VERAPAMIL HYDROCHLORIDE injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Verapamil Hydrochloride (UNII: V3888OEY5R) (Verapamil - UNII:CJ0O37KU29)

Beschikbaar vanaf:

General Injectables & Vaccines, Inc

INN (Algemene Internationale Benaming):

Verapamil Hydrochloride

Samenstelling:

Verapamil Hydrochloride 2.5 mg in 1 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 flut

Product samenvatting:

Verapamil Hydrochloride Injection, USP 2.5 mg/mL is supplied in single-dose containers as follows: Protect from light by retaining in package until ready to use. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised:  April, 2011 Printed in USA EN-2504 Hospira, Inc., Lake Forest, IL 60045 USA

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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VERAPAMIL HYDROCHLORIDE 2.5 MG/ML INJECTION, USP 4 ML PREFILLED
SYRINGE
DESCRIPTION
ANSYR® PLASTIC SYRINGE
AMPUL
FLIPTOP VIAL
PROTECT FROM LIGHT.
RX ONLY
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 for pH adjustment; pH is 4.9 (4.0 to 6.5).
The chemical name of Verapamil Hydrochloride, USP is
benzeneacetonitrile, a-[3-[{2-
(3,4-dimethoxyphenyl)ethyl}
methylamino]propyl]-3,4-dimethoxy-a-(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:
Molecular weight: 491.07
Molecular formula: C27H38N2O4 • HCl
Verapamil hydrochloride is not chemically related to other
antiarrhythmic drugs.
The plastic syringe is molded from a specially formulated
polypropylene. Water
permeates from inside the container at an extremely slow rate which
will have an
insignificant effect on solution concentration over the expected shelf
life. Solutions in
contact with the plastic container may leach out certain chemical
components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of
the syringe material.
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 it