Description
Caber' goline was first synthesized by scientists working for the Italian drug company Farmitalia-Carlo Erba SpA in Milan in 1981/82, who were experimenting with semisynthetic derivatives of the ergot alkaloids. Farmitalia-Carlo Erba was acquired by Pharmacia in 1992, which in turn was acquired  in 2002. The drug was approved by the FDA on December 23, 1996. It went generic in late 2005 following US patent expiration.

Caber' goline
Alias: Cabaser,Dostinex;Dostine
CAS: 81409 90 7
M.F.: C26H37N5O2
M.W.: 451.6
M.P.:102-104°C
Properties: white powder.soluble in ethyl alcohol, and N, Ndimethylformamide (DMF); slightly soluble in 0.1N; very slightly soluble in; and insoluble in water.

Clinical particulars
1.1 Therapeutic indications
Inhibition/suppression of physiological lactation
Caber' 'goline is indicated for the inhibition of physiological lactation soon after delivery and for suppression of already established lactation:

1. After parturition, when the mother elects not to breast feed the infant or when breast feeding is contraindicated due to medical reasons related to the mother or the new-born.
2. After stillbirth or abortion.
It prevents/suppresses physiological lactation by inhibiting prolactin secretion.
In controlled clinical trials, It given as a single 1 mg administration during the first day post-partum, was effective in inhibiting milk secretion, as well as breast engorgement and pain in 70 - 90% of the women. Less than 5% of women experienced rebound breast symptomatology during the third post-partum week (which was usually mild in severity).
Suppression of milk secretion and relief of breast engorgement and pain are obtained in approximately 85% of nursing women treated with a total dose of 1 mg caber' goline given in four divided doses over two days. Rebound breast symptomatology after day 10 is uncommon (approximately 2% of cases).
Treatment of hyperprolactinaemic disorders
It is indicated for the treatment of dysfunctions associated with hyperprolactinaemia, including amenorrhoea, oligomenorrhoea, anovulation and galactorrhoea. It is indicated in patients with prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinaemia, or empty sella syndrome with associated hyperprolactinaemia, which represent the basic underlying pathologies contributing to the above clinical manifestations.
On chronic therapy, it at doses ranging between 1 and 2 mg per week, was effective in normalising serum prolactin levels in approximately 84% of hyperprolactinaemic patients. Regular cycles were resumed in 83% of previously amennorhoeic women. Restoration of ovulation was documented in 89% of women with progesterone levels monitored during the luteal phase. Galactorrhoea disappeared in 90% of cases showing this symptom before therapy. Reduction in tumour size was obtained in 50 - 90% of female and male patients with micro- or macroprolactinoma.

1.2 Posology and method of administration
It is to be administered by the oral route. Since in clinical studies caber' goline has been mainly administered with food and since the tolerability of this class of compounds is improved with food, it is recommended that caber' goline be preferably taken with meals for all the therapeutic indications.
Inhibition/suppression of physiological lactation
For inhibition of lactation caber' goline 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). This dosage regimen has been demonstrated to be better tolerated than the single dose regimen in women electing to suppress lactation having a lower incidence of adverse events, in particular of hypotensive symptoms.
Treatment of hyperprolactinaemic disorders
The recommended initial dosage of caber' goline 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 caber' goline up to 4.5 mg per week have been used in hyperprolactinaemic patients.
The maximum dose should not exceed 3mg per day.
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 caber' goline withdrawal, recurrence of hyperprolactinaemia is usually observed. However, persistent suppression of prolactin levels has been observed for several months in some patients. Of the group of women followed up, 23/29 had ovulatory cycles which continued for greater than 6 months after caber' goline discontinuation.
Paediatric population
The safety and efficacy of it has not been established in subjects less than 16 years of age.
Use in the elderly
As a consequence of the indications for which it is presently proposed, the experience in elderly is very limited. Available data do not indicate a special risk.

1.3 Contraindications
Hypersensitivity to caber' goline, any of the excipients listed in section 6.1 or any ergot alkaloid.
History of pulmonary, pericardial and retroperitoneal fibrotic disorders.
It is contraindicated in patients with hepatic insufficiency and with toxaemia of pregnancy. It should not be co-administered with anti-psychotic medications or administered to women with a history of puerperal psychosis.
For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.

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