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Indications

Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. Adenosine injection, USP a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately ( 1 )

Contre-indications

Adenosine is contraindicated in patients with: Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions ( 5.2 )] Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions ( 5.2 )] Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see Warnings and Precautions ( 5.3 )] Known hypersensitivity to adenosine [see Warnings and Precautions ( 5.7 )] Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) ( 4 ) Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) ( 4 ) Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) ( 4 ) Known hypersensitivity to adenosine ( 4 )

Mises en garde et précautions d’emploi

Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction . Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available ( 5.1 ) Sinoatrial (SA) and Atrioventricular (AV) Nodal Block . First-, second- or third-degree AV block, or sinus bradycardia can occur. Discontinue adenosine if patient develops persistent or symptomatic high-grade AV block ( 5.2 ) Bronchoconstriction .

Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue adenosine if patient develops severe respiratory difficulties ( 5.3 ) Hypotension . Significant hypotension can occur. Discontinue adenosine if patient develops persistent or symptomatic hypotension ( 5.4 ) Cerebrovascular Accidents . Hemorrhagic and ischemic cerebrovascular accidents have occurred ( 5.5 ) Seizures .

Indications

Contre-indications

Mises en garde et précautions d’emploi

Effets indésirables

The following adverse reactions are discussed in more detail in other sections of the prescribing information: Fatal Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction [see Warnings and Precautions ( 5.1 )] Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions ( 5.2 )] Bronchoconstriction [see Warnings and Precautions ( 5.3 )] Hypotension [see Warnings and Precautions ( 5.4 )] Cerebrovascular Accident [see Warnings and Precautions ( 5.5 )] Seizures [see Warnings and Precautions ( 5.6 )] Hypersensitivity [see Warnings and Precautions ( 5.7 )] Atrial fibrillation [see Warnings and Precautions ( 5.8 )] Hypertension [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥ 10%) are: flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions, with an incidence of at least 1%, were reported with adenosine among 1,421 patients in clinical trials. 11% of the adverse reactions occurred several hours after adenosine administration. 8% of the adverse reactions began with adenosine infusion and persisted for up to 24 hours.

The most common (incidence ≥ 10%) adverse reactions to adenosine are flushing, chest discomfort, shortness of breath, headache, throat, neck or jaw discomfort, gastrointestinal discomfort, and dizziness (Table 2). Table 2. Adverse Reactions in Clinical Trials (Frequency ≥ 1%) Adverse Reactions Adenosine N=1,421 Flushing 44% Chest discomfort 40% Dyspnea 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 reactions to adenosine of any severity reported in less than 1% of patients include: Body as a Whole: back discomfort, lower extremity discomfort, weakness Cardiovascular System: myocardial infarction, ventricular arrhythmia, third-degree AV block, bradycardia, palpitation, sinus exit block, sinus pause, T-wave changes, hypertension (systolic blood pressure > 200 mm Hg) Respiratory System: cough Central Nervous System: drowsiness, emotional instability, tremors Genital/Urinary System: vaginal pressure, urgency Special Senses: blurred vision, dry mouth, ear discomfort, metallic taste, nasal congestion, scotomas, tongue discomfort

6.2Post-Marketing Experience

The following adverse reactions have been reported from marketing experience with adenosine. Because these reactions 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. Cardiac Disorders: cardiac arrest, atrial fibrillation, cardiac failure, myocardial infarction, tachycardia, ventricular arrhythmia Gastrointestinal Disorders: nausea and vomiting General Disorders and Administration Site Conditions: chest pain, injection site reaction, infusion site pain Immune System Disorders: hypersensitivity Nervous System Disorders: cerebrovascular accident including intracranial hemorrhage, seizure activity including tonic-clonic (grand mal) seizures, loss of consciousness Respiratory, Thoracic and Mediastinal Disorders: bronchospasm, respiratory arrest, throat tightness

Conditionnement	Code	Statut
ADENOSINE 60MG/20ML (3MG/ML)	ANDA090450-001	Prescription
ADENOSINE 90MG/30ML (3MG/ML)	ANDA090450-002	Prescription
ADENOSINE 90MG/30ML (3MG/ML)	ANDA077897-002	Prescription
ADENOSINE 60MG/20ML (3MG/ML)	ANDA077897-001	Prescription
ADENOSINE 90MG/30ML (3MG/ML)	ANDA090212-002	Prescription
ADENOSINE 60MG/20ML (3MG/ML)	ANDA090212-001	Prescription
ADENOSINE 60MG/20ML (3MG/ML)	ANDA202313-001	Prescription
ADENOSINE 90MG/30ML (3MG/ML)	ANDA202313-002	Prescription
ADENOSINE 60MG/20ML (3MG/ML)	ANDA203883-001	Discontinued
ADENOSINE 90MG/30ML (3MG/ML)	ANDA203883-002	Discontinued
ADENOSINE 90MG/30ML (3MG/ML)	ANDA205331-002	Prescription
ADENOSINE 60MG/20ML (3MG/ML)	ANDA205331-001	Prescription
ADENOSINE 90MG/30ML (3MG/ML)	ANDA077425-002	Prescription
ADENOSINE 60MG/20ML (3MG/ML)	ANDA077425-001	Prescription

Adenosine

Indications

Contre-indications

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

Adenosine

Indications

Contre-indications

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

5.1Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction Fatal

5.2Sinoatrial and Atrioventricular Nodal Block

5.3Bronchoconstriction

5.4Hypotension

5.5Cerebrovascular Accident Hemorrhagic

5.6Seizures New-onset

5.8Atrial Fibrillation

5.9Hypertension

5.5Cerebrovascular Accident Hemorrhagic

Interactions

7.1Effects of Other Drugs on Adenosine

7.2Effects of Adenosine on Other Drugs

Grossesse et allaitement

8.1Pregnancy Pregnancy Category

Effets indésirables

6.1Clinical Trials Experience

6.2Post-Marketing Experience

Dans d’autres pays

Conditionnements

Documents

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