INDICATIONS AND USAGE

Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.

DOSAGE

The recommended dosage of Cabergoline Tablets, USP for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.

Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered.

After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established.

ADVERSE REACTIONS

Nausea

Constipation

Abdominal pain

Dyspepsia

Vomiting

Headache

Dizziness

Paresthesia

Vertigo

Asthenia

Fatigue

Hot flashes

Somnolence

Depression

Nervousness

Postural hypotension

Breast pain

Dysmenorrhea

Abnormal vision

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/89ec147b-a6fe-49bb-9af5-52fc2ce5db7f/spl-doc?hl=Cabergoline

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