Drug: Adenoscan

Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6amino-9-beta-D-ribofuranosyl-9-H-purine and has the following structural formula:
C10H13N5O4      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 of the solution. Each Adenoscan vial contains a sterile, non-pyrogenic solution of adenosine 3 mg/mL and sodium chloride 9 mg/mL in Water for Injection, q.s. The pH of the solution is between 4.5 and 7.5.Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

The following reactions with an incidence of at least 1% were reported with intravenous Adenoscan among 1421 patients enrolled in controlled and uncontrolled U.S. clinical trials. Despite the short half-life of adenosine, 10.6% of the side effects occurred not with the infusion of Adenoscan but several hours after the infusion terminated. Also, 8.4% of the side effects that began coincident with the infusion persisted for up to 24 hours after the infusion was complete. In many cases, it is not possible to know whether these late adverse events are the result of Adenoscan infusion. Flushing 44% Chest discomfort 40% Dyspnea or urge to breathe deeply 28% Headache 18% Throat, neck or jaw discomfort 15% Gastrointestinal discomfort 13% Lightheadedness/dizziness 12% Upper extremity discomfort 4% ST segment depression 3% First-degree AV block 3% Second-degree AV block 3% Paresthesia 2% Hypotension 2% Nervousness 2% Arrhythmias 1% Adverse experiences of any severity reported in less than 1% of patients include: Body as a Whole Back discomfort; lower extremity discomfort; weakness Cardiovascular System Nonfatal myocardial infarction; life-threatening ventricular arrhythmia; third-degree AV block; bradycardia; palpitation; sinus exit block; sinus pause; sweating; T-wave changes; hypertension (systolic blood pressure > 200 mm Hg) Central Nervous System Drowsiness; emotional instability; tremors Genital/Urinary System Vaginal pressure; urgency Respiratory System Cough Special Senses Blurred vision; dry mouth; ear discomfort; metallic taste; nasal congestion; scotomas; tongue discomfort Post Marketing Experience (see WARNINGS) The following adverse events have been reported from marketing experience with Adenoscan. 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. Body as a Whole Injection site reaction Cardiovascular System Fatal and nonfatal cardiac arrest, myocardial infarction, ventricular arrhythmia Central Nervous System Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness Digestive Nausea and vomiting Respiratory Respiratory arrest, throat tightness Read the Adenoscan (adenosine injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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 mL/min kg lbs 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) x total body weight (kg)/ Adenoscan concentration (3mg / mL) = Infusion rate (mL/min) Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Source: http://www.rxlist.com

Intravenous 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. The vasoactive effects of Adenoscan are inhibited by adenosine receptor antagonists, such as methylxanthines (e.g., caffeine and theophylline). The safety and efficacy of Adenoscan in the presence of these agents has not been systematically evaluated. The vasoactive effects of Adenoscan are potentiated by nucleoside transport inhibitors, such as dipyridamole. The safety and efficacy of Adenoscan 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. Read the Adenoscan Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

Intravenous Adenoscan is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (See WARNINGS).

Source: http://www.rxlist.com

Intravenous Adenoscan (adenosine injection) should not be administered to individuals with:
  1. Second- or third-degree AV block (except in patients with a functioning artificial pacemaker).
  2. Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker).
  3. Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma).
  4. Known hypersensitivity to adenosine.
Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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.

Source: http://www.rxlist.com

Adenoscan (adenosine injection) is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic solution in normal saline. NDC 0469-0871-20 Product Code 87120 60 mg/20 mL (3 mg/mL) in a 20 mL single-dose, flip-top glass vial, packaged individually and in packages of ten. NDC 0469-0871-30 Product Code 87130 90 mg/30 mL (3 mg/mL) in a 30 mL single-dose, flip-top glass vial, packaged individually and in packages of ten. Store at controlled room temperature 15°-30°C (59°-86°F) 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 preservative. Discard unused portion. Product of Germany. Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062 USA. Manufactured by: Hospira, Inc., Lake Forest, IL 60045 USA. Revised October 2013 Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Carcinogenesis, Mutagenesis, Impairment Of Fertility Studies in animals have not been performed to evaluate the carcinogenic potential of Adenoscan (adenosine injection). Adenosine was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay. Adenosine, however, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is known to produce a variety of chromosomal alterations. Fertility studies in animals have not been conducted with adenosine. Pregnancy Category C Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. Because it is not known whether Adenoscan can cause fetal harm when administered to pregnant women, Adenoscan should be used during pregnancy only if clearly needed. Pediatric Use The safety and effectiveness of Adenoscan in patients less than 18 years of age have not been established. Geriatric Use Clinical studies of Adenoscan did not include sufficient numbers of subjects aged younger than 65 years to determine whether they respond differently. Other reported experience has not revealed clinically relevant differences of the response of elderly in comparison to younger patients. Greater sensitivity of some older individuals, however, cannot be ruled out. Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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