TELMISARTAN AND AMLODIPINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

AvKARE

INN (Διεθνής Όνομα):

TELMISARTAN

Σύνθεση:

TELMISARTAN 40 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Telmisartan and amlodipine tablets are available as 40 mg/5 mg Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'. 40 mg/10 mg Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'. 80 mg/5 mg Capsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'. 80 mg/10 mg Capsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'. Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations: Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].   Protect from moisture and light.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TELMISARTAN AND AMLODIPINE- TELMISARTAN AND AMLODIPINE TABLET
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
TELMISARTAN AND AMLODIPINE TABLETS
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: FATAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AND AMLODIPINE
TABLETS AS
SOON AS POSSIBLE ( 5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS ( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions
Dual Blockade of the Renin-Angiotensin-Aldosterone System ( 5.6)
12/2014
INDICATIONS AND USAGE
Telmisartan and amlodipine tablet is 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)
DOSAGE AND ADMINISTRATION
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 at l