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Adenoscan (adenosine) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
(note: change to PLR format)
WARNINGS AND PRECAUTIONS
- Cerebrovascular Accident Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Adenoscan including hypotension or hypertension can be associated with these adverse reactions.
- New-onset or recurrence of convulsive seizures has occurred following Adenoscan. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with Adenoscan. Methylxanthine use is not recommended in patients who experience seizures in association with Adenoscan administration
- Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Symptomatic treatment may be required. Have personnel and appropriate treatment available. Resuscitative measures may be necessary if symptoms progress.
- Cerebrovascular Accident
- *Some headers renamed*
- Cardiac disorders: ….atrial fibrillation, cardiac failure…tachycardia..
- General Disorders and Administration Site Conditions: chest pain, … infusion site pain
- Immune system disorders- hypersensitivity
- Respiratory, Thoracic and Mediastinal Disorders: bronchospasm….
USE IN SPECIFIC POPULATIONS
- It is not known whether Adenoscan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Adenoscan in nursing infants, the decision to interrupt nursing after administration of Adenoscan or not to administer Adenoscan, should take into account the importance of the drug to the mother.
PATIENT COUNSELING INFORMATION
- *Patient Counseling section added*
- throat tightness