NIFEDIPINE tablet, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Nifedipine (UNII: I9ZF7L6G2L) (Nifedipine - UNII:I9ZF7L6G2L)

থেকে পাওয়া:

TYA Pharmaceuticals

INN (আন্তর্জাতিক নাম):

Nifedipine

রচনা:

Nifedipine 30 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. 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. Nifedipine extended-release tablets are contraindicated in patients with a known hypersensitivity to any component of the tablet.

পণ্য সারাংশ:

NDC:64725-2057-1 in a BOTTLE of 100 TABLET, EXTENDED RELEASES The tablets should be protected from light and moisture and stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
TYA PHARMACEUTICALS
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NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 30 MG
Rx only
For Oral Use
DESCRIPTION
Nifedipine extended-release tablets are 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. The molecular formula is 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. Nifedipine extended-release tablets
contain 30 mg of nifedipine for once-
a-day oral administration.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, ethylcellulose,
hydroxyethyl cellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, polyacrylic
dispersion (copolymer of ethyl acrylate and methyl methacrylate),
polyethylene glycol, silicon dioxide,
sodium lauryl sulfate, talc, titanium dioxide, and yellow 10 ferric
oxide.
Nifedipine extended-release tablets meet USP Dissolution Test 4 (using
first derivative UV
spectrophotometry at 245 nm for sample analysis).
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
171826
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 resistance, an underlying