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ADENOSINE

Wockhardt Limited

Adenosine Injection, USP FOR RAPID BOLUS INTRAVENOUS USE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ADENOSINE DESCRIPTION



ADENOSINE

CLINICAL PHARMACOLOGY

Mechanism of Action



Hemodynamics

Pharmacokinetics

mmax

Clinical Trial Results




ADENOSINE INDICATIONS AND USAGE

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).1

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 injection administration.

CONTRAINDICATIONS

  • 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 artificial pacemaker).
  • Known hypersensitivity to adenosine.

WARNINGS

Heart Block



Arrhythmias at Time of Conversion


Bronchoconstriction

e2


PRECAUTIONS

Drug Interactions

WARNINGSWARNINGS


Carcinogenesis, Mutagenesis, Impairment of Fertility




Pregnancy Category C


Pediatric Use

DOSAGE AND ADMINISTRATION1

Geriatric Use


ADVERSE REACTIONS


Cardiovascular


Respiratory



Central Nervous System


Gastrointestinal


Post Marketing Experience (see WARNINGS)


Cardiovascular


Respiratory


Central Nervous System

OVERDOSAGE

DOSAGE AND ADMINISTRATION



Adenosine injection should be given as a rapid bolus by the peripheral intravenous route. To be certain the solution reaches the systemic circulation, it should be administered either directly into a vein or, if given into an IV line, it should be given as close to the patient as possible and followed by a rapid saline flush.

Adult Patients





Initial dose

Repeat administration

Pediatric Patients





Initial dose

Repeat administration


>

Doses greater than 12 mg are not recommended for adult and pediatric patients.



CAUTION: Product-Connector Incompatibility Notice:

®
BD Q-SyteTM adaptor or other suitable adaptor are required for use with LADs such as CLAVE® systems.
TM
®

HOW SUPPLIED

















DO NOT REFRIGERATE





Rx Only

REFERENCE
  • Paul T, Pfammatter. J-P. Adenosine: an effective and safe antiarrhythmic drug in pediatrics. Pediatric Cardiology 1997; 18:118-126. 

Manufactured by:



Distributed by:








ADENOSINE



ADENOSINE



ADENOSINE



ADENOSINE



ADENOSINE



ADENOSINE

ADENOSINE INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-630
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ADENOSINE 3 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55648-630-01 2 in 1 SYRINGE, GLASS
2 NDC:55648-630-02 4 in 1 SYRINGE, GLASS
3 NDC:55648-630-08 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090220 2009-07-20


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