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

Active substanceBromocriptineBromocriptine

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Dosage form: & nbsppills

Composition:

Each tablet contains:

Active substance: Bromocriptine mesylate in terms of bromocriptine 2.5 mg;

Excipients: lactose, silicon dioxide colloid, edetate disodium, magnesium stearate, maleic acid, corn starch.

Description:

Tablets of round shape, white or white with a cream-colored shade of color with a risk.

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, contributes to the normalization of menstrual function, reduces the size and number of cysts in the mammary gland due to the elimination of an imbalance in the 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.

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 of somatotropic hormone after 1-2 hours. The maximum effect is achieved after 4-8 weeks of therapy.

Pharmacokinetics:

When ingested, the drug is rapidly absorbed. The maximum concentration in the plasma is reached within 1-3 hours.It is actively metabolized, the drug and the products of its transformations are excreted from the body mainly through the intestine and only 3-6% by the kidneys. Bioavailability with oral administration is about 28-30%. Communication with plasma proteins is 90-96%.

Indications:

Menstrual cycle disorders (hyper- or normoprolactinemic, associated with shortening of the luteal phase).

Female infertility (prolactin-dependent and prolactin-independent).

Premenstrual syndrome.

Prolactin-dependent hypogonadism in men.

Prolactinomas: conservative treatment of secretory prolactin with microaden and macroid adenomas, in the preoperative period to reduce the size of the tumor and facilitate its removal, after surgery, if the level of prolactin remains elevated.

Benign mastopathy, mastalgia.

Hyperprolactinemia caused by medications (some psychotropic, antihypertensive, contraceptive).

Acromegaly (in the form of monotherapy or as an additional tool for surgical treatment and radiation therapy).

Galactorrhea (in combination with amenorrhea or without it): postpartum (for prevention or suppression of lactation for medical reasons), after abortion, idiopathic, tumor,induced drug.

Parkinson's disease and Parkinson's syndrome, incl. after encephalitis (in the form of monotherapy or in combination with other antiparkinsonian agents).

Contraindications:

Hypersensitivity to bromocriptine and other ergot alkaloids;
toxicosis of pregnancy;
arterial hypertension in pregnancy, hypertension in the early and late postpartum period;
essential and family tremor;
Goettington's chorea;
mental disorders, incl. in the anamnesis;

cardiovascular diseases (including arterial hypertension, hypotension);
insufficiency of liver function;
ulcerative lesions of the gastrointestinal tract;
heart valve disease in history;
children's age (up to 15 years, due to lack of sufficient clinical experience);
the period of breastfeeding.

Carefully:

Parkinsonism with symptoms of dementia; pregnancy; simultaneous carrying out of antihypertensive therapy, erosive-ulcerative lesions of the gastrointestinal tract, indications in the anamnesis for bleeding from the gastrointestinal tract.

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, except when there are medical indications for continuing therapy. 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.

If pregnancy occurs when a patient has pituitary adenoma and treatment with Bromocriptine-KV is stopped, it is necessary to monitor the patient throughout the gestation period. In case of signs of pronounced increase in prolactinoma, for example, headaches or narrowing of the fields of vision, Bromocriptine-KV treatment may be resumed or surgery may be performed. Since bromocriptine-KB suppresses lactation, it should not be prescribed during breast-feeding.

Dosing and Administration:

The drug is taken orally during a meal. Dosing regimen is individual.

With violations of the menstrual cycle and female infertility prescribe 1.25 mg (1/2 tablets) 2-3 times a day, if necessary, the dose is gradually increased to 5- 7.5 mg / day. Treatment is continued until the menstrual cycle is normalized and / or ovulation occurs. To prevent recurrence, treatment is carried out for several menstrual cycles.

Premenstrual syndrome: treatment start on the 14th day 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).

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.

With prolactinomas the initial dose is 1.25 mg (1/2 tablet) 2-3 times a day, then the dose is gradually increased to ensure a corresponding decrease in the concentration of prolactin in the plasma.

With acromegaly treatment is started with a dose of 1.25 mg (1/2 tablets) 2-3 times a day, then, depending on the clinical effect and severity of side effects, the dose is increased to 10-20 mg (4-8 tablets) per day. The course of treatment is 3-10 months.

For elimination engorgement of the mammary glands in the puerperium is prescribed once in a dose of 2.5 mg (1 tablet). The drug can be prescribed one more time (after 6-12 hours), which is not accompanied by undesirable suppression of lactation.

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

With hyperprolactinaemia in men is administered at 1.25 mg (1/2 tablets) 2-3 times a day, gradually increasing the dose to 5-10 mg (2-4 tablets per day).

