ADENOSINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 adenosine administration. Intravenous adenosine injection is contraindicated in:

Product summary:

Adenosine Injection, USP is supplied as a sterile non-pyrogenic solution in normal saline as follows: NDC Adenosine Injection, USP (3 mg per mL) Package Factor 72078-033-02 6 mg/2 mL Single-Dose Vial 10 vials per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Store upright. 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. The container closure is not made with natural rubber latex. Sterile, Nonpyrogenic, Preservative-free. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADENOSINE- ADENOSINE INJECTION
MYLAN INSTITUTIONAL LLC
----------
ADENOSINE INJECTION, USP
FOR RAPID BOLUS INTRAVENOUS USE
DESCRIPTION
Adenosine, USP 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, USP is a white crystalline powder. It is soluble in water
and practically
insoluble in alcohol. Solubility increases by warming and lowering the
pH. Adenosine, USP
is not chemically related to other antiarrhythmic drugs. Adenosine
injection, USP is a
sterile, nonpyrogenic solution for rapid bolus intravenous injection.
Each mL contains 3
mg adenosine, USP and 9 mg sodium chloride in water for injection,
USP. 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 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. Sin