Instructions for use RIGEVIDON 21+7 (RIGEVIDON 21+7)


Pharmacodynamics and pharmacokinetics

This oral monophasic combined estrogen-progestogen contraceptive drug can have an inhibitory effect on the pituitary production of gonadotropic hormones .

In this case, the contraceptive effect is associated with several mechanisms. The progestin component progestin includes a 19-nortestosterone derivative known as levonorgestrel . This substance is superior in its activity to the corpus luteum hormone progesterone or its synthetic analogue pregnin , which acts at the receptor level without undergoing metabolism .

The estrogenic component ethinyl estradiol leads to a blockade of the release of releasing hormones by the hypothalamus and inhibition of the production of gonadotropic hormones by the pituitary gland. At the same time, the maturation and release of the egg, ready for fertilization, is inhibited.

It has been established that ethinyl estradiol enhances the contraceptive effect of the drug. The increased viscosity of the cervical mucus remains, which makes it difficult for sperm to penetrate.

Also, regular use of the drug leads to normalization of the menstrual cycle and prevents the development of certain gynecological diseases, for example, tumors.

Inside the body, the drug undergoes rapid absorption. The concentration of Rigevidon depends on the dosage of the drug and the duration of use. In this case, the maximum concentration is usually detected after 2 hours, elimination occurs on average within 16 hours. The drug is excreted in metabolites and unchanged through the intestines and kidneys.

Pharmacological properties of the drug Rigevidon

A monophasic oral contraceptive hormonal drug consisting of two components - a progestogen (levonorgestrel) and estrogen (ethinyl estradiol). Its action is carried out, first of all, by inhibiting ovulation by preventing the release of FSH and LH, as well as by increasing the mobility of the fallopian tubes and increasing the viscosity of the cervical secretion, inhibiting the implantation of the egg into the endometrium and hindering the advancement of sperm. When administered orally, the components of Rigevidon are quickly and almost completely absorbed from the digestive tract. The maximum concentration of levonorgestrel in the blood plasma is reached after 2 hours, and ethinyl estradiol after 1.5 hours. Both components are metabolized in the liver. The half-life of ethinyl estradiol is 2–7 hours. 60% of levonorgestrel is excreted in the urine, 40% in the feces; 40% of ethinyl estradiol is excreted in the urine, 60% in feces. Both components pass into breast milk.

Contraindications

Birth control pills Rigevidon are not prescribed for:

  • sensitivity to the drug;
  • lactation, pregnancy;
  • severe liver diseases;
  • congenital hyperbilirubinemia;
  • cholecystitis;
  • thromboembolism;
  • tumor diseases;
  • severe forms of arterial hypertension;
  • diabetes mellitus and other diseases of the endocrine glands;
  • sickle cell anemia ;
  • chronic hemolytic anemia;
  • hydatidiform mole;
  • over 40 years of age;
  • migraine;
  • otosclerosis.

The drug is also contraindicated for use in cases of bleeding of various origins, idiopathic jaundice, skin itching and herpes in pregnant women.

Rigevidon is prescribed with caution to patients with liver, kidney and gall bladder diseases, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis , diseases of the cardiovascular system, arterial hypertension, renal dysfunction, varicose veins, phlebitis , otosclerosis and multiple sclerosis . Caution is also required when prescribing tablets to adolescent patients.

Contraindications to the use of the drug Rigevidon

Hypersensitivity to the components of the drug, pregnancy and lactation, severe liver failure, congenital hyperbilirubinemia (Dubin-Johnson and Rotor syndromes), cholelithiasis, cholecystitis, chronic colitis; the presence or indication in the anamnesis of severe cardiovascular and cerebrovascular diseases, thromboembolism and predisposition to them, liver tumors, malignant tumors, primarily breast or endometrial cancer; lipid metabolism disorders, severe hypertension (arterial hypertension), severe diabetes mellitus, other endocrinological diseases, sickle cell anemia, chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine, otosclerosis (which worsened during previous pregnancies); idiopathic jaundice in pregnant women, severe skin itching in pregnant women, history of herpes in pregnant women.

Side effects of Rigevidon

Usually this drug is well tolerated by patients, but sometimes side effects of Rigevidon occur, which develop transiently and disappear spontaneously. For example, nausea, vomiting, headaches, weight gain and changes in libido , mood, acyclic bleeding, conjunctivitis , vision problems, and so on.

