Pharmacological aspects of desogestrel. clinical features of the use of drugs novinet and regulon of the company "gedeon richter" a. Number of courses of treatment. International non-proprietary name

Synthetic progestogen, which transforms the endometrium, minimizes ovulation by preventing fertilization of the prepared egg. In addition, with its help, the receptors of the mucous membranes receive reduced sensitivity. In the article we will consider a preparation containing the named hormone.

Pharmacology

The drug "Levonorgestrel" is an estrogen that prevents the activation of spermatozoa due to an increase in the viscosity of mucus. The drug inside the uterus acts locally on the fallopian tubes, endometrium, mucus consistency, resulting in reduced activity.

When ingested, the named drug is actively absorbed in the gastrointestinal tract, bioindicators are up to 100%. In the blood, its components are maximally concentrated when taking 75 ml a single time in 60-130 minutes. The hormone in question interacts with plasma and binding globulin components by about 50%.

Metabolism is directed to the liver, with the formation of pharmacologically passive metabolites. The main isoenzyme of this hormone is CYP3A4. The half-life can last up to 30 hours.

Properties

In answer to the question "Levonorgestrel - what is this hormone?" you should be guided by the instructions for the drug of the same name and the recommendations of the attending doctor. Difference indicators in general meaning are about 1.0 ml / min. / kg (from plasma). The hormone is eliminated mainly through the ureter, a small part is removed with feces.

With systemic therapy, the rate of entry into the uterus is no more than 20 mcg daily, and after five years it drops to 11. On average, the rate of hormone release varies around 14 mcg / 24 hours for 50-60 months.

Intrauterine therapy is allowed for women with hormone replacement treatment in conjunction with estrogens that do not include a progestin composition. Levonorgestrel is a hormone that enters the plasma 60 minutes after ingestion. The maximum concentration in it is fixed after 14 days of use.

Indications

Application this drug possible with intrauterine therapy, as well as in the following cases:

• Idiopathic menorrhagia.
• Long-term contraceptive protection.
• Preventive measures in replacement recovery with estrogens.
• Emergency postcoital contraception.

The hormone levonorgestrel, which acts vast scope should only be used after a doctor's recommendation.

Application and dosage

The drug in question is activated by intrauterine injection - it is injected into the uterine cavity. It is used within 4 days after intercourse in a volume of 0.75 to 1.5 mg. Experts categorically do not advise emergency contraception to be practiced more than once every six months.

To rule out violation menstrual cycle, it is necessary to observe the recommended dosage without repeated use. You can not use the drug in question orally as a method of permanent contraception, as this provokes the appearance of side effects and reduces the effectiveness of the drug. In case of uterine bleeding after emergency contraception a procedure for examination by a gynecologist is highly recommended, and if menopause is violated for more than one week, you need to postpone conception.

Only after a consultative and informed decision of the gynecologist in extraordinary cases is it possible to use the drug for contraception in minors in case of emergency.

How is the hormone levonorgestrel used?

How does the use of the described hormone affect the body, and what to do to avoid side effects? Many people ask this question. Strict compliance recommendations of a specialist, compliance with the dosage and following the instructions are guarantees safe use drug.

Before using the IUD, it is necessary to undergo an examination by a gynecologist, including checking the mammary glands, pelvic organs, and making a smear of the cervix.

A re-examination is carried out after 30-40 days after the installation of the spiral, then annually, and if there are appropriate prerequisites, more often. This intrauterine therapy is effective for 4 to 5 years. Its installation should be carried out exclusively by a doctor who specializes in this field or has experience with the sorting of the drug in question.

Risks

In women taking drugs with a gestagen, an increase in venous thrombosis at a critical moment. With such symptoms, it is necessary to immediately take Urgent measures for diagnosis and treatment.

After removal of the IUD, fertility is resuscitated in six months in half of the women who applied, after 12 months - in more than 96 percent. Contraceptive orientation is less effective for obese patients.

