Charosetta
Charosetta: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. For violations of liver function
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Cerazette
ATX code: G03AC09
Active ingredient: desogestrel (desogestrel)
Manufacturer: ORGANON NV (Netherlands)
Description and photo updated: 2018-26-11
Prices in pharmacies: from 696 rubles.
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Charosetta is a gestagenic oral contraceptive.
Release form and composition
Charosetta is produced in the form of film-coated tablets: biconvex, round, white, on the one side with KV engraving above the number "2", on the other - ORGANON with the image of a five-pointed star; at the break - white (28 pcs. in a blister of polyvinyl chloride film and aluminum foil, in a hermetically sealed sachet made of laminated aluminum foil 1 blister; in a cardboard box 1, 3 or 6 sachets).
Composition of 1 film-coated tablet:
- active substance: desogestrel - 75 mcg;
- additional components: lactose monohydrate, povidone, colloidal silicon dioxide, alpha-tocopherol, corn starch, stearic acid;
- film casing: Opadray OY-S-28833 (macrogol-400, hypromellose, talc, titanium dioxide).
Pharmacological properties
Pharmacodynamics
Charosetta is a gestagen-containing oral contraceptive (PC) containing the active substance desogestrel progestogen. As well as other PCs containing only one hormone progestogen ("mini-pills"), the drug is most suitable for use during breastfeeding, as well as for women who do not want to take estrogens or have contraindications to taking them. The contraceptive effect of Charosetta is mainly due to the inhibition of ovulation, as well as an increase in the viscosity of cervical mucus.
During the first 56 days (2 cycles) of continuous use of this PC, the ovulation frequency does not exceed 1%, after discontinuation of the drug after this period, ovulation is achieved after about 17 days (after 7-30 days).
In a comparative efficacy study (in which the missed pills were allowed only for 3 hours), the overall Pearl index (a coefficient showing the number of unplanned conceptions in 100 women during 1 year of taking a contraceptive) Charosetta was 0.4 in the group of all participants in the study patients. This indicator for Charosetta was comparable to that of combined PCs in the general population receiving PCs.
The use of the drug ensures a decrease in the serum estradiol content to a level characteristic of the early follicular phase. At the same time, there was no clinically significant effect on carbohydrate metabolism, lipid metabolism and hemostasis indicators.
Pharmacokinetics
When taken orally, Charosetta is rapidly absorbed and converted to etonogestrel, a biologically active metabolite. After reaching equilibrium, the maximum serum levels of etonogestrel are observed 1.8 hours after oral administration of the tablet, and the absolute bioavailability of this substance is approximately 70%. Etonogestrel is associated with serum proteins by 95.5–99%, to a greater extent with albumin and to a lesser extent with globulin, a protein that binds sex hormones.
Etonogestrel is formed by hydroxylation and dehydrogenation of desogestrel. The biotransformation of etonogestrel is carried out by the formation of glucuronide and sulfate conjugates. With both single and repeated use of Charosetta, the half-life of the active metabolite of desogestrel reaches an average of 30 hours.
Stationary plasma concentrations of the drug are observed after 4–5 days. When etonogestrel is administered intravenously, serum clearance is approximately 10 L / h. Etonogestrel and its metabolites are excreted by the intestines and kidneys (in a ratio of 1: 1.5) in the form of free steroids and conjugates.
Indications for use
Contraception.
Contraindications
Absolute:
- bleeding from the vagina of an unclear nature;
- pregnancy (suspected / established);
- history of venous thromboembolism (including pulmonary embolism, deep vein thrombosis of the leg) or at present;
- liver failure, including history;
- severe liver damage, including instructions in the history (until the normalization of liver function tests);
- malignant hormone-dependent tumors (suspected / diagnosed);
- glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
- hypersensitivity to any of the components of the product.
