VERAPAMIL HYDROCHLORIDE injection, solution VERAPAMIL HYDROCHLORIDE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Baxter Healthcare Corporation

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Verapamil Hydrochloride Injection, USP is indicated for the following: 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/or fibrillation with a faster ventricular rate respond with a decrease in ventricular 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. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole – see CONTRAINDICATIONS and WARNINGS ), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS , Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient’s response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection. Verapamil hydrochloride injection is contraindicated in:

Povzetek izdelek:

Verapamil Hydrochloride Injection, USP 2.5 mg/mL is a sterile, nonpyrogenic clear colorless solution supplied in single dose vials as follows: 5 mg/2 mL (carton of 25 single dose vials) (NDC 43066-031-25) 10 mg/4 mL (carton of 5 single dose vials) (NDC 43066-035-05) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Call your doctor for medical advice about side effects. You may report side effects to Caplin Steriles at 1‑866‑978‑6111 or FDA at 1‑800‑FDA‑1088 or http://www.fda.gov/medwatch Protect from light by retaining in package until ready to use.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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VERAPAMIL HYDROCHLORIDE INJECTION, USP
(FOR INTRAVENOUS INJECTION)
Protect from light.
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 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 and/or
sodium hydroxide for pH adjustment; pH is 4.0 to 6.5.
The chemical name of Verapamil Hydrochloride, USP is
benzeneacetonitrile, α-[3-[{2- (3,4-
dimethoxyphenyl) ethyl} methylamino]propyl]
-3,4-dimethoxy-α-(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.
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.
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.