Contraindications

Asking the question "Levonorgestrel - what is this hormone?" all contraindications should be studied. Among them:

• Over (hyper) sensitivity, thrombophlebitis formations.
• Thromboembolism, changes in the arteries.
• orientation, pregnancy.
• Regarding ingestion: jaundice (including history), pathological complications of bile or liver excretion, lactation period.
• Maturity.
• In addition, for the IUD - urinary tract infections, relapses or active inflammation in the pelvis, excesses postpartum disease liver.
• Septic-abortive intervention in the last trimester, dysplastic transformation of the uterine cervix, pathologies with similar bleeding of unknown origin, malignant tumors.
• Came or congenital anomalies, deforming fibroids.
• Progestogenosis (tumor, including breast cancer).

Restrictions

The limiting factor is often relevant for therapeutic intervention inside the uterus, if there are the following symptoms or chronic diseases:

• severe headaches, common and local migraine with blurred vision, other symptoms focused on the possibility of coronary disease;
• overt arterial hypertension, jaundice, complex destructive processes in circulatory system, including heart attacks and strokes;
• diabetes diabetes.

It is necessary to immediately consult about the elimination of the IUD in the formation or the presence of any of these conditions.

Pregnancy and lactation period

Although levonorgestrel is female hormone, its use is unacceptable during pregnancy. If it has come, the elimination of the system is recommended due to the fact that any increases the risk premature birth and miscarriages. Conducting uterine intubation or elimination of the system sometimes leads to a miscarriage that occurs spontaneously. You will need to consult a specialist on the advisability of artificial termination of pregnancy if it is impossible to correctly extract the contraceptive.

If it is impossible to delete intrauterine system and persistent desire to maintain pregnancy, the patient should be aware of possible consequences and risk to the baby due to preterm delivery. In such cases, it is necessary to carefully monitor the course of pregnancy. The patient should be informed that she should immediately report all symptoms that will help to suggest a complication of the process.

Lactation

When breastfeeding and using Levonorgestrel, approximately one tenth of the drug enters the baby's body. Breast-feeding inside for emergency contraception should be stopped for 1.5 days.

For a therapeutic system installed intrauterine, as for any purely gestagenic method of contraception, it is characteristic that the use one and a half months after birth does not have a detrimental effect on the development and growth of the child, therefore, the drug most likely does not pose a risk to the fetus at the recommended dosage .

Adverse symptoms

And returning to the question "Levonorgestrel" - what is it? ", Let's look at the possible side effects and contraindications of the drug. They can occur in different systems body and present the following symptoms:

1. From the side nervous system: fatigue, depression, headache, mood swings.
2. GIT. Vomiting, upset, spasms, bloating.
3. Urogenital organs. Bleeding, discharge, pain, candidiasis, the likelihood of malignant and benign tumors.
4. Skin rashes, manifestation of eczema, itching, urticaria, acne.
5. Other: edema, joint pain, pressure surges, sepsis.

AT rare cases possible seizures of epilepsy, convulsions and fainting.

Combination with other drugs

When studying Levonorgestrel (what kind of hormone it is), it is necessary to mention the possibility of its combination with other medicinal and organic preparations. In the case of the use of the substance in question with inducers of cytochrome P450 isoenzymes, a decrease in efficiency is possible due to an increase in its metabolic processes.

The following medicines may reduce the effect of Levonorgestrel:

• A group of barbiturates, "Tretinoin", "Carbamazepine", compositions of St. John's wort and composition containing it.
• The effectiveness of anticoagulants, hypoglycemic, anticonvulsant drugs is reduced.
• Levonorgestrel increases the capacity of glucocorticosteroids in the blood, and is also capable of disorganizing metabolism.
• Due to the inhibition of the recycling of sex steroids, which is due to the reorganization intestinal flora, amplification may occur menstrual bleeding at complex application certain drugs.

It is impossible not to add, speaking about how Levonorgestrel is used, that this remedy causes an increase in the side effects of other medicines, there is no antidote to it. In case of overdose, it is required

International name:

Dosage form:

Pharmachologic effect:

Indications: Contraception.

