Bromocriptine-Richter - instructions for use, dose, side effects, contraindications

Excipients: silicon dioxide colloid 0.65 mg, magnesium stearate 1.30 mg, talc 3.90 mg, povidone-K30 5.20 mg, corn starch 35.08 mg, microcrystalline cellulose 40.00 mg, lactose monohydrate 41.00 mg.

Description:

Almost white, round, flat tablets, with a bevel, with a risk on one side and with an engraving "2.5" on the other.

Pharmacotherapeutic group:Dopamine receptor agonist

ATX: & nbsp

N.04.B.C Stimulants of dopamine receptors

N.04.B.C.01 Bromocriptine

Pharmacodynamics:

The ergot derivative, a stimulant of central and peripheral D2-dopamine receptors. Inhibiting the secretion of prolactin, suppresses physiological lactation, promotes the normalization of menstrual function,reduces the size and number of cysts in the mammary gland by eliminating the imbalance in levels of progesterone and estrogens. Does not affect the postnatal involution of the uterus and does not increase the risk of thromboembolism. Normalizes the secretion of luteinizing hormone, reduces the severity of the syndrome of polycystic ovaries. Stops growth and reduces the size of prolactin secretion-mediated pituitary adenomas.

In high doses, it stimulates the dopamine receptors of the striatum and the black core of the brain, the hypothalamus and mesolimbic system and restores the neurochemical balance in these structures. Has antiparkinsonian action (reduces tremor, stiffness and slowness of movements in all stages of Parkinson's disease), reduces the severity of concomitant depression, maintaining effectiveness for many years.

Suppresses the secretion of somatotropic and adrenocorticotropic hormones of the pituitary gland, without affecting other hormones of the pituitary gland, if their concentration is within normal limits.

After taking a single dose, the decrease in prolactin level in the blood comes in 2 hours, the maximum effect is observed after 8 hours; antiparkinsonian effect - after 30-90 minutes, maximum effect after 2 hours; decrease in somatotropic hormone - after 1-2 hours.The maximum effect is achieved after 4-8 weeks of therapy.

Pharmacokinetics:

Absorption from the gastrointestinal tract is ~ 30%, the half-absorption period is 20 min. Biological availability ~ 6% as a result of primary metabolism in the liver. The connection with proteins (albumins) of plasma is 90-96%. Penetrates into breast milk. The maximum concentration in the blood is reached after 1-3 hours. The half-life period is biphasic: the alpha phase is 4-4.5 hours, the final phase is 15 hours. The excretion is carried out in the form of metabolites, mainly with bile and 6%.

Indications:

Violations of the menstrual cycle, female infertility:

Prolactin-dependent diseases and conditions, accompanied or not accompanied by hyperprolactinaemia: amenorrhea with or without galactorrhea; oligomenorrhoea; Luteal phase insufficiency; secondary hyperprolactinemia associated with the use of medications (some psychostimulants, hypotensive drugs).
Prolactin-independent female infertility: polycystic ovary syndrome, anovulatory cycles (in addition to anti-estrogen therapy, eg clomiphene).
Premenstrual syndrome (tenderness of the mammary glands, swelling, flatulence, mood disorders).

Hyperprolactinemia in men: prolactin-dependent hypogonadism (oligospermia, decreased libido, impotence).

Prolactinomas: conservative treatment of prolactin secreting micro- and macroadenomas of the pituitary gland; preoperative preparation to reduce the volume of the tumor; Postoperative treatment if the level of prolactin remains elevated.
Acromegaly: as an additional tool in complex therapy, together with radiotherapy and surgical treatment, or, in special cases, as an alternative to surgical or radiation treatment.
Suppression of lactation: prevention or suppression of postpartum lactation medical conditions: after an abortion; postpartum engorgement of dairy glands; beginning postpartum mastitis.

Benign mammary gland diseases: mastalgia with premenstrual syndrome or without it; mastalgia with benign nodal or cystic gland changes; benign nodal or cystic changes, especially fibrocystic mastopathy.

All stages of idiopathic Parkinson's disease and postencephalitic parkinsonism (monotherapy or in combination with other antiparkinsonianmedicinal products).