In rare cases, long-term use of the drug causes chloasma, hearing loss, jaundice, generalized itching , convulsions, frequency of epileptic seizures, hypertriglyceridemia , hyperglycemia , increased blood pressure, thrombosis or venous thromboembolism, skin rashes, changes in vaginal secretion, high fatigue, vaginal candidiasis , etc. .

Side effects of the drug Rigevidon

The drug is usually well tolerated. When starting to use Rigevidon, in some cases, digestive disorders, nausea, vomiting, swelling of the mammary glands, headache, mood changes, increased fatigue, skin rash, calf muscle cramps, changes in libido, intermenstrual bleeding, discomfort when using contact lenses, may occur. Subsequently, the severity of these phenomena decreases or they completely disappear. Rigevidone can cause both an increase and a decrease in body weight. When taking the drug, it is necessary to consider the possibility of impaired glucose tolerance. With longer use, chloasma can very rarely occur. Occasionally, an increase in the level of TG in the blood plasma, an increase in blood pressure, thrombosis and thromboembolism of various localizations, hepatitis, gallbladder disease, jaundice, hair loss, changes in vaginal secretion, vaginal mycosis, and diarrhea are noted.

Rigevidon tablets, instructions for use (Method and dosage)

Instructions for use of Rigevidon recommend taking the tablets orally, whole, with water.

When hormonal contraception was not used during the previous menstrual cycle, it should be started on the 1st day of menstruation. Then you need to take one tablet every day for 21 days, preferably at a certain time of day.

After this, a break of 7 days is taken, during which menstrual-like bleeding occurs. For the next 21 days, the tablets are taken from a new package, that is, already on the 8th day, regardless of whether the bleeding has stopped or not.

The transition to these contraceptive pills from another contraceptive is carried out according to the same scheme. You can take the drug as long as you need it.

Taking the drug after an abortion can be started immediately on the day of surgery or the next day. After childbirth, the contraceptive is allowed for use by women who are not breastfeeding. You should start taking it from the first day of menstruation .

When skipping pills, it is important to know how to take Rigevidon in such cases. According to the instructions, the missed pill must be taken within the next 12 hours. If more than 36 hours pass after taking the drug, then contraception will be unreliable, so you need to take care of additional contraceptives .

The use of the drug for medicinal purposes requires individual selection of dosage and therapeutic regimen.

Instructions for use RIGEVIDON 21+7 (RIGEVIDON 21+7)

Before prescribing oral contraceptives or resuming their use, a thorough medical history (including family history) should be obtained, as well as a physical examination to identify contraindications and risk factors. This procedure should be carried out at least once a year during the entire period of use of oral contraceptives. It is also important to conduct periodic medical evaluation due to the possibility of contraindications (eg, transient cerebral ischemia) or risk factors (eg, hereditary venous or arterial thrombotic disorders) while taking oral contraceptives. The frequency and nature of such assessments depend on the woman’s condition, but especially blood pressure, the condition of the mammary glands, abdominal and pelvic organs, incl. carry out cytological examination of the cervix and relevant laboratory tests.

Women should be reminded that oral contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted infections. If there is a risk of HIV infection/AIDS, correct and consistent use of condoms should be recommended, incl. in combination with other methods of contraception.

When using oral contraceptives, smoking increases the risk of serious cardiovascular side effects. The risk increases with age depending on the number of cigars smoked, especially in women smokers over 35 years of age. All women taking oral contraceptives should be strongly advised to refrain from smoking. For women over 35 years of age who smoke, the use of other methods of contraception should be considered.

If a woman has any of the risk factors listed below, the benefits of using combined oral contraceptives should be carefully weighed against the potential risks on a case-by-case basis and discussed with the woman before starting combined oral contraceptives. If any of these symptoms or risk factors worsen, worsen, or appear, the woman should be advised to consult a doctor who will decide whether to stop taking oral contraceptives.

Circulatory disorders

Epidemiological studies have shown an association between the use of oral contraceptives and an increased risk of arterial and venous thrombosis and thromboembolic disorders such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolic disorders.

The drug should be stopped if symptoms appear that indicate the inevitable development of complications:

  • severe abnormal headaches, visual disturbances, increased blood pressure, clinical signs of deep vein thrombosis or pulmonary embolic disorders.

Venous thromboembolism (VTE), which manifests itself as deep vein thrombosis and/or pulmonary embolic disorders, can occur during the use of any oral contraceptives. The incidence of VTE in women using low-estrogen oral contraceptives (less than 50 mcg ethinyl estradiol) is approximately 4 cases per 10,000 women per year, compared with 0.5 cases per 10,000 women not using oral contraceptives per year. However, the likelihood of VTE from using oral contraceptives is much lower than from pregnancy (6 cases per 10,000 women per year).

