ADENOSINE injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

Compra'l ara

Descargar Fitxa tècnica (SPC)
04-12-2017

ingredients actius:

Adenosine (UNII: K72T3FS567) (Adenosine - UNII:K72T3FS567)

Disponible des:

Gland Pharma Limited

Designació comuna internacional (DCI):

Adenosine

Composición:

Adenosine 3 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Adenosine Injection, USP 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: 1. Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker). 2. Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patien

Resumen del producto:

Adenosine Injection, USP is supplied as a sterile solution in normal saline as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]   Do not freeze.   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.   Sterile, Nonpyrogenic, Preservative-free, DEHP-free, PVC-free. The container closure is not made with natural rubber latex.   Discard unused portion. May require needle or blunt. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

                                ADENOSINE - ADENOSINE INJECTION
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, USP is a sterile solution
for rapid bolus intravenous
injection. Each mL contains 3 mg adenosine, USP and 9 mg sodium
chloride, USP in water for injection,
USP. The pH of the solution is between 4.5 and 7.5.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Adenosine 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 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 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 adenosine deaminase, deamination plays 
                                
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