Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
EXELA PHARMA SCIENCES, LLC
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 2.5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: 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 fibrillation with a fast ventricular rate respond with a decrease in heart rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after Verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. The effect of a single injection lasts for 30–60 minutes when conversion to sinus rhythm does not occur. Because a small fraction (<1.0%) of patients treated with Verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation w
All forms are individually packaged. Size NDC Number Carton Size 5-mg (2 ml) vial 51754-0203-2 5 5-mg (2 ml) vial 51754-0203-4 25 10-mg (4 mL) vial 51754-0205-2 5 Store at 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature.] The stopper in the Verapamil hydrochloride injection vial is formulated with a synthetic base-polymer and does not contain natural rubber latex.
New Drug Application
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) and 10-mg (4 ml) vials. Each form contains Verapamil HCl 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-dimethoxy-α-(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. Ver Lesen Sie das vollständige Dokument