TELMISARTAN AND AMLODIPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Limited

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 B

Product summary:

Telmisartan and amlodipine tablets are available in four strengths as 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg and 80 mg/10 mg:             Oval shaped biconvex, bilayer, uncoated tablets with one white to off white color layer     and one blue color mottled layer debossed with ‘L389’. NDC 46708-184-08          80 tablets - 10 blister cards of 8 tablets each                     Oval shaped biconvex, bilayer, uncoated tablets with one white to off white color  layer and one blue color mottled layer debossed with ‘L390’. NDC 46708-185-08          80 tablets - 10 blister cards of 8 tablets each                       Oval shaped biconvex, bilayer, uncoated tablets with one white to off white color layer and one blue color mottled layer debossed with ‘L39l’. NDC 46708-186-06          60 tablets - 10 blister cards of 6 tablets each             Oval shaped biconvex, bilayer, uncoated tablets with one white to off white color layer and one blue color mottled layer debossed with ‘L388’. NDC 46708-187-06          60 tablets - 10 blister cards of 6 tablets each Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN AND AMLODIPINE - TELMISARTAN AND AMLODIPINE TABLET
ALEMBIC PHARMACEUTICALS LIMITED
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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._
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-Aldesterone 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) (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) (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 lea