Mercilon

International name: Ethinylestradiol + Desogestrel (Ethinylestradiol + Desogestrel)

Dosage form: tablets, coated tablets

Pharmachologic effect: contraceptive drug. Inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian ...

Indications: Contraception.

Novinet

International name: Ethinylestradiol + Desogestrel (Ethinylestradiol + Desogestrel)

Dosage form: tablets, coated tablets

Pharmachologic effect: contraceptive drug. Inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian ...

Indications: Contraception.

Regulon

International name: Ethinylestradiol + Desogestrel (Ethinylestradiol + Desogestrel)

Dosage form: tablets, coated tablets

Pharmachologic effect: contraceptive drug. Inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian ...

Indications: Contraception.

Tri Mercy

International name: Ethinylestradiol + Desogestrel (Ethinylestradiol + Desogestrel)

Dosage form: tablets, coated tablets

Pharmachologic effect: contraceptive drug. Inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian ...

Indications: Contraception.

Charosetta

International name: Desogestrel (Desogestrel)

Dosage form: coated tablets

Pharmachologic effect: Contraceptive gestagen-containing drug, suppresses ovulation, promotes thickening cervical mucus, reduces the level of estradiol to values, ...

Indications: Contraception.

Gross formula

Pharmacological group of the substance Desogestrel

Nosological classification (ICD-10)

CAS code

Characteristics of the substance Desogestrel

Contraceptive gestagen-containing drug.

Pharmacology

It suppresses ovulation, promotes the thickening of cervical mucus, reduces the level of estradiol to values ​​characteristic of the early follicular phase. The frequency of pregnancy when taking desogestrel is comparable to that when prescribing combined estrogen-progestin drugs: the Pearl index (the number of pregnancies that occurred during the use of a contraceptive method in 100 women during the year) for desogestrel - 0.4 (for drugs with 0.03 mg levonorgestrel - 1.6). Does not cause significant changes in carbohydrate, lipid metabolism and hemostasis.

Pharmacokinetics. It is rapidly and almost completely biotransformed by hydroxylation and dehydrogenation to form the active metabolite, etonogestrel, which is metabolized by the formation of sulfate and glucuronide conjugates. Bioavailability - 70%. T max - 1.8 hours. Etonogestrel binds to plasma proteins: with albumin - 66 ± 12%, with sex hormone-binding globulin (SHBG) - 31 ± 12%. C ss is achieved after 4-5 days of taking the drug. Penetrates into breast milk in a ratio of 0.33-0.55 (with a total amount of milk consumed 150 ml / kg / day, a newborn can receive 0.01-0.05 mcg). In an equilibrium state, on the 21st day, T 1/2 is 27.8 ± 7.2 hours. Etonogestrel and its metabolites are excreted in the urine and faeces in a ratio of 1.5/1 (as free steroids and as conjugates) .

The use of the substance Desogestrel

Contraception.

Contraindications

Hypersensitivity, established or suspected pregnancy, thromboembolism (including deep vein thrombosis of the lower leg, thromboembolism pulmonary artery, incl. in history) liver failure(including history), gestagen-dependent tumors, vaginal bleeding unclear etiology, breast cancer, liver cancer, prolonged immobilization associated with surgery or disease (risk of venous thromboembolism).

Side effects of Desogestrel

From the nervous system and sensory organs: mood change; rarely - headache, fatigue.

From the digestive tract: nausea; rarely - vomiting.

From the side genitourinary system: irregular bloody issues; rarely - amenorrhea, decreased libido; very rarely - vaginitis, dysmenorrhea, ovarian cysts.

From the side endocrine system: soreness of the mammary glands, weight gain, acne, alopecia.

Allergic reactions: in isolated cases - rash, urticaria, erythema nodosum.

Others: discomfort when using contact lenses.

A significant relationship with the use of progestogens has not been established: cholestatic jaundice, pruritus, cholelithiasis, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, chorea, herpes pregnancy, otosclerosis, deafness.

