Pergocoat

6 x 10 pc

Film-coated tablet

Active substance

Pergolide (Pergolid mesylate) : 1 mg

ATC code

QN04BC02 Pergolide

QN04BC Dopamine agonists

QN04B Dopaminergic agents

QN04 Anti-Parkinson drugs

QN Nervous system

Species

Horses (non food-producing).

Indications

Symptomatic treatment of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing’s Disease).

Dose to be administered and administration route

Oral use, once daily.

To facilitate administration, the required daily dose should be placed in a small amount of water and/or mixed with molasses or other sweetener and agitated until dissolved. In this case, the dissolved tablets should be administered with a syringe.

The whole amount should be administered immediately. Tablets should not be crushed, see section 4.5.

Starting dose

The starting dose is about 2 µg pergolide/kg (dose range: 1.3 to 2.5 µg/kg; see table below). The maintenance dose should then be titrated according to the individual response as determined by monitoring (see below), resulting in an average maintenance dose of 2 µg pergolide/kg bodyweight with a dose range of 0.6 to 10 µg pergolide/kg bodyweight.

Starting doses are recommended as follows:

Horse body weight	0.5 mg tablet		1 mg tablet	2 mg tablet	Starting dose	Dosage range
200 - 400 kg					0.5 mg	1.3 – 2.5 μg/kg
401 - 600 kg					1.0 mg	1.7 – 2.5 µg/kg
or
401 - 600 kg					1.0 mg	1.7 – 2.5 µg/kg
601 - 850 kg		+			1.5 mg	1.8 – 2.5 µg/kg
or
601 - 850 kg					1.5 mg	1.8 – 2.5 µg/kg
851 - 1000 kg					2.0 mg	2.0 – 2.4 µg/kg
or
851 - 1000 kg					2.0 mg	2.0 – 2.4 µg/kg

Maintenance dose

Lifelong treatment is anticipated for this disease.

Most horses respond to therapy and are stabilised at an average dose of 2 µg pergolide/kg body weight. Clinical improvement with pergolide is expected within 6 to 12 weeks. Horses may respond clinically at lower or varying doses; it is therefore recommended to titrate to the lowest effective dose per individual based on response to therapy, whether it is effectiveness or signs of intolerance. Some horses may require doses as high as 10 µg pergolide/kg body weight per day. In these rare situations, appropriate additional monitoring is advised.

Following initial diagnosis, repeat endocrinologic testing for dose titration and monitoring of treatment at intervals of 4 to 6 weeks until stabilisation or improvement of clinical signs and/or diagnostic testing occurs.

If clinical signs or diagnostic testing have not yet improved at the first 4 to 6 week interval, the total daily dose may be increased by 0.50 mg. In case clinical signs have improved but are not yet normalised, the veterinarian may decide to titrate or not to titrate the dose, considering the individual’s response/tolerance to the dose.

In case clinical signs are not adequately controlled (clinical evaluation and/or diagnostic testing) it is recommended to increase the total daily dose by 0.5 mg increments (if the drug is tolerated at that dose) every 4 to 6 weeks until stabilisation occurs. If signs of dose intolerance develop, treatment should be stopped for 2 to 3 days and reinstated at one-half of the previous dose. The total daily dose may then be titrated back up to the desired clinical effect by 0.5 mg increments every 2 to 4 weeks. If a dose is missed, the next scheduled dose should be administered as prescribed.

Following stabilisation, regular clinical assessment and diagnostic testing should be performed every 6 months to monitor treatment and dose. Where there is no apparent response to treatment, the diagnosis should be re-evaluated.

Adverse reactions

Horses:

Rare

(1 to 10 animals / 10,000 animals treated):

Inappetence, anorexia¹, lethargy¹.

Central nervous system signs² (e.g. depression², ataxia²).

Diarrhoea, colic.

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Sweating.

¹ transient

² mild

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section ‘contact details’ of the package leaflet for respective contact details.