Silest

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Silest: 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. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Terms of dispensing from pharmacies
17. Reviews
18. Price in pharmacies

Latin name: Cilest

ATX code: G03AA11

Active ingredients: norgestimate + ethinylestradiol (Norgestimate + Aethinyloestradiolum)

Manufacturer: SILAG, AG (CILAG, AG) (Switzerland)

Description and photo update: 2019-30-12

Silest is a contraceptive drug (estrogen + progestogen).

Release form and composition

Dosage form - tablets: round, flat-cylindrical, blue, with beveled edges and engraving "C250" on both sides (in a cardboard box 1 or 3 blisters containing 21 tablets each, and instructions for using Silest).

Active ingredients in 1 tablet:

norgestimate - 0.25 mg;
ethinylestradiol - 0.035 mg.

Auxiliary components: magnesium stearate, pregelatinized starch, lactose, FD&C blue No. 2 Varnish 13%.

Pharmacological properties

Pharmacodynamics

Silest is a combined oral contraceptive. Its action is due to central and peripheral mechanisms. The drug prevents ovulation and the maturation of eggs by suppressing the release of gonadotropins.

In addition, it increases the viscosity of cervical mucus, making it difficult for sperm to enter the uterus, and also affects the endometrial epithelium, reducing the likelihood of implantation.

Pharmacokinetics

Oral Norgestimate is well absorbed both separately and in combination with ethinyl estradiol. Its maximum concentration in blood plasma is reached after 60–120 minutes. The substance is actively metabolized, its half-life is approximately 4 hours. Norgestimate metabolites are excreted slowly from the body. After 14 days, almost 50% of the active substance is excreted in the urine, and about 40% - with feces.

Ethinylestradiol is absorbed quickly and almost completely when taken orally. Its maximum concentration in blood plasma is also reached after 60–120 minutes. The drug is metabolized in the body only partially, its half-life is 4.5 hours. The active metabolite of ethinyl estradiol is excreted unchanged in the urine (more than 17%) and with feces (over 10%). The metabolites of the substance are mainly 2-hydroxyethinyl estradiol and 16ß-hydroxyethinylestradiol, as well as estriol, estradiol.

Indications for use

Silest is used as a contraceptive for women.

Contraindications

Absolute:

precursors of thrombosis, including transient ischemic attack and angina pectoris;
arterial thrombosis, including a history (including acute cerebrovascular accident, myocardial infarction, retinal arterial thrombosis);
venous thrombosis, including history (including pulmonary thromboembolism, deep vein thrombosis);
the presence of serious or multiple risk factors for arterial thrombosis;
hereditary dyslipoproteinemia;
arterial hypertension (persistent increase in blood pressure above 160/100 mm Hg);
diabetes mellitus with vascular lesions;
migraine with aura;
hereditary predisposition to arterial or venous thrombosis, for example, the presence of antiphospholipid antibodies (a group of antibodies against negatively charged phospholipids, antibodies against cardiolipin), hyperhomocysteinemia, protein S deficiency, protein C deficiency, antithrombin-III deficiency;
benign or malignant neoplasms of the liver;
endometrial cancer or other suspected or confirmed estrogen-dependent tumors;
suspected or confirmed breast cancer;
liver failure;
sickle cell anemia;
hemolytic anemia;
otosclerosis;
genital bleeding of unknown origin;
cholestatic jaundice during pregnancy, including a history;
postmenopausal period;
28 days postpartum;
pregnancy (confirmed or suspected);
period of breastfeeding;
children and adolescents under 18 years of age;
individual intolerance to the components of the drug.

