ADENOSINE 3 mg/mL
adenosine injection, solution · INJECTION, SOLUTION · Henry Schein, Inc.
ADENOSINE is a injection, solution containing adenosine injection, solution at 3 mg/mL, taken intravenous. Manufactured by Henry Schein, Inc..
Key Facts
- Brand Name
- ADENOSINE
- Generic Name
- adenosine injection, solution
- NDC Code (Product)
0404-9993- Manufacturer
- Henry Schein, Inc.
- Strength
- 3 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA077133
- Drug Class
- Adenosine Receptor Agonist [EPC]
- Marketing Start
- 06/28/2023
Recall History
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Pharmedium Services, LLC
Lack of sterility assurance.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Central Admixture Pharmacy Services, Inc.
Non Sterility; microbial contamination identified as Aspergillus species
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
John W Hollis Inc
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Cantrell Drug Company
Lack of Sterility Assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
For rapid bolus intravenous use only. Adenosine injection, USP should be given as a rapid bolus by the peripheral intravenous route. To be certain the solution reaches the systemic circulation, it should be administered either directly into a vein or, if given into an intravenous line, it should be given as close to the patient as possible and followed by a rapid saline flush. Adult Patients The dose recommendation is based on clinical studies with peripheral venous bolus dosing. Central venous (CVP or other) administration of adenosine injection, USP has not been systematically studied. The recommended intravenous doses for adults are as follows: Initial dose: 6 mg given as a rapid intravenous bolus (administered over a 1 to 2 second period). Repeat administration: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 12 mg should be given as a rapid intravenous bolus. This 12 mg dose may be repeated a second time if required. Pediatric Patients The dosages used in neonates, infants, children and adolescents were equivalent to those administered to adults on a weight basis. Pediatric Patients with a Body Weight less than 50 kg:…
Warnings
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. Although no causal relationship or drug-drug interaction has been established, adenosine injection, USP should be used with caution in patients receiving digoxin or digoxin and verapamil in combination. Arrhythmias at Time of Conversion At the time of conversion to normal sinus rhythm, a variety of new rhythms may appear on t…
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.
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…
Frequently Asked Questions
What is ADENOSINE used for?
ADENOSINE contains adenosine injection, solution. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is ADENOSINE a controlled substance?
ADENOSINE is not classified as a controlled substance by the DEA.
What is the generic name for ADENOSINE?
The generic name for ADENOSINE is adenosine injection, solution. There are no other listed brand versions of adenosine injection, solution.
What is the NDC code for ADENOSINE 3 mg/mL?
The NDC (National Drug Code) for ADENOSINE 3 mg/mL is 0404-9993, listed by Henry Schein, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)