Edit the instructions. Bromocriptine in tablet dosage form 2.5 mg

The necessity of correcting the information and completing the instructions for the use of medicinal products is revealed as follows.

1. The section "Indications for Use" should be submitted in the following edition:

"1) Acromegaly: as an additional remedy or, in special cases, as an alternative to surgical treatment or radiation therapy.

2) Prolactinomas:

- 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 the concentration of prolactin in the blood plasma remains elevated.

3) Suppression of lactation for medical reasons:

- preventing or suppressing lactation in the postpartum period (for example, with intrapartum fetal death, stillbirth, HIV infection in the mother),including at the initial stage of postpartum mastitis;

- prevention of lactation after abortion.

4) Violation of the menstrual cycle and infertility in women:

- Prolactin-dependent diseases and conditions accompanying or not accompanied by hyperprolactinaemia:

- amenorrhea (accompanied or not accompanied by accompanying hyperprolactinemia);

- Luteal phase insufficiency;

- hyperprolactinemia caused by drugs (for example, some psychotropic or hypotensive drugs);

· Female infertility, not due to hyperprolactinaemia:

- Polycystic ovary syndrome;

- Anovulatory cycles (in addition to the use of antiestrogenic agents, for example, clomiphene).

5) Parkinson's disease: all stages of idiopathic Parkinson's disease and postencephalic parkinsonism - in the form of monotherapy or in combination with other antiparkinsonian agents.

6) Hyperprolactinemia in men: prolactin-dependent hypogonadism (oligospermia, loss of libido, impotence). "

2. In the "Contraindications" section only the following diseases / conditions / risk factors should be indicated:

· hypersensitivity to bromocriptine or to any auxiliary drug substance, or to other ergot alkaloids;

· uncontrolled arterial hypertension;

· arterial hypertension during pregnancy and in the puerperium;

· gestosis of the second half of pregnancy (including preeclampsia, eclampsia);

· the postpartum period in women with severe cardiovascular disease in the anamnesis;

· ischemic heart disease and other severe diseases of the cardiovascular system;

· cerebrovascular diseases in the anamnesis;

· obliterating endarteritis; Raynaud's syndrome; temporal arteritis;

· ulcerative diseases of the gastrointestinal tract and gastrointestinal bleeding;

· sepsis;

· severe mental disorders (including history);

· Abuse of tobacco smoking;

· simultaneous application with methylergometrin and other ergot alkaloids; moderate or potent inhibitors of cytochrome P450 (eg, itraconazole, voriconazole, cl. erythromycin th);

· Children under 7 years of age (safety and efficacy of bromocriptine in children younger than 7 years of age is not confirmed).

3. In the "Precautions" section, a list of diseases / conditions / risk factors requiring compliance with the precautionary measures when using the drug should be indicated:

· children over 7 years and adolescents <18 years;

· patients aged> 65 years;

· patients with cardiovascular diseases (for example, arterial hypertension, arrhythmia, the presence of a myocardial infarction in the anamnesis);

· Parkinson's disease (with long-term treatment with high doses of the drug);

· abnormal liver function;

· severe renal insufficiency;

· pregnancy (in patients with pituitary adenoma);

· the postpartum period.

Specify that special care should be taken when using bromocriptine in the postpartum period in patients with hypertension who have recently taken vasoconstrictive drugs (sympathomimetics or ergot alkaloids, for example, ergometrine or methylergomethrin).

4. In the section "Method of administration and dose" it is necessary:

· information of the section should be brought into line with the section "Indications for use";

· make information about the use of the drug in special clinical groups; a temporary decrease in the daily dose of the drug with the development of adverse reactions in the selection of a dose(duration of at least 1 week) and the possibility of a second dose increase with a reduction in side effects; stopping or decreasing the dose of levodopa in case of development of motor disorders in patients on the background of therapy prior to taking bromocriptine;

· make a correction in the field "Acromegaly" regarding the maximum daily dose (MSD) for children and adolescents aged 7 to 18 years - 10 mg; in the field of "Prolactinoma": MSD drug for children 7-12 years - 5 mg; 13-18 years - 10 mg; in the field "Parkinson's disease": the selection of the minimum effective dose for each patient; the time interval through which the dose of the drug can be increased - should be 1 week;

· indicate that MSD bromocriptine for monotherapy or as part of combination therapy should not exceed 30 mg per day.

