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Adenosine

These highlights do not include all the information needed to use Adenosine Injection, USP safely and effectively. See full prescribing information for Adenosine Injection, USP. Adenosine Injection, USP, for intravenous use Initial U.S. Approval: 1995

Approved
Approval ID

504b4b38-fb6c-4a59-b04f-73aa7b1cbfd9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 12, 2022

Manufacturers
FDA

NorthStar Rx LLC

DUNS: 830546433

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Adenosine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16714-556
Application NumberANDA202313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2022
FDA Product Classification

INGREDIENTS (3)

ADENOSINEActive
Quantity: 3 mg in 1 mL
Code: K72T3FS567
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Adenosine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16714-997
Application NumberANDA202313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2022
FDA Product Classification

INGREDIENTS (3)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ADENOSINEActive
Quantity: 3 mg in 1 mL
Code: K72T3FS567
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

DRUG INTERACTIONS SECTION

LOINC: 34073-7Updated: 7/12/2022

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Adenosine Injection

  • The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). The safety and efficacy of adenosine injection in the presence of these agents has not been systematically evaluated [see Overdosage (10)].
  • The vasoactive effects of adenosine are potentiated by nucleoside transport inhibitors such as dipyridamole. The safety and efficacy of adenosine in the presence of dipyridamole has not been systematically evaluated.
  • Whenever possible, drugs that might inhibit or augment the effects of adenosine should be withheld for at least five half-lives prior to the use of adenosine injection.

7.2 Effects of Adenosine on Other Drugs

Adenosine injection has been given with other cardioactive drugs (such as beta adrenergic blocking agents, cardiac glycosides, and calcium channel blockers) without apparent adverse interactions, but its effectiveness with these agents has not been systematically evaluated. Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, adenosine injection should be used with caution in the presence of these agents [see Warnings and Precautions (5.2)].

Key Highlight
  • Methylxanthines interfere with the activity of adenosine (7.1, 10)
  • Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine (7.1)

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