Indications

Intravenous adenosine injection, USP is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection, USP administration. It is important to be sure the adenosine injection, USP solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION ).

Adenosine injection, USP does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection, USP administration.

Contraindications

Intravenous adenosine injection, USP is contraindicated in: Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker). Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker). Known hypersensitivity to adenosine.

Warnings and precautions

Heart Block Adenosine injection, USP exerts its effect by decreasing conduction through the A-V node and may produce a short lasting first-, second- or third-degree heart block. Appropriate therapy should be instituted as needed. Patients who develop high-level block on one dose of adenosine injection, USP should not be given additional doses. Because of the very short half-life of adenosine, these effects are generally self-limiting.

Appropriate resuscitative measures should be available. Transient or prolonged episodes of asystole have been reported with fatal outcomes in some cases. Rarely, ventricular fibrillation has been reported following adenosine injection, USP administration, including both resuscitated and fatal events. In most instances, these cases were associated with the concomitant use of digoxin and, less frequently with digoxin and verapamil.

Indications

Contraindications

Warnings and precautions

Adverse reactions

The following reactions were reported with intravenous adenosine injection, USP used in controlled U.S. clinical trials. The placebo group had a 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 adenosine injection, USP.

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 Torsades de Pointes. Respiratory Bronchospasm. Central Nervous System Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness. Post-Marketing Experience (see WARNINGS ) The following adverse events have been reported from marketing experience with adenosine injection, USP.

Pack	Code	Status
ADENOSINE 3MG/ML	ANDA076501-001	Discontinued
ADENOSINE 3MG/ML	ANDA076404-001	Prescription
ADENOSINE 3MG/ML	ANDA078076-001	Prescription
ADENOSINE 3MG/ML	ANDA078640-001	Discontinued
ADENOSINE 3MG/ML	ANDA078686-001	Prescription
ADENOSINE 3MG/ML	ANDA090220-001	Discontinued
ADENOSINE 3MG/ML	ANDA076500-001	Prescription
ADENOSINE 3MG/ML	ANDA079147-001	None (Tentative Approval)
ADENOSINE 3MG/ML	ANDA077133-001	Prescription
ADENOSINE 3MG/ML	ANDA078618-001	None (Tentative Approval)
ADENOSINE 3MG/ML	ANDA205568-001	Prescription
ADENOSINE 3MG/ML	ANDA077283-001	Prescription
ADENOSINE 3MG/ML	ANDA090010-001	Discontinued
ADENOSINE 3MG/ML	ANDA076564-001	Discontinued
ADENOSINE 3MG/ML	ANDA078676-001	Discontinued
ADENOSINE 3MG/ML	ANDA206778-001	Prescription

Adenosine

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Adenosine

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Adverse reactions

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