For the treatment of Parkinson's disease and Parkinson's syndrome Bromocriptine-KV is used both in the form of monotherapy, and as part of combination therapy. The mean initial dose is 1.25 mg (1/2 pills); take the drug should be in the evening, for 1 week. If necessary, increase the dose by 1.25 mg per week, distributing 2-3 times per day. The therapeutic effect occurs within 6-8 weeks of treatment, otherwise you can continue to increase the daily dose, increasing it weekly by 2.5 mg / day.The average therapeutic dose varies from 10 to 40 mg per day.

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.

Side effects:

From the digestive system: nausea, vomiting, dry mouth, constipation, diarrhea, impaired liver function.

From the central nervous system: dizziness (usually occurs during the first week of treatment), headache, fatigue, drowsiness, sudden falling asleep, psychomotor agitation, dyskinesia, impaired vision, visual acuity, hallucinations, psychoses.

From the cardiovascular system: orthostatic hypotension, arrhythmia; in some cases, with prolonged use - Raynaud's syndrome (especially in predisposed patients), myocardial infarction, stroke.

Allergic reactions: skin rash.

Other: congestion of the nose, cramps in the calf muscles, caries, periodontal disease, orcandidosis.

In the treatment of Parkinsonism in large doses - confusion,spinal fluid discharge from the nasal passages, syncope, peptic ulcer, gastrointestinal bleeding, retroperitoneal fibrosis (pains in the abdomen, back, loss of appetite, nausea, vomiting, increased urination).

Overdose:

Symptoms: nausea, vomiting, dizziness, arterial hypotension, sweating, drowsiness, hallucinations.

Treatment: It is necessary to stop taking the drug. Treatment is symptomatic. To stop vomiting, parenteral administration of metoclopramide is recommended.

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% reduction in the dose of bromocriptine is recommended. Haloperidol, monoamine oxidase inhibitors, furazolidone, procarbazine, selegiline, loxapine, methyldopa, metoclopramide, molindone, reserpine, thioxanthins and phenothiazines increase plasma concentration and promote the development of adverse reactions.Drugs with antidopaminic action: butyrophenones, phenothiazines can weaken the effect of bromocriptine.

Do not use bromocriptine concomitantly with other derivatives of ergot alkaloids.

Simultaneous administration of ethanol leads to the development of disulfiram-like reactions.

Special instructions:

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

In the first days of treatment, hypotensive reactions, a state of anxiety, are possible, so the control of blood pressure and the general condition of the patient at the beginning of treatment is necessary. At the beginning of treatment it is also recommended to prescribe an anti-emetic for 1 hour before taking the drug.

Women with a regular menstrual cycle receiving bromocriptine long-term, there is a regular (once a year) gynecological examination, preferably with a cytological examination of the epithelium of the cervix and endometrium. After the onset of menopause, such a survey is carried out monthly for six months.

Treatment with bromocriptine-KB can restore normal reproductive function.To prevent an unwanted pregnancy, you need to consult a doctor regarding the use of a reliable method of contraception.

In the case of pregnancy on the background of pituitary adenoma, after discontinuation of treatment with Bromocriptine-KV, regular monitoring of the condition of the adenoma, including examination of the visual fields, is necessary.

When using the drug for the treatment of parkinsonism, periodic monitoring of the kidneys, liver, hematopoiesis, cardiovascular system is necessary.

With arterial hypertension, sharp, persistent headache with visual impairment or without vision impairment, discontinue Bromocriptine-KV treatment and conduct a patient examination.

In the presence of a history of peptic ulcer disease, it is desirable to abandon the treatment of acromegaly with Bromocriptine-KV and to apply, if possible, another therapy. In the case when treatment with Bromocriptine-KV 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.

When Bromocriptin-KB is used to suppress lactation, it is not necessary to limit the flow of fluid into the body.

When suppressing postpartum lactation, regular monitoring of blood pressure is necessary, especially within 1 week of treatment with Bromocriptine-KV.

In the treatment of diseases not accompanied by hyperprolactinemia, the lowest effective dose of Bromocriptin-KB 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.

With simultaneous use with alcohol, it is possible to develop pain in the chest, flushing of the skin, tachycardia, nausea, vomiting, reflex coughing, pulsating headache, blurred vision, weakness, seizures.

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.

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

When taking the drug should refrain from driving the car and classes 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:

10 tablets per contour cell pack.

By 3 contour mesh packages together with instructions for use in a pack of cardboard for consumer packaging.

30 packs per box of cardboard.

Storage conditions:

List B. Store in a dry, dark place at a temperature of + 2 ° C to + 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001388/10

Date of registration:25.02.2010 / 11.04.2012

Expiration Date:Unlimited

The owner of the registration certificate:KIEVSKY VITAMIN FACTORY, PAOKIEVSKY VITAMIN FACTORY, PAO Ukraine

Manufacturer: & nbsp

KIEVSKY VITAMIN FACTORY, PAO Ukraine

Representation: & nbspArt Bureau Ltd.Art Bureau Ltd.Russia

Information update date: & nbsp06.03.2017

Illustrated instructions

Instructions

Bromocriptine-KB (Bromocriptine-KV)