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:

Amneal Pharmaceuticals LLC

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Verapamil hydrochloride injection 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 and

Sommarju tal-prodott:

Verapamil Hydrochloride Injection, USP is a clear, colorless solution and supplied in 2 mL and 4 mL single-dose clear glass vial. Each mL contains verapamil hydrochloride, USP 2.5 mg. It is available as follows: 5 mg/2 mL (2.5 mg/mL) 2 mL Single-Dose Vial:                                   NDC 70121-1585-1 25 Vials in a Carton:                                       NDC 70121-1585-5 10 mg/4 mL (2.5 mg/mL) 4 mL Single-Dose Vial:                                   NDC 70121-1586-1 5 Vials in a Carton:                                         NDC 70121-1586-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light by retaining in carton until ready to use. Discard unused portion. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals  LLC Bridgewater, NJ 08807 Rev. 07-2023-03

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION
AMNEAL PHARMACEUTICALS LLC
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VERAPAMIL HYDROCHLORIDE INJECTION, USP
(5 MG/2 ML AND 10 MG/4 ML)
RX ONLY
DESCRIPTION
Verapamil hydrochloride is a calcium antagonist or slow-channel
inhibitor. Verapamil
hydrochloride injection, USP is a sterile, nonpyrogenic solution
containing verapamil
hydrochloride USP, 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 for pH
adjustment; pH is 4.9
(4.0 to 6.5).
The chemical name of verapamil hydrochloride is benzeneacetonitrile,
α-[3-[{2-(3,4-
dimethoxyphenyl)ethyl} methylamino]
propyl]-3,4-dimethoxy-α-(1-methylethyl)
monohydrochloride (±)-.
Verapamil hydrochloride, USP is white or practically white crystalline
powder. It is
practically odorless and has a bitter taste with a molecular formula C
H
N O •HCl, and
a molecular weight of 491.06 g/mol. 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.
27
38
2
4
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.
Elec