Charozetta – it gestagensoderzhaschy oral contraceptive that contains the progestin desogestrel. Like other gestagensoderzhaschim oral contraceptives ( “mini-pill”) Charozetta best suited for use during breast feeding and for women who are contraindicated or who do not want to take estrogen. Unlike the “mini-pill”, Charozetta contraceptive effect of the drug is achieved primarily by suppressing ovulation. Other effects include increased viscosity of the cervical mucus.
In applying the drug Charozetta in the first 56 days of ovulation frequency does not exceed 1%, after the termination of the 56-day dosing ovulation occurs after 7-30 days (average 17 days). In a comparative study of the effectiveness (in which you can take the missed pill a maximum of 3 hours) the overall Pearl Index (an indicator of the rate of pregnancy in 100 women during the year use of contraceptives) Charozetta drug was 0.4 in the group of patients included in the study.
Pearl Index charozetta drug comparable to Pearl Index of combined oral contraceptives in the general population taking oral contraceptives. The drug Charozetta leads to a decrease in serum estradiol levels to values characteristic of the early follicular phase. At the same time it did not reveal clinically significant changes in the carbohydrate and lipid metabolism and hemostasis.
Adults are prescribed by a doctor for women of childbearing age
1 tablet, film-coated, provides:
0.075 mg desogestrel.
Colloidal silicon dioxide;
- Hypersensitivity to the active substance or any auxiliary substance drug.
- or suspected pregnancy.
- Available at the moment or a history of venous thromboembolism (including deep vein thrombosis of the lower leg, pulmonary embolism).
- Available at the moment or a history of severe liver disease (as long as liver function tests are not normalized).
- liver failure, including history.
- or suspected malignant hormone-dependent tumors.
- Vaginal bleeding of unknown etiology.
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
If any of the following conditions / risk factors should weigh the benefits of the use of a progestogen, and the possible risks for each individual woman. This should be discussed with the woman before she decides to start taking the drug. In case of deterioration, exacerbation or occurrence of any of these states for the first time a woman should see a doctor. The physician should decide whether further use of the drug Charozetta):
- Resistant hypertension develops in patients receiving the drug Charozetta, or after failure of antihypertensive therapy.
- thromboembolic disorders, including history: the woman should be advised of the possibility of recurrence.
- prolonged immobilization associated with surgery or disease.
- As it is impossible to eliminate the biological effect of progestogens on liver cancer, should be an individual assessment of benefit-risk ratio in the appointment of the drug to women with cancer of the liver.
- chloasma, especially in women with chloasma during pregnancy in history: women with a predisposition to chloasma should avoid exposure to sunlight or UV radiation during use of the drug Charozetta li>.
The most common undesirable effects reported in clinical studies were irregular menstruation. Up to 50% of women using desogestrel, noted acyclic spotting: 20-30% of menstruating women are becoming more frequent, while in the other 20% – a rare or even may stop. Menstruation can also become longer.
After a few months of taking the drug menstruation tend to become less frequent. Informing the doctor, medical supervision, as well as the use of menstrual diary can improve patient compliance in the treatment of drug.
The following are unwanted effects having installed, probable or possible link with the drug.
In that case, if there is any of the following conditions / risk factors, you should carefully weigh the expected benefits and risks of the contraceptive in consultation with the doctor throughout the period of contraception. When prompted, strengthen, change any of the following conditions / risk factors, the patient should immediately consult your doctor to decide on the possibility of further use of the drug.
Often – acne, nausea, mood changes, decreased libido, breast tenderness, menstrual disorders, headache, weight gain.
It is not often – alopecia, fatigue, vomiting, discomfort while wearing contact lenses, vaginitis, dysmenorrhea, ovarian cyst.
Rarely – skin redness, rash, urticaria, erythema nodosum.
Although a significant association with the intake of progestogens has not been established, at their reception possible cholestatic jaundice, pruritus, cholelithiasis, chorea, herpes gestationis, otosclerosis, hearing loss, the development of hemolytic uremic syndrome.
How to accept, acceptance rate and dosage
The drug should be taken 1 tablet / day, every day, at one and the same time, within 28 days, in the order indicated on the package. Receiving each subsequent packaging should begin immediately after the previous one, without any interruption. Adopted tablet can drink a small amount of liquid.
In the absence of prior use of hormonal contraceptives (within the last month) reception of tablets should be started on day 1 of the menstrual cycle (day 1 of menstrual bleeding). Allowed to start reception on a 2-5 day, but then during the first cycle for the first 7 days of receiving the tablets is recommended to additionally use a barrier method of contraception.
