FELODIPINE tablet, film coated, extended release

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

FELODIPINE (UNII: OL961R6O2C) (FELODIPINE - UNII:OL961R6O2C)

Fáanlegur frá:

Aurobindo Pharma Limited

INN (Alþjóðlegt nafn):

FELODIPINE

Samsetning:

FELODIPINE 2.5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 felodipine. 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 1 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 pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents. Felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product.

Vörulýsing:

Felodipine Extended-Release Tablets USP, 2.5 mg are green coloured, round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘15’ on the other side.          Bottles of 90                                                     NDC 65862-673-90          Bottles of 100                                                   NDC 65862-673-01          Bottles of 1000                                                 NDC 65862-673-99          10 x 10 Unit-dose Tablets                                NDC 65862-673-78 Felodipine Extended-Release Tablets USP, 5 mg are pink coloured, round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘16’ on the other side.          Bottles of 90                                                     NDC 65862-674-90          Bottles of 100                                                   NDC 65862-674-01          Bottles of 1000                                                 NDC 65862-674-99 Felodipine Extended-Release Tablets USP, 10 mg are brown coloured, round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘17’ on the other side.          Bottles of 90                                                    NDC 65862-675-90          Bottles of 100                                                  NDC 65862-675-01          Bottles of 1000                                                NDC 65862-675-99          10 x 10 Unit-dose Tablets                               NDC 65862-675-78 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]  Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: January 2020

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FELODIPINE - FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
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DESCRIPTION
Felodipine is a calcium antagonist (calcium channel blocker).
Felodipine is a
dihydropyridine derivative that is chemically described as ± ethyl
methyl 4-(2,3-
dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate.
Its molecular
formula is C
H
Cl
NO and its structural formula is:
Felodipine USP is a light yellow to yellow, crystalline powder with a
molecular weight of
384.26. It is insoluble in water and is freely soluble in
dichloromethane and ethanol.
Felodipine is a racemic mixture.
Felodipine extended-release tablets, USP provide extended release of
felodipine USP.
They are available as tablets containing 2.5 mg, 5 mg or 10 mg of
felodipine USP for oral
administration. In addition to the active ingredient felodipine, the
tablets contain the
following inactive ingredients: colloidal silicon dioxide, heavy
aluminium silicate,
hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose
monohydrate,
microcrystalline cellulose, polyethylene glycol, polyoxyl 40
hydrogenated castor oil,
propyl gallate, sodium stearyl fumarate, titanium dioxide. In addition
the 2.5 mg strength
contains FD&C blue #2/Indigo carmine aluminum lake and iron oxide
yellow and the 5
mg and 10 mg strengths contain iron oxide red and iron oxide yellow.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Felodipine is a member of the dihydropyridine class of calcium channel
antagonists
(calcium channel blockers). It reversibly competes with nitrendipine
and/or other calcium
channel blockers for dihydropyridine binding sites, blocks
voltage-dependent
Ca
currents in vascular smooth muscle and cultured rabbit atrial cells,
and blocks
18
19
2
4
++
potassium-induced contracture of the rat portal vein.
_In vitro _studies show that the effects of felodipine on contractile
processes are selective,
with greater effects on vascular smooth muscle than cardiac muscle.
Negative inotropic
effects can be detected _in vitro_, but such effects