VERAPAMIL HYDROCHLORIDE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

HF Acquisition Co. LLC, DBA HealthFirst

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 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: 1. Severe hypotension or cardiogenic shock. 2. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). 4. Severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to verapamil therapy). 5. Patients receiving intravenous beta-adrenergic blocking drugs (e.g., propranolol). Intravenous verapamil and intravenous beta-adrenergic blocking drugs should not be administered in close proximity to each other (within a few hours), since both may have a depressant effect on myocardial contractility and AV conduction. 6. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff- Parkinson-White, Lown-Ganong-Levine syndromes) are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil is administered. Therefore, the use of verapamil in these patients is contraindicated. 7. Ventricular tachycardia: Administration of intravenous verapamil to patients with wide-complex ventricular tachycardia (QRS ≥ 0.12 sec) can result in marked hemodynamic deterioration and ventricular fibrillation. Proper pretherapy diagnosis and differentiation from wide-complex supraventricular tachycardia is imperative in the emergency room setting. 8. Known hypersensitivity to verapamil hydrochloride.

Proizvod sažetak:

VERAPAMIL HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1270-1 VERAPAMIL HYDROCHLORIDE INJECTION, USP 10mg (2.5 mg/mL) 4mL ANSYR SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Verapamil Hydrochloride Injection, USP 2.5 mg/mL is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light by retaining in package until ready to use. [Logo] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0885-3.0 05/2018

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO. LLC, DBA HEALTHFIRST
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VERAPAMIL HYDROCHLORIDE INJECTION, USP 10MG (2.5 MG/ML) 4ML ANSYR SYR
SPL UNCLASSIFIED
Ansyr™ Plastic Syringe
Ampul
Fliptop Vial
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
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.
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 appear