Rigevidon – drug group of combined oral contraceptives. Rigevidon is a monophasic drug, each tablet contains the same amount of estrogen and progestin components. The composition of the drug is levonorgestrel – a synthetic derivative of 19-nortestosterone, has activity similar to endogenous progesterone, however, surpasses it in the power of action, which allows the use of levonorgestrel in minimal doses. In addition, the drug is ethinyl estradiol – a synthetic analog of endogenous estradiol. The medication effectively prevents pregnancy, the Pearl index is 0.1 to 0.9. In applying the drug in a woman's body is a series of changes that contribute to the prevention of unwanted pregnancy, including marked suppression of ovulation, increased viscosity of cervical mucus, decreased receptivity of the endometrium to the blastocyst.
The mechanism of action of the drug based on the pharmacological properties of active ingredients included in its composition. So the drug blocks the release of growth hormone releasing factors of the hypothalamus (luteinizing and follicle-stimulating hormone), inhibits secretion of pituitary gonadotropins, resulting in slowing down the maturation of the follicle and its rupture. Thus, the active components of the drug inhibit ovulation, preventing fertilization and pregnancy. In addition, the progestin component of the drug – levonorgestrel – increases the viscosity of the secret of the cervix that inhibits sperm entry into the uterus, and by changing the structure of the endometrium prevents implantation of a fertilized egg.
In addition to the contraceptive effect of the drug with regular use reduces the risk of development of various gynecological diseases (including reduced risk of developing functional ovarian cysts, fibroadenomas and fibrocyst in the mammary glands and congestion in the pelvic organs) and reduces the frequency of dysmenorrhea and the amount of blood loss during menstruation. After a course of the drug reduced the risk of ectopic pregnancy. Even after prolonged use of the drug fertility is fully restored within 1-3 cycles after discontinuation of the drug.
The preparation comprises the Rigevidon pill-placebo (7 tablets placebo for 21 tablet containing active substances) which is due to the content of salts of iron, prevents the development of anemia as well, due to the lack of hormones contribute to rising levels of follicle stimulating hormone in the body that is necessary for the selection of the dominant follicle. Thus, in applying the drug Rigevidon is not the development of the syndrome of “gipertermiei”.
The pharmacokinetics of the drug based on the pharmacokinetic properties of the active ingredients included in its composition:
Ethinyl estradiol after oral administration is rapidly absorbed in the gastrointestinal tract. Its bioavailability is 48%. Peak concentrations of active substance in plasma observed after 1-1. 5 hours after oral administration. After absorption into the bloodstream ethinyl estradiol binds to plasma proteins, mainly with albumin, and a small part is in the unbound state. The first stage of metabolism is carried out in the intestine, the second in the liver, the major metabolites of ethinyl estradiol are HE-ethinyl estradiol and 2-methoxy-ethinyl estradiol. Excreted in unchanged form and as metabolites in the urine (about 40%) and faeces (about 60%). The half-life is about 26 hours.
Levonorgestrel is well absorbed in the gastrointestinal tract, its bioavailability is 100%. In plasma is bound mainly to globulin and albumin. It is metabolized in the body to form sulfate and glucuronide conjugates. Excreted as metabolites in the urine and feces.
Indications for use
The drug is used as a means of contraception in women of childbearing age.
The drug can also be assigned for correction of functional disorders of the menstrual cycle including dysmenorrhea, functional uterine bleeding, significant pain syndrome developing in mid-cycle and premenstrual syndrome.
The drug is recommended for women with moderately predominant estrogenic phenotype.
Method of application
The appointment of a drug Rigevidon should conduct a General physical and gynecological examination, which must include blood pressure control, glucose in the urine, General blood and urine tests, monitoring of liver function consultation with a mammologist and cytological analysis of the smears.
The drug is taken orally, the pill is recommended to swallow whole without chewing or crushing, drinking plenty of water. For maximum effect the drug should be taken at the same time.
