XYLOCAINE lidocaine hydrochloride injection solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

متاح من:

APP Pharmaceuticals, LLC

INN (الاسم الدولي):

LIDOCAINE HYDROCHLORIDE

تركيب:

LIDOCAINE HYDROCHLORIDE 20 mg in 1 mL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

New Drug Application

خصائص المنتج

XYLOCAINE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
APP PHARMACEUTICALS, LLC
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XYLOCAINE (LIDOCAINE HCL INJECTION, USP) FOR VENTRICULAR ARRHYTHMIAS
Rx only
DESCRIPTION
Xylocaine (lidocaine HCl Injection, USP) is a sterile nonpyrogenic
solution of an antiarrhythmic agent
administered intravenously by direct injection.
Xylocaine Injection is composed of an aqueous solution of lidocaine
hydrochloride. Lidocaine HCl
(C
H N O•HCl) is chemically designated acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and is represented by the following structural
formula:
pH adjusted to 5.0 to 7.0 with sodium hydroxide and/or hydrochloric
acid. Single use container.
Solution does not contain preservatives.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION AND ELECTROPHYSIOLOGY
Studies of the effects of therapeutic concentrations of lidocaine on
the electrophysiological properties
of mammalian Purkinje fibers have shown that lidocaine attenuates
phase 4 diastolic depolarization,
decreases automaticity, and causes a decrease or no change in
excitability and membrane
responsiveness. Action potential duration and effective refractory
period of Purkinje fibers are
decreased, while the ratio of effective refractory period to action
potential is increased. Action
potential duration and effective refractory period of ventricular
muscle are also decreased. Effective
refractory period of the AV node may increase, decrease or remain
unchanged, and atrial effective
refractory period is unchanged. Lidocaine raises the ventricular
fibrillation threshold. No significant
interactions between lidocaine and the autonomic nervous system have
been described and consequently,
lidocaine has little or no effect on autonomic tone.
Clinical electrophysiological studies with lidocaine have demonstrated
no change in sinus node
recovery time or sinoatrial conduction time. AV nodal conduction time
is unchanged or shortened, and
His-Purkinje conduction time is unchanged.
HEMODYNAMICS
At therapeutic doses, lidocaine has minimal hemody