PHARMACENT VILAR, JSC (Russia)
Active material: bromocriptine (bromocriptine)
Rec.INN registered by WHO
| Abergin | Tab. 4 mg: 30 or 100 PC. reg. №: LSR-001033/10 from 16.02.10 – Бессрочно |
| Pills | 1 tab. |
| bromocriptine (in the form of mesylate) | 4 mg |
10 PC. – упаковки ячейковые контурные (1) – пачки картонные.
10 PC. – упаковки ячейковые контурные (3) – пачки картонные.
30 PC. – банки (1) – пачки картонные.
Clinical and pharmacological group: The inhibitor of prolactin secretion. Of anti-drug
Pharmaco-therapeutic group: dopamine receptor agonist
Stimulator of central and peripheral dopamine D2 receptors, ergot alkaloid derivative. Reduces the secretion of prolactin, as well as increased secretion of GH, without affecting normal levels of other pituitary hormones. Suppresses physiological lactation, contributes to the normalization of menstrual function, reduces the size and number of cysts in the mammary gland (by correcting the imbalance between progesterone and estrogen). In doses higher, than required to suppress the secretion of prolactin, bromocriptine causes pronounced stimulation of dopamine receptors, in particular in the area of the striatum, black nucleus of the brain, hypothalamus and mesolimbic system. Has an anti-Parkinsonian effect, suppresses the secretion of GH and ACTH.
After taking a single dose, a decrease in the level of prolactin in the blood occurs through 2 no, максимальный эффект – через 8 no; antiparkinsonian effect develops through 30-90 m, максимальный эффект – через 2 no; a decrease in the level of STH occurs through 1-2 no, максимальный эффект – через 4-8 weeks of therapy.
After oral administration, the absorption of bromocriptine from the gastrointestinal tract is 28%. Подвергается эффекту “первого прохождения” через печень. Bioavailability - 6%. Время достижения максимальной концентрации в плазме крови – 1-3 no. T1 / 2 two-phase: 4-4.5 h in α-phase, 1 ч – в терминальной фазе.
Связывание с альбуминами плазмы – 90-96%.
Выводится преимущественно с калом – 85.6% и в незначительной степени с мочой – 2.5-5.5%.
Menstrual irregularities, anogyny: prolactin-dependent diseases and conditions, accompanied or not by hyperprolactinemia (amenorrhea, accompanied and not accompanied by galactorrhea; spanomenorrhea; insufficiency of the luteal phase; secondary hyperprolactinemia, drug-induced); prolactin-independent female infertility (polycystic ovary syndrome; ановуляторные циклы – в качестве дополнительной терапии к антиэстрогенам).
Premenstrual syndrome: breast tenderness; swelling, related to cycle phase; flatulence; mood disorders.
Hyperprolactinemia in men: prolactin-dependent hypogonadism (oligospermatism, loss of libido, impotence).
Prolaktinomy: conservative treatment of prolactin-secreting micro- and pituitary macroadenomas; in the preoperative period to reduce the size of the tumor and facilitate its removal; postoperative treatment, if prolactin levels remain elevated.
Suppression of lactation: предотвращение или прекращение послеродовой лактации по медицинским показаниям – предотвращение лактации после аборта; postpartum breast engorgement; incipient postpartum mastitis.
Benign diseases of the mammary glands: mastalgia alone or in combination with premenstrual syndrome or benign nodular or cystic changes; benign nodular and/or cystic changes, especially fibrocystic mastopathy.
Parkinson's disease and parkinsonism syndrome, incl. after encephalitis (as monotherapy or in combination with other antiparkinsonian drugs).
The method of application and dosing regimen of a particular drug depends on its form of release and other factors.. The optimal dosing regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed..
Individual, depending on indications and clinical situation. Внутрь – в дозе 1.25-2.5 mg 2-3 times / day. For male hypogonadism, prolactinoma, benign diseases of the mammary glands, acromegaly, the dose is gradually increased to 5-20 mg / day; при паркинсонизме – до 10-40 mg / day. If adverse reactions develop during dose selection, the daily dose should be reduced and maintained at this level for a week; when side effects disappear, the dose can be increased again.
Mental Disorders: нечасто – подавленное настроение, confusion, psychomotor agitation, hallucinations; редко – психоз.
From the nervous system: often - headache, dizziness, drowsiness; нечасто – дискинезия; редко – бессонница, paraesthesia; очень редко – эпизоды внезапного засыпания, rhinorrhea of cerebrospinal fluid.
On the part of the organ of vision: редко – снижение остроты зрения, blurred vision.
On the part of the organ of hearing and labyrinth disorders: редко – звон или шум в ушах.
Cardio-vascular system: нечасто – снижение АД, orthostatic hypotension (very rarely leading to fainting); rarely - tachycardia, bradycardia, arrhythmia, perikardit, constrictive pericarditis; очень редко – фиброз створок клапанов сердца, reversible pallor of the fingers of the upper and lower extremities (especially in patients with Raynaud's syndrome history); частота неизвестна – учащение приступов стенокардии.
The respiratory system: часто – заложенность носа; редко – одышка, pleurisy, pleural effusion, plyevralinyi fibrosis, fibrosis lyegkikh.
