VERAPAMIL HYDROCHLORIDE injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)

Disponibbli minn:

General Injectables and Vaccines, Inc.

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Verapamil Hydrochloride Injection, USP is indicated for the following: - Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. - Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes). In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter

Sommarju tal-prodott:

Verapamil Hydrochloride Injection, USP 2.5 mg/mL is supplied in single-dose containers as follows: For Product Inquiry call [phone] Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-VRP/P/01 Revised: November, 2019

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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VERAPAMIL HYDROCHLORIDE
DESCRIPTION
Verapamil hydrochloride is a calcium antagonist or slow-channel
inhibitor. Verapamil
Hydrochloride Injection, USP is a sterile, nonpyrogenic solution
containing verapamil
hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for
injection. The
solution contains no bacteriostat or antimicrobial agent and is
intended for single-dose
intravenous administration. May contain hydrochloric acid and/or
sodium hydroxide for
pH adjustment; pH is 4.0 to 6.5.
The chemical name of Verapamil Hydrochloride, USP is
benzeneacetonitrile, α-[3-[{2-
(3,4-dimethoxyphenyl)ethyl} methylamino]
propyl]-3,4-dimethoxy-α-(1-methylethyl)
hydrochloride. Verapamil hydrochloride is a white or practically white
crystalline powder.
It is practically odorless and has a bitter taste. It is soluble in
water; freely soluble in
chloroform; sparingly soluble in alcohol; practically insoluble in
ether. It has the following
structural formula:
Verapamil hydrochloride is not chemically related to other
antiarrhythmic drugs.
CLINICAL PHARMACOLOGY
Mechanism of Action: Verapamil inhibits the calcium ion (and possibly
sodium ion) influx
through slow channels into conductile and contractile myocardial cells
and vascular
smooth muscle cells. The antiarrhythmic effect of verapamil appears to
be due to its
effect on the slow channel in cells of the cardiac conduction system.
The vasodilatory
effect of verapamil appears to be due to its effect on blockade of
calcium channels as
well as α receptors.
In the isolated rabbit heart, concentrations of verapamil that
markedly affect SA nodal
fibers or fibers in the upper and middle regions of the AV node have
very little effect on
fibers in the lower AV node (NH region) and no effect on atrial action
potentials or His
bundle fibers.
Electrical activity in the SA and AV nodes depends, to a large degree,
upon calcium influx
through the slow channel. By inhibi