Bromocriptine (Parlodel®)
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Ingredients
Each tablet contains: Bromocriptine mesylate 2.87 mg (equal to 2.5 of base
bromocriptine)
Excipients Colloidal silica, magnesium stearate, polyvinyl pyrrolidine, corn
starch, lactose.
Parlodel Is Available In
Boxes containing 30 2.5-mg tablets, to be taken by mouth.
Pharmaceutical Classification
Prolactin secretion inhibitor with dopaminergic effect.
Parlodel Is Recommended For
Galactorrhoea accompanied or not by amenorrhoea; post-partum effects (Chiari-Frommel);
idiopathy (Aragonz-del Castillo); tumoral effects (Forbes Albright), side
effects from pharmaceutical products (psychotropic and contraceptive drugs).
Prolactin-dependent amenorrhoea without galactorrhoea. Hyperprolactinaemic
infertility. Menstrual disorders (premenstrual syndrome, brief luteinic phase)
Prolactin-dependent male hypogonadism Acromegaly: The initial treatment for this
problem is surgical or by means of radiotherapy. PARLODEL is a useful adjuvant
in either treatment and may be used without them in certain cases.
Idiopathic and arteriosclerotic Parkinson's disease. PARLODEL
is particularly beneficial to those patients who show a decreasing response to
L-dopa, and in cases where the effects of levodopa therapy are restricted by the
presence of the "on-off" phenomenon. Taking this product with L-dopa
brings about an increased anti-Parkinson effect which permits a lower dosage of
both pharmaceutical products. PARLODEL can be taken on its own in preliminary or
mild cases of Parkinson's disease and may also be taken with anticholinergic
drugs and/or other anti-Parkinson products.
Contraindications
If you are expecting a baby or think that you might be, it is unwise to take
this product.
The safety and effectiveness of PARLODEL (bromocriptine
mesylate) has not been confirmed for treatment of adolescents younger than
fifteen years of age.
Precautions
In patients with galactorrhoea and prolactin-dependent amenorrhoea, menstrual
disorders or acromegaly, PARLODEL may eliminate pre-existing sterility. Women
who may become fertile but who do not wish to conceive should therefore adopt a
mechanical form of contraception. The exact cause of infertility should be
determined before beginning PARLODEL treatment.
Pregnancy should be avoided if hypophysial adenoma has been
diagnosed. A marked lengthening of the sella turcica or a defect in the field of
vision requires, first of all, surgery or radiotherapy. PARLODEL is only
recommended should these measures fail. In the absence of hypophysial adenoma
and should the patient be anxious to conceive, PARLODEL treatment should be
stopped as soon after conception as possible (early pregnancy diagnosis with
immunological test) since knowledge of the possible effects of this
pharmaceutical product on the development of pregnancy and the fetus is as yet
inconclusive. As a precautionary measure in the case of confirmed pregnancy, the
possible negative effects of a pathological hypophysial problem associated with
the pregnancy should be controlled regularly (for example, checking the field of
vision).
Sporadic gastrointestinal bleeding has been known to occur in
patients with acromegaly, whether they are undergoing PARLODEL treatment,
another treatment, or no treatment at all. Until more complete information is
available, it is thus preferable for acromegaly patients with case-histories of
peptic ulcer to receive some other form of treatment. If it is essential that
such patients take PARLODEL, they can soon expect signs of such gastroenteric
reactions.
Caution is advised when PARLODEL is taken in large doses by
patients suffering from Parkinson's disease with case histories of psychotic
disorders, serious cardiovascular problems, peptic ulcers or gastroenteric
bleeding.
Some cases of pleural effusions have been reported in
Parkinson patients undergoing long-term high-dosage PARLODEL treatment. Although
the causal correlation between PARLODEL and these reports has not been proved,
it is still advisable for patients who show inexplicable pleuro-pulmonary signs
or symptoms to be examined and the possibility of stopping PARLODEL treatment
considered.
Interactions With Other Medicines
The possibility of interactions between bromocriptine and psychoactive or
hypotensive drugs should not be ruled out. Particular caution should be taken
with regard to patients undergoing treatment with ergot alkaloids or products
which might possibly increase arterial pressure.
Special Warning
For instructions as to the use of this product during pregnancy or by patients
with acromegaly and/or hypophysial adenoma, see "PRECAUTIONS".