Relative (in the presence of any of the conditions / diseases listed below, before taking Charosetta, you must carefully weigh the benefits of the use of gestagen and the possible risks):
- thromboembolic disorders, including a history of indications (the patient should be aware of the risk of recurrence);
- persistent hypertension that has arisen against the background of the use of the drug, or in case of ineffectiveness of antihypertensive treatment;
- liver cancer, since the biological effect of gestagens on its development cannot be ruled out; it is necessary to carry out a scrupulous individual assessment of the risk-benefit ratio when prescribing Charosetta to patients with this pathology;
- prolonged immobilization due to illness or surgery;
- chloasma, especially if there is a history of chloasma during pregnancy (if you have a tendency to chloasma, avoid prolonged exposure to ultraviolet radiation or sunlight).
Instructions for the use of Charosetta: method and dosage
Charosetta tablets are recommended to be taken orally, daily at about the same time for 28 days, 1 time per day, 1 pc. in the order indicated on the package. If necessary, the tablet can be taken with a small amount of liquid. Reception of funds from the next package must be started immediately after the previous one ends, without any interruption.
If hormonal contraceptives have not been used over the last month before using Charosetta, then the drug should be taken on the first day of the natural cycle (on the first day of menstrual bleeding). It is also permissible to start taking it on days 2–5, but in this case, during the initial cycle, you will need to resort to an additional (barrier) method of contraception during the first 7 days.
When switching from the use of a combined hormonal contraceptive to taking Charosetta, it is advisable to start it the next day without interruption, after using the last active tablet (containing hormones) of the previous drug. If you used a transdermal patch or vaginal ring before taking Charosetta, you should start using the pills on the day you remove these contraceptives. In these cases, there is no need to use an additional method of protection. You can also start taking the drug no later than the next day after the end of the usual interval for taking pills, rings, patches, or the day after using a placebo of the previous combined hormonal contraceptive (i.e., on the daywhen it would be required to start taking active pills from a new package of the previous product, stick a new patch or insert a new ring). In this case, during the first week of using Charosetta, it is recommended to resort to additional measures to prevent pregnancy.
The transition to taking Charosetta from the use of drugs containing only gestagen ("mini-pili") can be made any day. When using an intrauterine system or an implant, the transition to taking the drug can be carried out on the day of their removal. If injectable forms of contraceptives have been used, it is recommended to start taking Charosetta on the day when the next injection was required. In all these cases, there is no need to use additional methods of contraception.
After an abortion in the first trimester of pregnancy, the drug can be taken immediately, without additional methods of protection.
After childbirth or an abortion performed in the second trimester, it is allowed to start taking the drug no earlier than 21-28 days after the abortion and no earlier than the sixth week after childbirth. In the case of a later start of using Charosetta, it is necessary to use barrier methods of contraception during the first 7 days of the initial cycle. If unprotected intercourse has taken place after childbirth or abortion, you should exclude possible pregnancy before taking it, or wait for the first menstrual bleeding.
If a woman has forgotten to take a pill and the interval between two subsequent doses has exceeded 36 hours, the contraceptive effect of the drug may decrease. In case of a delay in using the next pill by less than 12 hours, it must be taken as soon as possible, and the next one - at the usual time. If the patient is late to take the pill by more than 12 hours, the above rules of admission should be followed, as well as additional methods of preventing pregnancy should be used within 7 days. If the drug was missed during the first week of the course, and there was unprotected sexual contact during the week preceding the missed pill, the possibility of pregnancy should be considered.
If severe gastrointestinal disorders (vomiting, diarrhea) occur within 3-4 hours after taking Charosetta, incomplete absorption of desogestrel may occur, in which case the recommendations for taking the missed tablets should be followed.