Interaction

With the simultaneous use of inducers of microsomal liver enzymes (phenytoin, barbiturates, carbamazepine, rifampicin, oxcarbazepine, rifabutin, griseofulvin), the effectiveness of oral contraceptives may decrease and the risk of breakthrough uterine bleeding. The maximum level of enzyme induction is usually reached no earlier than 2-3 weeks and may persist up to 4 weeks after discontinuation of the concomitant drug.

In research in vitro shown, that important role in the conversion of desogestrel to etonogestrel, the CYP2C9 isoenzyme of cytochrome P450 plays, therefore, interaction of desogestrel with substrates or inhibitors of CYP2C9 (such as ibuprofen, piroxicam, naproxen, phenytoin, fluconazole, diclofenac, glipizide, celecoxib, sulfamethoxazole, isoniazid, irbesartan, tanlosartan, valsartan) is possible; the clinical significance of this interaction is unknown.

Antibiotics (eg ampicillin and tetracycline) reduce the effectiveness of the contraceptive effect.

Activated charcoal reduces the absorption of desogestrel and reduces contraceptive effectiveness.

Overdose

Symptoms: potentially nausea, vomiting, minor bleeding from the vagina.

Treatment: symptomatic, there is no specific antidote.

Routes of administration

inside.

Desogestrel Substance Precautions

Perhaps the appointment of nursing mothers, as well as women who are contraindicated in estrogens.

It should be remembered that contraceptive effectiveness may decrease if the interval between taking 2 tablets. will be more than 36 hours. If taking the next pill is delayed by less than 12 hours, you should take the pill as soon as the woman remembered about it and take subsequent pills in regular time. If taking the next pill is delayed for more than 12 hours, you should follow the rules for taking the pills, additionally using barrier methods of contraception for the next 7 days. If the pill was missed in 1 week of their use and there was sexual contact during the 1 week preceding the missed pill, the presence of a possible pregnancy should be ruled out.

While taking oral contraceptives, the risk of developing breast cancer increases with age (does not depend on the duration of taking oral contraceptives, but depends on the age of the woman).

Although gestagens may affect peripheral tissue insulin resistance and glucose tolerance, there is no evidence that patients diabetes dose adjustment is required, but women with diabetes should be under medical supervision during the entire period of treatment.

With amenorrhea and the appearance of pain in the process of taking the drug, one should be aware of a potentially possible ectopic pregnancy.

Women with a predisposition to chloasma should avoid prolonged sun exposure or UV exposure.

Despite the regular use of the drug, irregular spotting is possible. If the bleeding is quite frequent and irregular, it is necessary to decide on the appointment of another contraceptive. If the above symptoms continue to occur even after discontinuation of desogestrel, organic pathology should be excluded.

When taking low-dose hormonal contraceptives, the size of the follicles can occasionally reach sizes that exceed normal. In most cases, they disappear on their own, sometimes it is noted slight pain in the lower abdomen, occasionally surgery is required.

Large-scale epidemiological studies have not revealed a teratogenic effect when taking oral contraceptives in early dates pregnancy, as well as an increased risk of having children with anomalies.

When taking rifampicin barrier contraception should be used throughout the course of treatment and for 28 days after discontinuation of this drug.

KNF (drug is included in the Kazakhstan National Formulary medicines)

Manufacturer: Laboratorios Leon Farma S.A.

Anatomical-therapeutic-chemical classification: Desogestrel

Registration number: No. RK-LS-5 No. 122137

Date of registration: 06.04.2016 - 06.04.2021

Limit price: 64.5 KZT

Instruction

• Russian

Tradename

International non-proprietary name

Desogestrel

Dosage form

Tablets, coated film sheath, 0.075 mg

Compound

One tablet contains

active substance: desogestrel 0.075 mg

Excipients: lactose monohydrate, α-tocopherol, corn starch, povidone K-30, colloidal anhydrous silicon dioxide, stearic acid, colloidal silicon dioxide,

shell composition: hypromellose, polyethylene glycol, titanium dioxide (E 171).

Description

Tablets round shape, smooth, film-coated white.

