About the drug:
Novinet — combined hormonal contraceptive drug for systemic use, which is related to the inhibition effect of gonadotropins and inhibition of ovulation, and reduced penetration of sperm through the cervical mucus and implantation of the fertilized ovum.
Indications and dosage:
The drug begin with the 1st day of menstrual cycle taking 1 tablet a day for 21 days, if possible at the same time. After taking the last tablet makes the 7-day break during which bleeding occurs menstrualnopodobnoe in the result of the discontinuation of the drug. The next day after a 7-day interval (4 weeks after taking the first pill, on the same day of the week) resume reception of the next pack that contains 21 pills, even if the bleeding has not stopped. So pills continue to take as long as there is a need for contraception. Subject to the rules of accepting the contraceptive effect of the drug persists at the time a 7-day interval.The first drug, the First pill should be taken in the 1st day of the menstrual cycle. In this case, additional contraceptive methods are required.
The pills can begin with the 2-5-th day of menstruation, but in this case in the first cycle should use additional methods of contraception during the first 7 days of taking the pills. If it is more than 5 days from the onset of menstruation, it is necessary to postpone the appointment until the next menstrual period.
Women who are not breastfeeding should start taking the pill 21 days after birth. In this case there is no need to use other methods of contraception. If after giving birth have already had sexual intercourse, the drug should be postponed until the next menstrual period. If a woman makes the decision on the drug later than 21 days after delivery, the first 7 days you must use additional methods of contraception.
The drug should start 1 day after the abortion, in this case, there is no need to use additional methods of contraception.Switching from another oral contraceptive. When a woman is transferred to Novinet from another oral contraceptive (21-, 22 - or 28-day drug), the first tablet Novinet it is recommended to take the next day after the course of the previous drug. No need to take a break or expect the onset of menstruation. There is no need to use additional methods of contraception. During the transition to Novinet with the so-called oral drug mini-pill containing only progestogen, the first tablet Novinite need to take in the 1st day of the cycle. There is no need to use additional methods of contraception. If during the reception, mini-pill, menstruation does not occur, you can start taking Novinet any day of the cycle, but in the first 7 days is necessary to use additional methods of contraception.
As additional methods of contraception in these cases it is recommended to use non-hormonal methods (the cervical cap with a spermicidal gel, condom). Calendar method in this case is not recommended. Delay the menstrual cycle If it becomes necessary to delay menstrual period, you must continue taking pills from a new package without the 7 day break as usual. When the delay of menstruation may occur breakthrough bleeding and spotting that is not evidence of reduction of the contraceptive effect of the drug. Regular use of the drug Novinet can be resumed after the usual 7 day break.
Possible severe headache, dyspepsia, cramps of calf muscles. There is no specific antidote, treatment is symptomatic.
Intermenstrual bleeding, amenorrhoea after discontinuation, changes in vaginal mucus, the growth of uterine fibroids, the occurrence of vaginal infections; a feeling of tension, soreness, and breast enlargement, galactorrhea; nausea, vomiting, cholelithiasis, cholestatic jaundice; erythema nodosum, rash, chloasma, hypersensitivity of the cornea while using contact lenses; headaches, migraine, mood changes, depression; fluid retention in the body, change in body weight, reduced tolerance to carbohydrates. The drug should be discontinued immediately in the event of such severe side effects as thrombosis and thromboembolism (myocardial infarction, stroke, thrombosis of deep veins of lower extremities, thromboembolism pulmonary, hepatic, mesenteric, renal arteries or retinal vessels), severe hypertension or moderate, the occurrence of gormonozawisimah tumors, breast cancer, reactive, systemic lupus erythematosus, chorea Sydenham. May develop benign or malignant liver tumors in women a long time taking hormonal contraceptives.
Absolute contraindications: pregnancy or suspected it, AG moderate or severe degree, lipid metabolism disorders, the presence or indication of a history of arterial thromboembolic diseases (myocardial infarction, ischemic stroke), the risk of arterial or venous thromboembolism, the presence of venous thromboembolism in a personal or family history, diabetic angiopathy, the presence or indication of a history of severe liver disease, cholestatic jaundice, hepatitis, jaundice during pregnancy, with the use of steroid drugs, the syndrome Dubin — Johnson or Rotor syndrome, with liver tumors, porphyria; hepatitis b (within 3 months after the normalization of laboratory parameters), cholelithiasis, the presence of estrogen-dependent tumors or suspicion of them, endometrial hyperplasia, genital bleeding of unknown etiology; the presence or indicate a history of systemic lupus erythematosus, first observed skin ulcers, genital herpes, otosclerosis or progression of otosclerosis during a previous pregnancy or while receiving steroid; hypersensitivity to the drug.