Contraindications:

Hypersensitivity to bromocriptine and other ergot alkaloids;
heart valve diseases;
gestosis;
arterial hypertension in the postpartum period;
essential and family tremor;
Goettington's chorea;
psychoses;
cardiovascular diseases (including arterial hypertension, hypotension);

liver failure;
ulcerative lesions of the gastrointestinal tract;
children's age (up to 15 years, due to lack of sufficient clinical experience).

Carefully:

Parkinsonism with symptoms of dementia; pregnancy; lactation period; simultaneous carrying out of antihypertensive therapy.

Pregnancy and lactation:

Pregnancy: Women of childbearing age during treatment with bromocriptine should ensure reliable, possibly non-hormonal contraception. If the patient wishes to save the pregnancy, bromocriptine should be discontinued, unless the benefits of using bromocriptine for the mother are greater than the harm done to the fetus. Taking bromocriptine in the first 8 weeks of pregnancy does not have a harmful effect on the course and outcome of pregnancy.After abortion abortion does not increase.

During lactation apply only on indications.

Dosing and Administration:

Inside, with food.

Violations of the menstrual cycle, female infertility: for 1.25 mg 2-3 times per day, if necessary, the dose is gradually increased to 5-7.5 mg / day. Treatment continues until the menstrual cycle is normalized and / or ovulation is restored. To prevent relapse, treatment can continue for several menstrual cycles.

Premenstrual syndrome: treatment begin on day 14 of the menstrual cycle with 1.25 mg / day, the dose is gradually increased by 1.25 mg / day to 5 mg / day (before menstruation).

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

Prolactinomas: 1.25 mg 2-3 times a day, gradually increasing the dose to several tablets per day, providing the desired level of prolactin in the blood.

Acromegaly: the initial dose of 1.25 mg 2-3 times a day, then, depending on the clinical and side effects, the daily dose can be gradually increase to 10-20 mg.

Cessation of lactation: on the first day of 1.25 mg 2 times (morning and evening), then for 14 days 2.5 mg twice a day.Treatment should be started several hours after childbirth or abortion, but not in the first 4 hours after them - after stabilization of vital body functions. 2-3 days after drug cancellation, a slight secretion of milk is possible, the resumption of taking the drug for another 1 week at the same dose leads to the cessation of secretion.

Beginning postpartum mastitis: see section cessation of lactation. If necessary, begin treatment with an antibiotic.

Postpartum engorgement of mammary glands: 2.5 mg once, after 6-12 hours the dose can be repeated, undesirable stopping of lactation does not occur.

Benign mammary gland diseases: 1.25 mg 2-3 times a day, the dose is gradually increased to 5 -7.5 mg / day.

Parkinson's disease: to ensure optimal tolerability, treatment starts with a small dose: 1.25 mg 1 time per day, preferably in the evening, for 1 week. Dose gradually, weekly increase by 1.25 mg, distributing for 2-3 doses per day.

The therapeutic effect occurs within 6-8 weeks. treatment, otherwise you can continue to increase the daily dose, weekly increasing it by 2.5 mg / day.

The average therapeutic doses of bromocriptine for mono- and combination therapy are 10-30 mg / day. The maximum daily dose is 30 mg. In case of side effects, the daily dose is to be reduced, after each next decrease the dose is prescribed for at least 1 week. With the disappearance of unwanted reactions, the dose can be increased again. Patients with motor disorders noted on the background of taking levodopa, it is recommended to lower the dose of levodopa before the application of bromocriptine. In case of a satisfactory therapeutic effect, a further gradual decrease in the dose of levodopa can be continued, sometimes until its complete cancellation. Treatment with bromocriptine should be started simultaneously with the development of side effects of levodopa, for example, dyskinesia, worsening of the condition at the end of the dose of levodopa, associated with a decrease in the duration of a single dose (effect "end of dose"), starting with the minimum effective dose of bromocriptine. Higher doses are used in exceptional cases.

