ADENOSINE solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Gland Pharma Limited

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Intravenous 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 injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection 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 adenosineinjection administration. Intravenous adenosine injection is contraindicated in: 1. Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker). 2. Sinus node disease, such as sick sin

Product samenvatting:

Adenosine Injection, USP is supplied as a sterile non-pyrogenic solution in normal saline. NDC 68083-156-10 6 mg/2 mL (3 mg/mL) 2 mL fill in 2 mL vial -10 vials per Carton. NDC 68083-157-10 12 mg/4 mL (3 mg/mL) 4 mL fill in 5 mL vial -10 vials per Carton. 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ADENOSINE - ADENOSINE SOLUTION
GLAND PHARMA LIMITED
----------
RX ONLY
DESCRIPTION
Adenosine is an endogenous nucleoside occurring in all cells of the
body. It is chemically 6-amino-9-
β-D-ribofuranosyl-9-H-purine and has the following structural
formula:
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 4.5 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 Injection 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,
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
adenosine deaminase in the
cytosol. Since adenosine kinase has a lower K and V
than adenos