DILTIAZEM HYDROCHLORIDE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Akorn

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Diltiazem hydrochloride injection is indicated for the following: - 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. - 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 shou

Rezumat produs:

Diltiazem Hydrochloride Injection, 0.5% (5 mg/mL) is supplied: SINGLE-DOSE CONTAINERS. DISCARD UNUSED PORTION. Storage: Store under refrigeration 2° to 8°C (36° to 46°F). DO NOT FREEZE. May be stored at room temperature for up to 1 month. Destroy after 1 month at room temperature. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 DH00N Rev. 05/18

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION
AKORN
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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
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