Charosette, 75 mcg 84 pcs

Charosette is a gestagen-containing oral contraceptive containing the gestagen desogestrel. Like other gestagen-containing oral contraceptives (“mini-pills”), Charosette is best suited for use while breastfeeding and for women who are contraindicated or who do not want to take estrogens. Unlike the “mini-pill,” Charosette’s contraceptive effects are achieved mainly by suppressing ovulation. Other effects include an increase in cervical mucus viscosity.

When using Charosette for the first 56 days, the rate of ovulation is less than 1%; after discontinuing the 56-day drug, ovulation occurs in 7-30 days (averaging 17 days). In a comparative efficacy study (in which missed pills were allowed for a maximum of 3 hours), the overall Perl index (an index reflecting the frequency of pregnancy in 100 women during a year of contraceptive use) of Charosette was 0.4 in the group of all patients included in the study.

The Perl index of Charosette is comparable to the Perl index of combined oral contraceptives in the general population of oral contraceptive users. Administration of Charosette leads to a decrease in serum estradiol levels to values characteristic of the early follicular phase. No clinically significant changes in carbohydrate, lipid metabolism and hemostasis parameters were found.

Indications

Active ingredient

Composition

1 film-coated tablet contains:

Desogestrel 0.075 mg.

Auxiliary substances:

Corn starch;

Povidone;

α-tocopherol;

p> Stearic acid;

Silicon dioxide colloid;

Lactose monohydrate.

Composition of the shell:

Hypromellose;

Macrogol 400;

Talc;

Titanium dioxide.

How to take, the dosage

The drug should be taken 1 tablet/day, daily, at the same time, for 28 days, in the order shown on the package. Each subsequent package should be started immediately after the end of the previous one, without any interruption. The tablet taken may be washed down with a small amount of liquid.

Interaction

Interactions between oral contraceptives and other medications may result in breakthrough bleeding and/or decreased contraceptive efficacy. The following interactions have been reported in the literature (mostly with combination contraceptives, but sometimes also reported with gestagen-containing contraceptives).

Hepatic metabolism: Interactions may occur 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 probably also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin, and Hypericum perforatum preparations.

Women using any of these drugs should temporarily use a barrier method in addition to Charosette or choose another contraceptive method. A barrier method of contraception should be used while using these medicines and for 28 days after stopping them. For women receiving long-term treatment with liver enzyme inducers, a non-hormonal contraceptive method should be considered.

If activated charcoal is used, absorption of the desogestrel in the pill may be reduced and therefore contraceptive efficacy may decrease. In this case, you should proceed according to the recommendations for missing pills to take.

Hormonal contraceptives can affect the metabolism of other medications. Accordingly, plasma and tissue concentrations of the drug may both increase (e.g., cyclosporine) and decrease.

To identify possible interactions, you should read the instructions for use for these medications.

Special Instructions

Medical examinations/consultations:Before prescribing the drug, the woman’s medical history should be carefully collected and a thorough gynecological examination should be performed to rule out pregnancy. The cause of menstrual irregularities, such as oligomenorrhea and amenorrhea, should be determined before prescribing the drug. The interval between control medical examinations is determined by the doctor in each individual case (frequency of examinations – at least once a year). If the prescribed drug may affect the latent or existing disease, an appropriate schedule of control medical examinations should be made.

Despite regular use of Charosette, occasional irregular bleeding may occur. If bleeding is very frequent and irregular, another contraceptive method should be considered. If the above symptoms are persistent, then organic pathology should be ruled out. The tactic for amenorrhea during the use of the drug depends on whether the pills were taken according to the instructions and may include a pregnancy test. If pregnant, the drug should be discontinued. In case of acute or chronic liver dysfunction, the woman should consult a specialist for examination and consultation. Women should be informed that Charosette does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Decreased efficacy:The effectiveness of gestagen-containing oral contraceptives may be reduced if pills are missed, gastrointestinal distress or other medications are taken.

Changes in menstrual bleeding patterns: when using gestagen-containing contraceptives, some women may experience more frequent or prolonged vaginal bleeding, while other women may experience less frequent or no bleeding at all. These changes are often the reason why women refuse this method of contraception or stop strictly following the doctor’s instructions. In a detailed consultation with women who decide to start Charosette, your doctor should discuss the possibility of these changes in menstrual bleeding patterns. Evaluation of vaginal bleeding should be based on the clinical picture and may include evaluation to rule out malignancy or pregnancy.

Follicle development:All low-dose hormonal contraceptives cause follicle development, occasionally follicle size may reach a size larger than that of a normal cycle. In general, these enlarged follicles disappear spontaneously. Often, it runs symptom-free; in some cases, mild lower abdominal pain is noted. Surgical intervention is rarely required.

Laboratory tests:. Data from combined oral contraceptives have shown that hormonal contraceptive use can affect several laboratory tests, including biochemical measures of liver, thyroid, adrenal and renal function, serum (transport) protein levels such as corticosteroid-binding globulin, lipid/lipoprotein fractions, carbohydrate metabolism and blood clotting and fibrinolysis measures. Usually these changes remain within the normal range. It is not known to what extent this also applies to gestagen-only contraceptives.