On the part of the digestive tract: often - nausea, vomiting, constipation; нечасто – сухость во рту; редко – боль в животе, diarrhea, ulcerative lesions of the walls of the stomach and intestines, gastrointestinal bleeding, ryetropyeritonyealinyi fibrosis.
Skin and subcutaneous tissue disorders: нечасто – аллергический дерматит, alopecia.
On the part of the musculoskeletal system: нечасто – спазм мышц.
From the urinary system: нечасто – недержание мочи.
General disorders and disorders at the injection site: нечасто – повышенная утомляемость; редко – периферические отеки; очень редко – возникновение в случае резкой отмены препарата синдрома, resembling neuroleptic malignant syndrome.
From laboratory and instrumental studies: очень редко – гипонатриемия.
Rare cases have also been reported (when using bromocriptine to suppress lactation in the postpartum period) increase blood pressure, myocardial infarction, stroke, seizures or mental disorders.
Hypersensitivity to bromocriptine, uncontrolled hypertension; arterial hypertension during pregnancy and in the postpartum period, gestosis in the second half of pregnancy (incl. preeclampsia and eclampsia), postpartum period in women with a history of severe cardiovascular disease; IHD and other serious diseases of the cardiovascular system, history of cerebrovascular disease, occlusive disease, Raynaud's syndrome, Temporal Arteritis, gastrointestinal ulcers and gastrointestinal bleeding, sepsis, severe mental disorders (incl. history); tobacco abuse; simultaneous use with methylergometrine or other ergot alkaloids, moderate or potent inhibitors of cytochrome P450 (eg, itraconazole, vorikonazolom, clarithromycin); Children up to age 7 years.
Carefully: children and adolescents from 7 to 18 years, elderly patients (senior 65 years), patients with cardiovascular disease (eg, hypertension, arrhythmias, having a history of myocardial infarction), Parkinson's disease (long-term treatment with high doses), abnormal liver function, severe renal failure, pregnancy (in patients with pituitary adenoma), postpartum, patients with arterial hypertension, recently taken vasoconstrictor drugs (sympathomimetics or ergot alkaloids, eg, ergometrine or methylergometrine), concomitant antihypertensive therapy.
If pregnancy is diagnosed during therapy with bromocriptine, its use should be discontinued., unless it is necessary to continue therapy for medical reasons.
Contraindicated for use during lactation, except for the need to suppress lactation for medical reasons.
Contraindicated in severe hepatic insufficiency (Class C classification Child-Pugh). To apply caution in patients with impaired hepatic function.
Use with caution in patients with severe renal insufficiency.
Contraindicated in children under the age of 7 years. Be wary appoint children and adolescents aged from 7 to 18 years.
Use with caution in elderly patients, treatment should be initiated at the lowest dose in the appropriate dose range.
Use with caution in parkinsonism with signs of dementia, while conducting antihypertensive therapy, in patients with erosive and ulcerative lesions of the gastrointestinal tract, a history of bleeding from the gastrointestinal tract.
Since hypotensive reactions are possible in the first days of treatment, status anxiety, regular monitoring of blood pressure and the patient's condition is necessary.
Most side effects of bromocriptine usually decrease or disappear with dose reduction.. At the beginning of treatment, it is recommended to prescribe an antiemetic for 1 h until taking bromocriptine.
Women with regular menstrual cycles, receiving bromocriptine for a long time, shown regular (1 once a year) gynaecological examination, preferably with a cytological examination of the tissues of the cervix and endometrium. After the onset of menopause, such an examination is carried out monthly for six months..
With pituitary adenoma, which is accompanied by a significant increase in the size of the Turkish saddle and a violation of visual fields, bromocriptine is prescribed only in those cases, when surgery and radiotherapy fail.
Treatment with bromocriptine may restore normal reproductive function. Use reliable birth control to prevent unwanted pregnancy (with the exception of hormonal contraceptives).
When prescribing bromocriptine for mastopathy, the presence of a malignant tumor should be excluded..
In Parkinson's disease and parkinsonism syndrome, the combined use of bromocriptine and levodopa leads to an increase in the clinical effect., which allows you to reduce the dose of levodopa up to complete abolition. This is especially important for patients, who develop motor impairment during treatment with levodopa, and there is no stable therapeutic effect.
Effects on ability to drive vehicles and mechanisms
During the period of treatment should refrain from potentially hazardous activities, requiring attention and quick emotional reactions.
With simultaneous use with bromocriptine, the effectiveness of antipsychotics of dopamine receptor antagonists decreases..
When used simultaneously with butyrophenone derivatives, phenothiazine may reduce the effects of bromocriptine.
Patients, simultaneously receiving bromocriptine and sympathomimetics, there have been cases of severe headache, hypertension, seizures, cardiac dysfunction, psychosis.
With simultaneous use with domperidone, it is possible to reduce the effect of bromocriptine when administered in order to reduce the level of prolactin.
With simultaneous use with levodopa, the anti-Parkinsonian effect is enhanced.; с антигипертензивными препаратами – усиливается гипотензивное действие.
When applied simultaneously with erythromycin, dzhozamytsynom, other macrolide antibiotics, octreotide may increase the concentration of bromocriptine in the blood plasma; с этанолом – возможно усиление побочных эффектов бромокриптина.
Bromocriptine reduces the effectiveness of oral contraceptives.
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