therapy in
patients likely to need multiple antihypertensive
agents to achieve their blood pressure goals. (1)
Substitute telmisartan and amlodipine tablets for its individually
titrated components for patients on amlodipine and
telmisartan. Telmisartan and amlodipine tablets may also be given with
increased amounts of amlodipine, telmisartan,
or both, as needed. (2.2, 2.3)
Use telmisartan and amlodipine tablets to provide additional blood
pressure lowering for patients not adequately
controlled with amlodipine (or another dihydropyridine calcium channel
blocker) alone or with telmisartan (or another
angiotensin receptor blocker) alone. (2.3)
Dosage may be increased after