TENORMIN Solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
Tenormin Injection 0.5 mg/ml.
Qualitative and quantitative composition
Atenolol 0.5 mg/ml (5 mg in 10 ml). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection or infusion. Type I clear glass ampoules containing a clear, colourless, sterile solution.
Therapeutic indications
Management of arrhythmias and for the early intervention treatment of acute myocardial infarction.
Posology and method of administration
Posology The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. The following are guidelines: Adults Cardiac arrhythmias A suitable initial ...
Contraindications
Tenormin, as with other beta-blockers, should not be used in patients with any of the following: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Cardiogenic ...
Special warnings and precautions for use
Tenormin as with other beta-blockers: Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta-blocker dosage. Patients should ...
Interaction with other medicinal products and other forms of interaction
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. verapamil and diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ...
Fertility, pregnancy and lactation
Caution should be exercised when Tenormin is administered during pregnancy or to a woman who is breast-feeding. Pregnancy Tenormin crosses the placental barrier and appears in the cord blood. No studies ...
Effects on ability to drive and use machines
Tenormin has no or negligible influence on the ability to drive and use machines. However, it should be taken into account that occasionally dizziness or fatigue may occur.
Undesirable effects
Tenormin is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol. The following undesired events, listed by body system, ...
Overdose
The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm. General treatment should include: close supervision; treatment in an intensive care ward; ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-blocking agents, plain, selective ATC code: CO7AB03 Mechanism of action Atenolol is a beta-blocker which is beta1-selective, (i.e. acts preferentially on beta1-adrenergic ...
Pharmacokinetic properties
Absorption Following intravenous administration, the blood levels of atenolol decay tri-exponentially with an elimination half-life of about 6 hours. Throughout the intravenous dose range of 5 to 10 mg ...
Preclinical safety data
Atenolol is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Prescribing Information.
List of excipients
Citric acid Sodium chloride Sodium hydroxide Water for Injection
Incompatibilities
None known.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton.
Nature and contents of container
Glass ampoules. 10 ml ampoules are packed in boxes of 10.
Special precautions for disposal and other handling
Use as instructed by the prescriber. Tenormin Injection is compatible with sodium chloride intravenous infusion (0.9 %w/v) and Glucose Intravenous Infusion BP (5 % w/v).
Marketing authorization holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK
Marketing authorization number(s)
17901/0050
Date of first authorization / renewal of the authorization
Date of first authorisation: 1<sup>st</sup> June 2000 Date of latest renewal: 18<sup>th</sup> February 2004
Date of revision of the text
12<sup>th</sup> January 2017
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