As contraceptives are prescribed 1 tablet white, 1 per day, starting from the first or fifth day of menstruation. The duration of the course of taking the white pills for 21 days, followed for 7 days take 1 tablet of red-brown color, 1 time per day. In the period of taking the pills red-brown color in women appears menstrualnopodobnoe bleeding. If necessary, further contraception after taking the pills red-brown color of the drug continues in the same pattern. You should not take a break between courses of the drug (the full course lasts 28 days – 21 tablet white tablets and 7 red-brown color). The beginning of a new course should be done 4 weeks after the beginning of the previous one, on the same day of the week.
In the case of the transition to drug Rigevidon after the use of other oral contraceptive should take the first white pill on the first day of menstruation and continue taking the drug according to the above scheme.
If the drug is well tolerated, it can take as much time as there is a need for contraception.
After the abortion the drug is administered as early as possible after the operation, but not later than the next day after an abortion.
The drug can be given to women after birth, if they are not breastfed. In this case, the drug should be started no earlier than the first day of menstruation.
If the pills were skipped, you should take the drug as soon as possible, however if between doses of the drug 36 hours or more, the efficacy of the drug is significantly reduced and it is recommended to use an additional barrier method of contraception. To prevent the development of intermenstrual bleeding should continue the drug of the already started packing, excluding the missed pill. In the case of missing pills red-brown color additional contraception is not required as the pills red-brown color does not contain hormones. In the case of vomiting or diarrhoea while taking the tablets are white in color may significantly reduce the contraceptive effect of Rigevidon drug, in this case, you should use additional non-hormonal method of contraception.
In appointing the drug for the treatment of functional disorders of the menstrual cycle, the duration of treatment and the dose determined by the attending physician individually for each patient.
Long-term use of the drug, patients should have a pelvic examination every six months, patients with impaired liver function control tests should be performed every 2-3 months.
If after taking of tablets of white color within 7 days does not occur menstrualnopodobnoe bleeding, the continuation of the drug is possible only after exclusion of pregnancy.
The drug is generally well tolerated, but in some cases may develop side effects such:
Side effects developing especially in the beginning of taking the drug and disappearing within 1-3 years:
The gastro-intestinal tract: nausea, vomiting, dyspepsia.
In the Central and peripheral nervous system: headache, emotional lability, fatigue, irritability, cramping calf muscles. In addition, it may both increase and decrease libido.
Other: breast engorgement, skin rash, intermenstrual bleeding, discomfort when wearing contact lenses.
Side effects that can occur with regular use of the drug:
Violation of tolerance to glucose;
Hyperpigmentation of the skin;
The change in body weight (possibly both increase and decrease in body weight);
Increasing the concentration of triglycerides in the blood;
Thrombosis and embolism of different localization (the risk of this side effect is higher in patients over the age of 35 and women who smoke);
Hepatitis, dysfunction of the gallbladder and biliary tract, diarrhea;
Changes in the vaginal secretion, fungal lesions of the mucous membrane of the vagina;
In addition, due to the fact that the tablets are red-brown color is iron fumarate, possible staining of stool in black.
In the case of acute pain in the upper abdomen, to rule out a liver tumor.
Increased individual sensitivity to product components.
Severe violations of liver function, syndrome Dubin-Johnson and Rotor's syndrome (congenital increased levels of bilirubin in the blood), concrements in the gallbladder, cholecystitis. Hepatitis, including transferred within 6 months before the appointment of the drug (the drug 6 months after the transferred hepatitis, is possible only in case of normalization of liver function).
Severe cardiovascular disease, thromboembolism, cerebrovascular diseases and cancer, including in history.
Disorders of lipid metabolism.
Severe arterial hypertension.
Diseases of the endocrine system, including diabetes.
Violations of the blood system, including chronic hemolytic anemia and sickle cell anemia.
The drug is not prescribed to patients with vaginal bleeding of undetermined origin.
