ADENOSINE (Page 2 of 2)

Pediatric Use

No controlled studies have been conducted in pediatric patients to establish the safety and efficacy of adenosine injection for the conversion of paroxysmal supraventricular tachycardia (PSVT). However, intravenous adenosine has been used for the treatment of PSVT in neonates, infants, children and adolescents (see DOSAGE AND ADMINISTRATION).1

Geriatric Use

Clinical studies of adenosine injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, adenosine injection in geriatric patients should be used with caution since this population may have a diminished cardiac function, nodal dysfunction, concomitant diseases or drug therapy that may alter hemodynamic function and produce severe bradycardia or AV block.

ADVERSE REACTIONS

The following reactions were reported with intravenous adenosine injection used in controlled U.S. clinical trials. The placebo group had less than 1% rate of all of these reactions.

Cardiovascular

Facial flushing (18%), headache (2%), sweating, palpitations, chest pain, hypotension (less than 1%).

Respiratory

Shortness of breath/dyspnea (12%), chest pressure (7%), hyperventilation, head pressure (less than 1%).

Central Nervous System

Lightheadedness (2%), dizziness, tingling in arms, numbness (1%), apprehension, blurred vision, burning sensation, heaviness in arms, neck and back pain (less than 1%).

Gastrointestinal

Nausea (3%), metallic taste, tightness in throat, pressure in groin (less than 1%).

Post Marketing Experience (see WARNINGS)

The following adverse events have been reported from marketing experience with adenosine injection. Because these events are reported voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, (3) strength of causal connection to the drug, or a combination of these factors.

Cardiovascular

Prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, atrial fibrillation, and Torsade de Pointes.

Respiratory

Bronchospasm, throat tightness.

Central Nervous System

Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness.

OVERDOSAGE

The half-life of adenosine injection is less than 10 seconds. Thus, adverse effects are generally rapidly self-limiting. Treatment of any prolonged adverse effects should be individualized and be directed toward the specific effect. Methylxanthines, such as caffeine and theophylline, are competitive antagonists of adenosine.

DOSAGE AND ADMINISTRATION

For rapid bolus intravenous use only.

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

The dose recommendation is based on clinical studies with peripheral venous bolus dosing. Central venous (CVP or other) administration of adenosine injection has not been systematically studied.

The recommended intravenous doses for adults are as follows:

Initial dose: 6 mg given as a rapid intravenous bolus (administered over a 1 to 2 second period).

Repeat administration: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 12 mg should be given as a rapid intravenous bolus. This 12 mg dose may be repeated a second time if required.

Pediatric Patients

The dosages used in neonates, infants, children and adolescents were equivalent to those administered to adults on a weight basis.

Pediatric Patients with a Body Weight <50 kg:

Initial dose: Give 0.05 to 0.1 mg/kg as a rapid IV bolus given either centrally or peripherally. A saline flush should follow.

Repeat administration: If conversion of PSVT does not occur within 1 to 2 minutes, additional bolus injections of adenosine can be administered at incrementally higher doses, increasing the amount given by 0.05 to 0.1 mg/kg. Follow each bolus with a saline flush. This process should continue until sinus rhythm is established or a maximum single dose of 0.3 mg/kg is used.

Pediatric Patients with a Body Weight >50 kg: Administer the adult dose.

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

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

CAUTION: Product-Connector Incompatibility Notice:

Certain Needleless IV sets with Luer-Activated Devices (LADs) may be incompatible with Wockhardt’s syringe. Some LADs that are incompatible with this syringe include the Clave® needle-free IV devices. While the Wockhardt’s syringes may be connected to these LADs successfully, the physical incompatibility caused by the luer tip diameter significantly impairs or even prevents administration of the drug.

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

BD Q-SYTETM is a trademark of Becton, Dickinson and Company.

® is a registered trademark of ICU Medical, Inc.

HOW SUPPLIED

Adenosine injection, USP is supplied as a sterile non-pyrogenic solution in normal saline in the following configurations:

NDC 64679-630-01

6 mg/2 mL (3 mg/mL) single dose pre-filled syringe of USP type 1 clear glass barrel with chlorobutyl plunger stopper and polypropylene plunger rod in a carton of 1

NDC 64679-630-07

6 mg/2 mL (3 mg/mL) single dose pre-filled syringe of USP type 1 clear glass barrel with chlorobutyl plunger stopper and polypropylene plunger rod in a carton of 10 x 2 mL Single dose Pre-filled Syringe.

NDC 64679-630-02

12 mg/4 mL (3 mg/mL) single dose pre-filled syringe of USP type 1 clear glass barrel with chlorobutyl plunger stopper and polypropylene plunger rod in a carton of 1

NDC 64679-630-08

12 mg/4 mL (3 mg/mL) single dose pre-filled syringe of USP type 1 clear glass barrel with chlorobutyl plunger stopper and polypropylene plunger rod in a carton of 10 x 4 mL Single dose Pre-filled Syringe.

Store at 20°-25°C (68°C 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.

Rx Only

REFERENCE

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

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.010311

2 ML SYRINGE LABEL
(click image for full-size original)

2 ML BLISTER LABEL
(click image for full-size original)
2 ML MONO CARTON
(click image for full-size original)
2 ML 10s CARTON
(click image for full-size original)
4 ML MONO CARTON
(click image for full-size original)
ADENOSINE adenosine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-630
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE (ADENOSINE) ADENOSINE 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-630-07 10 SYRINGE, GLASS (SYRINGE) in 1 CARTON contains a SYRINGE, GLASS (64679-630-01)
1 NDC:64679-630-01 2 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (64679-630-07)
2 NDC:64679-630-08 10 SYRINGE, GLASS (SYRINGE) in 1 CARTON contains a SYRINGE, GLASS (64679-630-02)
2 NDC:64679-630-02 4 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (64679-630-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090220 07/20/2009
Labeler — WOCKHARDT USA LLC. (170508365)

Revised: 10/2012 WOCKHARDT USA LLC.

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