Bromocriptine tabs 2.5mg #30

Bromocriptine user manual

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Release form and composition

Bromocriptine is available in the form of 2.5 mg tablets (10, 20, 30, 40, 50, 60 or 100 pieces in blisters or polymer containers).
The active ingredient of the drug is bromocriptine.

Pharmacodynamics

Bromocriptine is an ergot derivative and dopamine receptor agonist (D2). The compound suppresses the production of prolactin in the anterior lobe of the pituitary gland and does not affect the synthesis and release of other pituitary hormones (with the exception of patients with acromegaly, in whom bromocriptine reduces the level of growth hormone). In the postpartum period, prolactin is required for the initiation and further maintenance of lactation. In other periods of life, an increase in prolactin production causes menstrual irregularities and ovulation and / or pathological lactation (galactorrhea).
Bromocriptine, which belongs to specific inhibitors of prolactin synthesis, can be used to prevent or suppress physiological lactation, as well as in the treatment of pathological conditions provoked by prolactin hypersecretion.
In anovulatory menstrual cycles, which are accompanied or not accompanied by galactorrhea, and / or amenorrhea, bromocriptine helps to normalize ovarian function and restore endocrine regulation at the ovarian-pituitary level.
The use of bromocriptine does not lead to impaired postpartum involution of the uterus and does not increase the risk of thromboembolism, and also reduces the severity of clinical symptoms in polycystic ovary syndrome.
The drug inhibits the growth or reduces the size of prolactinomas (prolactin-secreting adenomas).
In patients with acromegaly, bromocriptine not only reduces the content of prolactin and growth hormone in the blood plasma, but also has a positive effect on the clinical manifestations of the disease and glucose tolerance.
In Parkinson's disease, accompanied by a dopamine deficiency in certain structures of the brain, the drug is used in higher doses than in the treatment of endocrine diseases. Bromocriptine activates dopamine receptors, ensuring the restoration of neurochemical balance in these structures. When prescribing the drug, the severity of the symptoms of depression, which are often observed in patients with parkinsonism (gait disturbance, tremor, akinesia and rigidity at all stages of the disease), decreases.
The drug is able to lower blood pressure, but the mechanism of this action remains poorly understood. There are suggestions that this effect is due to an agonistic effect on central dopamine receptors. As a result, the vascular tone decreases, and the concentration of catecholamines in the blood plasma also decreases. Thus, the drug acts as a vasodilator.

Pharmacokinetics

After oral administration, bromocriptine is absorbed from the gastrointestinal tract by 25-30%. Its maximum content in blood plasma is reached within 1-3 hours. When the drug is taken orally at a dose of 5 mg, its maximum plasma concentration is 0.465 ng / ml. The effect of reducing prolactin is observed 1-2 hours after oral administration of the drug and reaches a peak after 5-10 hours - the concentration of prolactin decreases by about 80%, after which it remains unchanged for 8-12 hours.
Bromocriptine binds to blood plasma proteins by about 96%. It is extensively metabolized in the liver during "primary passage", forming a number of metabolites. The bioavailability of this compound is approximately 6%. In vitro studies have shown that bromocriptine has a high affinity for the CYP3A enzyme. Competing substrate and / or CYP3A4 inhibitors can inhibit metabolic processes in which bromocriptine is involved and increase its plasma level. The effect of microsomal liver oxidation enzymes (CYP2C19, CYP2C8, CYP2D6) on the metabolism of the drug is not well understood. Bromocriptine is a CYP3A4 inhibitor.
The unchanged drug is excreted from the blood plasma in a biphasic manner. The final half-life on average reaches 15 hours (the range of the spread is 8-20 hours). Bromocriptine and its metabolites are almost completely excreted in feces, only 6% is excreted in the urine.
In patients with liver dysfunctions, the rate of excretion of bromocriptine may decrease, and its content in the blood plasma may increase, which requires dose adjustment. The effect of gender, race and age of patients on the pharmacokinetic parameters of the active component of the drug and its metabolites has not been sufficiently studied.

