DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Akorn, Inc.

INN (الاسم الدولي):

Diltiazem Hydrochloride

تركيب:

Diltiazem Hydrochloride 5 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Diltiazem hydrochloride injection is indicated for the following: 1.Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. 2.Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. The use of diltiazem hydrochloride injection for control of ventricular response in patients with atrial fibrillation or atrial flutter or conversion to sinus rhythm in patients with PSVT should b

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION
AKORN, INC.
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DILTIAZEM HYDROCHLORIDE INJECTION,
0.5% (5 MG/ML)
Rx only
DESCRIPTION:
Diltiazem hydrochloride injection is a calcium ion influx inhibitor
(slow channel blocker or calcium
channel antagonist). 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
structural formula is:
The molecular formula is C
H N O S•HCl
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 injection is a clear, colorless, sterile,
nonpyrogenic solution. It has a pH range
of 3.7 to 4.1.
Diltiazem hydrochloride injection is for direct intravenous bolus
injection and continuous intravenous
infusion.
EACH ML CONTAINS: ACTIVE: 5 mg Diltiazem Hydrochloride. INACTIVES:
0.75 mg Citric Acid USP, 0.65
mg Sodium Citrate Dihydrate USP, 71.4 mg Sorbitol Solution USP, and
Water for Injection USP up to 1
mL, Sodium Hydroxide and/or Hydrochloric Acid are used for pH
adjustment.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTION
Diltiazem inhibits the influx of calcium (Ca
) ions during membrane depolarization of cardiac and
vascular smooth muscle. The therapeutic benefits of diltiazem in
supraventricular tachycardias are
related to its ability to slow AV nodal conduction time and prolong AV
nodal refractoriness. Diltiazem
exhibits frequency (use) dependent effects on AV nodal conduction such
that it may selectively reduce
the heart rate during tachycardias involving the AV node with little
or no effect on normal AV nodal
conduction at normal heart rates.
Diltiazem slows the ventricular rate in patients with a rapid
ventricular response during atrial fibrillation
or atrial flutter. Diltiazem converts paroxysmal supraventricular
tachycardia (PSVT) to normal sinus
rhythm by interrupting the reentry circuit in AV nodal r