Bromocriptine pills 2,5mg №30

Dosage form

Pills

Composition

1 pill contains:

- Active substances
- Bromocriptine mesilate 2.87 mg.
- In terms of bromocriptine 2.5 mg.

- Excipients Lactose monohydrate 55.63 mg, microcrystalline cellulose 20 mg, potato starch 15 mg, carboxy methyl starch sodium 2 mg, povidone (polyvinylpyrrolidone) 3.5 mg, Magnesium stearate 1 mg.

Packing

In the blister of 30 tablets. In packing 1 blister.

Mechanism of action

Bromocriptine is a stimulator of the central and peripheral D 2 -dopamine receptors (a derivative of the ergot alkaloid). Inhibiting prolactin secretion, inhibits physiological lactation, helps normalize menstrual function, inhibits increased secretion of growth hormone, reduces the size and number of cysts in the breast (by eliminating imbalance between Progesterone and estrogen).

In high doses, it stimulates the dopamine receptors of the striatum, the black nucleus of the brain, the hypothalamus and the mesolimbic system. It has anti-Parkinsonian effect, inhibits the secretion of somatotropic (GH) and adrenocorticotropic (ACTH) hormones.

After receiving a single dose, the decrease in the level of prolactin in the blood plasma occurs after 2 hours,maximum effect - after 8 hours, anti-parkinsonian effect - after 30-90 minutes, maximum - after 2 hours, decrease in the level of growth hormone - after 1-2 hours, the maximum effect is achieved in 4-8 weeks. therapy.

Indications and usage

- Disorders of the menstrual cycle, 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 medication (for example, some psychoactive or antihypertensive drugs).

- Polycystic ovary syndrome.
- Anovulatory cycles (in addition to antiestrogens, such as clomiphene).

- Soreness of the mammary glands.
- Edema associated with the phase of the cycle.
- Flatulence.
- Mood disorders.

- Prolactin-dependent hypogonadism (oligospermia, loss of libido, impotence).

- Conservative treatment of prolactin-secreting micro- and macroadenomas of the pituitary gland.
- Preoperative preparation to reduce the volume of the tumor and facilitate its removal.
- Postoperative treatment if prolactin levels remain elevated.

- As an additional drug in combination with radiation therapy and surgical treatment.
- In special cases, as an alternative to surgical or radiation treatment.

- Prevention or termination of postpartum lactation for medical reasons.
- Prevention of lactation after an abortion.
- Postpartum breast engorgement.
- Starting postpartum mastitis.

- Mastalgiya (isolated, as well as in combination with premenstrual syndrome).
- Mastalgia with benign nodular or cystic gland changes.
- Benign nodular and / or cystic changes, especially fibrocystic mastopathy.

Contraindications

- Hypersensitivity to bromocriptine and other ergot alkaloids.
- Gestosis.
- Arterial hypertension in the postpartum period.
- Diseases of the cardiovascular system (including arterial hypertension, hypotension).
- Essential, family tremor.
- Psychoses.
- Liver failure.
- Chorea of ​​Gottington.
- Ulcerative lesions of the gastrointestinal tract.
- Childhood.

- Parkinsonism with symptoms of dementia.
- Pregnancy.
- Lactation period.
- Simultaneous implementation of antihypertensive therapy.

Pregnancy and Breastfeeding

Use with caution during pregnancy and lactation.

Dosage and administration

Inside, during meals, the maximum daily dose is 100 mg.

- Violations of the menstrual cycle, female infertility At 1.25 mg 2-3 times a day; if the effect is insufficient, the dose is gradually increased to 5-7.5 mg / day (the frequency of intake is 2-3 times / day). Treatment continues until the normalization of the menstrual cycle and / or the restoration of ovulation.If necessary, for the prevention of relapses, treatment can be continued for several cycles.

- Premenstrual syndrome Treatment begins on the 14th day of the cycle from 1.25 mg / day. Gradually increase the dose by 1.25 mg / day to 5 mg / day (before the onset of menstruation).

- Hyperprolactinemia in men On 1.25 mg 2-3 times a day, gradually increasing the dose to 5-10 mg / day.

- Prolactinoma 1.25 mg 2-3 times a day, with a gradual increase in the dose to several pills per day, necessary to maintain an adequate reduction in the concentration of prolactin in the plasma.

- Acromegaly. The initial dose is 1.25 mg 2-3 times a day, and then, depending on the clinical effect and side effects, the daily dose is gradually increased to 10-20 mg.

- Suppression of lactation On 1 day, 1.25 mg is prescribed 2 times (with meals at breakfast and dinner), then within 14 days, 2.5 mg twice a day. To prevent the onset of lactation, the drug should be started within a few hours after giving birth or abortion (after stabilization of vital functions). 2-3 days after discontinuation of the drug, there is sometimes a slight secretion of milk. It can be eliminated by resuming the drug in the same dose for another 1 week.

