Generic Parlodel

1. Denomination
Parlodel

2. Active Substance
Bromocriptine

3. Indications for Use.
The drug is used to treat prolactin-dependant menstrual disorders and women’s infertility, polycystic ovarian syndrome; anovulatory cycles (in addition to antiestrogens); premenstrual syndrome; hyperprolactinemia in men; prolactinomas; acromegalia; delimitation or depression of lactation (on medical indications); post-natal breast engorgement, insipient post-natal mastitis, mastalgia, and other benign diseases of lacteal glands; Parkinson disease.

4. Action
Parlodel delimitates secretion of the hormone of anterior lobe of pituitary gland – prolactin, not influencing on the levels of other pituitary hormones, if they are within normal limits.

Prolactin is needed for onset and upkeep of lactation. In other periods of the life the increase of secretion results in pathologic lactation and/or distortion of ovulation and menstrual cycle.

5. Posology and Administration
Parlodel should always be taken during meal.
In disruption of menstrual cycle and woman’s infertility the drug is administered 1.25 mg (1/2 tab.) 2-3 times/day; if the performance is not sufficient, the drug dose should be increased up to 5-7.5 mg/a day (number of intakes 2-3 times/a day). The treatment will go on till resetting of menstrual cycle and/or restoration of ovulation. If needed, for prevention of backsets the treatment may be continued during several cycles.

In premenstrual syndrome the treatment will start on the 14-th day of the cycle from 1.25 mg (1/2 tab.) a day. The dose is to be increased gradually by1.25 mg/day till 5 mg/day and it is administered till menstruation onset.

In blood hormone fortification of prolactin in men a dose should be 1.25 mg (1/2 tab.) 2-3 times/day and is to be gradually increased till 5-10 mg (2-4 tab.) a day.
In prolactinomas a dose should be 1.25 mg (1/2 tab.) 2-3 times/a day with gradual increase of the dose till several tablets a day, it is necessary to sustain an adequate decrease of concentration of prolactin in plasma.
In acromegalia the initial dose is 1.25 mg (1/2 tab.) 2-3 times/day further on according to clinical performance and side effects a day’s dose of the drug is to be gradually increased up to 10-20 mg (4-8 tab.).
For lactation depression in the first day it is administered 1/2 tab. 2 times a day (during breakfast or dinner), then during 14 days - 1 tab. 2 times/day. To prevent the beginning of lactation the drug intake should be started in several hours after birth or abortion, but however only after stabilization of vitally important functions. In 2 or 3 days after cancellation of the drug sometimes a small secretion of milk occurs. It may be stopped by renewing the intake of the drug in the same dose during next 1 week.

In post-natal breast engorgement it is administered singularly a dose of 2.5 mg (1 tab.), the drug may be administered once more (in 6-12 hours), it is not accompanied by an undue depression of lactation.
In a nascent post-natal mastitis the dosage of the drug is performed in the same way as in the case of lactation depression. If needed an antibiotic is added to the treatment.
In benign diseases of lacteal glands the drug will be administered 1.25 mg (1/2 tab.) 2-3 times /day. A day’s dose will be gradually increased up to 5-7.5 mg (2-3 tab.).

In Parkinson disease for providing an optimal tolerance the treatment should be started from the use of the drug in a small dose: 1.25 mg (1/2 tab.) once/day (preferably in the evening) during the first week. A dose of Parlodel should be increased slowly, so as every patient will receive a minimal efficient dose. A day’s dose of the drug is to be increased gradually, every week by 1.25 mg; a day’s dose is to be divided in 2-3 intakes. An adequate therapeutic result may be attained during 6-8 weeks of the treatment. If it does not occur, a day’s dose may be increased further on – every week by 2.5 mg/a day.

Average curative dose of Bromocriptine for a mono-therapy and a combined one are from 10 mg to 40 mg a day, but some patients may need bigger doses.

If in a drug dosage there occur side effects, a day’s dose should be decreased and be maintained on a lower level not less than one week. With disappearance of side effects the drug dose may be increased anew.

6. Counterindications
– non-controlled arterial hypertension;
– arterial hypertension in pregnancy;
– arterial hypertension in an early post-natal period and in a late one;
– cardio ischemia and other severe cardio-vascular diseases;
– severe mental illnesses at the moment and/or in anamnesis;
– hyper sensitivity to the components of Parlodel or other alkaloids of ergot.

7. Should Be Taken with Precautions, if…
There is information about single cases of the development of intestinal bleedings and stomach ulcer. If such complications do progress Parlodel should be cancelled.
Precautions should be taken while using in post-natal period
There is information about rare cases of progression of severe side effects, including arterial hypotension, myocardial infarction, convulsions, cerebral insult or psychic disturbances in women using Parlodel in a post-natal period for the depression of lactation. In some patients progression of convulsions or distortion of brain circulation were preceded by severe headaches and/or transient vision disorders. Though casual relation of these events with Parlodel use is not determined, it is necessary to measure AT in women taking the drug in post-natal period, likewise in patients using Parlodel at any other indications at regular time.

8. Interface with Other Medications
A special care is needed in the patients who have recently taken drugs which influences arterial tension, or continue to take them.
In any case if you take any medications together with Parlodel consult your doctor by all means.

9. Overdosing
- nausea,
- vomiting,
- dizziness,
- diminution of arterial tension,
- drowsiness,
- hallucinations.
No lethal outcomes have been registered.

10. Side Effects
During the first several days of the treatment some patients may have nausea; less frequently – dizziness, general weakness, vomiting, but because of these events, as a rule, it is not necessary to cease the treatment.
Parlodel may reduce arterial tension dramatically, which sometimes may result in collapse; that is why it is recommended to control AT especially in the first days of treatment.

Moreover, there is information about stuffiness in nose, constipation, drowsiness, headaches and, less frequently, mental confusion, psychomotor agitation, hallucinations, dyskinesias, dry mouth, convulsions of calves, allergic skin reactions and loss of hair. Usually these side effects are dose-dependant and may be controlled by a dose decline of Parlodel.

Sometimes in a long-term treatment there are noticed cases of inversive blanching of finger points and that of toes in response of cold, especially in patients who were suffering from Raynaud’s syndrome in the past.
Using Pardlodel for depression of physiologic lactation in post-natal period is accompanied with progression of arterial hypertension, myocardial infarction, convulsions, cerebral insult or psychical distortions in rare cases.

11. Pregnancy and Lactation
If a patient is planning to be pregnant, Parlodel like other medications should be cancelled after confirmation of pregnancy except the cases when there are medical indications to continue the therapy. Cancellation of Parlodel during pregnancy did not result in increase of the frequency of cases of unprompted miscarriage. A vast experience shows that the use of Parlodel in pregnancy does not influence negatively on its course or outcome.
If pregnancy occurs in a patient suffering from pituitary adenoma and a Parlodel treatment is cancelled, an attentive care for the patient is needed during all the gestation term. In cases of occurrence of the signs of frank increase of prolactinoma, for instance, headaches or coning of vision, the Parlodel treatment may be renewed or surgery interference will be needed.
As Parlodel depresses lactation it is should not be administered to the mothers who prefer breastfeeding.
Parlodel treatment may restore reproductive abilities. That is why women of child-bearing age who do not plan pregnancy must use a reliable contraception method.

12. Driving
The patients whose activities are connected with driving of vehicles or work with mechanisms should take special care as, sometimes, especially during the first days of Parlodel therapy, arterial hypotension may progress which result in the reduction of reactions.

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