Rigevidon 21 + 7 pills 28 pcs
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Active ingredients
Levonorgestrel + Ethinyl Estradiol
Release form
Pills
Composition
Ethinyl estradiol 30 mcg; levonorgestrel 150 mcg; Excipients: colloidal silicon dioxide - 0.275 mg, magnesium stearate - 0.55 mg, talc - 1.1 mg, corn starch - 19.895 mg, lactose monohydrate - 33 mg; shell composition: sucrose - 22.459 mg, talc - 6.826 mg, calcium carbonate - 3.006 mg, titanium dioxide - 1.706 mg, copovidone - 0.592 mg, macrogol 6000 - 0.148 mg, colloidal silicon dioxide - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg.
Pharmacological effect
Combined monophasic oral hormonal contraceptive drug. When ingestion inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As a gestagen component (progestin) contains a derivative of 19-nortestosterone - levonorgestrel, surpassing the activity of the corpus luteum hormone progesterone (and the synthetic analogue of the latter - pregnin), acts at the receptor level without prior metabolic transformations. Ethinyl estradiol is an estrogen component. Under the influence of levonorgestrel, LH and FSH are blocked from the hypothalamus, the pituitary secretion of gonadotropic hormones is inhibited, which leads to inhibition of maturation and release of the ovum (ovulation) ready for fertilization. Contraceptive action is enhanced by ethinyl estradiol. Retains a high viscosity of the cervical mucus (makes it difficult for sperm to enter the uterus). Along with the contraceptive effect with regular use, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including neoplastic nature.
Pharmacokinetics
Ethinyl estradiol; Ethinyl estradiol is rapidly and almost completely absorbed from the intestines. Ethinyl estradiol undergoes a “first pass” effect through the liver, Tmax is 1.5 hours, T1 / 2 is about 26 hours; When ingested, ethinyl estradiol is eliminated from blood plasma for 12 hours, T1 / 2 is 5.8 hours; Ethinyl estradiol is metabolized in the liver and intestine. Ethinyl estradiol metabolites are water-soluble sulfate or glucuronide conjugates, enter the intestine with bile, where they are disintegrated by intestinal bacteria.; Metabolized in the liver, T1 / 2 is 2-7 hours; Ethinyl estradiol is eliminated by the kidneys (40%) and through the intestines (60 %); It is excreted in breast milk.; Levonorgestrel; After ingestion, Levonorgestrel is rapidly absorbed (in less than 4 hours).Levonorgestrel is not exposed to the “first pass” effect through the liver When combined with the use of levonorgestrel with ethinyl estradiol, there is a relationship between dose and maximum plasma concentration. Tmax (time to reach maximum concentration) of levonorgestrel is 2 h, T1 / 2 - 8-30 h (average 16 h). Most of the levonorgestrel binds to albumin and SHBG (sex hormone-binding globulin) in the blood. Metabolized in the liver.; Levonorgestrel is excreted by the kidneys (60%) and through the intestines (40%). It is excreted in breast milk.
Indications
- oral contraception; - functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia); - premenstrual tension syndrome.
Contraindications
- severe liver disease; - congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome); - cholecystitis; - the presence or indication in the history of severe cardiovascular and cerebrovascular diseases; - thromboembolism and predisposition to them; - malignant tumors (especially breast or endometrial cancer); - liver tumors; - familial forms of hyperlipidemia; - severe forms of arterial hypertension; - endocrine diseases (including severe diabetes); - sickle cell anemia; - chronic hemolytic anemia; - vaginal bleeding of unknown etiology; - bubble skid; - migraine; - otosclerosis; - idiopathic jaundice of pregnant women in history; - severe pruritus during pregnancy; - herpes pregnant; - age over 40 years; - pregnancy; - lactation period (breastfeeding); - hypersensitivity to the drug components.; The drug should be used with caution in diseases of the liver and gallbladder, epilepsy, depression, ulcerative colitis, uterine myoma, mastopathy, tuberculosis, kidney diseases, diabetes, diseases of the cardiovascular system, arterial hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, minor chorea, intermittent porphyria, latent tetany, bronchial asthma, in adolescence (without regular ovulatory cycles).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding).
