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| SCRIPTIN™ PHARMACOLOGY Physiological hyperprolactinaemia is necessary for
the initiation and maintenance of puerperal lactation. Pathological
hyperprolactinaemic states due to neuroendocrine disorders such
as hyper-functions,pituitary microadenomas or adenomas may, in the
women, give rise to symptomatology characterized by galactorrhoea
frequently associated with disorders of ovulation and menstruation
(secondary amenorrhoea, oligomenorrhoea). Prolactin may also have
a role in the pathogenesis of several cases of male hypogonadism;
in these patients bromocriptine treatment permits to restore the
normal gonadal and sexual function by regulating the prolactin secretion
rate. It is also useful in non-functioning pituitary tumors,
acromegaly, premenstrual syndrome, cyclical mastalgia, polycystic
ovary syndrome. CLINICAL INDICATIONS WITH DOSAGE PRECAUTIONS In such cases, Sicriptin™ is indicated only if these treatments are unsuccessful. In the absence of pituitary adenoma and in cases in which the patient wishes to become pregnant, it is recommended that the treatment with Sicriptin™ be discontinued as soon as possible after conception (early test for pregnancy by immunological test). Although the present knowledge does not indicate that bromocriptine is teratogenic, data accumulated today do not allow a firm conclusion because of the rarity of infertility of prolactin origin. As a precautionary measure, in cases of established
pregnancy, the evolution of pituitary adenoma associated with pregnancy
should be monitored regularly, for example by examination of the
visual field. In acromegalic patients gastrointestinal bleeding
has been rarely reported, though the connection with bromocriptine
mesylate treatment is not proven. Hypotensive reactions may be disturbing in some patients during the first few days of treatment and particularly care should be exercised when driving vehicles or operating machinery. Caution is required where bromocriptine mesylate is being given in high doses to Parkinsonian patients with a history of psychotic disorders, severe cardiovascular diseases, peptic ulceration or gastrointestinal bleeding. Among Parkinsonian patients on long-term, high dose bromocriptine mesylate treatment, pleural effusions have been observed in some cases. While a causal relationship between bromocriptine and these findings is uncertain, patients presenting with unexplained pleuropulmonary signs or symptoms should be examined thoroughly and discontinuation of bromocriptine mesylate therapy should be contemplated. Bromocriptine was used in the past to prevent breast engorgement following delivery in women who chose not to breast-feed. However, this indication has been withdrawn because of the risk of myocardial infarction, seizures, hypertension and severe headache.WARNINGS Care should be exercised when bromocriptine is administered concomitantly with hypotensive or psychoactive drug because interactions with bromocriptine cannot be excluded. Gynaecological assessment, preferably including cervical and endometrial cytology, is recommended for women receiving bromocriptine for extensive periods. Six-monthly assessment is suggested for post-menopausal women and annual assessment for women with regular menstruation. When women of child-bearing age are treated with bromocriptine for conditions not associated with hyperprolactinaemia the lowest effective dose should be used. This is in order to avoid suppression of prolactin to below normal levels, with consequent impairment of luteal function. In such patients and if the treatment is prolonged for more than 6 months, assessments are advised at regular intervals to check the plasma prolactin and post-ovulatory progesterone levels. SIDE-EFFECTSDuring the first days of treatment the preparation may induce slight nausea in some patients and more rarely vertigo or vomiting. However, the intensity of these symptoms is not such as to require the discontinuation of the treatment. On rare occasions, Sicriptin™ may induce a lowering of the blood pressure. In out- patients it is thus advisable to monitor the blood pressure, particularly during the first days of therapy. Postural hypotension may be disturbing but it can be controlled by a symptomatic treatment. If side effects persist, it should be sufficient to reduce the dosage. In patients liable to Raynaud's syndrome or in acromegalic patients receiving high doses of Sicriptin™ reversible pallor of the face, hands and feet induced by cold have occasionally occured. Overdosage with Sicriptin™ is likely to result in vasospasm, hallucinations and confusion, hypotension, dyskinesia and, in Parkinsonian patients, also constipation and drowsiness, Psychomotor excitation, dry mouth and leg cramps have been rarely reported. All these side effects are dose- dependent and, in general, may be overcome by a reduction of the dosage. PHARMACEUTICAL PRECAUTIONS PACKING |
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