Sicriptin

Bromocriptine Mesylate tablets I.P.

SCRIPTIN™ 2.5 mg
SCRIPTIN™ 1.25 mg

Bromocriptine (Dopaminergic agonist, inhibitor of prolactin secretion)


COMPOSITION
The active principle of SICRIPTIN™ is bromocriptine.

Each tablet of SICRIPTIN™ contains 2.87 mg bromocriptine mesylate IP equivalent to 2.5 mg bromocriptine base.

Each tablet of SICRIPTIN™ 1.25 contains bromocriptine mesylate IP 1.435 mg equivalent to 1.25 mg bromocriptine base.

PHARMACOLOGY
Sicriptin™ is a semi synthetic ergot alkaloid. The basis of its therapeutic application lies in its action as a potent dopamine agonist. Bromocriptine inhibits the secretion of the anterior pituitary hormone, prolactin, without affecting other pituitary hormones (growth hormone, gonadotrophins, thyrotrophin). However, in many acromegalic patients with elevated growth hormone and/or prolactin levels, bromocriptine lowers blood levels of growth hormone by a dopaminergic mechanism.

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.
In galactorrhoea associated with amenorrhoea and/or anovulation, bromocriptine can be used to establish a normal ovulatory and menstrual cycle and thus promotes fertility.

In acromegalic patients, as a result of lowering of elevated circulating growth hormone and prolactin levels, an improvement of the clinical picture and glucose tolerance results. Bromocriptine is effective when given orally.

It is also useful in non-functioning pituitary tumors, acromegaly, premenstrual syndrome, cyclical mastalgia, polycystic ovary syndrome.

CLINICAL INDICATIONS WITH DOSAGE
Parkinson's disease
:- Sicriptin™ treatment should be initiated with 1.25 mg (1 tab/day). Weekly increments in daily dosage by 1.25 mg (1 tab/day) is advised to achieve the lowest effective dose. The weekly dosage increase is advised till a satisfactory therapeutic response is achieved in 2 or 3 divided doses. The normal therapeutic range of Sicriptin™ 10-40 mg/day. In case adverse effects are observed, reduce the dose temporarily for 1 week and increase the dose once adverse effect disappears.

Female infertility:-
Sicriptin™ 1.25 mg (1 tab) two or three times daily. The dosage may be increased by 1.25 mg(1 tab) for adequate response. Sicriptin™ should be administered for few cycles to prevent relapse and till normal menstrual cycle and ovulation is not attained. If menstruation does not occur within 3 days of the expected date, Sicriptin™ should be discontinued and pregnancy test performed.

Galactorrhoea:-
Sicriptin™ 1.25 mg (1 tab) two or three times a day and gradually increase to therapeutic range. The duration of treatment should not exceed six months.

Acromegaly:- Sicriptin™ 1.25 mg (1 tab) 2 or 3 times daily. Gradual increase in dosage depending on response to achieve therapeutic effect and minimal incidence of adverse effect to a maximum of 10-20 mg Bromocriptine.

Premenstrual syndrome
Sicriptin™ 1.25 mg (1 tab) daily from day 14 of the menstrual cycle and gradual increase in dose by 1.25 mg ( 1 tab) upto 2.5mg (Sicriptin™ 2.5 mg 1 tab)twice daily until menstruation begins.

Benign Breast diseases:-
Sicriptin™ 1.25 mg(1 tab) 2-3 times daily to a maximum dose of 5-7.5 mg daily. Treatment to be taken over the complete menstrual cycle. Discontinue the therapy if no significant clinical improvement observed in 3 months duration.

Male hyperprolactinaemia:-
Sicriptin™ 1.25 mg (1 tab) 2-3 times daily with a gradual increase in dose to 5-10 mg.

Prolactinoma:-
Sicriptin™ 1.25 mg (1 tab) 2-3 times daily with gradual dosage as required for control of plasma prolactin.

CONTRA-INDICATIONS
Hypersensitivity to any ergot alkaloid.

PRECAUTIONS
The cause of the infertility should be determined before the start of Sicriptin™ treatment. Pregnancy should be avoided if a diagnosis of pituitary adenoma has been made, as pregnancy may induce adenoma enlargement.
In patients with galactorrhoea with or without amenorrhoea, treatment with Sicriptin™ may result in restoration of fertility. Therefore, patients who do not desire pregnancy should be advised to use contraceptive measures, other than the oral contraceptive. An excessive enlargement of the sella turcica or a defect of the visual field due to an adenoma requires initial surgical procedures and/or radiotherapy.

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.

Therefore, in absence of further information, acromegalic patients should be carefully assessed for peptic ulceration prior to treatment with Scriptin™ and advised to report gastrointestinal side effects promptly.

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-EFFECTS
During 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
Should be stored below 25°C and protected from light and moisture.

PACKING
SICRIPTIN™ and SICRIPTIN™ 1.25 is packed in a box containing five strips of 10 tablets each,

   
 
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