VERAPAMIL HYDROCHLORIDE- verapamil hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Verapamil Hydrochloride (UNII: V3888OEY5R) (Verapamil - UNII:CJ0O37KU29)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Verapamil Hydrochloride

Composition:

Verapamil Hydrochloride 2.5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 flut

Product summary:

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. Revised:  May 2018 EN-2504 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VERAPAMIL HYDROCHLORIDE - VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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VERAPAMIL HYDROCHLORIDE 2.5 MG/ML INJECTION, USP SINGLE DOSE VIAL
DES CRIPTION
ANSYR Plastic Syringe
Ampul
Fliptop Vial
Protect from light.
Rx only
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 4.9 (4.0 to 6.5).
The chemical name of Verapamil Hydrochloride, USP is
benzeneacetonitrile, a-[3-[{2-(3,4-
dimethoxyphenyl)ethyl}methylamino]propyl]-3,4-dimethoxy-a-(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 appears to be due to its effec