DILTIAZEM HYDROCHLORIDE capsule extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 240 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE - DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ST MARYS MEDICAL PARK PHARMACY
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DESCRIPTION
Diltiazem 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 C22H26N2O4S
HCl and its molecular weight is 450.99. Its structural formula is as
follows:
Diltiazem hydrochloride, USP is a white to off-white crystalline
powder with a bitter taste. It is soluble
in water, methanol and chloroform.
Diltiazem Hydrochloride Extended-release Capsules, USP (Once-a-Day
Dosage), for oral
administration, contain multiple units of diltiazem hydrochloride
extended-release 60 mg, resulting in
the 120 mg, 180 mg or 240 mg dosage strengths allowing for the
controlled release of diltiazem
hydrochloride over a 24-hour period. In addition, each capsule
contains the following inactive
ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl
sebacate, ethylcellulose,
hypromellose, magnesium stearate, maltodextrin, microcrystalline
cellulose, oleic acid, polyethylene
glycol and sodium lauryl sulfate. The empty hard-shell gelatin
capsules contain FDandC Blue No. 1,
FDandC Red No. 40 Aluminum Lake, gelatin, sodium lauryl sulfate and
titanium dioxide. In addition, the
120 mg and 180 mg empty hard-shell gelatin capsules contain DandC Red
No. 28.
The imprinting ink contains black iron oxide, DandC Yellow No. 10
Aluminum Lake, FDandC Blue No.
1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, FDandC Red No. 40
Aluminum Lake, propylene
glycol and shellac glaze.
Diltiazem Hydrochloride Extended-release Capsules, USP (Once-a-Day
Dosage) 120 mg, 180 mg and
240 mg meet USP Drug Release Test 8.
CLINICAL PHARMACOLOGY
The therapeutic benefits of diltiazem are believed to be related to
its ability to inhibit the influx of
calcium ions during membrane depolarization of cardiac and vascular
smo