5. In the section "Side effect" you need:

· the names of system-organic classes should be brought into line with MedDRA indicating the incidence of side effects (according to WHO recommendations);

· in the subsection "Violations from the psyche" indicate in the category "infrequently": depressed mood, confusion, psychomotor agitation, hallucinations; in the category "rarely" - psychosis;

· in the subsection "Violations from the nervous system" indicate in the category "often": headache, dizziness, drowsiness; in the category of "infrequently": dyskinesia; in the category of "rare" - insomnia, paresthesia; at categories "very rare" - episodes of sudden falling asleep;

· in the section "Disturbances on the part of the eye" in the category "rarely" - reduced visual acuity, "blurred vision";

· in the subsection "Violations from the organ of hearing and labyrinthine disorders" indicate in the category "rarely" - ringing or tinnitus;

· in the subsection "Heart disorders", indicate in the category "rarely" - tachycardia, bradycardia, arrhythmia, pericarditis, constrictive pericarditis; in the category of "very rare" - fibrosis valves valve heart; in the category "frequency is unknown" - increased frequency of angina attacks;

· in the subsection "Vascular disturbances" indicate in the category "infrequently" - lowering of arterial pressure, orthostatic hypotension (very rarely leading to fainting); in the category "very rare" - the reversible pallor of the fingers of the upper and lower extremities (especially in patients with Raynaud's syndrome in history);

· in the subsection "Disturbances from the respiratory system,organs of the chest and mediastinum "in the category" often "- nasal congestion, in the category" rarely "- shortness of breath, pleurisy, pleural effusion, pleural fibrosis, pulmonary fibrosis;

· in the subsection "GI disorders" indicate in the category "often" - nausea, vomiting, constipation; in the category "infrequently" - dry mouth; in the category of "rare" - abdominal pain, diarrhea, ulcerative lesions of the walls of the stomach and intestines, gastrointestinal bleeding, retroperitoneal fibrosis;

· in the subsection "Infringements from the skin and subcutaneous tissues" indicate in the category "infrequently" - allergic dermatitis, alopecia;

· in the subsection "Disturbances from the musculoskeletal and connective tissue" indicate in the category "infrequently" - muscle spasm;

· in the subsection "Infringements from the side of the kidneys and urinary tracts" indicate in the category "infrequently" - incontinence;

· in the section "General disorders and disorders at the place of administration", indicate in the category "rarely" - peripheral edema; in the category of "very rare" - the occurrence in the case of a sharp withdrawal of the drug syndrome, reminiscent of malignant neuroleptic syndrome;

· to introduce information on registration in rare cases (with the use of bromocriptine to suppress lactation in the postpartum period) - increasing blood pressure, myocardial infarction, stroke,seizures or mental disorders; when using high doses of bromocriptine for the treatment of Parkinson's disease - the possible development of pathological attraction to gambling; increased libido, hypersexuality (usually reversible after dose reduction or drug withdrawal).

6. In the section "Overdose" it is necessary to indicate symptoms of an overdose of bromocriptine (nausea, vomiting, dizziness, lowering of arterial pressure, orthostatic hypotension, tachycardia, drowsiness, apathy, lethargy, hallucinations); recommendations in case of drug overdose (gastric lavage, taking activated charcoal, conducting symptomatic therapy).

7. In the section "Interaction with other drugs" it is necessary to provide information on the interaction of bromocriptine with inhibitors CYP3A4 (itraconazole, voriconazole, fluconazole, macrolide antibiotics, indinavir, nelfinavir, ritonavir, grapefruit juice); octreotide; sumatriptan; drugs metabolized with CYP3A4 (amiodarone, imipramine, terbinafine); other ergot alkaloids; sympathomimetics; antagonists of dopaminereceptors; ethanol.

8. In the section "Special instructions" it is necessary to provide more detailed information on the diseases / conditions / risk factors specified in the "With caution" section, including in the section it is necessary to provide information that the use of the drug to prevent or suppress lactation in the puerperium should not be routine (the administration of the drug is advisable in case of ineffectiveness application of antispasmodics, analgesics, wearing comfortable underwear); about the possible development of "cold" spasm of blood vessels in patients with acromegaly; recording cases of cerebrospinal fluid rhinorrhea with bromocriptine; regular (no less than 1 time in 4 weeks) pregnancy test in the amenorrhea period in the treatment of prolactin; the need to inform patients and their relatives about the possible development of behavioral disorder in patients (gambling, hypersexuality, compulsive shopping, spending money, overeating); careful monitoring of patients with Parkinson's disease receiving long-term high doses of bromocriptine in mind the possible development of retroperitoneal fibrosis; from pleuropulmonary diseases of unclear etiology; with secondary adrenal insufficiency; the need to monitor the visual fields during the treatment of the pituitary macroprolactin.