DILTIAZEM HYDROCHLORIDE capsule, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Διαθέσιμο από:

PuraCap Laboratories LLC

INN (Διεθνής Όνομα):

DILTIAZEM HYDROCHLORIDE

Σύνθεση:

DILTIAZEM HYDROCHLORIDE 360 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina. Diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic),(4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Περίληψη προϊόντος:

Diltiazem hydrochloride Extended-Release Capsules Strength Description Quantity NDC# 120 mg #3 lavender/lavender capsule imprinted: 120 90’s 30’s 24658-170-90 24658-170-30 180 mg #2 white/blue-green capsule imprinted: 180 90’s 30’s 24658-171-90 24658-171-30 240 mg #1 blue-green/lavender capsule imprinted: 240 90’s 30’s 24658-172-90 24658-172-30 300 mg #0 white/lavender capsule imprinted: 300 90’s 30’s 24658-173-90 24658-173-30 360 mg #0 blue-green/blue-green capsule imprinted: 360 90’s 30’s 24658-174-90 24658-174-30 420 mg #00 white/white capsule imprinted: 420 90’s 24658-346-90 Storage conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Rx Only. Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, Manitoba R5G 1Z7, Canada For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807, USA Distributed by: Blu Pharmaceuticals 301 Robey St. Franklin, KY 42134 Made in Canada Rev. 10/2016 170-10-2016

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Αρχείο Π.Χ.Π.

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PURACAP LABORATORIES LLC
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker). Chemically,
diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 _H_)-one,
3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,
3-dihydro- 2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-.
The chemical structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is soluble in
water, methanol and chloroform and has a molecular weight of 450.98.
Diltiazem Hydrochloride
extended-release capsules contain diltiazem hydrochloride in
extended-release beads at doses of 120,
180, 240, 300, 360 and 420 mg.
Diltiazem Hydrochloride extended-release capsules also contains: black
iron oxide, D&C Red No. 28,
ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue
No. 1, FD&C Green No. 3,
FD&C Red No. 40, gelatin, hypromellose, magnesium stearate,
microcrystalline cellulose, polysorbate,
povidone, simethicone, sucrose stearate, talc, and titanium dioxide.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride are believed to be
related to its ability to inhibit the
cellular influx of calcium ions during membrane depolarization of
cardiac and vascular smooth muscle.
MECHANISMS OF ACTION
HYPERTENSION: Diltiazem produces its antihypertensive effect primarily
by relaxation of vascular
smooth muscle and the resultant decrease in peripheral vascular
resistance. The magnitude of blood
pressure reduction is related to the degree of hypertension: thus
hypertensive individuals experience an
antihypertensive effect, whereas there is only a modest fall in blood
pressure in normotensives.
ANGINA: Diltiazem HCl has been shown to produce increases in exercise
tolerance, probably due to its
ability to reduce myocardial oxygen demand. This is accomplished via
reductions in heart rate and
systemic