DOSTINEX TABLET 0.5 MG [SIN09545P]

Product Info

DOSTINEX TABLET 0.5 MG

[SIN09545P]

4.1. Therapeutic indications

Inhibition/Suppression of Physiologic Lactation:
Cabergoline is indicated for 1) the inhibition of physiologic lactation soon after parturition and 2) suppression of established lactation.

Treatment of Hyperprolactinemic Disorders:
Cabergoline is indicated for the treatment of hyperprolactinemic disorders.

4.2. Posology and method of administration

General:
Cabergoline tablets are for oral administration. Since the tolerability of dopaminergic agents is improved when administered with food, it is recommended that cabergoline be taken with meals.

In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events may be lessened by starting therapy with cabergoline 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 Physiologic Lactation:
For inhibition of lactation: The recommended dose is 1 mg (two 0.5 mg tablets) given as a single dose during the first post-partum day.

For suppression of established lactation: The recommended dosage is 0.25 mg (one-half 0.5 mg tablet) every 12 hours for 2 days (1 mg total dose). (See section 4.4. Special warnings and precautions for use – Inhibition/Suppression of Physiologic Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Treatment of Hyperprolactinemic Disorders:
The recommended initial dosage of cabergoline is 0.5 mg per week given in one or two (one-half of one 0.5 mg tablet) doses (e.g., 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 but may range from 0.25 mg to 2 mg per week. (See section 4.4. Special warnings and precautions for use – Treatment of Hyperprolactinemic Disorders – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

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.

Patients should be evaluated during dose escalation to determine the lowest effective dose that produces the therapeutic effect. Monitoring of serum prolactin levels at monthly intervals is advised since once a therapeutic dosage has been reached, serum prolactin normalization is usually observed within 2 to 4 weeks.

After discontinuation of cabergoline, recurrence of hyperprolactinemia 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 discontinuation of cabergoline.

Patients with Severe Hepatic Insufficiency:
Lower doses of cabergoline should be considered in patients with severe hepatic insufficiency. (See section 4.4. Special warnings and precautions for use – Hepatic Insufficiency – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Children:
Safety and efficacy have not been established in patients younger than 16 years.

Elderly:
Cabergoline has not been formally studied in elderly patients with hyperprolactinemic disorders.

4.3. Contraindications

Hypersensitivity to cabergoline, any other component of the product, or any ergot alkaloid.

History of pulmonary, pericardial and retroperitoneal fibrotic disorders. (See section 4.4. Special warnings and precautions for use – Fibrosis/Valvulopathy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Long-term treatment:
Anatomical evidence of cardiac valvulopathy of any valve as determined by pre-treatment echocardiogram showing valve leaflet thickening, valve restriction, valve mixed restriction-stenosis. (See section 4.4. Special warnings and precautions for use – Fibrosis/Valvulopathy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)