DILTIAZEM HYDROCHLORIDE capsule, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

diltiazem hydrochloride (UNII: OLH94387TE) (diltiazem - UNII:EE92BBP03H)

Dostupné z:

Aphena Pharma Solutions - Tennessee, LLC

INN (Medzinárodný Name):

diltiazem hydrochloride

Zloženie:

diltiazem hydrochloride 120 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Diltiazem hydrochloride extended-release capsules is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is 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.

Prehľad produktov:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Diltiazem hydrochloride Extended-Release Capsules Storage conditions: Store at controlled room temperature                               20°-25°C (68°-77°F).                               Avoid excessive humidity.

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
DILTIAZEM HYDROCHLORIDE
EXTENDED RELEASE CAPSULES
USP Drug Release Test 6
DESCRIPTION
Diltiazem hydrochloride) is a calcium ion cellular influx inhibitor
(slow channel blocker). Chemically,
diltiazem hydrochloride is
1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5[2-(dimethylamino)ethyl]-2,-3-
dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-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 contain:
Microcrystalline Cellulose NF,
Sucrose Stearate, Eudragit, Povidone USP, Talc USP, Magnesium Stearate
NF, Hypromellose USP,
Titanium Dioxide USP, Polysorbate NF, Simethicone USP, Gelatin NF,
FD&C Blue #1, FD&C Red
#40, D&C Red #28, FD&C Green #3, Black Iron Oxide USP, and other
solids.
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 he