Cases of thrombosis of other blood vessels have been reported extremely rarely, and damage to the hepatic, mesenteric, renal or retinal veins and arteries may occur among women taking oral contraceptives. There is no consensus as to whether these lesions are related to the use of contraceptives.

The risk of developing thromboembolism (venous and/or arterial) increases:

  • with age;
  • when smoking (women over 35 years of age are advised to stop smoking if they want to take oral contraceptives);
  • with a hereditary predisposition, for example, the presence of venous or arterial thromboembolism in siblings or parents at a relatively young age (if a hereditary predisposition is suspected, the woman should be referred to a specialist before she decides to take oral contraceptives);
  • for obesity (body mass index above 30 kg/m2);
  • with dyslipoproteinemia;
  • with arterial hypertension;
  • for diseases of the heart valves;
  • with atrial fibrillation;
  • with prolonged immobilization, major surgery, leg surgery, or serious injury. In such cases, it is recommended to interrupt the use of oral contraceptives (in the case of planned surgery, at least 4 weeks before the operation) and not to resume use until 2 weeks have passed after the complete restoration of an active lifestyle.

There is no consensus regarding the possible influence of varicose veins and superficial thrombophlebitis on venous thromboembolism.

The increased risk of thromboembolism during childbirth should be taken into account.

Other conditions that may be associated with circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

If migraine attacks become more frequent or more severe (which may precede cerebrovascular events), the patient should immediately stop taking oral contraceptives.

Biochemical factors characterizing hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Tumors

Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of oral contraceptives, but there is no evidence to what extent this is influenced by sexual behavior and other factors such as human papillomavirus (HPV).

A meta-analysis of 54 epidemiological studies found that the relative risk (RR) of diagnosed breast cancer is only slightly greater (RR=1.24) in women taking combined oral contraceptives. This rate gradually decreases over the next 10 years after stopping oral contraceptives. Because breast cancer is quite rare among women under 40 years of age, the increase in breast cancer diagnoses among women who are current or former users of oral contraceptives is small compared with the lifetime risk of breast cancer.

These studies do not provide evidence of causation. The observed pattern of increased risk may be due to earlier diagnosis of breast cancer among women taking oral contraceptives, biological effects of oral contraceptive use, or a combination of both. Diagnosed cases of breast cancer among women taking oral contraceptives tend to be clinically less advanced compared with diagnosed cases of breast cancer among women not taking oral contraceptives.

The occurrence of benign and malignant liver tumors has been reported among women taking combined oral contraceptives. These tumors in some cases led to life-threatening intra-abdominal bleeding. As a differential diagnosis, the possibility of a liver tumor should be considered if women complain of severe upper abdominal pain or signs of intra-abdominal bleeding in women taking oral contraceptives.

Other pathological conditions

Women with hypertriglyceridemia or a family history of hypertriglyceridemia may have an increased risk of pancreatitis when taking oral contraceptives.

In acute or chronic liver dysfunction, the drug should be discontinued until laboratory liver function tests return to normal. Steroid hormones may be poorly absorbed by patients with impaired liver function.

Women with hyperlipidemia require careful monitoring when using oral contraceptives.

Although slight increases in blood pressure have been reported in many women taking oral contraceptives, clinically significant increases in blood pressure are rare. If persistent arterial hypertension develops as a result of the use of this drug, then use should be stopped and treatment of arterial hypertension should be started. The use of oral contraception can be resumed, if necessary, as soon as normal blood pressure levels are achieved with antihypertensive therapy.

The following conditions may appear or worsen, both during pregnancy and during the use of oral contraceptives, but there is no convincing evidence of a relationship with the use of oral contraceptives:

  • jaundice and/or itching associated with bile stagnation;
  • formation of gallstones;
  • porphyria;
  • systemic lupus erythematosus;
  • hemolytic-uremic syndrome;
  • chorea;
  • herpes during pregnancy;
  • hearing loss due to otosclerosis.

Oral contraceptives may affect peripheral insulin resistance and glucose tolerance. Therefore, patients with diabetes require careful monitoring while using oral contraceptives.

Rigevidon 21+7 contains lactose and sucrose. Patients with rare hereditary conditions such as galactose intolerance, lactase intolerance, glucose-galactose malabsorption or fructose intolerance should not take this medicine.

