ADENOSINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Adenosine

Composition:

Adenosine 3 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 art

Product summary:

Adenosine injection is supplied as a sterile non-pyrogenic solution in normal saline as follows: NDC 17478-542-02, 6 mg/2 mL vial in a carton of 10 (not shrink wrapped). NDC 17478-542-25, 6 mg/2 mL vial in a carton of 25. 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. May require needle or blunt. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADENOSINE- ADENOSINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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ADENOSINE INJECTION, USP
FOR RAPID BOLUS INTRAVENOUS USE
RX ONLY
AI00N 01/19
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 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, 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 d