Side effects:

Nausea, vomiting, headache, dizziness, rarely - orthostatic hypotension,fatigue (these side effects do not require discontinuation of treatment), myocardial infarction, stroke, obstipation, drowsiness, sudden falling asleep, psychomotor agitation, hallucinations, psychoses, dyskinesia, decreased visual acuity, dry mouth, caries, periodontal disease, orcandiosis, nasal congestion, allergic skin rash, cramps in the calf muscles.

With prolonged therapy - Raynaud's syndrome; in the treatment of Parkinsonism in large doses - confusion, the isolation of cerebrospinal fluid from the nasal passages, syncope, peptic ulcer, gastrointestinal bleeding, retroperitoneal fibrosis (pain in the abdomen, back, loss of appetite, nausea, vomiting, rapid urination).

Overdose:

Symptoms: headache, hallucinations, arterial hypotension.

Treatment: parenteral administration of metoclopramide.

Interaction:

Reduces the effectiveness of oral contraceptives.

Enhances the effects of levodopa, hypotensive drugs.

Erythromycin, clarithromycin, troleandomycin increase the bioavailability and maximum concentration in the plasma.

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

Inhibitors of monoamine oxidase, furazolidone, procarbazine, selegiline, ergot alkaloids (can not be used together), loxapine, methyldopa, metoclopramide, molindone, reserpine, thioxanthins increase the concentration in the plasma and promote the development of adverse reactions.

Drugs that have an antidopaminic effect: butyrophenones, phenothiazines can weaken the effect of bromocriptine.

The use of ethanol leads to the development of disulfiram-like reactions: chest pain, hyperemia, tachycardia, nausea, vomiting, reflex cough, pulsatingheadache, decreased visual acuity, weakness, convulsions.

Special instructions:

To prevent dizziness, nausea and vomiting at the beginning of treatment, it is advisable to prescribe anti-emetics for 1 hour before taking the drug. Periodic monitoring of arterial pressure, kidney and liver function is recommended, with Parkinsonism - additionally functions of the cardiovascular system, blood paintings.

It should be remembered about the possibility of pregnancy after childbirth on the background of drug treatment due to rapid recovery of ovulatory cycles, in connection with which it is advisable to use non-hormonal contraception.

In the case of pregnancy on the background of pituitary adenoma, after the cessation of bromocriptine treatment, regular monitoring of the condition of the adenoma, including examination of the visual fields, is necessary.

When suppressing postpartum lactation, regular monitoring of blood pressure is necessary, especially in the first week of bromocriptine treatment.

Before beginning treatment of benign breast diseases, the presence of a malignant tumor of the same localization should be excluded.

With arterial hypertension, sharp, persistent headache with visual impairment or without vision impairment, bromocriptine treatment should be discontinued and the patient should be examined.

In the presence of a history of peptic ulcer disease, it is desirable to abandon the treatment of acromegaly with bromocriptine and apply, if possible, another therapy. In the case when treatment with bromocriptine will still be performed, the patient should be warned about the possible development of gastrointestinal disorders and the importance of treatment in such cases to the treating doctor.

Careful hygiene of the oral cavity is necessary. With continued dryness of the oral cavity for more than 2 weeks, you should consult your doctor.

In the presence of mental disorders, the appointment of large doses requires special care.

In the case of a pronounced increase in prolactinoma size, it is necessary to start treatment again.

In the treatment of diseases not accompanied by hyperprolactinemia, the lowest effective dose of bromocriptine is prescribed.

With the development of pleuropulmonary symptoms (infiltration in the lungs, pleural effusion), discontinue treatment and conduct a thorough medical examination of the patient.

Effect on the ability to drive transp. cf. and fur:

You should refrain from driving a car and doing activities that require increased attention and speed of physical and psychomotor reactions (sudden falling asleep, reduced visual acuity). These restrictions are of an individual nature.

Form release / dosage:

Tablets 2.5 mg.

Packaging:

For 30 tablets in brown glass vial of hydrolytic class III. 1 vial with Instructions for use are placed in a pack of cardboard.

Storage conditions:

Keep in a dark place at temperature not higher than 30 ° С.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N011972 / 01

Date of registration:02.04.2011 / 15.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER OJSC Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp06.03.2017

Illustrated instructions

Instructions

Bromocriptin-Richter (Bromocriptin-Richter)