Relative (contraceptive pills Silest are used under medical supervision):

lesions of the valve apparatus of the heart with complications (mitral stenosis with atrial fibrillation);
impaired renal function;
tuberculosis;
epilepsy;
varicose veins and thrombophlebitis of superficial veins;
pathology of the gallbladder;
uterine fibroids;
menstrual irregularities;
mastopathy;
arterial or venous embolism in parents, sisters or brothers at a relatively young age;
hypertriglyceridemia, including a family history;
extensive surgery or prolonged immobilization;
risk factors for coronary heart disease such as smoking, obesity, hypertension, or hyperlipidemia;
arterial hypertension (persistent blood pressure levels - 140-159 / 90-99 mm Hg. Art.);
diabetes;
severe depression or a history of this disease;
systemic lupus erythematosus;
Crohn's disease;
ulcerative colitis;
acute dysfunction of the liver with the previous use of sex hormones or during a previous pregnancy.

Silest, instructions for use: method and dosage

The contraceptive pill Silest is taken orally.

Taking the drug begins with 1 tablet on the first day of menstrual bleeding. Then, for 20 days, take 1 tablet daily. After that, take a break of 7 days. Usually, a few days after the end of the drug intake, menstrual bleeding occurs.

On the eighth day, that is, after 7 days have passed after the cancellation of taking Silest during the previous cycle, the next cycle of drug administration begins. The first pill of the new cycle is taken regardless of whether menstrual bleeding has ended or is still continuing.

The blister pack with Silest contains the indication of the days of the week. It is recommended to start each new cycle with the tablet marked on this day of the week and continue taking it without interruption throughout the cycle. In this case, it will be convenient to check the regularity of the contraceptive use.

Silest is most effective when used at the same time of day, such as in the morning.

If the usual time is missed, Silest is taken immediately. A deviation from the usual time of use lasting no more than 12 hours provides reliable contraceptive protection. A decrease in the effectiveness of the drug occurs with a delay in admission exceeding 12 hours. In cases where more than 12 hours have passed from the usual time of use, or more than 1 tablet has been missed, the contraceptive is used immediately, leaving the missed tablet in the blister. At the same time, before the end of the cycle, it is important to use additional contraceptives - vaginal contraceptive suppositories or condoms. In these cases, you cannot rely on the temperature method of contraception or the method of safe days.

After childbirth, Silest can be used no earlier than 28 days after the birth of the child, provided that the woman does not breastfeed.

In cases of miscarriage or abortion less than 20 weeks pregnant, you can start using Silest immediately, without using additional contraception. In case of spontaneous or induced abortion at a gestational age of more than 20 weeks, hormonal contraceptives can be taken on the first day of the onset of natural menstruation or on the 21st day after the abortion (whichever comes first). Moreover, during the first 7 days, in addition to the drug, it is important to use additional local contraceptives. In the presence of medical indications, in exceptional cases, in order to ensure immediate reliable contraception, pills can be taken 7 days after the abortion. It is important to take into accountthat the likelihood of thromboembolic complications is increased when taking the drug during the period after abortion.

The development of diarrhea or vomiting can lead to a loss of the effectiveness of Silest, since it takes 4 hours for its complete absorption by the body. In this case, the use of the drug should be continued, supplementing its action before the onset of menstruation with other contraceptives.

Side effects

cardiovascular system: edema, thromboembolism of the pulmonary or other vessels, arterial thromboembolism, deep vein thrombosis, cerebrovascular accident, myocardial infarction, arterial hypertension;
tumors: breast and cervical cancer, benign and malignant liver tumors;
hepatobiliary system: cholelithiasis. intrahepatic cholestasis, Budd-Chiari syndrome, cholestatic jaundice;
gastrointestinal tract: abdominal pain, colitis, nausea, flatulence, vomiting;
genitals: temporary infertility after the end of the use of the contraceptive, premenstrual syndrome, decreased libido, erosion of the cervix, increased secretion of the cervix, vaginal candidiasis, an increase in the size of uterine fibroids, changes in the menstrual cycle, amenorrhea, spotting spotting, intermenstrual bleeding;
breasts: decreased lactation when taken immediately after childbirth, galactorrhea, enlargement, engorgement, feeling of tension and soreness of the mammary glands;
skin: melasma with a tendency to persistence, gestational herpes (pemphigoid), hypertrichosis, age spots on the face, hirsutism, alopecia, seborrhea, acne, exudative erythema, chloasma, skin rash, erythema nodosum;
organs of vision: a feeling of discomfort when wearing contact lenses, changes in the curvature of the cornea, damage to the optic nerve, cataracts;
central nervous system: chorea, depression, irritability, mood changes, headache;
metabolism: changes in appetite, decreased glucose tolerance, decrease or increase in body weight, fluid retention;
kidneys: hemolytic uremic syndrome, decreased renal function;
others: migraine, dizziness.

