Posology : מינונים

4.2.     Posology and method of administration
Dostinex® is to be administered by the oral route. Since the tolerability of this class of compounds is improved with food, it is recommended that Dostinex® be preferably taken with meals for all the therapeutic indications.

In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events may be lessened by starting therapy with Dostinex® at reduced doses (e.g., 0.25 mg once a week) with subsequent gradual increase until the therapeutic dosage is reached. If persistent or severe adverse events occur, temporary reduction of dosage followed by a more gradual increase (e.g., increments of 0.25 mg per week every two weeks) may increase tolerability.

Inhibition/suppression of physiological lactation
For inhibition of lactation Dostinex® should be administered during the first day post-partum.
The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as a single dose.
For suppression of established lactation: The recommended therapeutic dosage regimen is 0.25 mg (one-half 0.5 mg tablet) every 12 hours for two days (1 mg total dose). (See section Special warnings and precautions for use – Inhibition/Suppression of Physiologic Lactation) Treatment of hyperprolactinaemic disorders (See sections Contraindications and Special warnings and precautions for use – Long term treatment)

The recommended initial dosage of Dostinex ®is 0.5 mg per week given in one or two (one- half of one 0.5 mg tablet) doses (e.g. on Monday and Thursday) per week. The weekly dose should be increased gradually, preferably by adding 0.5 mg per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1 mg per week and ranges from 0.25 mg to 2 mg per week. Doses of cabergoline up to 4.5 mg per week have been used in hyperprolactinaemic patients. (See section Special warnings and precautions for use – Treatment of Hyperprolactinemic Disorders).

The weekly dose may be given as a single administration or divided into two or more doses per week according to patient tolerability. Division of the weekly dose into multiple administrations is advised when doses higher than 1 mg per week are to be given since the tolerability of doses greater than 1 mg taken as a single weekly dose has been evaluated only in a few patients.

Patients should be evaluated during dose escalation to determine the lowest dosage that produces the therapeutic response. Monitoring of serum prolactin levels at monthly intervals is advised since, once the effective therapeutic dosage regimen has been reached, serum prolactin normalisation is usually observed within two to four weeks.

After Dostinex® withdrawal, recurrence of hyperprolactinaemia is usually observed.
However, persistent suppression of prolactin levels has been observed for several months in some patients. In most women ovulatory cycles persist for at least 6 months after Dostinex® discontinuation.

Patients with Severe Hepatic Insufficiency:
Lower doses of Dostinex® should be considered in patients with severe hepatic insufficiency.
(See section Special warnings and precautions for use – Hepatic Insufficiency) 
Children
The safety and efficacy of Dostinex® has not been established in patients less than 16 years.

Elderly
Dostinex® has not been formally studied in elderly patients with hyperprolactinemic disorders.