Composition, form of production and packaging
The tablets covered with a cover of white color, round, biconcave.
1 tab.
ethinylestradiol 30 Ојg
levonorgestrel 150 Ојg
[PRING] silicon dioxide colloid - 0.275 mg, magnesium stearate - 0.55 mg, talc - 1.1 mg, corn starch - 19.895 mg, lactose monohydrate - 33 mg.
Sheath 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, silicon dioxide colloid - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg.
21 pcs. - blisters (1) - packs of cardboard.
21 pcs. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Combined monophasic oral hormonal contraceptive. When ingested, depresses the pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As progestin, the progestin derivative contains a derivative of 19-nortestosterone, levonorgestrel, which is progesterone, which is superior in activity to the hormone of the yellow body, and acts on the level of receptors without preliminary metabolic transformations. The estrogen component is ethinyl estradiol.
Under the influence of levonorgestrel comes the blockade of the release of LH and FSH from the hypothalamus, oppression of the pituitary gland by gonadotropic hormones, which leads to inhibition of maturation and release of the ovum ready for fertilization (ovulation). The contraceptive effect is enhanced by ethinyl estradiol.Preserves high viscosity of the cervical mucus (making it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect with regular intake normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including. tumor nature.
PHARMACOKINETICS
Ethinylestradiol
Ethinyl estradiol is rapidly and almost completely absorbed from the intestine. Ethinyl estradiol undergoes the "first pass" effect through the liver, T max is 1.5 h, T 1/2- about 26 h.
When ingestion, ethinyl estradiol is excreted from the blood plasma for 12 hours, T 1/2 is 5.8 hours.
Ethinyl estradiol is metabolized in the liver and intestines. Metabolites ethinyl estradiol - water-soluble sulfate or glucuronide conjugates, enter the intestines with bile, where they are disintegrated with intestinal bacteria.
Metabolised in the liver, T 1/2 is 2-7 hours.
Ethinyl estradiol is excreted by the kidneys (40%) and through the intestine (60%).
Excreted in breast milk.
Levonorgestrel
After ingestion, levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel is not exposed to the effect of "first passage" through the liver. When levonorgestrel is used together with ethinylestradiol, there is a relationship between dose and maximum plasma concentration. T max (time to reach the maximum concentration) of levonorgestrel is 2 h, T 1/2 - 8-30 h (average 16 h). Most of the levonorgestrel binds in the blood with albumin and SHBG (globulin, binding sex hormones). Metabolised in the liver.
Levonorgestrel is excreted by the kidneys (60%) and through the intestine (40%).
Excreted in breast milk.
INDICATIONS
- oral contraception;
- functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia);
- Premenstrual tension syndrome.
DOSING MODE
The drug is taken orally, without liquid and squeezed with a small amount of liquid.
If hormonal contraception was not performed during the previous menstrual cycle , then Rigevidon В® for the purpose of contraception is prescribed from the 1st day of menstruation daily for 1 tablet for 21 days. Then follows a 7-day break, during which menstrual bleeding occurs. The next 21-day cycle of taking tablets from a new package containing 21 tablets should start the day after the 7-day break, i.e. on the 8th day, even if the bleeding did not stop. Thus, the start of taking the drug from each new package falls on the same day of the week.
When you switch to taking Rhevidone from another oral contraceptive , a similar scheme is used. The drug is taken as long as there is a need for contraception.
After abortion , it is recommended to start taking the drug on the day of abortion or the day after the operation.
After giving birth, the drug can be prescribed only to women who do not breast-feed; to receive a contraceptive should be started no earlier than the 1st day of menstruation. During lactation, the use of the drug is contraindicated.
The missed tablet should be taken within the next 12 hours. If 36 hours have elapsed since the last pill was taken, contraception is unreliable. To avoid intermenstrual bloody discharge, the preparation should be continued from the already started package, with the exception of the missed tablet (s). In cases of missing tablets, it is recommended to additionally use another, non-hormonal method of contraception (for example, barrier).
For therapeutic purposes, the dose of Rigevidone and the schedule of application the doctor establishes individually in each case.
SIDE EFFECT
The drug is usually well tolerated.
Possible side effects of transitory nature, spontaneously passing: nausea, vomiting, headache, breast engorgement, weight and libido changes, mood changes, acyclic spotting; in some cases - eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary and disappear after withdrawal without prescribing any therapy).
