ADENOCARD Solution for injection (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Astellas Pharma US, Inc.

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1. Description

Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula: Adenosine is a white crystalline ...

2. Clinical Pharmacology

Mechanism of Action Adenocard (adenosine injection) slows conduction time through the A-V node, can interrupt the reentry pathways through the A-V node, and can restore normal sinus rhythm in patients ...

3. Indications and Usage

Intravenous Adenocard (adenosine injection) is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass ...

4. Contraindications

Intravenous Adenocard (adenosine injection) 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 ...

5. Warnings

Heart Block Adenocard (adenosine injection) 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 ...

6.4. Drug Interactions

Intravenous Adenocard (adenosine injection) has been effectively administered in the presence of other cardioactive drugs, such as quinidine, beta-adrenergic blocking agents, calcium channel blocking agents, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals have not been performed to evaluate the carcinogenic potential of Adenocard (adenosine injection). Adenosine was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian ...

6.7. Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. As adenosine is a naturally occurring material, widely dispersed ...

6.10. Pediatric Use

No controlled studies have been conducted in pediatric patients to establish the safety and efficacy of Adenocard for the conversion of paroxysmal supraventricular tachycardia (PSVT). However, intravenous ...

6.11. Geriatric Use

Clinical studies of Adenocard did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

The following reactions were reported with intravenous Adenocard (adenosine injection) used in controlled U.S. clinical trials. The placebo group had less than 1% rate of all of these reactions. Cardiovascular: ...

9. Overdosage

The half-life of Adenocard (adenosine injection) is less than 10 seconds. Thus, adverse effects are generally rapidly self-limiting. Treatment of any prolonged adverse effects should be individualized ...

10. Dosage and Administration

For rapid bolus intravenous use only. Adenocard (adenosine injection) should be given as a rapid bolus by the peripheral intravenous route. To be certain the solution reaches the systemic circulation, ...

11. How Supplied

Adenocard (adenosine injection) is supplied as a sterile non-pyrogenic solution in normal saline. NDC 0469-8234-12 Product Code 823412 6 mg/2 mL (3 mg/mL) in 2 mL (fill volume) Ansyr plastic disposable ...

12. Storage and Handling

Store at controlled room temperature 15º-30ºC (59º-86ºF). DO NOT REFRIGERATE as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The ...

14. References

1. Paul T, Pfammatter. J-P. Adenosine: an effective and safe antiarrhythmic drug in pediatrics. Pediatric Cardiology 1997; 18:118-126.