Rigevidon coated pills N63
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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. The estrogen component is ethinyl estradiol .; Under the influence of levonorgestrel, a blockade of release of LH and FSH from the hypothalamus occurs, the pituitary secretion of gonadotropic hormones is inhibited, which leads to inhibition of maturation and release of the ovum 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 ingestion, ethinyl estradiol is eliminated from blood plasma within 12 hours, T1 / 2 is 5.8 hours; Ethinyl estradiol is metabolized in the liver and intestines. Ethinyl estradiol metabolites - water-soluble sulfate or glucuronide conjugates, enter the intestine with bile, where they undergo disintegration using intestinal bacteria .; Metabolized in the liver, T1 / 2 is 2-7 hours; Ethinyl estradiol is excreted by the kidneys (40%) and through the intestines (60%) .; It is excreted in breast milk .; Levonorgestrel; After oral administration, 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 components of the drug .; The drug should be used with caution in diseases of the liver and gallbladder, epilepsy, depression, ulcerative colitis, uterus myoma, mastopathy, tuberculosis, kidney diseases, diabetes mellitus, cardiovascular diseases, hypertension, impaired renal function, 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, without chewing and with a small amount of liquid .; If during the previous menstrual cycle, hormonal contraception was not performed, 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 .; When switching to the reception of Rigevidon from another oral contraceptive, a similar scheme is used. The drug is taken as long as the need for contraception persists .; After an abortion, it is recommended to start taking the drug on the day of the abortion or the day after the operation .; After birth, the drug can be prescribed only 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 the last pill was taken, 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 the case of missed pills, it is recommended to additionally use another, non-hormonal method of contraception (eg, 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, changes in mood, acyclic bleeding; in some cases - eyelid edema, conjunctivitis, blurred vision,discomfort when wearing contact lenses (these phenomena are temporary and disappear after the cancellation without the appointment of any therapy) .; With prolonged use, chloasma, hearing loss, generalized itching, jaundice, gastrocnemius spasms, an increase in the frequency of epileptic seizures may very rarely occur .; Hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, jaundice, skin rashes, changes in the nature of vaginal secretion, candidiasis, fatigue, diarrhea are rarely observed.
Overdose
Cases of toxic effects due to overdose are unknown.
Interaction with other drugs
Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives are able to increase the metabolism of steroid hormones that make up the drug .; Reduced contraceptive efficacy can be observed with simultaneous administration with some antimicrobial agents (including ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in intestinal microflora .; When applied simultaneously with anticoagulants derived from coumarin or indandione, additional determination of the prothrombin index and a change in the dose of the anticoagulant may be required .; With the use of tricyclic antidepressants, maprotiline, beta-blockers may increase their bioavailability and toxicity .; The use of oral hypoglycemic drugs and insulin may necessitate a change in their dose .; When combined with bromocriptine, its effectiveness decreases .; When combined with drugs with a potential hepatotoxic effect, for example, with the drug dantrolen, there is an increase in hepatotoxicity, especially in women over 35 years of age.
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 indicators of liver function, blood pressure control,Analysis of urine.; 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 .; The use of oral contraception is allowed no earlier than 6 months after suffering viral hepatitis, provided that the liver functions normally. With the appearance of sharp pain 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 during reception of Rigevidon, consultation of the therapist is necessary .; With the appearance of acyclic (intermenstrual) bleeding, the reception of Rigevidon should be continued, since in most cases, these bleedings stop spontaneously. If the acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be conducted to exclude organic pathology of the reproductive system .; In the case of vomiting or diarrhea, the drug should be continued using a different, non-hormonal method of contraception .; Smoking women who take hormonal contraceptives have an 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 older than 35 years) .; The drug should be discontinued in the following cases:; - when you first appear or increase migraine-like headache; - 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; - With the onset of pregnancy .; Impact 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.