With prolonged admission , chloasma, hearing loss, generalized pruritus, jaundice, calf muscle cramps, and increased frequency of epileptic seizures can very rarelyoccur.
Rarely there is hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, jaundice, skin rashes, a change in the nature of vaginal secretion, candidiasis, fatigue, diarrhea.
CONTRAINDICATIONS
- severe liver disease;
- congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome);
- cholecystitis;
- presence or indication in the history of severe cardiovascular and cerebrovascular diseases;
- thromboembolism and predisposition to them;
- malignant tumors (primarily breast cancer or endometrium);
- Liver tumors;
- family forms of hyperlipidemia;
- severe forms of arterial hypertension;
- endocrine diseases (including severe forms of diabetes mellitus);
sickle cell anemia;
- chronic hemolytic anemia;
vaginal bleeding of unknown etiology;
- bladder skidding;
- Migraine;
otosclerosis;
- idiopathic jaundice of pregnant women in anamnesis;
- severe itching of pregnant women;
- Herpes pregnant women;
- age over 40 years;
- Pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
With caution , the drug should be used for liver and gallbladder, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, diabetes, cardiovascular diseases, hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, small chorea, intermittent porphyria, latent tetany, bronchial asthma, in adolescence (without regular ovulatory cycles).
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Care should be taken when administering the drug to patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe liver diseases (including congenital hyperbilirubinemia - syndromes Gilbert, Dubin-Johnson and Rotor, liver tumors).
APPLICATION IN ELDERLY PATIENTS
Contraindicated at the age of over 40 years.
SPECIAL INSTRUCTIONS
Before starting the use of hormonal contraception and every six months thereafter, a general medical and gynecological examination is recommended, including a cervical smear examination, assessment of the mammary glands condition, determination of blood glucose, cholesterol and other indicators of liver function, blood pressure control, urinalysis.
The appointment of Rhevidone to women with thromboembolic disease at a young age and an increase in blood coagulability in a family history is not recommended.
The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis, provided that the liver functions normalize.
When there are sharp pains in the upper abdominal areas, hepatomegaly and signs of intra-abdominal bleeding, there may be a suspicion of a liver tumor. If necessary, the drug should be discontinued.
If there is a violation of the liver during the reception of Rigevidone, a consultation of the therapist is necessary.
When acyclic (intermenstrual) bleeding occurs, Rigevidone should be taken, in most cases these bleedings spontaneously cease. If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be performed to exclude the organic pathology of the reproductive system.
In the case of vomiting or diarrhea, the drug should be continued using another, non-hormonal method of contraception.
Smoking women taking 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 in women older than 35 years).
The drug should be discontinued in the following cases:
- with the appearance of a migraine headache for the first time or augmentation;
- when there is an unusually strong headache;
- with the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of the veins on the legs);
- if there is jaundice or hepatitis without jaundice;
- with cerebrovascular disorders;
- with the appearance of stitching pains of unclear etiology during breathing or coughing, pain and tightness in the chest;
- with acute deterioration of visual acuity;
- with suspected thrombosis or heart attack;
- with a sharp increase in blood pressure;
- when generalized itching occurs;
- with increased epileptic seizures;
- 3 months before the planned pregnancy;
- approximately 6 weeks before the planned surgical intervention;
- with prolonged immobilization;
- with the onset of pregnancy.
Impact on the ability to drive vehicles and manage mechanisms
Admission of the drug does not affect the ability to drive vehicles and to manage other mechanisms, work with which is associated with an increased risk of injury.
OVERDOSE
Cases of toxic effects due to overdose are unknown.
DRUG INTERACTION
Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives are able to enhance the metabolism of the steroid hormones that make up the drug.
Reduction of contraceptive effectiveness 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 the intestinal microflora.
When used simultaneously with anticoagulants, coumarin or indanedione derivatives, an additional prothrombin index and dose change of the anticoagulant may be required.
With the use of tricyclic antidepressants, maprotiline, beta-blockers may increase their bioavailability and toxicity.
When using oral hypoglycemic drugs and insulin, it may be necessary to change their dose.
When combined with bromocriptine, its effectiveness decreases.
When combined with drugs with a potential hepatotoxic effect, for example, with dantrolene, there is an increase in hepatotoxicity, especially in women older than 35 years.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
Do not use after the expiry date printed on the package.
