ADENOSINE injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Hikma Pharmaceuticals USA Inc.

Designació comuna internacional (DCI):

ADENOSINE

Composición:

ADENOSINE 3 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 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. Intravenous 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 patient

Resumen del producto:

Adenosine Injection, USP is supplied as a sterile, nonpyrogenic solution in normal saline. NDC 0641-6113-10  6 mg/2 mL (3 mg/mL) in 2 mL flip-top vials, packaged in shelf packs of ten. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°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.  To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ADENOSINE- ADENOSINE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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ADENOSINE INJECTION, USP
FOR RAPID BOLUS INTRAVENOUS USE
RX ONLY
DESCRIPTION
Adenosine is an endogenous nucleoside occurring in all cells of the
body. It is chemically 6-amino-9-
ß-D-ribofuranosyl-9-H-purine and has the following structural
formula:
C
H N O 267.24
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 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
10
13
5
4
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. Si