Indications for use

According to the instructions, it is advisable to use Bromocriptine for female infertility and menstrual irregularities:
    Prolactin-dependent conditions and diseases, which are accompanied or not accompanied by hyperprolactinemia (oligomenorrhea; secondary hyperprolactinemia induced by drugs; amenorrhea, accompanied and not accompanied by galactorrhea; luteal phase insufficiency);
    Prolactin-independent female infertility (polycystic ovary syndrome, anovulatory cycles - as an additional treatment to antiestrogens).
Also indications for prescribing the drug are:
    Hyperprolactinemia in men: prolactin-dependent hypogonadism (loss of libido, oligospermia, impotence);
    Benign breast diseases: benign cystic and / or nodular changes, especially fibrocystic breast disease; mastalgia in isolation or in combination with benign cystic or nodular changes or with premenstrual syndrome;
    Premenstrual syndrome: edema associated with the phase of the cycle; soreness of the mammary glands; flatulence; mood disorders;
    Prolactinomas: as a conservative treatment for prolactin-secreting micro- and macroadenomas of the pituitary gland; in order to reduce the size of the tumor and facilitate its removal (in the preoperative period of therapy); as a postoperative therapy if the level of prolactin remains elevated;
    Parkinson's disease, parkinsonism syndrome, including after encephalitis (as monotherapy, or as part of a combination treatment with other antiparkinsonian drugs).
Bromocriptine is also prescribed to stop lactation or prevent it after childbirth if there are medical indications (postpartum engorgement of the mammary glands, prevention of lactation after abortion, postpartum mastitis that begins).

Contraindications

    Chorea of ​​Huntington;
    Arterial hypotension / hypertension;
    Essential and familial tremors;
    Severe forms of cardiovascular disease;
    Endogenous psychoses;
    Pregnancy toxicosis;
    Hypersensitivity of the patient to ergot alkaloids.

Instructions for the use of Bromocriptine: method and dosage

The exact dosage and duration of therapy are determined individually.
Tablets are taken orally at 1.25-2.5 mg 2-3 times a day.
The daily dose of the drug can be gradually increased:
    With prolactinoma, male hypogonadism, acromegaly, benign breast diseases - up to 5-20 mg;
    With parkinsonism - up to 10-40 mg.
In the event that side reactions appear during the selection of the dose, it is necessary to reduce the daily dose of Bromocriptine and maintain it at this level for a week. With the disappearance of side effects, you can increase the dose again.

Side effects

In some cases, the use of Bromocriptine can cause the following side effects:
    From the side of the central nervous system: headaches, dizziness (usually occurs in the first week of therapy), psychomotor agitation, decreased visual acuity, drowsiness, dyskinesia, hallucinations;
    From the digestive system: diarrhea, nausea and vomiting, constipation, liver dysfunction, dry mouth;
    From the side of the cardiovascular system: arrhythmia, orthostatic hypotension; with prolonged use, in some cases - Raynaud's syndrome (especially in patients with a predisposition);
    Allergic reactions: skin rash;
    Others: cramps in the calf muscles, nasal congestion.

Overdose

Overdose symptoms include hallucinations, blurred consciousness, headache, drowsiness, nausea, vomiting, chest pain, cold extremities, heart palpitations, weak pulse, changes in blood pressure (most often a decrease).
In this case, symptomatic therapy is recommended. During the first 3 hours after taking the drug, it is necessary to flush the stomach and take activated charcoal in order to reduce the absorption of the drug from the gastrointestinal tract.

