Adenoscan

Name: Adenoscan

What are some things I need to know or do while I take Adenoscan?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have an ECG checked often. Talk with your doctor.
  • High or low blood pressure may happen with Adenoscan. Have your blood pressure checked as you have been told by your doctor.
  • Avoid use of caffeine (for example, tea, coffee, cola) and chocolate.
  • If you are taking aminophylline, dipyridamole, theophylline, or any drug containing caffeine, talk with doctor. These drugs can affect how well this medicine works.
  • Heart attacks and very bad fast heartbeat have rarely happened with Adenoscan. Sometimes this has been deadly. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Drug Interactions

Effects of Other Drugs on Adenoscan

• The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). The safety and efficacy of Adenoscan in the presence of these agents has not been systematically evaluated [see Overdosage (10)]. • The vasoactive effects of Adenoscan are potentiated by nucleoside transport inhibitors such as dipyridamole. The safety and efficacy of adenosine in the presence of dipyridamole has not been systematically evaluated. • Whenever possible, drugs that might inhibit or augment the effects of adenosine should be withheld for at least five half-lives prior to the use of Adenoscan.

Effects of Adenoscan on Other Drugs

Adenoscan adenosine injection has been given with other cardioactive drugs (such as beta adrenergic blocking agents, cardiac glycosides, and calcium channel blockers) without apparent adverse interactions, but its effectiveness with these agents has not been systematically evaluated. Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, Adenoscan should be used with caution in the presence of these agents [see Warnings and Precautions (5.2)].

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mL Vial Carton

Adenoscan®
adenosine injection

NDC 0469-0871-20     87120

60 mg/20 mL
(3 mg/mL)
For Intravenous Infusion Only

20 mL
Single-Dose Vial

PACKAGE/LABEL DISPLAY PANEL – 30 ml Vial Carton

Adenoscan®
adenosine injection

NDC 0469-0871-30     87130

90 mg/30 mL
(3 mg/mL)

For Intravenous Infusion Only

30 mL
Single-Dose Vial

Adenoscan 
adenosine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0469-0871
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
adenosine (adenosine) adenosine 3 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:0469-0871-20 10 VIAL in 1 CARTON
1 20 mL in 1 VIAL
2 NDC:0469-0871-30 10 VIAL in 1 CARTON
2 30 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020059 05/18/1995
Labeler - Astellas Pharma US, Inc. (605764828)
Revised: 08/2014   Astellas Pharma US, Inc.

Adenoscan Overview

Adenoscan is a brand name medication included in a group of medications called Miscellaneous Cardiac Preparations. For more information about Adenoscan see its generic Adenosine

Manufacturer

  • Astellas Pharma US, Inc.

  • Remedyrepack Inc.

Overdosage

The half-life of adenosine is less than 10 seconds and side effects of Adenoscan (when they occur) usually resolve quickly when the infusion is discontinued, although delayed or persistent effects have been observed. Methylxanthines, such as caffeine and theophylline, are competitive adenosine receptor antagonists and theophylline has been used to effectively terminate persistent side effects. In controlled U.S. clinical trials, theophylline (50-125 mg slow intravenous injection) was needed to abort Adenoscan side effects in less than 2% of patients.

Dosage and Administration

For intravenous infusion only.

Adenoscan should be given as a continuous peripheral intravenous infusion.

The recommended intravenous dose for adults is 140 mcg/kg/min infused for six minutes (total dose of 0.84 mg/kg).

The required dose of thallium-201 should be injected at the midpoint of the Adenoscan infusion (i.e., after the first three minutes of Adenoscan). Thallium-201 is physically compatible with Adenoscan and may be injected directly into the Adenoscan infusion set.

The injection should be as close to the venous access as possible to prevent an inadvertent increase in the dose of Adenoscan (the contents of the IV tubing) being administered.

There are no data on the safety or efficacy of alternative Adenoscan infusion protocols.

The safety and efficacy of Adenoscan administered by the intracoronary route have not been established.

The following Adenoscan infusion nomogram may be used to determine the appropriate infusion rate corrected for total body weight:

Patient Weight Infusion Rate
     kg lbs      mL/min
    45  99     2.1
    50 110     2.3
    55 121     2.6
    60 132     2.8
    65 143     3.0
    70 154     3.3
    75 165     3.5
    80 176     3.8
    85 187     4.0
    90 198     4.2

This nomogram was derived from the following general formula:

0.140 (mg/kg/min) ×
 total body weight (kg)  =  infusion rate
Adenoscan concentration (mL/min)
(3 mg/mL)

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

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