Expiration date: 05/2025

Composition 

In 1 tablet contains: bromocriptine mesylate 2.87 mg. 

Excipients: lactose monohydrate 55, 63 mg microcrystalline cellulose 20 mg starch 15 mg, carboxy methyl starch sodium 2 mg, povidone (polivinilpirrolidon) 3, 5 mg magnesium stearate 1 mg.

Packaging

In blister packs of 30 tablets. In the packaging of 1 blister.

Pharmacological action

Bromocriptine is a stimulant of the Central and peripheral D 2 dopamine receptors (a derivative of ergot alkaloid). By inhibiting the secretion of prolactin, suppresses the physiological lactation, promotes normalization of menstrual function, inhibits the increased secretion of growth hormone, reduces size and number of cysts in the breast (due to elimination of the imbalance between progesterone and estrogen).

In high doses it stimulates dopamine receptors striped body, black nucleus of the brain, hypothalamus and mesolimbic system. Exerts antiparkinsonian action, suppresses the secretion of somatotropin (GH) and adrenocorticotropic (ACTH) hormones .

After administration of a single dose reduction of prolactin levels in blood plasma occurs in 2 hours, maximal effect - after 8 hours, the antiparkinsonian effect in 30 to 90 minutes, maximum 2 hours, the reduction of STG - after 1-2 hours, the maximum effect is achieved after 4-8 weeks. therapy.

Testimony

• Menstrual disorders, female infertility:
  
• Prolactin dependent diseases and conditions, accompanied or not accompanied by hyperprolactinemia:
  
• Amenorrhea (accompanied and not accompanied by galactorrhea).
  
• Oligomenorrhea.
  
• Insufficiency of the luteal phase.
  
• Secondary hyperprolactinemia in patients receiving drugs (for example, some psychoactive or antihypertensive drugs).
  
• Polycystic ovary syndrome.
  
• Anovulatory cycles (in addition to antiestrogens, such as clomiphene).
  
• Breast tenderness.
  
• Edema associated with cycle phase.
  
• Flatulence.
  
• Mood disorders.
  
• Prolaktinzawisimae hypogonadism (oligospermia, loss of libido, impotence).
  
• Conservative treatment prolactinsecreting micro - and macroadenoma the pituitary gland.
  
• Preoperative preparation to reduce the volume of the tumor and facilitate its removal.
  
• Post - operative treatment, if the prolactin level remains elevated.
  
• As a complementary drug in combination with radiation therapy and surgical treatment.
  
• In special cases, as an alternative to surgical or radiation treatment.
  
• To prevent or stop postpartum lactation for medical reasons.
  
• Prevention of lactation after abortion.
  
• Postpartum breast engorgement.
  
• Beginning on postpartum mastitis.
  
• Mastalgia (isolated or in combination with premenstrual syndrome).
  
• Mastalgia with benign nodular or cystic changes in the gland.
  
• Benign nodular and/or cistenie changes, especially fibrocystic mastopathy.
  

Contraindications

• Hypersensitivity to bromocriptine and other ergot alkaloids.
  
• Preeclampsia.
  
• Arterial hypertension in the postpartum period.
  
• Cardiovascular disease (including hypertension, hypotension).
  
• Essential, family tremor.
  
• Psychosis.
  
• Liver failure .
  
• Chorea Of Gentingtona.
  
• Ulcerative lesions of the gastrointestinal tract .
  
• The children's age.
  

With caution:

• Parkinson disease with dementia symptoms .
  
• Pregnancy.
  
• Lactation.
  
• Simultaneous antihypertensive therapy.
  

Application of pregnancy and breastfeeding

Be used with caution during pregnancy and lactation.

Method of application and doses

Inside, during a meal, the maximum daily dose of 100 mg.

• Menstrual irregularities, female infertility 1, 25 mg 2-3 times a day, if the effect is insufficient, the dose is gradually increased to 5-7. 5 mg/day (reception frequency 2-3 times/day). Treatment continued until normalization of the menstrual cycle and/or recovery of ovulation. If necessary to prevent a recurrence, treatment can continue for several cycles.
  
• Premenstrual syndrome Treatment started on day 14 of cycle 1, 25 mg/day. Gradually increase the dose of 1 25 mg/day to 5 mg/day (before the onset of menstruation).
  
• Hyperprolactinaemia in men 1, 25 mg 2-3 times a day, gradually increasing the dose to 5-10 mg/day.
  