An association has been reported between the development of Crohn's disease and ulcerative colitis and the use of combined oral contraceptives.

Chloasma may occasionally develop, especially in women with a history of chloasma during pregnancy. Women predisposed to chloasma should avoid direct sunlight or ultraviolet radiation while taking oral contraceptives.

There are reports of cases of retinal thrombosis while taking oral contraceptives. Taking oral contraceptives should be stopped if there is unexplained partial or complete loss of vision, the onset of proptosis or diplopia, swelling of the optic nerve, or pathological changes in the retinal vessels.

If depression develops while using oral contraceptives, you should stop taking them; in such cases, it is recommended to use alternative methods of contraception until it is determined whether the development of depression is associated with taking oral contraceptives. Women with a history of depression require careful clinical monitoring. If symptoms of depression return, you should stop taking oral contraceptives.

Medicines containing St. John's wort (Hypericum perforatum) should not be used while taking Rigevidon 21+7 due to the possibility of reducing the concentration of active substances in plasma and reducing the clinical effectiveness of Rigevidon 21+7.

The effectiveness of oral contraceptives may be reduced by missing tablets, vomiting, or concomitant use of another drug.

When taking any oral contraceptives, irregular bleeding (spotting or spotting) is possible, especially during the first months. Therefore, bleeding irregularity should be assessed after an adaptation period, which lasts approximately 3 cycles.

If bleeding remains irregular or becomes irregular after a previously stable cycle, non-hormonal causes should be considered and appropriate evaluation undertaken to rule out malignancy or pregnancy. If non-hormonal causes are excluded, the use of hormonal-rich oral contraceptives may need to be considered.

Sometimes, during a break from taking pills, bleeding may not occur. When using the drug in accordance with the dosage regimen, pregnancy is unlikely. However, if the dosage regimen is violated, the possibility of pregnancy should be excluded before continuing the use of oral contraceptives.

Taking hormonal contraceptives may affect the results of laboratory parameters, incl. for biochemical indicators of liver function, thyroid gland, functional tests of the adrenal glands and kidneys; on plasma concentrations of transport proteins, for example, corticosteroid binding globulin and lipid/lipoprotein fractions; on the parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. As a rule, changes remain within normal limits.

Impact on the ability to drive vehicles and operate machinery

Rigevidon 21+7 does not affect or has virtually no effect on the ability to drive vehicles or other mechanisms with an increased risk of injury.

Experimental results

The acute toxicity of ethinyl estradiol and levonorgestrel is low. Because of the observed variations, preclinical results have limited predictive value in human estrogen use. In experimental animals, estrogens have shown an embryo-lethal effect even in relatively small doses; Malformations of the genitourinary tract and feminization of male embryos were observed. Levonorgestrel had a virilizing effect on female embryos. Reproductive toxicology studies in rats, mice and rabbits did not reveal a teratogenic effect, regardless of gender differentiation.

Preclinical data based on generally accepted repeated dose toxicity, genotoxicity, and carcinogenic potential studies have not revealed any risks to humans other than those described elsewhere in the instructions.

Interaction

Combination with barbiturates, antiepileptic drugs, for example, Carbamazepine and Phenytoin , as well as sulfonamides, pyrazolone derivatives, can lead to increased metabolism of steroid hormones included in the drug.

The combined use of Rigevidon and certain antimicrobial drugs can reduce the contraceptive effect: Ampicillin, Rifampicin, Chloramphenicol, Neomycin, Polymyxin B , sulfonamides and Tetracycline , as they change the composition of microflora .

This drug can increase the bioavailability and toxicity of tricyclic antidepressants, beta-blockers and Maprotiline , and reduce the effectiveness of Bromocriptine .

Combined use with hypoglycemic drugs and insulin often requires changing their dosage. When taken with the drug Dantrolene, it is possible that its hepatotoxicity may increase, mainly in women over 35 years of age.

Interactions of the drug Rigevidon

Rigevidone should be used with caution in combination with ampicillin, rifampicin, chloramphenicol, neomycin, phenoxymethylpenicillin, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone (these drugs may reduce the contraceptive effect, so it is recommended to use another non-hormonal method of contraception), with anticoagulants, coumarin derivatives or indindione (it may be necessary to determine the prothrombin time and adjust the dose of the anticoagulant), tricyclic antidepressants, maprotiline, β-adrenergic receptor blockers (bioavailability and toxicity may increase), with oral hypoglycemic drugs, insulin (dosage adjustment may be necessary), bromocriptine (decreased effectiveness), hepatotoxic drugs, primarily dantrolene (risk of increased hepatotoxicity, especially in women over 35 years of age).

special instructions

Before starting to take contraceptive pills, and every six months when using them, it is necessary to undergo a general medical and gynecological examination. It usually includes a cytological analysis, examination of the mammary glands, assessment of blood glucose, cholesterol , liver function, pressure and urine composition.