- Postpartum breast engorgement Assign once a dose of 2.5 mg, after 6-12 hours, if necessary, repeat the reception (this is not accompanied by undesirable suppression of lactation).

- Starting postpartum mastitis. Dosage regimen is the same as in the case of lactation suppression. If necessary, an antibiotic is added to the treatment.

- Benign diseases of the mammary glands 1.25 mg 2-3 times a day. The daily dose is gradually increased to 5-7.5 mg.

- Parkinson's disease. To ensure optimal tolerability, treatment should begin with a small dose of the drug: 1.25 mg 1 time per day (preferably in the evening) for 1 week. The daily dose of the drug is increased gradually, every week by 1.25 mg, the daily dose is divided into 2-3 doses. An adequate therapeutic result can be achieved within 6-8 weeks of treatment. If this does not occur, the daily dose can be increased further - every week at 2.5 mg / day. The average therapeutic dose of bromocriptine for mono-or combination therapy is 10-30 mg / day. The maximum daily dose is 30 mg. If during the selection of the dose side effects occur, the daily dose should be reduced and maintained at a lower level for at least 1 week. If side effects disappear, the dose can be increased again. Patients with motor impairments occurring during the administration of levodopa are advised to reduce the dose of levodopa before using bromocriptine. After achieving a satisfactory effect, a further gradual reduction in the dose of levodopa can be undertaken. In some patients, complete elimination of levodopa is possible.

Adverse reactions

- Nausea, vomiting.
- Dizziness.
- Orthostatic hypotension (rare).
- Myocardial infarction.
- Stroke.
- Constipation.
- Drowsiness.
- Headache.
- Psychomotor agitation.
- hallucinations.
- Psychoses.
- Dyskinesia.
- Decreased visual acuity.
- Dry mouth (caries, periodontal disease, orocandiasis, discomfort).
- Nasal congestion.
- Allergic reactions.
- Skin rash.
- Cramps in the calf muscles.

- With long-term use of Raynaud's syndrome.

- In treatment with high doses (parkinsonism) Confusion of consciousness, discharge of cerebrospinal fluid from the nasal passages, fainting, peptic ulcer, Gastrointestinal bleeding (black feces, blood in vomit), retroperitoneal fibrosis (abdominal pain, decreased appetite, pain in back, nausea, vomiting, weakness, frequent urination).

Special notes

To prevent nausea and vomiting at the beginning of treatment, it is advisable to prescribe antiemetic drugs 1 hour before taking the drug.

Periodic monitoring of blood pressure, liver function and kidney function is recommended.

The use of the drug in high doses over a long period increases the risk of developing cardiac fibrosis.

Treatment can cause an accelerated resumption of ovarian function after childbirth, and therefore, it is necessary to warn women about the possibility of early postpartum conception. In women taking bromocriptine, treatment is stopped when the pregnancy occurs, unless the potential positive effect of treatment outweighs the potential risk to the fetus.During therapy, the use of non-hormonal contraception is advisable.

In the event of pregnancy on the background of pituitary adenoma after cancellation, systematic monitoring of its condition is necessary, including the study of visual fields. Before starting the treatment of benign breast diseases, it is necessary to exclude the presence of a malignant tumor of the same localization.

When treating acromegaly, if there is an indication in the history of the presence of gastric ulcer, it is better to refuse treatment. If treatment is necessary, it is necessary to draw the attention of patients to the need to inform the physician in the event of disorders of the gastrointestinal tract.

It is necessary to carefully observe the oral hygiene, with continued dryness of the oral cavity for more than 2 weeks, you should consult with your doctor.

- Influence on the ability to drive vehicles and control mechanisms Patients taking the drug should refrain from engaging in activities that require increased attention and quick physical and mental reactions.

Reduces the effectiveness of oral contraceptives.

Enhances the effect of levodopa, antihypertensive drugs.

Monoamine oxidase inhibitors, furazolidone, procarbazine, sepegyline, ergot alkaloids, Haloperidol , loxapine, methyldopa, metocopopramide, molindone, reserpine, thioxanthines and phenothiazines increase plasma concentration and the risk of side effects.

Erythromycin, Clarithromycin , troleandomycin increase bioavailability and maximum concentration, butyrophenones reduce effectiveness.

Simultaneous administration of ethanol leads to the development of disulfiram-like reactions (chest pain, skin redness, tachycardia, nausea, vomiting, reflex cough, pulsating headache, blurred vision, weakness, cramps).

When administered jointly with ritonavir, a 50% dose reduction is recommended.

Symptoms: headache, hallucinations, low blood pressure.

Treatment: parenteral administration of Metoclopramide.

- Store in a dry, dark place at a temperature not exceeding 25 ° C.

3 years.