Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome).
Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years.
Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenocor will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity.
Sensitisation of intra-cavitary electrophysiological investigations.
Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use.
It should be administered by rapid IV bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush.
Adenocor should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments.
Initial dose: 3 mg given as a rapid intravenous bolus (over 2 seconds).
Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1–2 minutes, 6 mg should be given also as a rapid intravenous bolus.
Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1–2 minutes. 12 mg should be given also as a rapid intravenous bolus.
Additional or higher doses are not recommended.
During administration of adenosine cardio-respiratory resuscitation equipment must be available for immediate use if necessary.
Adenosine is intended for use with continuous monitoring and ECG recording during administration.
The dosing recommended for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:
Adenosine should be administered by rapid intravenous (IV) bolus injection into a vein or into an IV line. If given into an IV line it should be injected through as proximally as possible, and followed by a rapid saline flush. If administered through a peripheral vein, a large bore cannula should be used.
See dosage recommendations for adults.
The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.
Rapid intravenous injection only.
Overdose would cause severe hypotension, bradycardia or asystole. The half-life of adenosine in blood is very short, and side effects (when they occur) would quickly resolve. Administration of IV aminophylline or theophylline may be needed. Pharmacokinetic evaluation indicates that methyl xanthines are competitive antagonists to adenosine, and that therapeutic concentrations of theophylline block its exogenous effects.
Shelf life: 3 years.
Any portion of the vial not used at once should be discarded.
Do not refrigerate.
Clear, type I glass vials with chlorobutyl rubber closures secured with aluminium caps. Packs of 6 vials in plastic trays in cardboard cartons.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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