ADENOSINE injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

adenosine (UNII: K72T3FS567) (adenosine - UNII:K72T3FS567)

Beszerezhető a:

Mylan Institutional LLC

INN (nemzetközi neve):

adenosine

Összetétel:

adenosine 3 mg in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Adenosine Injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. Adenosine is contraindicated in patients with: Pregnancy Category C . Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. Because it is not known whether adenosine can cause fetal harm when administered to pregnant women, adenosine should be used during pregnancy only if clearly needed. It is not known whether adenosine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from adenosine in nursing infants, the decision to interrupt nursing after administration of adenosine or not to administer adenosine, should take into account the importance of the drug to the mother. The safety and effectiveness of adenosine in patients less than 18 years of age have not been established. Clinical studies with adenosine did not include suffic

Termék összefoglaló:

Adenosine Injection, USP is supplied as 20 mL and 30 mL single-dose vials of sterile, nonpyrogenic solution in normal saline as follows: NDC Adenosine Injection, USP (3 mg per mL) Package Factor 67457-856-20 60 mg per 20 mL Single-Dose Vial 1 vial per carton 67457-857-30 90 mg per 30 mL Single-Dose Vial 1 vial per carton Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [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. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ADENOSINE- ADENOSINE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADENOSINE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADENOSINE
INJECTION.
ADENOSINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Adenosine Injection, 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
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)
DOSAGE FORMS AND STRENGTHS
Adenosine Injection: 3 mg per mL in single-dose vials (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 10%) are: flushing; chest
discomfort; shortness of breath;
headache; throat, neck or jaw discomfort; gastrointestinal discomfort;
and dizziness (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-
446-3679 (1-877-4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.
GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2022
Second- or third-degree AV block (except in patients with a
functioning artificial pacemaker) (4)
Sinus node disease, such as sick sinus syndrome or symptomatic
bradycardia (except in patients with
a functioning artificial pacemaker) (4)
Known or suspected bronchoconstrictive or bronchospastic lung disease
(e.g., asthma) (4)
Known hypersensitivity to adenosine (4)
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction.
Fatal cardiac events have
occurred. Avoid use in patients with symptoms or signs of acute
myocardial ischemia. Appropriate
resuscitative measures should be available (5.1)
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First-,
second-or third-degree AV