Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Endocrinology
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Dostinex Tablets (cabergoline tablets)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Pharmacia & Upjohn
Approval Status: Approved January 1997
Treatment Area: hyperprolactinemic disorders
Dostinex has been approved for the treatment of
hyperprolactinemic disorders, either idiopathic or due to pituitary
In a clinical trial involving approximately 450 subjects,
Dostinex was compared with bromocriptine in treating
hyperporlactinemia. In the eight-week, double blind trial,
prolactin levels returned to normal in 77% of subjects treated with
Dostinex (0.5mg twice weekly) compared to 59% of those treated with
bromocriptine (2.5 mg twice-daily). Restoration of menses occurred
in 77% of women treated with Dostinex, compared to 70% of those
treated with bromocriptine.
Among subjects with galactorrhea (excessive breast milk
discharge), the symptom disappeared in 73% of those treated with
Dostinex, compared to 56% of 231 subjects taking bromocriptine.
Clinical studies also showed the safety profile of Dostinex
compares favorably to bromocriptine. Two percent of 221 subjects
taking Dostinex discontinued treatment due to side effects during
the eight-week study, versus six percent of 231 subjects taking
Nausea is the most common side effect of both drugs. During the
eight-week, double-blinded portion of the trial, 29% of subjects
experienced nausea with Dostinex compared with 43% of those taking
Dostinex is contraindicated in subjects with uncontrolled
hypertension or known hypersensitivity to ergot derivatives.
Hyperprolactinemia is usually caused by a benign tumor on the
pituitary gland that results in excess production of prolactin, the
hormone that controls lactation. Doctors treat from 70,000 to
100,000 patients with the condition each year, the vast majority of
whom are women. It most commonly affects women between the ages of
20 to 50 and can cause cessation of menstruation, excessive milk
discharge and infertility. In men, the condition can cause
decreased libido and impotence.