DILTIAZEM HYDROCHLORIDE capsule, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Diltiazem Hydrochloride (UNII: OLH94387TE) (Diltiazem - UNII:EE92BBP03H)

Mevcut itibaren:

Apotex Corp.

INN (International Adı):

DILTIAZEM HYDROCHLORIDE

Kompozisyon:

DILTIAZEM HYDROCHLORIDE 120 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] are indicated for the management of chronic stable angina. Diltiazem hydrochloride 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 hypotension (less than 90 mmHg systolic); (4) patients who have demonstrated hypersensitivity to the drug; and (5) patients with acute myocardial infarction and pulmonary congestion as documented by X-ray on admission.

Ürün özeti:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Keep out of the reach of children. APOTEX INC. DILT-XR [DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE CAPSULES, USP (Once-a-day dosage)] 120 mg, 180 mg and 240 mg Revised: July 2012

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
APOTEX CORP.
----------
DILT-XR [DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
(ONCE-A-
DAY DOSAGE), 120 MG, 180 MG AND 240 MG
DESCRIPTION
Diltiazem hydrochloride is a calcium ion influx inhibitor (slow
channel blocker or calcium
antagonist). Chemically, diltiazem hydrochloride is
1,5-Benzothiazepin-4(5H)one, 3-
(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)
monohydrochloride, (+)-cis-. Its molecular formula is C
H
N O S HCl and its molecular
weight is 450.99. Its structural formula is as follows:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
soluble in water, methanol and chloroform. DILT-XR [Diltiazem
Hydrochloride Extended-
Release Capsules, USP (Once-a-day dosage)] complies with USP Drug
Release Test #2.
DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-day
dosage)] contain multiple units of diltiazem HCI extended-release 60
mg, resulting in 120
mg, 180 mg, or 240 mg dosage strengths allowing for the controlled
release of diltiazem
HCI over a 24-hour period.
INACTIVE INGREDIENTS
DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP
(Once-a-day
dosage)] also contain Black SW-9008/SW9009, colloidal silicon dioxide,
D&C Red #
No.28, D&C Yellow # No.10, FD&C Blue # No.1, FD&C Red # No.40,
gelatin,
hypromellose, magnesium stearate, red iron oxide, titanium dioxide and
yellow iron
oxide.
For oral administration.
CLINICAL PHARMACOLOGY
The therapeutic benefits of diltiazem hydrochloride are believed to be
related to its ability
to inhibit the influx of calcium ions during membrane depolarization
of cardiac and
vascular smooth muscles.
22
26
2
4
MECHANISM OF ACTION
_HYPERTENSION_
Diltiazem HCl produces its antihypertensive effect primarily by
relaxation of vascular
smooth muscle with a resultant decrease in peripheral vascular
resistance. The
magnitude of blood pressure reduction is related to the degree of
hypertension; thus
hyperte