For patients who have suffered viral hepatitis and their liver functions have normalized, the drug is prescribed no earlier than 6 months from the moment of recovery.

If sharp abdominal pain, hepatomegaly and signs of intra-abdominal bleeding , this may indicate a liver tumor. If necessary, the drug is immediately discontinued.

The appearance of intermenstrual bleeding does not require discontinuation of the contraceptive, since it usually stops on its own. When this does not happen, consultation with a gynecologist is necessary.

As is known, women who smoke when taking hormonal contraceptives can develop vascular diseases with serious consequences - myocardial infarction and stroke.

Rigevidon's analogs

Level 4 ATC code matches:
Ovidon

Non-Ovlon

Mercilon

Yarina Plus

Yarina

Miniziston 20 fem

Novinet

Microgynon

Janine

Lindineth

Cyclo-Proginova

Regulon

Logest

Midiana

Belara

Femoden

Jess Plus

Jess

Zoely

Main analogues: Yarina, Regulon and Janine.

Rigevidon or Regulon – which is better?

To understand which of these drugs is better, you just need to compare Rigevidon and Regulon. Their main difference lies in the gestagen component - in Regulon it is desogestrel, which also does not have an antiandrogenic effect. Moreover, before taking these pills, it is difficult to understand how suitable they are and how they will be tolerated by patients.

There are many reviews of women taking one of these drugs for a long time. This did not lead to the development of undesirable effects, such as changes in libido or weight gain. Moreover, immediately after discontinuation of these contraceptives, pregnancy occurred almost immediately. Therefore, the selection of such drugs must be carried out taking into account individual characteristics after consultation with a gynecologist.

Reviews about Rigevidon

Many women of reproductive age take various contraceptive medications. Therefore, you can find reviews about Rigevidon on forums where women actively discuss such products.

Of course, the attitude towards them is completely different. Some believe that birth control pills have only benefits and willingly take them. Others, on the contrary, are afraid of using any hormonal drugs and therefore use other methods of contraception, which are not always effective. There are also reports when users do not know what the pills are for or why they are taking them.

Women who have tested this drug on themselves also express completely different opinions. Some patients report that while taking it they experienced constant nausea, mood swings and gained significant weight. However, many women say that they have been taking Rigevidon 21+7 for several years and during all this time they have not felt any unwanted effects. At the same time, the drug provides them with reliable protection from unwanted pregnancy.

The reviews of doctors who use different drugs in their practice deserve special attention. They once again note that the choice of such funds should not be done independently. If the need for contraception arises, you can always consult a gynecologist to conduct a full examination, determine your hormonal status, discuss pregnancy plans and choose the appropriate method of protection against unwanted conception.

Rigevidon price, where to buy

The price of Rigevidon in pharmacies varies between 200-650 rubles.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine
  • Online pharmacies in KazakhstanKazakhstan

ZdravCity

  • Rigevidon tablets p.p.o.
    21 pcs. JSC Gedeon Richter RUR 284 order
  • Rigevidon tablets p.p.o. 63 pcs. JSC Gedeon Richter

    RUR 713 order

  • Rigevidon 21+7 tablets p.p.o. 28 pcs. JSC Gedeon Richter

    RUB 346 order

Pharmacy Dialogue

  • Rigevidon (tab. No. 21x3)Gedeon-Richter

    RUR 717 order

  • Rigevidon (tab. No. 21)Gedeon-Richter

    RUB 283 order

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Pharmacy24

  • Rigevidon No. 21 tablets VAT "Gedeon Richter", Ugorshchina
    153 UAH. order
  • Rigevidon No. 63 tablets VAT "Gedeon Richter", Ugorshchina

    478 UAH. order

PaniPharmacy

  • Rigevidon tablets Rigevidon tablets. p/o No. 21 Hungary, Gedeon Richter

    168 UAH order

  • Rigevidon tablets Rigevidon tablets. p/o No. 63 Hungary, Gedeon Richter

    496 UAH. order

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