Treatment must be carried out under medical supervision, including hormone
dosage and gynaecological consultation. All women being treated with PARLODEL
for a continuous period of longer than 6 months should have gynaecological
check-ups once a year if they have not reached menopause, and every 6 months if
they are undergoing menopause (with cervical and if possible endometrial
cytology). Women with affections not linked to hyperprolactaemia should take the
lowest possible effective dosage of PARLODEL to alleviate the symptoms, so as to
avoid the possibility of lowering the prolactin level below normal with a
consequent alteration of the luteinic function. Tests concerning plasmatic
prolactin and post-ovulatory progesterone should be carried out on such patients
if treatment is prolonged for longer than 6 months. In the event of hypotensive
reactions, which can occur with certain patients especially during the first
days of treatment, particular care should be taken when driving or operating
machinery.
Directions For Use
This product is always to be taken at mealtimes. Galactorrhoea and/or prolactin-dependent
amenorrhoea, hyperprolactaemic infertility: half a tablet 3 times daily. If this
is not sufficient, increase the dosage gradually to 1 tablet, 2-3 times daily
with meals. Continue the treatment until the mammary secretion disappears
completely, and, should the problem be compounded by amenorrhoea, until the
menstrual cycle returns to normal. The treatment may be continued if necessary
for several menstrual cycles in order to avoid a relapse. Disorders of the
menstrual cycle:- Pre-menstrual syndrome. Begin treatment on the 14th day of the
menstrual cycle with a half tablet per day, then gradually increase the dosage
by half a tablet until reaching the dosage of 1 tablet twice daily. Continue
this treatment until the onset of the menstrual flow.
Brief luteinic phase. Half a tablet 3 times daily, gradually
increasing the dosage to 1 tablet twice daily with meals until the luteinic
phase has returned to normal.
Male hypogonadism: half a tablet 3 times daily, gradually
increasing to 1 tablet 3 times daily for a period of 2-3 months.
Acromegaly: Start by taking 1 tablet per day, gradually
increasing the dosage over 1-2 weeks to 4-8 tablets, according to the patient's
needs, clinical response and tolerance. The daily dosage should be divided into
4 separate and equal doses.
Parkinson's disease: The effects of Parkinson's disease can be
combated with low doses, 10-15 mg daily. The effective therapeutic dosage when
PARLODEL is taken alone is usually high (30 mg or more per day).
However, if PARLODEL is taken together with L-dopa, with or
without the dopa-decarboxylase inhibitor, a lower dosage may suffice. The
recommended initial dosage is 2.5 mg twice a day (at mealtimes) for a week. The
dosage increase must be gradual and regular: normally not by more than 5 mg
every 2-3 days in the initial phase of treatment. Later on, the final dosage
increase can be done gradually, not more than 10 mg at a time, depending on
therapeutic response and tolerance. Similarly, each reduction of the L-dopa
dosage must be gradual until optimum results are obtained. In certain cases
L-dopa treatment may be stopped altogether.
In Case Of Overdose
Cases of life-threatening overdoses have not been reported. The single maximum
dose taken by an adult has been 225 mg. Nausea, vomiting, dizziness, orthostatic
hypotension, excessive perspiration and hallucinations have been observed.
Treatment of acute intoxication is symptomatic. Metoclopramide may be used for
vomiting and hallucinations.
Adverse Effects
During the first days of treatment, some patients may experience mild nausea
and, less frequently, dizziness, fatigue or vomiting. However these side effects
have never been of such an intensity as to require a suppression of treatment.
In rare cases, PARLODEL may lead to a lowering of blood
pressure. For this reason supervision and evaluations of out-patients are
advisable during the early days of treatment. Should such undesired side effects
persist, the dosage should be reduced.
Reversible pallor in fingers and toes caused by cold should be
reported in the case of patients undergoing a prolonged treatment of 20 mg and
more, especially in patients who have previously suffered from Raynaud's
phenomenon.
There have also been cases of vasospasm, hallucinations and
confusion, hypotension and diskinesia.
Constipation, drowsiness and, less frequently, psychomotor
excitation, leanness of the jaw and leg cramp have also been reported during
treatment of Parkinson's disease with PARLODEL.
At times certain dose-dependent effects may be controlled by a
lowering of the dosage. Postural hypotension may be unpleasant but can be
treated symptomatically.
If, after taking this pharmaceutical product, the patient
notes unpleasant side effects which are not described in this leaflet, he should
consult his family doctor.
Special Storage Precautions
Store this product out of the sunlight and at a temperature not exceeding 25°C.
Attention
Do not use this product following the expiry date
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