ADENOSINE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)

Disponible desde:

Physicians Total Care, Inc.

Designación común internacional (DCI):

ADENOSINE

Composición:

ADENOSINE 3 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration. It is important to be sure the adenosine solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration. Adenosine injection is contraindicated in: - Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker). - Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning arti

Resumen del producto:

Adenosine Injection USP is supplied as a sterile, nonpyrogenic solution in normal saline. NDC 54868-5551-0 6 mg/2 mL (3 mg/mL) in 2 mL flip-top vials, carton of 10. Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.   DO NOT REFRIGERATE as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Contains no preservatives. Discard unused portion.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ADENOSINE - ADENOSINE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
ADENOSINE INJECTION USP
RX ONLY
For Rapid Bolus Intravenous Use
DESCRIPTION
Adenosine is an endogenous nucleoside occurring in all cells of the
body. It is chemically 9-β-D-
Ribofuranosyladenine and has the following structural formula:
C
H N 0 M. W. = 267.25
Adenosine is a white crystalline powder. It is soluble in water and
practically insoluble in alcohol.
Solubility increases by warming and lowering the pH. Adenosine is not
chemically related to other
antiarrhythmic drugs. Adenosine injection is a sterile, nonpyrogenic
solution for rapid bolus intravenous
injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in
water for injection. The pH of
the solution is between 5.5 and 7.5.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Adenosine injection slows conduction time through the A-V node, can
interrupt the reentry pathways
through the A-V node, and can restore normal sinus rhythm in patients
with paroxysmal supraventricular
tachycardia (PSVT), including PSVT associated with
Wolff-Parkinson-White Syndrome.
Adenosine injection is antagonized competitively by methylxanthines
such as caffeine and theophylline,
and potentiated by blockers of nucleoside transport such as
dipyridamole. Adenosine is not blocked by
atropine.
HEMODYNAMICS
The intravenous bolus dose of 6 or 12 mg adenosine injection usually
has no systemic hemodynamic
effects. When larger doses are given by infusion, adenosine decreases
blood pressure by decreasing
peripheral resistance.
PHARMACOKINETICS
Intravenously administered adenosine is rapidly cleared from the
circulation via cellular uptake,
10
13
5
primarily by erythrocytes and vascular endothelial cells. This process
involves a specific
transmembrane nucleoside carrier system that is reversible,
nonconcentrative, and bidirectionally
symmetrical. Intracellular adenosine is rapidly metabolized either via
phosphorylation to adenosine
monophosphate by adenosine kinase, or via deamination to inosine by
adenosi