The drug should be continued if menstrual bleeding occurs. In cases where bleeding does not stop, it is important to conduct an examination in order to exclude organic causes. Similar recommendations apply to spotting bleeding, which may occur irregularly during several cycles of taking Silest or for the first time after prolonged use. If bleeding does not occur at the end of the contraceptive cycle, it is important to exclude pregnancy before starting a new cycle of taking the drug.

Overdose

As a result of an overdose of Silest, there were no serious cases of intoxication. The development of vaginal bleeding, nausea and vomiting is possible.

In case of an overdose, it is necessary to wash the stomach (within the first hour after taking Silest) and symptomatic treatment. There is no specific antidote.

special instructions

It is important to take into account that oral contraceptives do not protect against HIV infections (acquired immunodeficiency syndrome) and other sexually transmitted diseases.

Before prescribing an oral contraceptive, the doctor should take a complete family history of the patient and conduct a thorough physical examination. Periodically, this examination must be repeated in accordance with the standards of quality gynecological care. Also, before prescribing the drug, a woman should clarify whether she is taking any herbal remedies, and read the instructions in the leaflets for the medications that she will take in combination with Silest.

In cases of undiagnosed, persistent, or recurring abnormal vaginal bleeding, it is important to exclude the presence of malignant neoplasms.

It is possible to take Silest after hepatitis only after 3 months (in severe cases - after 6 months) after the normalization of the results of functional liver tests.

It has been found that the use of oral contraceptives increases the likelihood of thrombosis and thromboembolic complications. The conducted studies of the type "case-control" revealed that in patients receiving such drugs, compared with women who did not use them, the relative risk for pulmonary embolism or deep vein thrombosis was 11: 4, for the first episode of superficial vein thrombosis - 3: 1, for pathologies predisposing to thromboembolic complications - 6: 1.5. Also, studies have found that the relative risk was slightly lower and was approximately 3: 1 for new cases, and 4.5: 1 for new cases that require hospitalization. The likelihood of thromboembolic complications associated with the use of these drugs,does not depend on the duration of their intake and disappears after the end of therapy.

The relative risk of postoperative thromboembolic complications in patients receiving oral contraceptives is 2–4 times increased, the risk of venous thrombosis against the background of pathologies predisposing to its development is 2 times. If possible, these drugs are not recommended to be used at least 28 days before and for 14 days after elective surgery associated with an increased likelihood of thromboembolism, during prolonged immobilization and during the recovery period.

The risk of thromboembolic complications is also increased in the early postpartum period, and therefore women who do not plan to breastfeed can start taking Silest no earlier than 21 days after childbirth. After a spontaneous or induced abortion that took place in the 20th week of pregnancy or later, you can start using the drug either on the 21st day after the abortion, or on the first day after a sudden menstruation (whichever comes first).

The relative risk of developing arterial thrombosis (eg, myocardial infarction, stroke) increases in the presence of other predisposing factors. These include:

a history of preeclampsia;
smoking;
diabetes;
arterial hypertension;
obesity;
hyperlipidemia;
middle age.

These severe vascular complications were observed in patients taking oral contraceptives with an estrogen content of 50 μg or more. The risk of vascular complications is probably lower with such low estrogen and progestogen drugs, but this assumption has not yet been firmly supported.

The likelihood of developing serious adverse effects from the cardiovascular system increases with the age of the patient (especially high over the age of 35), as well as with heavy smoking. It is important to strongly advise women using oral contraceptives to quit smoking.

