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Drug Catalog - Product Detail

ADENOSINE FOR INJECTION INJECT. 3MG/ML 1X30ML

NDC Mfr Size Str Form
17478-0544-30 AKORN 30 3MG/ML SOLUTION
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PACKAGE FILES

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Generic Name
ADENOSINE
Substance Name
ADENOSINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
ANDA090450
Description
11 DESCRIPTION Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula: The molecular formula for adenosine is C 10 H 13 N 5 O 4 and its molecular weight is 267.24. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH of the solution. Each Adenosine Injection, USP vial contains a sterile, non-pyrogenic solution of adenosine 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5. ade0d-0009-01
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Adenosine Injection, USP is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, solution in normal saline: NDC 17478-544-20 60 mg/20 mL (3 mg/mL) in a 20 mL single-dose, flip-top glass vial, packaged individually NDC 17478-544-30 90 mg/30 mL (3 mg/mL) in a 30 mL single-dose, flip-top glass vial, packaged individually Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion.
Indications & Usage
1 INDICATIONS AND USAGE 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 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended Adenosine Injection dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) ( Table 1 ). Administer adenosine only as a continuous peripheral intravenous infusion Inject Thallium-201 at the midpoint of the adenosine infusion (i.e., after the first three minutes of adenosine) Thallium-201 is physically compatible with adenosine and may be injected directly into the adenosine infusion set Inject Thallium-201 as close to the venous access as possible to prevent an inadvertent increase in the dose of adenosine (the contents of the intravenous tubing) being administered Visually inspect adenosine for particulate matter and discoloration prior to administration. Do not administer adenosine if it contains particulate matter or is discolored. There are no data on the safety or efficacy of alternative adenosine infusion protocols. The safety and efficacy of adenosine administered by the intracoronary route have not been established. Table 1 Dosage Chart for Adenosine Injection Patient Weight (kilograms) Infusion Rate (mL per minute over 6 minutes for total dose of 0.84 mg/kg) 45 2.1 50 2.3 55 2.6 60 2.8 65 3 70 3.3 75 3.5 80 3.8 85 4 90 4.2 The nomogram displayed in Table 1 was derived from the following general formula: 0.14 (mg/kg/min) x total body weight (kg) = Infusion rate Adenosine concentration (mL/min) (3 mg/mL) Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) ( 2 )