Bromocriptine pills 2.5 mg 30 pcs
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Active ingredients
Bromocriptine
Release form
Pills
Composition
1 tablet contains: Active ingredient: bromocriptine 2.5 mg (in the form of 2.87 mg bromocriptine mesylate). Excipients: colloidal silicon dioxide 0.65 mg, magnesium stearate 1.30 mg, talc 3.90 mg, povidone 5.20 mg, corn starch 35.08 mg, microcrystalline cellulose 40.00 mg, lactose monohydrate 41.00 mg .
Pharmacological effect
The drug Bromkriptin is a derivative of the medicinal herb ergot, stimulating the central and peripheral D2 - dopamine receptors in the body. Inhibits physiological lactation by inhibiting the action and secretion of prolactin. Bromkriptin contributes to the normalization of normal menstrual function, reduces the size and promotes the resorption of cysts of the mammary glands. This property is based on eliminating the imbalance of estrogen and progesterone in the body. The drug does not affect the postpartum involution of the uterus, does not increase blood coagulation. It reduces the manifestations of polycystic ovary syndrome by acting on the luteinizing hormone of the pituitary gland. Reduces the size and stops the growth of pituitary tumors that produce prolactin. In high dosages, it stimulates the work of the dopamine receptors of the black nucleus of the brain and the striatum, the mesolimbic system and the hypothalamus, thereby normalizing the neurochemical processes in these brain structures. Bromkriptin has antiparkinsonic action (reduces tremor of limbs, slow movements and rigidity at any stage of Parkinson's disease). Bromkriptin also reduces concomitant Parkinson's disease depression. It suppresses the secretion of adrenocorticotropic and somatotropic hormones of the pituitary, without affecting other pituitary hormones, if their amount in the body is normal. After drinking a single dose after 2 hours, there is a decrease in the level of prolactin in the blood, the maximum effect after taking the drug comes after 8 hours. The maximum anti-Parkinsonian effect is after 2 hours.
Pharmacokinetics
Derivative of ergot, a stimulator of central and peripheral D2-dopamine receptors. Inhibiting prolactin secretion, suppresses physiological lactation, helps normalize menstrual function, and reduces the size and number of cysts in the breast by eliminating the imbalance of progesterone and estrogen levels. It does not affect the postpartum involution of the uterus and does not increase the risk of thromboembolism.Normalizes the secretion of luteinizing hormone, reduces the severity of polycystic ovary syndrome. Stops growth and reduces the size of pituitary prolactin-secreting adenomas. In high doses, it stimulates the dopamine receptors of the striatum and the black core of the brain, the hypothalamus and the mesolimbic system and restores the neurochemical balance in these structures. It has an anti-Parkinsonian effect (reduces tremor, rigidity and slowness of movements in all stages of Parkinson's disease), weakens the severity of concomitant depression, while maintaining effectiveness over the years. Inhibits the secretion of somatotropic and adrenocorticotropic hormones of the pituitary, without affecting other hormones of the pituitary gland, if their concentration is within normal limits. After taking a single dose, a decrease in the level of prolactin in the blood occurs after 2 hours, the maximum effect is observed after 8 hours; anti-Parkinsonian effect - in 30-90 minutes. , maximum effect - after 2 h; 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 period of semi-absorption is 20 minutes. Bioavailability ~ 6% as a result of primary metabolism in the liver. Communication with proteins (albumin) of plasma - 90-96%. Penetrates into breast milk. The maximum concentration in the blood is reached after 1-3 hours. The half-life is two-phase: 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% kidneys.
Indications
Disorders of the menstrual cycle, female infertility: prolactin-dependent diseases and conditions, accompanied or not accompanied by hyperprolactinemia (amenorrhea, accompanied and not accompanied by galactorrhea, oligomenorrhea, luteal phase insufficiency, secondary hyperprolactinemia, induced by drugs). prolactin-independent female infertility (polycystic ovary syndrome. anovulatory cycles, as an additional therapy to anti-estrogens). Premenstrual syndrome: breast tenderness. swelling associated with the phase of the cycle. flatulence. mood disturbances.Male hyperprolactinemia: prolactin-dependent hypogonadism (oligospermia, loss of libido, impotence). Prolactinomas: 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: prevention or termination of postpartum lactation for medical reasons, prevention of lactation after an abortion. postpartum breast engorgement. beginning postpartum mastitis. Benign breast diseases: mastalgia in isolation or in combination with premenstrual syndrome or benign nodular or cystic changes). benign nodular or cystic changes, especially fibrocystic mastopathy. Parkinson's disease and parkinsonism syndrome, including after encephalitis (as monotherapy or in combination with other anti-Parkinsonian drugs).
