CATAPRES Ampoules Ref.[2674] Active ingredients: Clonidine

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 ampoules) in a 24 hour period.

Patients undergoing anaesthesia should continue their Catapres treatment before, during and after anaesthesia using oral or intravenous administration according to individual circumstances.

Intravenous injection of Catapres should be given slowly over 10-15 minutes to avoid a possible transient pressor effect.

Catapres injection solution is compatible with 0.9% sodium chloride solution and with 5% Dextrose solution.

Paediatric Population

There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years.

Renal insufficiency

Dosage must be adjusted:

• according to the individual antihypertensive response which can show high variability in patients with renal insufficiency
• according to the degree of renal impairment

Symptoms

Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma and respiratory depression including apnoea. Paradoxical hypertension caused by stimulation of peripheral alpha1-receptors may occur. Transient hypertension may be seen if the total dose is over 10 mg.

Treatment

There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate.

Supportive care may include atropine sulphate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs.

Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression.

Unopened: 5 years.

Once opened, use immediately and discard any unused contents.

Do not store above 30°C.

Keep the ampoules in the outer carton.

1 ml colourless glass (Ph. Eur. Type I) ampoules, marketed in packs of 5.

For single use only. Discard any unused contents.