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system. Hormonal contraceptives for system use. Progestogens. Desogestrel

ATX code G03AC09

Pharmacological properties

Pharmacokinetics

When taken orally, desogestrel is rapidly and completely absorbed into the bloodstream. gastrointestinal tract and is converted to the biologically active metabolite etonogestrel. When equilibrium is reached, the peak plasma concentration of etonogestrel is reached 1.8 hours after oral administration of the tablet, and the absolute bioavailability of etonogestrel is approximately 70%.

Etonogestrel is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to sex hormone-binding globulin.

Desogestrel is metabolized by hydroxylation and dehydrogenation to the active metabolite etonogestrel. Etonogestrel is completely metabolized through the formation of sulfate and glucuronide conjugates.

Etonogestrel is eliminated with a half-life of about 30 hours, both with single and multiple doses. Equilibrium plasma concentrations are reached after 4-5 days. Serum clearance at intravenous administration etonogestrel is approximately 10 l / h. Excretion of etonogestrel and its metabolites is carried out both in the form of free steroids and in the form of conjugates by the kidneys and intestines (in a ratio of 1.5: 1).

Pharmacodynamics

Desiret is a progestin-based tablet and contains the progestin desogestrel. Like other progestin-based tablets, Desiret is best for use during breastfeeding and for women who cannot or do not want to take estrogens. The contraceptive effect of the drug Desiret is achieved mainly by suppressing ovulation and changing the secretion of cervical mucus.

When using the drug Desiret in the first 56 days, the frequency of ovulation does not exceed 1%, after stopping the 56-day intake of the drug, ovulation occurs after 7-30 days (average after 17 days).

In a comparative efficacy study (in which missed pills were allowed to be taken for a maximum of 3 hours), the overall Pearl Index (an indicator reflecting the frequency of pregnancy in 100 women during the year of using a contraceptive) of Desiret was 0.4 in the group of all patients included in the study.

The Pearl Index of Desiret is comparable to the Pearl Index of combined oral contraceptives.

Taking the drug Desiret leads to a decrease in serum estradiol levels to values ​​characteristic of early follicular phase. However, no clinical significant changes on the part of carbohydrate, lipid metabolism and indicators of hemostasis.

Indications

Hormonal contraception

Dosage and administration

Tablets should be taken in the order indicated on the blister pack, every day at about the same time.

Take 1 tablet daily for 28 days. Each subsequent package is started immediately after the completion of the previous package.

If the drug is taken for the first time

Tablets should be taken on the first day of menstruation. It is allowed to start taking pills from 2-5 days of menstruation, but in this case, during the first 7 days, during the first cycle of the drug, it is recommended to use additional non-hormonal (barrier) methods of contraception.

After an abortion in the first trimester: a woman can start taking the drug immediately. There is no need to use any additional methods contraception.

After childbirth or abortion in the second trimester: It is recommended to start taking the drug on the 21-28th day after an abortion in the second trimester, and not earlier than 6 weeks after childbirth. When you start taking the drug at a later date, it is recommended to exclude pregnancy and use barrier methods of contraception during the first seven days of taking Desiret.

If you have previously used another combined hormonal contraceptive(combined oral contraceptive, vaginal ring or transdermal patch)

Reception Desiret begin the next day after taking the last active dragee, or no later than the 7-day break in the reception for drugs containing 21 tablets.

In the case of using a vaginal ring or transdermal patch, after removing the vaginal ring or transdermal patch, but no later than the day after removing the vaginal ring or transdermal patch.

A woman can start taking Desiret the day after the end of her usual tablet, patch, ring interval, or the day after taking the placebo tablets of the previous COC, but an additional dose is recommended during the first 7 days of taking the tablets. barrier method contraception.

Switching from contraceptives containing only gestogens (mini-pills, injectable forms, implant)

You can switch from mini-pill to Leverett mini any day, with injection form- on the day when the next injection is due, from the implant - on the day of its removal. In all these cases, additional methods of contraception are not required.

