CATAPRES Tablet Ref.[6730] Active ingredients: Clonidine

Catapres Tablets are for oral administration only.

Adults

Oral treatment should commence with 50-100 micrograms three times daily. This dose should be increased gradually every second or third day until control is achieved. Most patients will be controlled on divided daily doses of 300-1200 micrograms. However, some patients may require higher doses, e.g. 1800 micrograms or more.

Catapres may be added to an existing antihypertensive regimen where blood pressure control has not been satisfactorily achieved. If side-effects with existing therapy are troublesome the concomitant use of Catapres may allow a lower dose of the established regimen to be employed. Patients changing treatment should have their existing therapy reduced gradually whilst Catapres is added to their regimen.

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

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

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.

Patients with renal impairment

Dosage must be adjusted:

• According to the individual antihypertensive response which can show high variability in patients with renal insufficiency, careful monitoring is required (See Section 4.4).
• 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 sulfate 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.

Shelf life: 3 years.

Do not store above 30°C.

Keep the blisters in the outer carton.

Opaque PVC 250µm thick/PVDC 40 g/m² blisters with aluminium lidding foil 20µm in packs of 100 tablets.

No special requirements.