ADALAT CC- nifedipine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See PRECAUTIONS, Drug Interactions .)  Nifedipine must not be used in cases of cardiogenic shock. Adalat is contraindicated in patients with a known hypersensitivity to any component of the tablet.

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows: 30 mg Pink 30 on one side and ADALAT CC on the other side 60 mg Salmon 60 on one side and ADALAT CC on the other side 90 mg Dark Red 90 on one side and ADALAT CC on the other side Adalat® CC Tablets are supplied in: Bottles of 100 30 mg 50419-701-05 60 mg 50419-702-05 90 mg 50419-703-05 Bottles of 1000 30 mg 50419-701-10 60 mg 50419-702-10 The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers. Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Manufactured in Germany Adalat is a registered trademark of Bayer Aktiengesellschaft. Rx Only ©2011 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A. The following are representative examples of ADALAT labeling. See the "How Supplied" section for a complete listing of all components.

Authorization status:

New Drug Application

Summary of Product characteristics

ADALAT CC- NIFEDIPINE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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ADALAT CC
(NIFEDIPINE)
EXTENDED RELEASE TABLETS
FOR ORAL USE
DESCRIPTION
Adalat
CC is an extended release tablet dosage form of the calcium channel
blocker nifedipine.
Nifedipine is 3,5-pyridinedicarboxylic acid,
1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester,
C
H N O , and has the structural formula:
Nifedipine is a yellow crystalline substance, practically insoluble in
water but soluble in ethanol. It has
a molecular weight of 346.3. Adalat CC tablets consist of an external
coat and an internal core. Both
contain nifedipine, the coat as a slow release formulation and the
core as a fast release formulation.
Adalat CC tablets contain either: 30, 60, or 90 mg of nifedipine for
once-a-day oral administration.
Inert ingredients in the formulation are: hydroxypropylcellulose,
lactose, corn starch, crospovidone,
microcrystalline cellulose, silicon dioxide, and magnesium stearate.
The inert ingredients in the film
coating for Adalat CC 30 and 60 are: hypromellose, polyethylene
glycol, ferric oxide, and titanium
dioxide. The inert ingredients in the film coating for Adalat CC 90
are: hypromellose, polyethylene
glycol and ferric oxide
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist) which
inhibits the transmembrane influx of calcium ions into vascular smooth
muscle and cardiac muscle. The
contractile processes of vascular smooth muscle and cardiac muscle are
dependent upon the movement
of extracellular calcium ions into these cells through specific ion
channels. Nifedipine selectively
inhibits calcium ion influx across the cell membrane of vascular
smooth muscle and cardiac muscle
without altering serum calcium concentrations.
MECHANISM OF ACTION
The mechanism by which nifedipine reduces arterial blood pressure
involves peripheral arterial
vasodilatation and, consequently, a reduction in peripheral vascular
resistance. The increased peripheral
vascular