Bromocriptine (Dopaminergic agonist, inhibitor of prolactin secretion)
The active principle of SICRIPTIN
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.
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
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
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.
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.
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.
Sicriptin 1.25 mg (1
tab) 2-3 times daily with a gradual increase in dose to 5-10 mg.
Sicriptin 1.25 mg (1 tab) 2-3 times
daily with gradual dosage as required for control of plasma prolactin.
Hypersensitivity to any ergot alkaloid.
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
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
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.
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.
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.
Should be stored below 25°C and protected from light and moisture.
SICRIPTIN and SICRIPTIN 1.25 is packed in a box
containing five strips of 10 tablets each,