• Prolactinomas and 1, 25 mg 2-3 times a day, gradually increasing the dose to a few pills a day needed to maintain adequate reduction in the concentration of prolactin in plasma.
  
• Acromegaly Initial dose is 1. 25 mg 2-3 times a day, in the future, depending on clinical effect and side effects, the daily dose is gradually increased up to 10-20 mg.
  
• Suppression of lactation In 1 day appoint 1, 25 mg 2 times (during meals for Breakfast and dinner), then within 14 days for 2, 5 mg 2 times a day. To prevent the lactation the drug should be started a few hours after childbirth or abortion (after stabilization of vital functions). 2-3 days after discontinuation of the drug sometimes there is a slight secretion of milk. It can be eliminated by resuming the drug at the same dose for another 1 week.
  
• Postpartum breast engorgement Prescribe a single dose of 2, 5 mg, 6-12 hours if necessary, repeat the reception (it is not accompanied by unwanted suppression of lactation).
  
• Starting postpartum mastitis dosing regimen is same as in the case of suppression of lactation. If necessary, to the treatment of add antibiotic.
  
• Benign diseases of mammary glands 1, 25 mg 2-3 times a day. The daily dose gradually increased to 5-7. 5 mg.
  

Parkinson's disease To ensure optimal tolerability, treatment should be started with small doses of the drug: 1, 25 mg 1 time a day (preferably evening) for 1 week. The daily dose increase gradually every week 1, 25 mg, the daily dose divided into 2-3 doses. Adequate therapeutic result can be achieved within 6-8 weeks of treatment. If not, the daily dose can be increase further - every week on 2, 5 mg/day. The average therapeutic dose of bromocriptine for mono - or combination therapy amount of 10-30 mg/day. Maximum daily dose 30 mg. If the selection of doses side effects occur, the daily dose should be reduced and maintained at a lower level for at least 1 week. If the side effects disappear, the dose can again be increased. Patients with motor impairments observed in patients receiving levodopa , it is recommended that prior to use of bromocriptine to reduce the dose of levodopa. After achieving a satisfactory effect can be further gradual reduction of the dose of levodopa. Some patients may complete abolition of levodopa.

Special instructions

For the prevention of nausea and vomiting in the beginning of treatment appropriate to prescribe anti-nausea drugs 1 hour before taking the drug.

Recommended periodic monitoring of blood pressure , liver and kidney.

In applying the drug in high doses over a long period increased risk of the development of cardiac fibrosis.

Treatment may cause the rapid resumption of ovarian function after childbirth, therefore, need to prevent women early postpartum conception. Women taking bromocriptine when pregnancy occurs the treatment should be stopped, except when there is a positive effect of treatment outweighs the potential risk to the fetus. During therapy it is advisable to use nonhormonal contraception.

In case of pregnancy of pituitary adenoma after the cancellation requires systematic monitoring of its condition, including measurement of visual field. Before treatment of benign diseases of mammary glands it is necessary to exclude the presence of malignant tumors of the same localization.

In the treatment of acromegaly, if history is an indication of the presence of gastric ulcer, the treatment should be abandoned. If treatment is needed, to make patients aware of the need to put health care provider know if you experience disorders from the gastrointestinal tract.

You must carefully observe the hygiene of the mouth, with persistent dryness of the mouth more than 2 weeks, consult a doctor.

Effects on ability to drive vehicles and operate machinery Patients receiving the drug should refrain from activities, require increased attention and rapid physical and mental reactions.

Drug interactions

Reduces effectiveness of oral contraceptives.

Enhances the effect of levodopa , antihypertensive drugs.

Monoamine oxidase inhibitors furazolidone , procarbazine , sepehri, ergot alkaloids, haloperidol , loxapine, methyldopa , metoclopramide , molindone, reserpine , and phenothiazines thioxanthene increase the concentration in plasma and the risk of side effects.

Erythromycin , clarithromycin , troleandomycin increase the bioavailability and maximum concentration, reduce butirofenona effective.

Simultaneous administration of ethanol leads to the development of disulfiramopodobna reactions (chest pain, flushing skin, tachycardia , nausea, vomiting , cough reflex, throbbing headache, blurry vision, weakness, convulsions).

The joint appointment with ritonavir, it is recommended 50% dose reduction.

Overdose

Symptoms: headache, hallucinations, drop in blood pressure.

Treatment: parenteral administration of metoclopramide .

Storage conditions

Store in a dry, protected from light place at temperature not exceeding 25°C.

Shelf life

3 years