Side effects
- infections and invasions: infrequently - vaginal infection;
- nervous system: often - headache;
- organ of vision: infrequently - intolerance to contact lenses;
- psyche: often - mood changes, decreased libido;
- digestive tract: often - nausea; infrequently - vomiting;
- skin and subcutaneous tissue: often - acne; infrequently - alopecia; rarely - urticaria, skin rash, erythema nodosum;
- reproductive system and mammary glands: often - amenorrhea, irregular menstruation, breast tenderness; infrequently - vaginitis, ovarian cyst, dysmenorrhea; rarely - ectopic pregnancy, discharge from the mammary glands;
- general disorders: often - weight gain; infrequently - fatigue.
In patients using combined PCs, various (including serious) undesirable effects were recorded. They included hormone-dependent tumors (including breast cancer), arterial and venous thrombosis and thromboembolism, and chloasma.
Disorders, the connection of which with gestagens has not been established, include the following diseases: itching of the skin and / or jaundice caused by cholestasis, porphyria, the formation of gallstones, hemolytic uremic syndrome, herpes of pregnant women, systemic lupus erythematosus, hearing loss caused by otosclerosis, Sydenham's chorea, hereditary angioedema.
Overdose
Serious side effects resulting from an overdose of Charosetta have not been reported to date. In such cases, the following reactions may occur: vomiting, nausea, slight vaginal bleeding (in young girls). There is no antidote, if necessary, symptomatic treatment is carried out.
special instructions
Before taking Charosetta, a thorough history taking and a gynecological examination of the patient is required in order to exclude a possible pregnancy. Before prescribing the remedy, the causes of menstrual irregularities (amenorrhea, oligomenorrhea) should be identified. With prolonged use of the drug, control medical examinations are carried out with a frequency determined for each patient individually, but at least once a year. If during the use of this agent there is a possibility of its effect on latent or overt disease, systematic appropriate follow-up examinations should be planned.
Despite regular use of the contraceptive, in some cases, irregular bleeding may occur. If these violations occur very often, you need to consider replacing the contraceptive. If these symptoms are persistent, organic pathology must be excluded.
Therapy for amenorrhea during the course depends on strict adherence to the recommendations for the use of pills and may include a pregnancy test. In case of pregnancy, you must refuse to take the contraceptive.
The patient should be warned that PCs do not protect against HIV (AIDS) and other sexually transmitted infections.
Against the background of the use of low-dose hormonal contraceptives, follicles appear, the size of which in rare cases can exceed those in the normal cycle. These enlarged structural components of the ovary, as a rule, disappear spontaneously and without symptoms, only occasionally the appearance of mild pain in the lower abdomen is possible. It is extremely rare that surgery may be required.
During the period of use of gestagen-containing contraceptives, some patients may have more frequent and prolonged vaginal bleeding, while others may have more rare and scanty, or none at all. Women who decide to start taking Charosetta tablets should be aware of the possible appearance of such changes in the nature of menstruation and not interrupt the course for this reason. Assessment of vaginal bleeding is required on the basis of the clinical picture, with adequate diagnostic measures, if necessary, to exclude pregnancy or malignant neoplasms.
Taking Charosetta is accompanied by a decrease in serum estradiol concentration to a level that corresponds to the early follicular phase. Whether this decrease can have any clinically significant effect on bone mineral density has not yet been established.
It is known that gestagens can influence glucose tolerance and the resistance of peripheral tissues to the action of insulin. However, there are no data indicating the need to correct the therapeutic regimen in patients with diabetes mellitus using progestogen-containing PCs. Despite this, during the first months of taking Charosetta, women with diabetes need to be closely monitored.
The risk of breast cancer has been proven to worsen with age. When using combined PCs, a woman's risk of developing breast cancer slightly increases. This increased threat gradually disappears over the course of 10 years after the end of the PC intake; it is not related to the duration of the use of these drugs, but depends on the woman's age during the treatment with combined PC.
With the development of amenorrhea or abdominal pain while taking Charosetta, despite the fact that it effectively inhibits ovulation, it is necessary to carry out a differential diagnosis of an ectopic pregnancy in order to exclude the latter.