When you skip pills

Contraceptive protection may be reduced if the interval between taking two pills is more than 36 hours. If the next pill is delayed by less than 12 hours, the reliability of contraception does not decrease. The woman should take the pill as soon as she remembers, and take subsequent pills at the usual time.

If taking the next pill is delayed by more than 12 hours, then the woman should follow the above recommendations, as well as use an additional method of contraception for the next 7 days. If the tablets were missed in the first week of taking the drug and sexual intercourse took place during the week preceding the missed dose, pregnancy should be excluded.

At gastrointestinal disorders Oh

In the event of severe gastrointestinal disorders (vomiting, diarrhea), absorption may be incomplete and in this case additional methods of contraception should be used. If vomiting occurs within 3-4 hours after taking the drug, absorption may not be complete. In this case, you should use the recommendations regarding skipping the next dose of the drug.

Side effects

Often (≥ 1/100 to<1/10)

Headache

Nausea, abdominal pain

Weight gain

Depressed state, mood swings

Soreness of the mammary glands

Decreased libido

Pain in the chest

Irregular spotting, amenorrhea

Uncommon (≥1/1000 to<1/100)

Intolerance to contract lenses

Vaginal infections

Vomiting, diarrhea

Alopecia

Dysmenorrhea

Ovarian cyst

Rare (≥1/10000 to<1/1000)

Rash, hives

Nodular erythema

Breast discharge, ectopic pregnancy

Contraindications

- hypersensitivity to the active substance or any auxiliary component of the drug

- venous thromboembolism or a history of venous thromboembolism (eg, deep vein thrombosis, pulmonary embolism) with or without risk factors

Arterial thromboembolism or its history, in particular myocardial infarction and cerebrovascular accident

Malignant hormone-dependent tumors established or suspected

Presence of serious or multiple risk factors for venous or arterial thrombosis

Presence of a history of precursors of thrombosis (eg, transient cerebrovascular accident or angina pectoris)

Severe arterial hypertension

- diagnosed or suspected hormone-dependent malignant tumors of the breast and genital organs

Serious liver diseases or their presence in history (before the normalization of indicators of functional "liver" tests)

Vaginal bleeding of unknown etiology

Pregnancy established or suspected, as well as an ectopic history

Allergy to peanuts or soy

Lactose intolerance, lactose deficiency, glucose-galactose malabsorption.

Drug Interactions

Medicines that may affect the effects of COCs

In order to identify potential drug interactions, you should always study the information on the use of any concomitant medicinal products!

Drug interactions that lead to increased clearance of sex hormones can cause breakthrough bleeding and ineffective contraceptive protection. This effect has been found in hydantoins (eg, phenytoin), barbiturates, primidone, carbamazepine, rifampicin, bosentan, nelfinavir. Other active substances that may reduce effectiveness are oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

The mechanism of their action is probably based on the ability of these substances to increase the activity of "liver" enzymes. The maximum induction of enzymes, as a rule, is observed no earlier than 2-3 weeks after the start of taking these drugs, but can persist for at least 4 weeks after their cancellation.

In the case of short-term use of any of these drugs that cause an increase in the activity of "liver" enzymes, it is recommended to use additional barrier methods of contraception from the moment you start taking these drugs, during the entire period of treatment and for 4 weeks after their withdrawal. In the case of treatment with these drugs in for a long time it is necessary to use other non-hormonal methods of contraception. When using activated charcoal, the absorption of desogestrel in the tablet may decrease, which can lead to a decrease in contraceptive effectiveness. In this case, you should act in accordance with the recommendations regarding the missed tablets for taking.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, the concentration of drugs in plasma and tissues can both increase and decrease. Sex steroid hormones can increase the plasma concentration of cyclosporine, which can lead to the development of toxic effects.

special instructions

Before you start taking Desiret, you need to conduct a complete clinical examination, exclude pregnancy, tumors. The interval between control medical examinations is determined by the doctor in each individual case.

Desirete does not protect against HIV infection (AIDS) and sexually transmitted diseases!

