diltiazem hydrochloride extended release- Diltiazem hydrochloride tablet, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Watson Laboratories Inc.

INN (Alþjóðlegt nafn):

Diltiazem hydrochloride

Lyfjaform:

TABLET, EXTENDED RELEASE

Samsetning:

120 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Diltiazem Hydrochloride Extended Release Tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended Release Tablets are indicated for the management 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 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.

Vörulýsing:

Diltiazem Hydrochloride Extended Release Tablets are supplied as: 120 mg: white to off-white round tablets imprinted with “WPI” over “3360” in black ink, supplied in bottles of 30, 90 and 1000. 180 mg: white to off-white round tablets imprinted with “WPI” over “3361” in black ink, supplied in bottles of 30, 90 and 1000. 240 mg: white to off-white round tablets imprinted with “WPI” over “3362” in black ink, supplied in bottles of 30, 90 and 1000. 300 mg: white to off-white round tablets imprinted with “WPI” over “3368” in black ink, supplied in bottles of 30, 90 and 1000. 360 mg: white to off-white round tablets imprinted with “WPI” over “3363” in black ink, supplied in bottles of 30, 90 and 1000. 420 mg: white to off-white round tablets imprinted with “WPI” over “3364” in black ink, supplied in bottles of 30, 90 and 1000. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. Rx Only. Watson Laboratories Inc. Corona, CA 92880 USA Rev. October 2005

Vara einkenni

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE- DILTIAZEM HYDROCHLORIDE
TABLET,
EXTENDED RELEASE
WATSON LABORATORIES INC.
----------
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS
ISSUED: OCTOBER 2005
RX ONLY
ONCE-A-DAY DOSAGE
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular 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-.
The structural formula is:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is soluble in
water, methanol and chloroform. It has a molecular weight of 450.99.
Diltiazem Hydrochloride
Extended Release Tablets, for oral administration, are formulated as a
once-a-day extended release
tablet containing either120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420
mg of diltiazem
hydrochloride.
Also contains: Monosodium Citrate Anhydrous Powder; Polyethylene
Glycol, NF (PEG-6000);
Povidone, USP; Magnesium Stearate, NF; Dehydrated Alcohol, USP;
Lactose Monohydrate, NF;
Acetyltributyl Citrate, NF; Sodium Bicarbonate, USP; Multipor
Coating Polymer; Titanium Dioxide,
USP; Acetone, NF; Ethylcellulose, NF; Hypromellose, USP; Purified
Water, USP; Talc, USP;
Isopropyl Alcohol, USP; n-Butyl Alcohol, NF; Propylene Glycol, USP;
Opacode Black Ink.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem are believed to be related to its
ability to inhibit the 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 has b