Adenosine adverse reactions: Difference between revisions
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The following reactions were reported with intravenous Adenocard (adenosine injection) used in controlled U.S. clinical trials. The placebo group had less than 1% rate of all of these reactions. | The following reactions were reported with intravenous Adenocard (adenosine injection) used in controlled U.S. clinical trials. The placebo group had less than 1% rate of all of these reactions. | ||
===Cardiovascular=== | ===Cardiovascular=== | ||
Facial [[flushing]] (18%),[[headache]] (2%), sweating, [[palpitations]], [[chest pain]], [[hypotension]] (less than 1%). | Facial [[flushing]] (18%),[[headache]] (2%), [[sweating]], [[palpitations]], [[chest pain]], [[hypotension]] (less than 1%). | ||
===Respiratory=== | ===Respiratory=== | ||
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===Central Nervous System=== | ===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%). | [[Lightheadedness]] (2%), [[dizziness]], tingling in arms, [[numbness]] (1%), apprehension, [[blurred vision]], burning sensation, heaviness in arms, neck and [[back pain]] (less than 1%). | ||
===Gastrointestinal=== | ===Gastrointestinal=== | ||
Nausea (3%), metallic taste, tightness in throat, pressure in groin (less than 1%). | Nausea (3%), [[metallic taste]], tightness in throat, pressure in groin (less than 1%). | ||
==Post Marketing Experience (see Warnings)== | ==Post Marketing Experience (see Warnings)== | ||
The following adverse events have been reported from marketing experience with Adenocard. 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. | The following adverse events have been reported from marketing experience with Adenocard. 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=== | ===Cardiovascular=== | ||
Prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, atrial fibrillation, and Torsade de Pointes | Prolonged [[asystole]], [[ventricular tachycardia]], [[ventricular fibrillation]], transient increase in blood pressure, [[bradycardia]], [[atrial fibrillation]], and [[Torsade de Pointes]] | ||
===Respiratory=== | ===Respiratory=== | ||
| Line 26: | Line 26: | ||
===Central Nervous System=== | ===Central Nervous System=== | ||
Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ADENOCARD (ADENOSINE) SOLUTION [ASTELLAS PHARMA US, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f0e32589-dad9-4887-8481-bcf7f6618466 | publisher = | date = | accessdate = }}</ref> | Seizure activity, including tonic clonic (grand mal) [[seizures]], and [[loss of consciousness]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ADENOCARD (ADENOSINE) SOLUTION [ASTELLAS PHARMA US, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f0e32589-dad9-4887-8481-bcf7f6618466 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
Revision as of 18:07, 11 March 2014
| Adenosine |
|---|
| ADENOCARD®, ADENOSCAN® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Overdosage |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| Clinical Studies |
| How Supplied/Storage and Handling |
| Labels and Packages |
| Clinical Trials on Adenosine |
| ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Adverse Reactions
The following reactions were reported with intravenous Adenocard (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 Adenocard. 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
Central Nervous System
Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness.[1]
References
Adapted from the FDA Package Insert.