If you have any of the conditions or risk factors listed below, you should carefully weigh the benefits and possible harms of taking Desiret. In the event of an exacerbation of diseases, worsening of the condition or the appearance of the first symptoms of the above conditions or risk factors, the patient should immediately consult a doctor.

The risk of breast cancer increases with age. During the use of 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 stopping the use of oral contraceptives, it is not related to the duration of use, but depends on the age of the woman at the time of using the COC.

The risk in women using progestogen-only oral contraceptives, such as Desiret, may be similar to that of COCs.

Since a biological effect of progestogens on patients with liver cancer cannot be excluded, an individual assessment of the benefit / risk ratio in women with this disease should be made.

A relationship has been established between the use of COCs and an increased incidence of venous thromboembolism (venous thromboembolism, deep vein thrombosis, pulmonary embolism). Although the clinical significance of these data for desogestrel as an estrogen-free contraceptive is unknown, the use of Desiret should be discontinued in the event of thrombosis. Discontinuation of Desirette should also be considered in the event of long-term immobilization due to surgery or illness. A patient with a history of thromboembolism should be aware of the possibility of recurrence.

There is no evidence that there is a need to change the therapeutic regimen in diabetic patients using progestogen-containing oral contraceptives. However, women with diabetes should be closely monitored during the first months of using the drug.

Against the background of taking the drug Desiret, persistent arterial hypertension may develop. If antihypertensive therapy fails, the drug should be discontinued.

Taking the drug Desiret leads to a decrease in serum estradiol levels to a level corresponding to the early follicular phase. It has not yet been established whether the decrease has any clinically significant effect on bone mineral density.

With amenorrhea and the appearance of pain in the process of taking the drug, one should be aware of a potentially possible ectopic pregnancy.

Women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation.

When taking all low-dose hormonal contraceptives, the development of follicles occurs, occasionally the size of the follicle can reach sizes that exceed those in the normal cycle. In general, these enlarged follicles disappear spontaneously. Often this occurs without symptoms; in some cases, there is mild pain in the lower abdomen.

Despite the regular use of the drug, irregular spotting is possible. If the bleeding is quite frequent and irregular, it is necessary to decide on the appointment of another contraceptive. If the above symptoms continue to occur even after discontinuation of desogestrel, organic pathology should be excluded.

Application for lactation.

Desiret does not affect the quantity or quality of breast milk. However, small amounts of etonogestrel are excreted in breast milk. As a result, 0.01-0.05 micrograms of etonogestrel per kg of body weight per day can be supplied with breast milk (based on consumption of 150 ml/kg/day of breast milk). Assessment of growth, physical and psychomotor development in the child did not reveal any differences with children whose mothers used copper intrauterine devices. Available data led to the conclusion that Desiret can be used during lactation. However, the development and growth of an infant whose mother is taking Desiret should be carefully monitored.

Laboratory research

The use of contraceptive steroid hormones may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma transport protein concentrations (for example, corticosteroid-binding globulin, lipid/lipoprotein fractions), indicators of carbohydrate metabolism, coagulation, and fibrinolysis . The observed changes usually remain within the reference values.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.

Does not affect.

Overdose

Symptoms: nausea, vomiting, and in young girls - menstrual bleeding.

Treatment: symptomatic.

Release form and packaging

28 tablets in a blister pack of aluminum foil and polyvinyl chloride / polyvinyl dichloride film.

1, 3 or 6 blister packs, together with instructions for medical use in the state and Russian languages, are put into a pack of cardboard

Storage conditions

Store in a dry, dark place, at a temperature not exceeding 30 °C. Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Laboratorios Leon Farma S.A., Spain

Registration certificate holder

Exeltis Healthcare S.L., Spain

Address of the organization accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Representative office of Exceltis Healthcare S.L., Almaty, st. 22 line, 45

E-mail address: [email protected]

Attached files

Desogestrel is an active substance that is included in contraceptive gestagen-containing drugs.

What is the effect of drugs with desogestrel on the body, action?

The action of birth control pills containing the substance desogestrel can suppress ovulation, thicken cervical mucus, and also lower the level of estradiol to such values ​​that are usually fixed in the early follicular phase.

