VERAPAMIL HYDROCHLORIDE injection

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Armas Pharmaceuticals 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 flutte

Sommarju tal-prodott:

Verapamil Hydrochloride Injection, USP 2.5 mg/mL is a clear, colorless solution, free from any visible particles and is supplied in single-dose containers as follows: Storage: Store at 20° to 25°C (68° to 77° F) (See USP Controlled Room Temperature). Protect from light by retaining in package until ready to use. Manufactured by: Micro Labs Limited Bangalore-560 099. INDIA M. L. No. : KTK/28/357/2006 Distributed by: Armas Pharmaceuticals, Inc . Manalapan, NJ 07726 (USA) Revised: September 2019

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION
ARMAS PHARMACEUTICALS INC.
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VERAPAMIL HYDROCHLORIDE INJECTION, USP
INTRAVENOUS INJECTION
VIAL
Protect from light.
Rx only
DESCRIPTION
Verapamil Hydrochloride is calcium antagonist or slow channel
inhibitor. Verapamil Hydrochloride
Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose
vials (for intravenous
administration). Each 1 mL of solution contains 2.5 mg verapamil HCl
and 8.5 mg sodium chloride in
water for injection. Hydrochloric acid and/or sodium hydroxide is used
for pH adjustment. The pH of
the solution is 4.9 (4.0 to 6.5). Protect contents from light.
Verapamil Hydrochloride Injection, USP
vials are sterile.
The structural formula of verapamil HCl USP is given below:
Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]
methylamino]propyl]-3,4-dimethoxy-α-(1-
methylethyl) hydrochloride
Molecular weight: 491.07
Molecular formula: C
H
N
O
HCl
Verapamil HCl USP is an almost white, crystalline powder practically
free of odor, with a bitter taste. It
is soluble in water, chloroform and methanol. Verapamil HCl 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 cha