Transition to a combined hormonal contraceptive (combined oral contraceptive vaginal rings or transdermal patch): woman should begin receiving drug Charozetta preferably on the next day after the last active tablet combined oral contraceptive (the last tablet containing active substance) or on the day of removal of the vaginal ring or patch. In these cases there is no need for additional contraception. At the latest, a woman may also start taking the drug Charozetta the next day after the usual tablet-free interval, patch, ring or the next day after taking the placebo pills the previous combined oral contraceptive (ie on the day when it would be necessary to begin to use the new packaging combined oral contraceptive, enter a new ring or paste new patch), but during the first 7 days of tablet is recommended to use an additional barrier method of contraception .
The transition to other products containing only progestin ( “mini-pill”, injection, implant or intrauterine system gestagenvysvobozhdayuschey): a woman taking “mini-pill”. can go to the reception Charozetta drug any day. Woman using an implant or intrauterine system – the day of removal. Women using the injectable form of contraception – the day when the next injection should be done. In all these cases, an additional method of contraception is not required.
After the abortion done in the first trimester , is recommended to start taking the drug immediately: an additional method of contraception is not required.
Acceptance of the drug is possible not earlier than 21-28 days after abortion done in the second trimester , and not earlier than 6 weeks after giving birth. At the beginning of the drug at a later time necessary to additionally use a barrier method of contraception during the first 7 days of tablet. However, if a woman after childbirth or abortion before you start taking the drug Charozetta already had sexual intercourse before the start of the drug should exclude pregnancy or the woman must wait for the first menstruation.
How do in case of missing the next reception of tablets: contraceptive protection may be reduced if the interval between receiving two tablets of more than 36 hours. If the delay in receiving the tablet is less than 12 hours, the missed tablet should be taken as soon as she remembers this, and the next tablet should be taken at the usual time. If the delay in the reception of pills is more than 12 hours, the woman should follow the above recommendations, and apply additional contraceptive protection for the next 7 days. If tablets were missed in the very first week of taking the drug, and there was a sexual intercourse in the week before skipping a tabletok-, pregnancy should be ruled.
In case of severe gastro-intestinal disorders (vomiting,
diarrhea), absorption may be incomplete and in this case
to use additional methods of contraception. If vomiting occurred in
within 3-4 hours after administration, the absorption may be incomplete. IN
this case should be guided by recommendations for
receiving missed pills.
Store in a dry, dark place at a temperature of from 2 ° C to 30 ° C.
The interaction between oral contraceptives and other drugs may lead to breakthrough bleeding and / or to reduce contraceptive efficacy. The literature reports the following interactions (mainly with combined contraceptives but occasionally also been reported in relation gestagensoderzhaschih contraceptives).
Hepatic metabolism: there may arise interaction with drugs that induce microsomal enzymes, resulting in increased clearance of sex hormones (e.g., hydantoins (e.g., phenytoin), barbiturates (e.g., phenobarbital), primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and preparations containing St. John’s wort (Hypericum perforatum)).
Women using any of these drugs should temporarily use a barrier method in addition to the drug Charozetta or choose another method of contraception. Barrier contraceptive method should be used during application of these medications and for 28 days after cessation of administration. For women receiving prolonged treatment with hepatic enzyme inducers, should consider using a non-hormonal method of contraception.
In the application of the activated carbon absorption desogestrel present in the tablet can be reduced and, consequently, may decrease contraceptive efficacy. In this case, to proceed in accordance with recommendations for the missed for receiving pills.
Hormonal contraceptives may affect the metabolism of other drugs. Accordingly, the concentration of drug in plasma and tissues may either increase (e.g., cyclosporin) and decrease.
To identify possible interactions should read the instructions for use of these drugs.
Medical examination / consultation: before prescribing the drug should be carefully collected history of a woman and a thorough gynecological examination to exclude pregnancy. Before the appointment of the drug should be to establish the cause of menstrual disorders such as oligomenorrhea and amenorrhea. The interval between the medical check is determined by the physician in each individual case (the frequency of inspections – at least 1 times per year). If the prescribed medication can affect latent or existing disease, should draw up an appropriate schedule control medical examinations.
Despite the regular intake of the drug Charozetta, sometimes there may be irregular bleeding. If bleeding is very frequent and irregular, you should consider using another method of contraception. If the above symptoms are resilient, in this case it is necessary to exclude organic pathology. Tactics in relation to amenorrhea during the drug depends on whether the tablets made in accordance with the instructions, and may include a pregnancy test. In the case of pregnancy, the drug should be discontinued. In case of acute or chronic liver dysfunction woman should go to a specialist for examination and advice. Women should be informed that Charozetta does not protect against HIV infection (AIDS) and other sexually transmitted diseases through.
Reduced efficacy: gestagensoderzhaschih efficacy of oral contraceptives may be lowered in the event of missed tablets, gastro-intestinal disorders or taking other medications.