Rigevidon is contraindicated in patients with a migraine, otosclerosis, including, if noted hearing loss in previous pregnancies.
The drug should not be administered to patients with a history of idiopathic jaundice pregnant and herpes and pronounced itching pregnant.
The drug is contraindicated in women who are close relatives which have disorders of coagulation and thromboembolism at a young age.
The drug should be discontinued for 6 weeks prior to the scheduled surgery, and in the case of pregnancy, the development of thrombosis, thromboembolism and thrombophlebitis.
In addition, the drug should be stopped at the development of cerebrovascular disorders, myocardial infarction, visual impairment, retinal thrombosis, diplopia and proptosis.
Further use of the drug as a means of contraception is not recommended in case of repeated severe headaches and with the development of severe chronic diseases of different localization.
The drug should be used with caution in women older than 40 years, as well as increased load on the vocal cords, diseases of the liver and biliary tract.
Be wary appoint patients with uterine myoma, mastopathy and girls in adolescence, in the absence of regular ovulatory cycles.
In addition, care should be taken when administering the drug to patients with epilepsy (including history), depression, tuberculosis, ulcerative colitis, varicose veins, phlebitis, multiple sclerosis and kidney disease. Also care should be taken in intermittent porphyria, tetany and bronchial asthma.
The drug is contraindicated in pregnancy. The appointment of a drug should be deleted pregnancy. You should stop taking the drug Rigevidon at least 3 months before planned pregnancy, in this period, you should use non-hormonal method of contraception.
The drug is not used in the period of breastfeeding, as the active components are excreted in breast milk. The use of the drug is possible only in case if the woman is not breastfeeding, and she already had menstruation after childbirth.
While the use of medication with antimicrobial drugs, including ampicillin, rifampicin, chloramphenicol, penicillin, sulfonamides, tetracyclines and neomycin may reduce the contraceptive effect of the drug Rigevidon. If necessary, use of these drugs is recommended to apply non-hormonal method of contraception or to use in addition to drug Rigevidon means of barrier contraception, like a condom.
Dihydroergotamine, tranquilizers, phenylbutazone reduce the effectiveness of hormonal contraceptives.
While the use of the drug with anticoagulants, coumarin group derivatives or indandiona it is possible to increase the efficiency of the latter. While the use of these drugs should be monitored prothrombin time and if necessary to adjust the dose of anticoagulants.
With the concomitant use of beta-blockers, maprotiline and tricyclic antidepressants with the drug Rigevidon marked increase in bioavailability and toxicity of these drugs.
While the use of the drug with oral hypoglycemic drugs and insulin required to control blood sugar levels and if necessary to adjust the dose of insulin and oral hypoglycemic drugs.
The drug in the combined use reduces the effectiveness of bromocriptine.
The drug with simultaneous use with drugs with hepatotoxic effect, increases their toxicity (the highest risk of hepatotoxicity with this combination in women aged over 35 years).
In the appointment of iron preparations should be taken into account the iron content in the tablets are red-brown.
At the moment, the cases of drug overdose Rigevidon was not reported. In the case of the drug in doses, greatly exceeding recommended, patients may develop headache, nausea, vomiting, pain in epigastralna area and vaginal bleeding.
There is no specific antidote. In overdose shows removal of the drug, gastric lavage and receive enterosorbents. If necessary, symptomatic therapy.
Tablets, film-coated, 21 pieces in blister, 1 cardboard box. Each blister contains 21 tablet, film-coated, white color.
The drug should be stored in a dry place away from direct sunlight at temperature not exceeding 30 degrees Celsius.
Shelf life – 5 years.
1 tablet coated liner, white contains:
Ethinyl estradiol – 30мкг;
Levonorgestrel – 150мкг;
Excipients, including lactose monohydrate and sucrose.
1 tablet coated liner, reddish-brown contains:
Iron fumarate – of 76.05 mg;
Excipients, including lactose monohydrate and sucrose.