Dosage and administration
The drug is taken orally, not chewed and squeezed with a small amount of liquid.; If during the previous menstrual cycle, hormonal contraception was not carried out, then Rigevidon; for the purpose of contraception prescribed from the 1st day of menstruation daily 1 tablet for 21 days. This is followed by a 7-day break, during which menstrual-like bleeding occurs. The next 21-day cycle of taking pills from a new package containing 21 pills should be started the next day after a 7-day break, i.e. on the 8th day, even if the bleeding has not stopped. Thus, the start of taking the drug from each new package falls on the same day of the week. A similar scheme is used when switching to receiving Rigevidon from another oral contraceptive. The drug is taken as long as there is a need for contraception. After an abortion, it is recommended to start taking the drug on the day of the abortion or the next day after surgery. After delivery, the drug can only be given to women who are not breastfeeding; to receive contraceptive should begin no earlier than the 1st day of menstruation. During lactation, the use of the drug is contraindicated.; The missed pill should be taken within the next 12 hours. If 36 hours have passed since taking the last pill, then contraception is unreliable. In order to avoid intermenstrual bleeding, taking the drug should be continued from the already started packaging, with the exception of the missed tablet (s). In case of missed pills, it is recommended to additionally use another, non-hormonal method of contraception (for example, barrier); For therapeutic purposes, the doctor sets the dose of Rigevidon and the scheme of use in each case individually.
Side effects
The drug is usually well tolerated. Possible side effects of a transient nature that pass spontaneously: nausea, vomiting, headache, engorgement of the mammary glands, changes in body weight and libido, mood changes, acyclic bleeding; in some cases - eyelid edema, conjunctivitis, blurred vision,discomfort when wearing contact lenses (these phenomena are temporary in nature and disappear after withdrawal without any therapy); ; Hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, jaundice, skin rashes, changes in the nature of vaginal secretion, candidiasis, fatigue Th, diarrhea.
Overdose
Cases of toxic effects due to overdose are unknown.
Interaction with other drugs
Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can increase the metabolism of steroid hormones that make up the drug. chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in the intestinal microflora.; When used simultaneously with anticoagulum With ntami, coumarin or indanedione derivatives, an additional determination of the prothrombin index and a change in the dose of the anticoagulant may be required. .; In combination with bromocriptine, its effectiveness is reduced.; In combination with drugs with potential hepatotoxic effect tviem, for example, with the drug dantrolen, there is an increase in hepatotoxicity, especially in women older than 35 years.
special instructions
Before starting hormonal contraception and every 6 months thereafter, a general medical and gynecological examination is recommended, including a cytological analysis of a smear from the cervix, assessment of the mammary glands, determination of blood glucose, cholesterol and other liver function indicatorsurine analysis.; Appointment of Rigevidon to women with thromboembolic diseases at a young age and an increase in blood clotting in the family history is not recommended.; Oral contraception is allowed no earlier than 6 months after suffering viral hepatitis, provided that the liver functions. in the upper abdomen, hepatomegaly and signs of intra-abdominal bleeding, a liver tumor may be suspected. If necessary, the drug should be discontinued.; In case of liver dysfunction while receiving Rigevidon, consultation of the therapist is necessary.; When acyclic (intermenstrual) bleeding appears, Rigevedon should be continued because in most cases, these bleedings stop spontaneously. If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be conducted to exclude organic pathology of the reproductive system. In case of vomiting or diarrhea, the drug should be continued using a different non-hormonal method of contraception. increased risk of developing cardiovascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially for women over 35 years old). The drug should be stopped in the following cases: - when a migraine-like headache appears for the first time or increases; - when an unusually severe headache; - at the onset of early signs of phlebitis or phlebothrombosis (unusual pain or distended veins in the legs); - in the event of jaundice or hepatitis without jaundice; - with cerebrovascular disorders; - with the appearance of stitching pains of unclear etiology when breathing or coughing, pain and chest tightness; - with acute deterioration of visual acuity; - at suspicion on thrombosis or a heart attack; - With a sharp increase in blood pressure; - in the event of a generalized itching; - with an increase in epileptic seizures; - 3 months before the planned pregnancy; - Approximately 6 weeks before the planned surgical intervention; - during prolonged immobilization; - in the event of a pregnancy. Influence on the ability to drive vehicles and control mechanisms; Taking the drug does not affect the ability to drive vehicles and to control other mechanisms,work with which is associated with an increased risk of injury.