Special instructions

Bromocriptine is prescribed with caution with concurrent antihypertensive therapy, as well as if the patient has:
    Parkinsonism with signs of dementia;
    A history of gastrointestinal bleeding;
    Erosive and ulcerative lesions of the gastrointestinal tract.
During therapy, it is necessary to regularly monitor the patient's condition and blood pressure due to the possibility (especially in the first days of treatment) of the occurrence of hypotensive reactions.
As the dose is reduced, most of the side effects of Bromocriptine tend to decrease. At the initial stages of treatment, it is recommended to prescribe an antiemetic agent one hour before taking the drug.
With prolonged use of the drug by women with a regular monthly cycle, it is necessary to undergo a gynecological examination once a year, preferably with a cytological examination of the tissues of the cervix and endometrium. When menopause occurs within six months, diagnostics are carried out every month.
Bromocriptine therapy can normalize reproductive function. In order to prevent unwanted pregnancy, you should use reliable contraception (with the exception of hormonal contraceptives).
With pituitary adenoma, accompanied by a significant increase in the size of the sella turcica and impaired visual fields, the appointment of the drug is possible only in cases of ineffectiveness of surgical treatment and radiation therapy.
In the case of the appointment of the drug for mastopathy, the presence of a malignant tumor should be completely excluded.
Combination therapy with bromocriptine and levodopa for Parkinson's disease and parkinson's syndrome can increase the clinical effect, which allows you to reduce the dose of levodopa or cancel it completely. This is especially important in the treatment of patients in whom levodopa therapy does not lead to a stable therapeutic effect, or causes the development of motor disorders.
Patients taking the drug are advised to refrain from carrying out potentially hazardous activities that require psychomotor speed and increased concentration.

Application during pregnancy and lactation

When pregnancy occurs, Bromocriptine is immediately discontinued unless the potential benefit of therapy to the mother significantly outweighs the potential risks to the fetus (with large pituitary tumors showing a tendency to grow). Taking the drug in the first 8 weeks of pregnancy does not have a negative effect on the course and outcome of pregnancy. After the abolition of bromocriptine, the risk of spontaneous miscarriage does not increase.
The drug reduces the production of breast milk, so it should not be used during lactation.
To stop lactation, the drug may be prescribed if medically indicated.

Drug interactions

With the simultaneous use of bromocriptine with oral contraceptives, the level of prolactin in the blood plasma increases. The drug should not be administered together with other ergot alkaloids.
Bromocriptine enhances the effect of antihypertensive drugs and levodopa. The effectiveness of their treatment may decrease when combined with tricyclic antidepressants (amitriptyline, imipramine) or dopamine agonists (butyrophenones, phenothiazines).
Phenothiazines, monoamine oxidase inhibitors, thioxanthines, furazolidone, reserpine, loxapine, metoclopramide, methyldopa increase plasma bromocriptine levels and increase the risk of side effects.
When combining bromocriptine with ritonavir, it is recommended to reduce the dose of the former by 50%. The combination of the drug with sympathomimetics can provoke attacks of severe headache and increased blood pressure. With the simultaneous administration of bromocriptine and sumatriptan, the risk of a vasospastic reaction increases due to the additive action of these compounds.
The maximum concentration of bromocriptine in blood plasma and its bioavailability increase when the drug is combined with octreotide, erythromycin, clarithromycin and josamycin.
The drug increases the concentration in the blood of drugs that are metabolized by the isoenzyme CYP3A4. When combining the drug with drugs with a narrow therapeutic index, especially those provoking a prolongation of the QT interval (for example, terbinafine, imipramine, amiodarone), caution should be exercised.
The combination of ethanol with the drug can lead to the development of disulfiram-like reactions, expressed in convulsive seizures, weakness, chest pain, decreased visual acuity, hyperemia, throbbing headache, reflex cough, nausea, vomiting.

Terms and conditions of storage

Shelf life - 3 years, store in a dry, dark place at a temperature of 2-8 ° C. Keep out of the reach of children.

Reviews about Bromocriptine

Numerous reviews of Bromocriptine prove the effectiveness of the drug. Patients report a decrease in prolactin levels, a rapid cessation of lactation, and the disappearance of breast lumps. For many breastfeeding women, the drug has helped to stop the production of breast milk, but there are reports that not all patients have been helped by it. Some patients speak negatively about Bromocriptine due to frequent and severe side effects.

Terms of sell

You can buy Bromocriptine without a prescription from a doctor.