Contraindications
Hypersensitivity to the active substance, other ergot alkaloids, or any of the fillers. In the case of long-term treatment: signs of failure of the heart valves, obtained during echocardiography, conducted before the start of treatment. Pregnant toxemia, postpartum and generic hypertension, uncontrolled hypertension, idiopathic or hereditary tremor, Huntington's chorea. Bromocriptine is contraindicated for the purpose of suppressing lactation in patients with atherosclerotic heart disease or other severe cardiovascular diseases in history or symptoms / history of severe mental disorders. Patients with these conditions, who require bromocriptine as indicated by macroadenomas, can take it only if the expected benefits are more substantial than the potential risks (see Section “Special Security Measures”). Bromocriptine should not be taken simultaneously with other ergot alkaloids. Bromocriptine should not be prescribed to patients with a history of fibrous disorders or signs of heart valve insufficiency, obtained by echocardiography, performed before the start of treatment.Treatment during the period of pregnancy is described in the section “Use during pregnancy or breastfeeding”.
Precautionary measures
One should refrain from driving a car and practicing activities that require increased attention and speed of physical and psychomotor reactions (sudden falling asleep, reduced visual acuity are possible). These restrictions are individual.
Use during pregnancy and lactation
Pregnancy: Women of childbearing age during treatment with bromocriptine need to ensure reliable, if possible non-hormonal contraception. If the patient wants to continue the pregnancy, treatment with bromocriptine should be discontinued, except for cases when the benefit of using bromocriptine for the mother is greater than the harm to the fetus. Receiving bromocriptine in the first 8 weeks of pregnancy does not adversely affect the course and outcome of pregnancy. After the abolition of the drug, abortions do not increase. During the period of lactation is used exclusively for indications.
Dosage and administration
Inside, during meals, the maximum daily dose is 100 mg. Violations of the menstrual cycle, female infertility: 1, 25 mg 2-3 times a day. if the effect is insufficient, the dose is gradually increased to 5-7, 5 mg / day (the frequency of intake 2-3 times a day). Treatment continues until the normalization of the menstrual cycle or the restoration of ovulation. If necessary, for the prevention of relapses, treatment can be continued for several cycles. Premenstrual syndrome: treatment begins on the 14th day of the cycle with 1, 25 mg days. Gradually increase the dose by 1, 25 mg days to 5 mg days (before the onset of menstruation). Hyperprolactinemia in men: 1, 25 mg 2-3 times a day, gradually increasing the dose to 5-10 mg a day. Prolactinomas: 1, 25 mg 2-3 times a day, with a gradual increase in the dose to several pills per day, necessary to maintain an adequate reduction in the concentration of prolactin in the plasma. Acromegaly: the initial dose is 1, 25 mg 2-3 times a day, later, depending on the clinical effect and side effects, the daily dose is gradually increased to 10-20 mg. Suppression of lactation: on 1 day, appoint 1, 25 mg 2 times (with meals at breakfast and dinner), then within 14 days, 2, 5 mg 2 times a day.To prevent the onset of lactation, the drug should be started within a few hours after giving birth or abortion (after stabilization of vital functions). 2-3 days after discontinuation of the drug, there is sometimes a slight secretion of milk. It can be eliminated by resuming the drug in the same dose for another 1 week. Postpartum breast engorgement: prescribed once in a dose of 2.5 mg, after 6-12 hours, if necessary, repeat the reception (this is not accompanied by undesirable suppression of lactation). Starting postpartum mastitis: the dosing regimen is the same as in the case of lactation suppression. If necessary, an antibiotic is added to the treatment. Benign breast diseases: 1, 25 mg 2-3 times a day. The daily dose is gradually increased to 5-7, 5 mg. Parkinson's disease: for optimal tolerability, treatment should begin with a small dose of the drug: 1, 25 mg 1 time per day (preferably in the evening) for 1 week. The daily dose of the drug is increased gradually, every week by 1, 25 mg, the daily dose is divided into 2-3 doses. An adequate therapeutic result can be achieved within 6-8 weeks of treatment. If this does not occur, the daily dose can be increased further - every week by 2.5 mg days. The average therapeutic dose of bromocriptine for mono-or combination therapy is 10-30 mg per day. The maximum daily dose is 30 mg. If during the selection of the dose side effects occur, the daily dose should be reduced and maintained at a lower level for at least 1 week. If side effects disappear, the dose can be increased again. Patients with motor impairments occurring during the administration of levodopa are advised to reduce the dose of levodopa before using bromocriptine. After achieving a satisfactory effect, a further gradual reduction in the dose of levodopa can be undertaken. In some patients, complete elimination of levodopa is possible.