Changes in the nature of menstruation: at the time of application gestagensoderzhaschih contraceptives in some women, vaginal bleeding may become more frequent or longer, while the other women bleeding may become less frequent or even stop. These changes are often the reason why the woman refuses this method of contraception, or ceases to strictly follow the doctor’s. When full consultation with women who have decided to start accepting Charozetta drug, the physician should discuss the possibility of such changes in the nature of the menstrual cycle. Evaluation of vaginal bleeding should be performed on the basis of clinical picture and may include examination to exclude pregnancy or malignancies.
The development of follicles: at the reception of all low-dose hormonal contraceptives follicular development occurs and occasionally the follicle size can reach sizes greater than those in the normal cycle. Generally, these enlarged follicles disappear spontaneously. Often, this occurs without symptoms; In some cases, there is slight pain in the lower abdomen. Surgery is rarely needed.
Laboratory tests: data obtained in relation to combined oral contraceptives, have shown that the use of hormonal contraceptives may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney, to levels ( transport) proteins in serum, e.g., for binding globulin corticosteroids fractionated lipids / lipoproteins, carbohydrate metabolism indices and blood clotting and fibrinolysis. Usually, these changes are within the normal range. It is not known to what extent this also applies to contraceptives containing only progestin.
Breast Cancer: the risk of breast cancer increases with age. During use of combined oral contraceptives, the risk that a woman will be diagnosed with breast cancer is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of oral contraceptives, it is not associated with the duration of application, and is dependent on the woman’s age at the time of use of combined oral contraceptives.
Risk in women using oral contraceptives which contain only progestogen, e.g., a drug Charozetta possibly similar to that when using a combined oral contraceptives. However, data for oral contraceptives containing only progestin, is not so certain. Compared with the risk of breast cancer throughout their lives, increasing the risk associated with taking combined oral contraceptives is small. Breast cancer is diagnosed in women using combined oral contraceptives, have a tendency to be less clinically advanced than cancers diagnosed in women who never used COCs. Increased risk in women using combined oral contraceptives, possibly due to earlier diagnosis, biological effects of the drug or a combination of these two factors.
Venous thromboembolism: in epidemiological studies have established a link between the use of combined oral contraceptives and an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical significance of these data for desogestrel as contraceptive, containing no estrogenic component is unknown, the use of the preparation should be discontinued Charozetta in case of thrombosis. Should be considered to stop receiving Charozetta preparation in case of prolonged immobilization associated with surgery or disease.
Diabetes: Although progestogens may influence the resistance of peripheral tissues to insulin and glucose tolerance, there is no evidence that there is a need to change the therapeutic scheme for patients with diabetes who use oral contraceptives gestagensoderzhaschie. However, women with diabetes should be monitored closely during the first month of the drug.
bone mineral density: Charozetta use of the drug leads to a decrease in serum estradiol levels to a level corresponding to the early follicular phase. So far, it is unknown whether this decrease has any clinically relevant effect on bone mineral density.
Warning ectopic pregnancy gestagensoderzhaschimi traditional oral contraceptives ( “mini-pill”) is not as effective as when combined oral contraceptives, since the application of a “mini-pill” is often ovulate. Despite the fact that Charozetta effectively inhibits ovulation, in the case of amenorrhea or abdominal pain should be deleted ectopic pregnancy in the differential diagnosis.
Charozetta preparation comprises not more than 65 mg of lactose, however, women with rare inherited disorders associated with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, should refrain from taking the drug.
Effects on ability to drive vehicles and management mechanisms:
based on the pharmacodynamic profile, it is believed that the drug has no effect on the ability to drive and operate machinery.
Pregnancy and lactation
During pregnancy, the use of the drug is contraindicated. Preclinical studies have shown that very high doses of progestogens may cause masculinization of female fetuses. Extensive epidemiological studies have revealed no increased risk of congenital developmental defects in children whose mothers took oral contraceptives prior to pregnancy, nor a teratogenic effect at unintentional use of oral contraceptives in early pregnancy.
The drug does not affect the amount or quality (concentration of protein, fat, or lactose) breast milk. However, small amounts of etonogestrel are excreted in breast milk. As a result, a child may come 0.01 – 0.05 .mu.g etonogestrel per kg body weight per day (based on the consumption of 150 ml / kg / day of breast milk).
There are limited data long-term monitoring of children whose mothers started taking Charozetta drug for 4-8-th week after birth. The duration of breastfeeding was 7 months, the children were followed to achieve age to 1.5 (n = 32) or up to 2.5 years (n = 14). Evaluation of growth and physical and psychomotor development did not reveal any differences with the kids whose mothers used copper IUDs.
Evidence suggests that a drug Charozetta can be used during lactation. However, you must carefully observe the development and growth of the infant, whose mother uses Charozetta drug.
There are no reports of any serious complications in overdose Charozetty.
In POSSIBILITY: nausea, vomiting, and in young girls – a slight vaginal bleeding.
Treatment: There is no specific antidote, and further treatment should be symptomatic.