Influence on the ability to drive vehicles and complex mechanisms
Taking into account the pharmacodynamic profile of Charosetta, it is believed that the drug does not have a negative effect on the ability to drive a car and work with any complex equipment.
Application during pregnancy and lactation
During pregnancy, the use of Charosetta is contraindicated.
According to the results of preclinical studies, excessively high doses of gestagens can lead to masculinization of the female fetus. At the same time, in the course of extensive epidemiological studies, neither an aggravation of the risk of congenital developmental defects in children born to mothers who took PC before pregnancy, nor a teratogenic effect in case of accidental use of PC at the beginning of pregnancy, was revealed.
Charosetta has no effect on the quantity and composition of breast milk (lactose, protein and fat levels). However, it has been established that in women during breastfeeding, etonogestrel is excreted in milk in a milk / serum ratio of 0.37–0.55. As a result, with an average daily consumption of breast milk of 150 ml / kg, a child can receive etonogestrel at a dose of 0.01–0.05 μg / kg per day.
There are limited data from long-term follow-up of children whose mothers started using Charosetta 4–8 weeks after delivery. Children were breastfed for 7 months, and they were followed up to 1.5 (n = 32) or 2.5 years (n = 14). When comparing the physical development, physical activity and growth of these babies with those whose mothers used intrauterine devices, no differences were found. According to the available data, the drug can be used during lactation, but it requires careful monitoring of the growth and development of a breastfed baby.
For violations of liver function
According to the instructions, Charosetta is contraindicated to take if you currently have or have a history of liver failure and severe liver disease (until normal liver function is restored). When prescribing a contraceptive for women with liver cancer, it is necessary to carefully assess the benefits and risks of the forthcoming therapy.
If during the period of treatment acute or chronic functional disorders of the liver occur, it is necessary to consult a specialist and conduct an examination.
Drug interactions
- drugs that induce microsomal enzymes (which causes an increase in the clearance of sex hormones): barbiturates (including phenobarbital), hydantoins (including phenytoin), rifampicin, carbamazepine, primidone, rifabutin, oxcarbazepine, ritonamatavir, fishery, griseofulvin, nelfinavir, drugs containing St. temporarily additionally resort to a barrier method of protection against pregnancy;against the background of long-term use of hepatic enzyme inducers, it is necessary to resolve the issue of the possible use of non-hormonal methods of contraception;
- activated charcoal: it is possible that the contraceptive effectiveness of desogestrel may be weakened due to a decrease in its absorption (you should follow the recommendations that relate to the missed receptions of Charosetta);
- cyclosporine - its level in plasma and tissues increases.
Since contraceptives can affect the action of other drugs, before their combined use, you must study the instructions for each of these drugs.
Analogs
The analogues of Charosetta are: Lactinet, Diamilla, Laktinet-Richter, Model Mam.
Terms and conditions of storage
Keep out of the reach of children. Store in a place protected from moisture and light at a temperature of 2-30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Charosette
Reviews about Charosette are mixed. Most of the patients taking the drug consider it an effective PC that does not contain estrogens and has no contraindications for use during breastfeeding.
But there are also many patients who complain of a large number of Charosetta's adverse reactions, such as irregular menstruation, weight gain, deterioration of the skin, breast tenderness. In some cases, during the intake, a decrease in the amount of milk was noted. Many also attribute the high cost to the disadvantages of the contraceptive.
Price for Charosetta in pharmacies
The price of Charosetta can be: film-coated tablets, 28 pcs. in the package - 1290-1400 rubles, 84 pcs. - 3250-3470 rubles.
Charosetta: prices in online pharmacies
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Drug name Price Pharmacy |
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Charosetta 75 mcg coated tablets 28 pcs. 696 r Buy |
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Charosetta tablets p.p. 75μg 28 pcs. 1259 RUB Buy |
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Charosetta 75 mcg coated tablets 84 pcs. 2995 RUB Buy |
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Charosetta tablets p.p. 75μg 84 pcs. 3352 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