Relative contraindications (if any of the following state benefits or possible negative effects of taking oral contraceptives evaluated individually): breach of the blood coagulation system, all diseases in which there is a likelihood of circulatory disorders: heart failure, renal failure, and the presence of these diseases in anamnesis; epilepsy or references to it in history; migraine or references to it in history; gallstone disease in history; the risk of developing estrogen-dependent tumors or estrogen-dependent gynecologic diseases; diabetes mellitus; the presence of severe depression, including in history; sickle cell anemia.
Interaction with other medications and alcohol:
Possible violation of the loop or the loss of efficiency when used in combination with Novinama antispasmodics, barbiturates, antibiotics (tetracycline, ampicillin, rifampicin, griseofulvin), laxatives and certain herbs (e.g. St. John's wort). Oral contraceptives may reduce tolerance to carbohydrates, which may require dose adjustment of insulin or oral antidiabetic agents.
Composition and properties:
Composition: ethinyl estradiol 0.02 mg, desogestrel 0,15 mg. other ingredients: quinoline yellow dye, magnesium stearate, alpha tocopherol, silica colloidal anhydrous, povidone, potato starch, lactose monohydrate, propylene glycol, macrogol 6000, hypromellose, stearic acid.
The release form: at
Novinet — combined hormonal contraceptive drug for systemic use, which is related to the inhibition effect of gonadotropins and inhibition of ovulation, and reduced penetration of sperm through the cervical mucus and implantation of the fertilized ovum.The action of the drug due to the properties of its components: synthetic estrogen — ethinyl estradiol and a synthetic progestogen — desogestrel, which when administered orally have a marked inhibitory effect on ovulation.Desogestrel is rapidly absorbed and almost completely metabolized to 3-keto-desogestrel, which is a biologically active metabolite of desogestrel. The average maximum concentration of drug in serum (2 ng/ml) is reached 1.5 hours after administration. Bioavailability of 62-81%. In the body of the 3-keto-desogestrel associated with blood plasma proteins, mainly albumin and globulins, which bind to sex hormones (SHBG — globulinemias sex hormones). The volume of distribution is 1.5 l/kg. in addition to 3-keto-desogestrel (which is formed in the liver and in the intestinal wall), there are other metabolites: 3α-IT-desogestrel, 3β-IT-desogestrel, and 3α-IT-5α-H-desogestrel (metabolite of the first phase). The pharmacological activity of these metabolites is missing, by conjugation, they are partially (phase II metabolism) into polar metabolites, sulfate and glucuronate. Clearance of blood plasma — about 2 ml/min per 1 kg of body weight. The half-life of 3-keto-desogestrel is approximately 30 h. Metabolites excreted in the urine and feces at a ratio of 6:4. Equilibrium concentration is established in the second half of the cycle, this time, the level of the keto-desogestrel increases in 2-3 times.
Ethinylestradiol is rapidly and completely absorbed. The average maximum concentration in serum is 80 PG/ml is reached 1-2 h after ingestion. Because of presystemic conjugation and first pass effect, the bioavailability is about 60%. Ethinylestradiol is fully associated with plasma proteins, mainly to albumin. Causes an increase in the level of globulin, linking sex hormones (SHBG). The volume of distribution is 5 l/kg. Presystemic conjugation ethinyl estradiol significant. Penetrating through the intestinal wall (first phase metabolism), it undergoes conjugation in the liver (phase II metabolism). Ethinyl estradiol and its conjugates (sulfate and glucuronide) excreted in the bile and enter the enterohepatic circulation. Clearance of plasma of about 5 ml/min/kg of body weight. The half-life of ethinyl estradiol is approximately 24 h. Approximately 40% is excreted in urine and 60% in the feces. Equilibrium concentration is established at 3-4th day, the level of ethinyl estradiol in the serum of 30-40% higher than after a single dose.
Storage conditions: at a temperature of 15-30 °C.