Medications based on desogestrel do not cause significant changes in fat and carbohydrate metabolism, and also do not change the main indicators of hemostasis.

The contraceptive is rapidly biotransformed by hydroxylation and dehydrogenation, resulting in the formation of etonogestrel, which is an active metabolite. Bioavailability is 70%. Penetrates into breast milk. It binds to albumin and globulin. It is excreted in the urine and through the intestines in the form of conjugates and so-called free steroids.

Indications for the use of tablets with desogestrel

Contraindications to the use of tablets with desogestrel

The contraceptive drug is contraindicated in the following situations:

Hypersensitivity to the substance desogestrel;
With an established pregnancy;
With thromboembolism;
With liver cancer;
With liver failure;
In the presence of gestagen-dependent tumors;
With vaginal bleeding of unknown origin;
With breast cancer.

In addition, the contraceptive drug is contraindicated for prolonged immobilization caused by any disease or associated with surgery, since the risk of venous thromboembolism is high.

Application and dosage of tablets with desogestrel

The contraceptive is taken orally, the tablets are washed down with a small amount of water, usually the doctor prescribes a dosage of 0.075 mg / day daily at the same time, while the medication should be used for 28 days in the order indicated directly on the medicine package.

Contraceptive pills with desogestrel - side effects

Drugs that include desogestrel in their composition cause some side effects, among which the following symptoms can be distinguished: nausea and vomiting, mood changes occur, headache joins, increased fatigue is often noted, irregular spotting occurs, amenorrhea is characteristic, ovarian cysts, and also a decrease in libido, in addition, vaginitis develops.

Among other manifestations, some changes in the endocrine system should be noted, which will be expressed in the form of soreness of the mammary glands, the appearance of acne is not excluded, in addition, an increase in body weight, and baldness joins.

Sometimes allergic reactions develop, they are manifested by erythema nodosum, a rash joins, the occurrence of urticaria is not excluded, in addition, a woman may experience some discomfort while using contact lenses.

Among other undesirable effects, it can be noted: the development of cholestatic jaundice, skin itching, cholelithiasis is not excluded, porphyria is possible, in addition, systemic lupus erythematosus, the so-called hemolytic-uremic syndrome, herpes of pregnant women, as well as otosclerosis and even deafness.

If any side effects on a contraceptive drug appear, a woman should consult a qualified gynecologist in a timely manner.

Overdose of tablets with desogestrel

With an overdose of contraceptive pills, a woman will experience nausea, vomiting, bloody discharge from the vagina will join, which will not be very abundant. In this situation, symptomatic treatment is recommended.

special instructions

It is possible to prescribe such contraceptive drugs to nursing mothers, as well as to those patients who are contraindicated in estrogens. It should be remembered that the effectiveness of a drug containing desogestrel may decrease slightly if the interval between the use of tablets is more than 36 hours.

Against the background of taking contraceptives, with age, women may increase the risk of developing oncological processes of a malignant nature, in particular, breast cancer.

Women suffering from diabetes and simultaneously taking contraceptives based on the substance desogestrel must be under medical supervision during the entire period of tablet use.

With amenorrhea, as well as when pain occurs while taking contraceptive pills, a woman should be aware of a potential ectopic pregnancy.

Despite the regular use of the drug, bleeding from the genital tract is possible, if this phenomenon is frequent enough, the doctor should decide whether to prescribe another contraceptive to the patient.

If spotting continues after discontinuation of the drug containing the substance desogestrel, then the doctor should exclude organic pathology.

Preparations containing desogestrel

Contraceptives, Charozetta, in addition, Marvelon, Mercilon, Regulon, as well as Tri-Merci medicine contain the active substance desogestrel.

Conclusion

We have reviewed contraceptive pills with Desogestrel, instructions, use, indications, contraindications, action, side effects, analogues, composition, and their dosage. The contraceptive should be prescribed by a qualified gynecologist. If a woman notices the addition of any side effects, it is worth notifying the doctor immediately.

Be healthy!

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