HYDRALAZINE HYDROCHLORIDE tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

HYDRALAZINE HYDROCHLORIDE (UNII: FD171B778Y) (HYDRALAZINE - UNII:26NAK24LS8)

থেকে পাওয়া:

Direct_Rx

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Essential hypertension, alone or as an adjunct. Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

পণ্য সারাংশ:

HydrALAZINE Hydrochloride Tablets, USP 10 mg - round, convex, pink film coated tablet engraved with HP above 1 on one side and plain on the other side Bottles of 100 w/ CRCBottles of 1000 25 mg - round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other side Bottles of 100 w/ CRC Bottles of 1000 50 mg - round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other side Bottles of 100 w/ CRCBottles of 1000 100 mg - round, convex, pink film coated tablet engraved with HP above 4 on one side and plain on the other side Bottles of 100 w/ Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. MANUFACTURED FOR: Heritage Pharmaceuticals Inc East Brunswick, NJ 08816 1-866-901-DRUG (3784) 51U000000172US03 Issued: 05/18

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
DIRECT_RX
----------
HYDRALAZINE HYDROCHLORIDE
HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral
administration. Its
chemical name is 1-hydrazinophthalazine monohydrochloride, and its
structural formula
is:
[a9cb621b-figure-01]
HydrALAZINE hydrochloride, USP is a white to off-white, odorless
crystalline powder. It
is soluble in water, slightly soluble in alcohol, and very slightly
soluble in ether. It melts at
about 275°C, with decomposition, and has a molecular weight of
196.64.
Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or
100 mg
hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red
#40/Allura Red AC
Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil,
microcrystalline
cellulose, magnesium stearate, pregelatinized starch, sodium lauryl
sulfate, and titanium
dioxide.
Although the precise mechanism of action of hydrALAZINE is not fully
understood, the
major effects are on the cardiovascular system. HydrALAZINE apparently
lowers blood
pressure by exerting a peripheral vasodilating effect through a direct
relaxation of
vascular smooth muscle. HydrALAZINE, by altering cellular calcium
metabolism,
interferes with the calcium movements within the vascular smooth
muscle that are
responsible for initiating or maintaining the contractile state.
The peripheral vasodilating effect of hydrALAZINE results in decreased
arterial blood
pressure (diastolic more than systolic); decreased peripheral vascular
resistance; and an
increased heart rate, stroke volume, and cardiac output. The
preferential dilatation of
arterioles, as compared to veins, minimizes postural hypotension and
promotes the
increase in cardiac output. HydrALAZINE usually increases renin
activity in plasma,
presumably as a result of increased secretion of renin by the renal
juxtaglomerular cells
in response to reflex sympathetic discharge. This increase in renin
activity leads to the
production of angiotensin II, which then causes