Breast Cancer:The risk of breast cancer increases with age. While using combined oral contraceptives, the risk that a woman will be diagnosed with breast cancer increases slightly. This increased risk gradually disappears within 10 years after discontinuation of oral contraceptives, it is not related to the duration of use, but depends on the age of the woman at the time of use of combined oral contraceptives.

The risk in women using gestagen-only oral contraceptives, such as Charosette, may be similar to that of combined oral contraceptives. However, the data for gestagen-only oral contraceptives are less certain. Compared with the lifetime risk of breast cancer, the increase in risk associated with taking the combined oral contraceptive pill is small. Breast cancer diagnosed in women who use combined oral contraceptives tends to be less clinically advanced than cancer diagnosed in women who have never used combined oral contraceptives. The increased risk in women who use combined oral contraceptives may be due to earlier diagnosis, biological effects of the drug, or a combination of the two.

Venous thromboembolism:Epidemiologic studies have linked combined oral contraceptive use to an increased incidence of venous thromboembolism (VTE, deep vein thrombosis, and pulmonary embolism). Although the clinical significance of these data for desogestrel as an estrogen-free contraceptive is unknown, Charosette should be discontinued if thrombosis develops. Consideration should be given to discontinuing Charosette if there is prolonged immobilization associated with surgery or disease.

Diabetes mellitus:While gestagens may affect peripheral tissue insulin resistance and glucose tolerance, there is no evidence that there is a need to change the therapeutic regimen in diabetic patients using gestagen-containing oral contraceptives. However, women with diabetes should be closely monitored during the first months of use.

Bone mineral density:The use of Charosette leads to a decrease in serum estradiol levels to levels consistent with the early follicular phase. To date, it is not known whether this decrease has any clinically significant effect on bone mineral density.

The prevention of ectopic pregnancy with traditional gestagen-containing oral contraceptives (“mini-pills”) is not as effective as with combined oral contraceptives because ovulation is common with “mini-pills.” Despite the fact that Charosette effectively suppresses ovulation, in the case of amenorrhea or abdominal pain, ectopic pregnancy should be excluded in differential diagnosis.

The drug Charosette contains no more than 65 mg of lactose, so women with rare hereditary disorders associated with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should refrain from taking the drug.

Influence on driving and operating machinery:

Based on the pharmacodynamic profile, the drug is not considered to affect the ability to drive and operate machinery.

Contraindications

Side effects

The most common adverse effect reported in clinical trials was irregular menstruation. Up to 50% of women who used desogestrel reported acyclic bleeding: in 20-30% of women, menstruation became more frequent, while in the other 20%, menstruation became less frequent or may even stop completely. Menstruation may also become longer.

Menstrual periods tend to become less frequent after a few months of taking the drug. Informing your doctor, monitoring your doctor, and using a menstrual diary may improve compliance with treatment with the drug.

The following are adverse effects that have an established, probable, or possible association with the use of the drug.

If any of the following conditions/risk factors are observed, the expected benefits and risks of contraceptive use should be carefully weighed in consultation with your doctor for the duration of contraception. If any of the following conditions/risk factors appear, worsen, or change, the patient should see her doctor immediately to decide whether to continue using the medication.

Often – acne, nausea, mood changes, decreased libido, breast soreness, menstrual irregularities, headache, weight gain.

Infrequent – alopecia, fatigue, vomiting, discomfort when wearing contact lenses, vaginitis, dysmenorrhea, ovarian cysts.

Rarely – redness of skin, rash, urticaria, erythema nodosum.

While no reliable association with gestagen intake has been established, cholestatic jaundice, skin itching, cholelithiasis, chorea, pregnancy herpes, otosclerosis, deafness, development of hemolytic-uremic syndrome are possible with their intake.

Overdose

There have been no reports of any serious complications from an overdose of Charosette.

Inpossible: nausea, vomiting , in young girls – minor vaginal bleeding.

Treatment:There is no specific antidote and further treatment must be symptomatic.

Pregnancy use

The use of the drug is contraindicated during pregnancy. Preclinical studies have shown that very high doses of gestagens can cause masculinization of the female fetus. Extensive epidemiological studies have found no increased risk of birth defects in children whose mothers took oral contraceptives before pregnancy, nor a teratogenic effect if oral contraceptives were inadvertently taken early in pregnancy.

The drug does not affect the quantity or quality (concentrations of proteins, lactose, or fats) of breast milk. However, small amounts of etonogestrel are excreted with breast milk. As a result, 0.01 to 0.05 mcg of etonogestrel per kg body weight per day (based on breast milk intake of 150 ml/kg/day) may be delivered to the baby.

Limited long-term follow-up data are available for children whose mothers were started on Charosette within 4-8 weeks after delivery. The duration of breastfeeding was 7 months, and children were monitored until age 1.5 (n=32) or 2.5 years (n=14). Assessment of growth, physical and psychomotor development showed no differences with babies whose mothers used copper IUDs.

The evidence suggests that Charosette can be used during lactation. However, the development and growth of the infant whose mother uses Charosette should be monitored carefully.

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