Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
Cardinal Health
VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE 2.5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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 flutte
Verapamil Hydrochloride Injection, USP 2.5 mg/mL is supplied in single-dose containers as follows: NDC No. Container Volume Total Content 0409-4011-01 Ampul 2 mL 5 mg 0409-9633-05 ANSYR™ Plastic Syringe 4 mL 10 mg 0409-1144-01 Fliptop Vial 2 mL (5 pack carton) 5 mg 0409-1144-02 Fliptop Vial 4 mL 10 mg 0409-1144-05 Fliptop Vial 2 mL (25 pack tray) 5 mg 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: March, 2010 Printed in USA EN-2463 Hospira, Inc., Lake Forest, IL 60045 USA Cardinal Health Zanesville, OH 43701 IA6892 0612
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION CARDINAL HEALTH ---------- VERAPAMIL HYDROCHLORIDE INJECTION, USP 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 4.9 (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: C H N O • 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 effect on the slow channel in cells of the cardiac Đọc toàn bộ tài liệu