Adenoscan

Name: Adenoscan

What do I need to tell my doctor BEFORE I take Adenoscan?

  • If you have an allergy to adenosine or any other part of Adenoscan (adenosine).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Certain types of abnormal heartbeats (heart block, sick sinus syndrome) without a working pacemaker.
  • If you have a certain type of chest pain (unstable angina).
  • If you have any of these health problems: Asthma or other breathing problems like COPD (chronic obstructive pulmonary disease).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Adenoscan with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Chest pain or pressure.
  • Fast or slow heartbeat.
  • A heartbeat that does not feel normal.
  • Shortness of breath.
  • Seizures.
  • Throat, neck, or jaw pain.

Contraindications

Adenoscan is contraindicated in patients with:

• Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2)] • Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2)] • Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see Warnings and Precautions (5.3)] • Known hypersensitivity to Adenoscan [see Warnings and Precautions (5.7)]

Warnings and Precautions

Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction

Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following Adenoscan infusion. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example, unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to Adenoscan. Appropriate resuscitative measures should be available [see Overdosage (10)].

Sinoatrial and Atrioventricular Nodal Block

Adenoscan exerts a direct depressant effect on the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia. In clinical trials, approximately 6% of patients developed AV block following Adenoscan administration (first-degree heart block developed in 3%, second-degree in 3%, and third-degree in 0.8% of patients) [see Clinical Trials Experience (6.1)].

Use Adenoscan with caution in patients with pre-existing first-degree AV block or bundle branch block. Do not use in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker). Discontinue Adenoscan in any patient who develops persistent or symptomatic high-grade AV block.

Bronchoconstriction

Adenoscan administration can cause dyspnea, bronchoconstriction, and respiratory compromise. Adenoscan should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis). Do not use in patients with bronchoconstriction or bronchospasm (e.g., asthma). Discontinue Adenoscan in any patient who develops severe respiratory difficulties. Resuscitative measures should be available prior to Adenoscan administration [see Clinical Trials Experience (6.1), Overdosage (10), and Clinical Pharmacology (12.2)].

Hypotension

Adenoscan is a potent peripheral vasodilator and can induce significant hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. Discontinue Adenoscan in any patient who develops persistent or symptomatic hypotension.

Cerebrovascular Accident

Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Adenoscan including hypotension or hypertension can be associated with these adverse reactions [see Warnings and Precautions (5.4) and (5.9)].

Seizures

New-onset or recurrence of convulsive seizures has occurred following Adenoscan. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with Adenoscan. Methylxanthine use is not recommended in patients who experience seizures in association with Adenoscan administration [see Overdosage (10)].

Hypersensitivity

Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Symptomatic treatment may be required. Have personnel and appropriate treatment available. Resuscitative measures may be necessary if symptoms progress [see Post-Marketing Experience (6.2)].

Atrial Fibrillation

Adenoscan can cause atrial fibrillation in patients with or without a history of atrial fibrillation. Atrial fibrillation typically began 1.5 to 3 minutes after initiation of Adenoscan, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm [see Post-Marketing Experience (6.2)].

Hypertension

Adenoscan can induce clinically significant increases in systolic and diastolic blood pressure. Most increases resolved spontaneously within several minutes, but in some cases, hypertension lasted for several hours [see Clinical Trials Experience (6.1)].

Adenoscan 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 C10H13N5O4 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 Adenoscan 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.

How Supplied/Storage and Handling

How Supplied

Adenoscan is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, solution in normal saline:

• 20 mL single-dose vial: NDC 0469-0871-20
60 mg/20 mL (3 mg/mL) in a 20 mL single-dose, flip-top glass vial, packaged individually and in packages of ten • 30 mL single-dose vial: NDC 0469-0871-30
90 mg/30 mL (3 mg/mL) in a 30 mL single-dose, flip-top glass vial, packaged individually and in packages of ten

Storage and Handling

• Store at controlled room temperature 15°-30°C (59°-86°F) • 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

Description

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

C 10 H 13 N 5 O 4                                                             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 Adenoscan vial contains a sterile, nonpyrogenic solution of adenosine 3 mg/mL and sodium chloride 9 mg/mL in Water for Injection, q.s. The pH of the solution is between 4.5 and 7.5.

Warnings

Fatal Cardiac Arrest, Life Threatening Ventricular Arrhythmias, and Myocardial Infarction.

Fatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and nonfatal myocardial infarction have been reported coincident with Adenoscan infusion. Patients with unstable angina may be at greater risk. Appropriate resuscitative measures should be available.

Sinoatrial and Atrioventricular Nodal Block

Adenoscan (adenosine injection) exerts a direct depressant effect on the SA and AV nodes and has the potential to cause first-, second- or third-degree AV block, or sinus bradycardia. Approximately 6.3% of patients develop AV block with Adenoscan, including first-degree (2.9%), second-degree (2.6%) and third-degree (0.8%) heart block. All episodes of AV block have been asymptomatic, transient, and did not require intervention. Adenoscan can cause sinus bradycardia. Adenoscan should be used with caution in patients with pre-existing first-degree AV block or bundle branch block and should be avoided in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker). Adenoscan should be discontinued in any patient who develops persistent or symptomatic high-grade AV block. Sinus pause has been rarely observed with adenosine infusions.

Hypotension

Adenoscan (adenosine injection) is a potent peripheral vasodilator and can cause significant hypotension. Patients with an intact baroreceptor reflex mechanism are able to maintain blood pressure and tissue perfusion in response to Adenoscan by increasing heart rate and cardiac output. However, Adenoscan should be used with caution in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or uncorrected hypovolemia, due to the risk of hypotensive complications in these patients. Adenoscan should be discontinued in any patient who develops persistent or symptomatic hypotension.

Hypertension

Increases in systolic and diastolic pressure have been observed (as great as 140 mm Hg systolic in one case) concomitant with Adenoscan infusion; most increases resolved spontaneously within several minutes, but in some cases, hypertension lasted for several hours.

Bronchoconstriction

Adenoscan (adenosine injection) is a respiratory stimulant (probably through activation of carotid body chemoreceptors) and intravenous administration in man has been shown to increase minute ventilation (Ve) and reduce arterial PCO 2 causing respiratory alkalosis. Approximately 28% of patients experience breathlessness (dyspnea) or an urge to breathe deeply with Adenoscan. These respiratory complaints are transient and only rarely require intervention.

Adenosine administered by inhalation has been reported to cause bronchoconstriction in asthmatic patients, presumably due to mast cell degranulation and histamine release. These effects have not been observed in normal subjects. Adenoscan has been administered to a limited number of patients with asthma and mild to moderate exacerbation of their symptoms has been reported. Respiratory compromise has occurred during adenosine infusion in patients with obstructive pulmonary disease. Adenoscan should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis, etc.) and should be avoided in patients with bronchoconstriction or bronchospasm (e.g., asthma). Adenoscan should be discontinued in any patient who develops severe respiratory difficulties.

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