There are reports of an increase in blood pressure while taking oral contraceptives. Studies have shown that prolonged use of estrogen at a dose of 50 mcg or more leads to the risk of increased blood pressure with age. In many patients, blood pressure returned to normal after discontinuation of such drugs. It was not possible to identify differences in the incidence of arterial hypertension in patients using oral contraceptives and in women who never use these drugs.

Before starting therapy with arterial hypertension (persistent level of blood pressure - 140–159 / 90–99 mm Hg), blood pressure should be normalized. If there is a strong increase in blood pressure, the use of Silest is discontinued.

It was reported about the development of retinal thrombosis with the use of oral contraceptives. The use of such funds should be canceled in the event of changes in the retinal vessels, edema of the optic nerve nipple, diplopia, a veil before the eyes, unexplained partial, complete or transient loss of vision. In this case, appropriate diagnostic and therapeutic actions should be immediately carried out.

Malignant and benign neoplasms of the liver (hepatocellular carcinoma and adenomas) are rare. Case-control studies have shown that the likelihood of these tumors may increase with oral contraceptives and depends on the duration of their use. Rupture of benign liver adenomas due to internal bleeding can be fatal.

The incidence of cancer of the cervix, ovary, endometrium and breast with oral contraceptive use has been the subject of numerous epidemiological studies. The available results are conflicting, but most of them showed that the overall increase in breast cancer risk was not associated with the use of such drugs. Some authors have noted an increase in the relative likelihood of malignant neoplasms of the mammary glands, especially in young women. This increased relative likelihood has been shown to depend on the duration of therapy.

A meta-analysis of the results of 54 epidemiological studies has shown a slightly increased risk of breast cancer with combined oral contraceptives, currently or within the previous 10 years. Given these data, it is impossible to establish whether the increased risk is due to the biological effects of hormonal contraceptives, an earlier diagnosis of the pathology, or a combination of these two factors. This meta-analysis also suggests that the age at which patients stop taking such drugs is an important risk factor for breast cancer - the older the woman is, the more often the pathology is diagnosed. The duration of therapy is not so important.

Before prescribing Silest with the patient, it is necessary to discuss the possibility of increasing the likelihood of breast cancer and correlate this risk with the potential benefit from its use.

Some epidemiological studies have found an increase in the likelihood of cervical tumors with long-term use of oral contraceptives. The relationship between these data and the use of combined oral contraceptives has not been proven. However, it should be noted that it is uncertain to what extent these data may be due to many factors, including differences in sexual behavior.

Silest can reduce glucose tolerance. It has been shown that this effect is directly dependent on the dose of estrogen. It is important to take into account that progestogens can increase the secretion of insulin and cause the emergence of resistance to it, and this effect is not the same for different progestogens. It should be noted that in the absence of diabetes, oral contraceptives are likely to have no effect on fasting glucose levels. In this regard, one should closely monitor the condition of patients with diabetes mellitus or impaired glucose tolerance who take such drugs.

In a small number of cases, the use of oral contraceptives led to persistent hypertriglyceridemia. In patients taking such drugs, there was a change in the level of serum lipoproteins and triglycerides.

In the event of the occurrence or intensification of migraine, as well as the appearance of a new type of headache (severe, persistent or recurrent), you should stop using Silest and find out the cause of the headache.

During the period of taking the drug, especially during the first 3 months, spotting, intermenstrual bleeding and / or amenorrhea may appear. It is recommended to consider the possible causes of these non-hormonal disorders and, if necessary, carry out appropriate diagnostic procedures in order to exclude pregnancy or cancer.

Sometimes, while taking Silest, oligomenorrhea or amenorrhea develops, especially if these conditions occurred before the start of therapy.

In some cases, taking oral contraceptives leads to the appearance of chloasma, in particular in patients with a history of chloasma of pregnant women. If you have a tendency to develop chloasma, it is recommended to avoid exposure to ultraviolet radiation and the sun during therapy. Pathology often does not completely disappear.

