CATAPRES Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Catapres Ampoules 150 micrograms in 1 ml Solution for Injection.
Qualitative and quantitative composition
Each 1 ml ampoule contains clonidine hydrochloride 150 micrograms. For a full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
Catapres is indicated for the treatment of hypertensive crises.
Posology and method of administration
Adults, including the elderly In hypertensive crises 150 to 300 micrograms (1 to 2 ampoules) should be given by slow intravenous injection. This dose may be repeated up to a maximum of 750 micrograms (5 ...
Contraindications
Catapres should not be used in children (please refer to section 4.4 Special Warnings and Precautions for Use) or in patients with known hypersensitivity to the active ingredient or other components of ...
Special warnings and precautions for use
Clonidine should only be used with caution in patients with depression or a history thereof, with Raynauds disease, or other peripheral vascular occlusive disease. The product should only be used with ...
Interaction with other medicinal products and other forms of interaction
The reduction in blood pressure induced by clonidine can be further potentiated by concurrent administration of other hypotensive agents. This can be of therapeutic use in the case of other antihypertensive ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of clonidine in pregnant women. This product should only be used in pregnancy if considered essential by the physician. Careful monitoring of mother ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, sedation and ...
Undesirable effects
Most adverse effects are mild and tend to diminish with continued therapy. Adverse events have been ranked under headings of frequency using the following convention: Very common ≥1/10, Common ≥1/100, ...
Overdose
Symptoms Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma and ...
Pharmacodynamic properties
Clonidine acts primarily on the central nervous system, resulting in reduced sympathetic outflow and a decrease in peripheral resistance, renal vascular resistance, heart rate and blood pressure. Renal ...
Pharmacokinetic properties
The pharmacokinetics of clonidine is dose-proportional in the range of 100-600 micrograms. Clonidine, the active ingredient of Catapres, is well absorbed and no first pass effect exists. It is rapidly ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Sodium chloride Water for injections Hydrochloric acid
Incompatibilities
None known.
Shelf life
<u>Unopened:</u> 36 months. Once opened, use immediately and discard any unused contents.
Special precautions for storage
Do not store above 30°C. Keep the ampoules in the outer carton.
Nature and contents of container
1 ml colourless glass (Ph. Eur. Type I) ampoules, marketed in packs of 5.
Special precautions for disposal and other handling
For single use only. Discard any unused contents.
Marketing authorization holder
Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany
Marketing authorization number(s)
PA2256/002/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1979 Date of last renewal: 01 November 2005
Date of revision of the text
July 2022
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