Side effects
On the part of the digestive system: nausea, vomiting, dry mouth, constipation, diarrhea, abnormal liver function. On the part of the central nervous system: dizziness (usually occur in the first week of treatment), headache, drowsiness, psychomotor agitation, dyskinesia, decreased visual acuity, hallucinations.Since the cardiovascular system: orthostatic hypotension, arrhythmia. in some cases, with long-term use - Raynaud's syndrome (especially in susceptible patients). Allergic reactions: skin rash. Other: nasal congestion, cramps in the calf muscles.
Overdose
Symptoms: headache, hallucinations, arterial hypotension. Treatment: parenteral administration of metoclopramide.
Interaction with other drugs
Reduces the effectiveness of oral contraceptives. Enhances the effects of levodopa, antihypertensive drugs. Erythromycin, clarithromycin, troleandomycin increase bioavailability and maximum plasma concentration. When administered with ritonavir, a 50% dose reduction is recommended. Monoamine oxidase inhibitors, furazolidone, procarbazine, selegilin, ergot alkaloids (cannot be used together), loxapine, methyldof, metoclopramide, molindone, reserpine, thioxanthins increase the concentration in plasma and promote the development of adverse reactions. Drugs with anti-dopamine action: butyrophenones, phenothiazines can weaken the effect of bromocriptine. Acceptance of ethanol leads to the development of disulfiram-like reactions: chest pain, hyperemia, tachycardia, nausea, vomiting, reflex cough, pulsating headache, decreased visual acuity, weakness, convulsions
special instructions
For the prevention of dizziness, nausea and vomiting at the beginning of treatment, it is advisable to prescribe an antiemetic for 1 hour before taking the drug. Periodic monitoring of blood pressure, kidney and liver function is recommended, in case of parkinsonism, it is additionally a function of the cardiovascular system, a blood picture. It should be remembered about the possibility of pregnancy after childbirth on the background of drug treatment due to the rapid recovery of ovulatory cycles, and therefore it is advisable to use non-hormonal contraception. In case of pregnancy on the background of pituitary adenoma, after cessation of treatment with bromocriptine, regular monitoring of the condition of the adenoma, including visual field research, is necessary. When suppressing postpartum lactation, regular monitoring of blood pressure is necessary, especially in the first week of treatment with bromocriptine.Before the treatment of benign breast diseases, the presence of a malignant tumor of the same localization should be excluded. In case of arterial hypertension, a sharp, persistent headache with impaired visual acuity or without visual impairment, treatment with bromocriptine should be discontinued and the patient should be examined. If you have a history of gastric ulcer, it is desirable to refuse treatment of acromegaly with bromocriptine and apply, if possible, another therapy. If bromocriptine is still to be treated, the patient should be warned about the possible development of gastrointestinal disorders and the importance of contacting the attending physician in such cases. Careful oral hygiene is necessary. With continued dryness of the oral cavity for more than 2 weeks, you should consult with your doctor. In the presence of mental disorders the appointment of large doses requires special care. In the case of a pronounced increase in the size of prolactinoma, treatment should be resumed. In the treatment of diseases not involving hyperprolactinemia, prescribe the lowest effective dose of bromocriptine. With the development of pleural-pulmonary symptoms (infiltration in the lungs, pleural effusion), treatment should be discontinued and a thorough medical examination of the patient should be carried out.