Application during pregnancy and lactation

Silest is not prescribed during pregnancy / lactation.

Epidemiological studies have not identified an increased risk of birth defects in infants whose mothers used oral contraceptives prior to pregnancy. Most modern studies have also not found teratogenic effects, including shortening of the limbs and heart abnormalities in children whose mothers mistakenly took such drugs during pregnancy.

Combined oral contraceptives can affect breast milk - change its composition or reduce the amount. In addition, some contraceptive steroids and / or their metabolites can pass into breast milk, and therefore Silest is contraindicated to prescribe during lactation.

Pediatric use

Silest is not prescribed for patients under 18 years of age.

With impaired renal function

Silest is contraindicated in cases of impaired renal function.

For violations of liver function

use is contraindicated: liver failure, benign or malignant neoplasms of the liver;
use requires medical supervision: acute liver dysfunction during previous pregnancy or previous use of sex hormones.

Drug interactions

The contraceptive efficacy of hormonal drugs decreases when combined with drugs that induce the induction of enzymes that metabolize estrogens (for example, estrogen-2-hydroxylase - coenzyme 3A4 of the cytochrome P _{450 system}). It is assumed that the induction of these isoenzymes can lead to a decrease in the content of the progestogen component of Silest in the blood. In this regard, drugs and herbal remedies that affect the enzymes involved in the biological transformation of contraceptive steroid hormones (for example, rifampicin, pyrazolone derivatives, sulfonamides, phenytoin, carbamazepine, barbiturates, St. John's wort) are potentially clinically significant.

It has been shown that some antiretroviral drugs and protease inhibitors lower (for example, ritonavir) or increase (for example, indinavir) the content of combined hormonal contraceptives in the blood. Another type of interaction consists in a violation of the intrahepatic circulation of estrogens, as a result of which the content decreases and the excretion of ethinyl estradiol is accelerated. Combined administration with some antibacterial agents (for example, tetracycline or ampicillin) leads to insufficient cleavage of the conjugates of fatty acids and estrogens by intestinal bacteria.

The use of oral contraceptives can cause changes in liver function and hormonal parameters, namely:

increased platelet aggregation caused by norepinephrine;
a decrease in the level of antithrombin 3;
an increase in the level of factors II, VII, VIII, IX, X, XII and XIII, as well as prothrombin;
an increase in the content of thyroxine-binding globulin (this leads to an increase in the concentration of total thyroid hormone);
an increase in the level of globulins that bind sex hormones, as a result of which the content of the latter increases. In this case, the level of biologically active or free sex hormones decreases or does not change at all;
an increase (possible) in the concentration of other binding proteins in the serum, high-density lipoprotein cholesterol, total cholesterol. Low-density lipoprotein cholesterol can both increase and decrease, while the ratio of low-density lipoprotein cholesterol to high-density lipoprotein cholesterol can decrease, and triglyceride levels remain unchanged;
lowering (possible) glucose tolerance.

The use of Silest can lead to a decrease in serum folate levels. From a clinical point of view, this change can be of great importance if pregnancy occurs soon after the withdrawal of the oral contraceptive.

Analogs

The analogues of Silest are Mersilon, Gynoflor E, Gestarella, Manuel 30, Benidetta, Marvelon, Klimodien, Logest, etc.

Terms and conditions of storage

Store in a place protected from light and moisture at a temperature of 15 to 30 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sileste

According to reviews, Silest is an effective, affordable and easy-to-use contraceptive.

Among the shortcomings, the rare presence of the drug in pharmacies, the content of hormones in its composition, a large list of contraindications to its use and possible adverse events are noted. There are reports of a decrease in libido, the development of bleeding, chest pain, polycystic ovary syndrome and infertility during its use.

Price for Silest in pharmacies

The approximate price for Silest (21 tablets in a package) is 398 rubles.

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!