VERAPAMIL HYDROCHLORIDE injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
23-01-2017

Aktīvā sastāvdaļa:

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

Pieejams no:

EXELA PHARMA SCIENCES, LLC

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: - Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil 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 [WPW] and Lown-Ganong-Levine [LGL] syndromes). In controlled studies in the U.S., 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/or fi

Produktu pārskats:

All forms are individually packaged. Size NDC Number Carton Size 5-mg (2 ml) vial 51754-0204-2 5-mg (2 ml) vial 51754-0204-4  25 Store at 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature.]

Autorizācija statuss:

New Drug Application

Produkta apraksts

                                VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION
EXELA PHARMA SCIENCES, LLC
----------
VERAPAMIL
HYDROCHLORIDE INJECTION, USP
FOR INTRAVENOUS INJECTION
PROTECT FROM LIGHT
DESCRIPTION
Verapamil hydrochloride is a calcium antagonist or slow-channel
inhibitor available as a sterile
solution for intravenous injection in 5-mg (2 ml) vials. Each vial
contains Verapamil hydrochloride 2.5
mg/ml and sodium chloride 8.5 mg/ml in water for injection.
Hydrochloric acid and/or sodium
hydroxide is used for pH adjustment. The pH of the solution is between
4.1 and 6.0.
The structural formula of Verapamil HCl is given below:
Benzeneacetonitrile,
α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxyα-(1-
methylethyl) hydrochloride
Verapamil hydrochloride is an almost white, crystalline powder,
practically free of odor, with a bitter
taste. It is soluble in water, chloroform, and methanol. 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 conductile system.
Electrical activity through the SA and AV nodes depends, to a
significant degree, upon calcium influx
through the slow channel. By inhibiting this influx, Verapamil slows
AV conduction and prolongs the
effective refractory period within the AV node in a rate-related
manner. This effect results in a
reduction of the ventricular rate in patients with atrial flutter
and/or atrial fibrillation and a rapid
ventricular response. By interrupting reentry at the AV node,
Verapamil can restore normal sinus rhythm
in patients with paroxysmal supraventricular tachycardias (PSVT),
including Wolff-Parkinson-White
(WPW) syndrome. Verapamil has no effect on conduction across accessory
bypass tracts. Verapamil
do
                                
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