Klostilbegit pills of 10 pieces
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Active ingredients
Clomiphene
Release form
Pills
Composition
1 tablet contains: Active substance: clomiphene citrate 50 mg. Adjuvants: gelatin - 2 mg, magnesium stearate - 2 mg, stearic acid - 2 mg, talc - 5 mg, potato starch - 39 mg, lactose monohydrate - 100 mg.
Pharmacological effect
Anti-estrogen drug nonsteroidal structure. The mechanism of action is due to specific binding to the ovarian and ovarian receptors of the pituitary gland. With a low content of estrogen in the body, it exhibits a moderate estrogenic effect; with a high content, it has an anti-estrogenic effect. In small doses, it increases the secretion of gonadotropins (prolactin, FSH and LH), stimulates ovulation; in high doses inhibits the secretion of gonadotropins. Progestin and androgenic activity does not possess.
Pharmacokinetics
AbsorptionAfter taking the drug inside, clomiphene is well absorbed from the gastrointestinal tract. MetabolismClomiphene is metabolized in the liver. It is subject to enterohepatic recirculation. Clomiphene T1 / 2 withdrawal is 5-7 days. Excreted mainly with bile.
Indications
- Anovulatory infertility (induction of ovulation); - Amenorrhea (dysgonadotropic form); - Secondary amenorrhea; - Postcontraceptive amenorrhea; - Stein-Leventhal syndrome (polycystic ovarian syndrome); Frommel (syndrome of long-term postpartum amenorrhea-galactorrhea); - Androgenic deficiency; - In men: oligospermia.
Contraindications
- Hepatic and / or renal failure; - Ovarian cyst (except for polycystic ovarian syndrome); - Pituitary gland tumor or hypofunction; - Thyroid dysfunction; - Adrenal dysfunction; - Metrorrhagia of unknown etiology; - Long-existing or newly developed visual impairment; - Genital neoplasms; - Endometriosis; - Ovarian function insufficiency on the background of hyperprolactinemia; - Pregnancy; - Lactation (breastfeeding); - Galactose intolerance, lactase deficiency or malabsorb glucose Ia - Increased sensitivity to the drug.
Use during pregnancy and lactation
Use during pregnancy and during breastfeeding is contraindicated.
Dosage and administration
With infertility, the dose and duration of treatment depends on the sensitivity (reaction to the drug) of the ovaries. Patients with a regular menstrual cycle are advised to begin treatment on the 5th day of the cycle (or on the 3rd day of the cycle during early ovulation or the duration of the follicular phase less than 12 days) . With amenorrhea, treatment can begin on any day. Scheme I: 50 mg / day for 5 days while simultaneously controlling the reaction of the ovaries with the help of clinical and laboratory studies. Ovulation usually occurs between 11 and 15 days of the cycle. If such treatment does not lead to ovulation, then the scheme II should be applied. Scheme II: from the 5th day of the next cycle, 100 mg / day is prescribed for 5 days. If ovulation is not observed at this time, then the same scheme should be repeated again (100 mg / day). In case of continuing anovulation, the drug should be discontinued for 3 months, and then repeat the treatment for 3 months. With the ineffectiveness of the second course, subsequent drug treatment is also not effective. The maximum total dose of the drug taken during each course is 750 mg. In case of polycystic ovarian syndrome, due to the tendency to overstimulation, the initial dose of the drug is 50 mg / day. In postcontraceptive amenorrhea, the drug should be administered at a dose of 50 mg / day. As a rule, when using Scheme I, a five-day course of treatment is successful. According to the indications, men are prescribed 50 mg 1-2 times / day for 6 weeks under the systematic control of the spermogram.
Side effects
Determination of the frequency of side effects: often -> 1%; rarely - <1%. From the digestive system: nausea, vomiting; rarely - gastralgia, flatulence, diarrhea, acute abdomen syndrome, increased appetite. For the central nervous system: headache, dizziness, drowsiness; rarely - slowing down of mental and motor reactions, irritability, depression, insomnia. On the part of the sense organs: visual impairment (including impaired light perception, doubling, blurring of contours, photophobia). On the part of the urinary system: increased urination, polyuria. On the part of the reproductive system: pain in the lower abdomen, vaginal dryness. On the part of the endocrine system: compaction of the mammary glands, dysmenorrhea, abnormal uterine bleeding, an increase in the size of the ovary (includingcystic); rarely, pain in the chest. When treating clomiphene, the likelihood of multiple pregnancy, ectopic pregnancy, endometriosis, growth of existing uterine fibroma increases. There may be a cystic enlargement of the ovaries, especially with Stein-Leventhal syndrome. In these cases, the size of the ovaries can reach 4-8 cm. At the same time, you should monitor the body temperature and stop treatment as soon as it becomes two-phase. Dermatological reactions: rarely - alopecia. On the metabolic side: rarely - increase or decrease in body weight. Allergic reactions: rarely - rash, urticaria, allergic dermatitis, vasomotor disorders. Other: sensations of flushing of the face with a feeling of heat (stop after the end of taking the drug).
Overdose
Symptoms: nausea, vomiting, vasomotor reactions, feelings of flushing, visual disturbances (reduced visual acuity, outbreaks, scotoma), ovarian enlargement and pain in the pelvic organs and abdomen. Treatment: measures aimed at removing clomiphene from the body; conducting maintenance therapy. Data on the possibility of elimination of clomiphene during dialysis are not available.
Interaction with other drugs
Compatible with gonadotropic hormone preparations.
special instructions
It is recommended to investigate the function of the liver before taking the drug. Before the start of treatment, a thorough gynecological examination should be carried out. Treatment begins when the total content of gonadotropin in the urine is normal or below the lower limit of normal, the state of the ovaries on palpation is normal, the functions of the thyroid gland and the adrenal glands are normal. the occurrence of the ovarian increase or cystic changes while taking the drug should be stopped until the size of the ovaries returns to normal. In the future, you can resume reception, but at the same time reduce the dose of the drug or the duration of treatment. In the process of treatment, it is necessary to constantly monitor the gynecologist, you should monitor the function of the ovaries, conduct vaginal studies, observe the phenomenon of the pupil.Often during the course of treatment it is difficult to determine the time of ovulation, and there is often deficiency of the corpus luteum. Therefore, after conception, it is recommended to carry out prophylactic treatment with progesterone. Increases the likelihood of multiple pregnancies. The drug is contraindicated in patients with galactose intolerance, lactase deficiency or glucose malabsorption, because each tablet contains 100 mg of lactose. Effects on the ability to drive vehicles and control mechanisms. Because the drug can cause visual impairment, during treatment, patients should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.