Pharmacological properties of the drug Novinet
Novinet is a combined hormonal contraceptive drug for systemic use, the action of which is associated with inhibition of the effect of gonadotropins and suppression of ovulation, as well as a decrease in the penetration of sperm through the cervical mucus and implantation of a fertilized egg. The effect of the drug is due to the properties of its components: synthetic estrogen - ethinyl estradiol and synthetic progestogen - desogestrel, which, when administered orally, have a pronounced 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 the drug in the blood serum (2 ng/ml) is achieved 1.5 hours after administration. Bioavailability - 62–81%. In the body, 3-keto-desogestrel binds to blood plasma proteins, mainly albumin and sex hormone binding globulin (SHBG). 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-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (first phase metabolites). These metabolites have no pharmacological activity; by conjugation they are partially converted (the second phase of metabolism) into polar metabolites, sulfates and glucuronates. Blood plasma clearance is about 2 ml/min per 1 kg of body weight. The half-life of 3-keto-desogestrel is on average 30 hours. Metabolites are excreted in urine and feces in a ratio of 6:4. The equilibrium concentration is established in the second half of the cycle, at which time the level of keto-desogestrel increases 2-3 times. Ethinyl estradiol is rapidly and completely absorbed. The average maximum serum concentration is 80 pg/ml and is achieved 1–2 hours after oral administration. Due to presystemic conjugation and the first-pass effect, bioavailability is approximately 60%. Ethinyl estradiol is completely bound to plasma proteins, mainly albumin. Causes an increase in sex hormone binding globulin (SHBG) levels. The volume of distribution is 5 l/kg. Presystemic conjugation of ethinyl estradiol is significant. Penetrating through the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinyl estradiol and its conjugates (sulfates and glucuronides) are excreted in the bile and enter the enterohepatic circulation. Blood plasma clearance is about 5 ml/min/kg body weight. The half-life of ethinyl estradiol is on average 24 hours. Approximately 40% is excreted in the urine and 60% in the feces. The equilibrium concentration is established on the 3rd–4th day, while the level of ethinyl estradiol in the blood serum is 30–40% higher than after a single dose.
Analogs
Level 4 ATC code matches:
Ovidon
Rigevidon
Non-Ovlon
Mercilon
Yarina Plus
Yarina
Miniziston 20 fem
Microgynon
Janine
Lindineth
Cyclo-Proginova
Regulon
Logest
Midiana
Belara
Femoden
Jess Plus
Jess
Zoely
Analogues of Novinet: Marvelon , Regulon , Mercilon , Tri-Mercy .
Which is better - Janine or Novinet?
The composition of Janine of ethinyl estradiol as active substances (Novinet tablets contain this component in the amount of 0.02 mg) and 2 mg of dienogest . The latter is a testosterone and is characterized by antiandrogenic activity .
Thus, Janine contains more hormones and is more suitable for women who have an excess of male hormones.
Use of the drug Novinet
Taking the drug begins on the 1st day of the menstrual cycle and takes 1 tablet per day for 21 days, if possible at the same time of day. After taking the last tablet, take a 7-day break, during which menstrual-like bleeding occurs as a result of drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week) resume taking from the next package, which contains 21 tablets, even if the bleeding has not stopped. Thus, the pills continue to be taken as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect of the drug remains during the 7-day break. First dose of the drug The first tablet should be taken on the 1st day of the menstrual cycle. In this case, additional methods of contraception are not required. You can start taking pills from the 2nd–5th day of menstruation, but in this case, in the first cycle, additional methods of contraception should be used in the first 7 days of taking the pills. If more than 5 days have passed since the start of menstruation, it is necessary to postpone the start of use until the next menstruation. Taking the drug after childbirth Women who are not breastfeeding should start taking the pills 21 days after giving birth. In this case, there is no need to use other methods of contraception. If there has already been sexual intercourse after childbirth, taking the drug should be postponed until the next menstruation. If a woman decides to take the drug later than 21 days after birth, then additional methods of contraception must be used in the first 7 days. Taking the drug after an abortion Taking the drug should start on the 1st day after the abortion; in this case, there is no need to use additional methods of contraception. Switching from taking another oral contraceptive When transferring a woman to Novinet from another oral contraceptive (21-, 22- or 28-day drug), it is recommended to take the first Novinet tablet the day after the end of the course of the previous drug. There is no need to take a break or wait for your period to start. There is no need to use additional methods of contraception. When switching to Novinet from a so-called oral mini-pill containing only progestogen, the first Novinet tablet should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception. If menstruation does not occur while taking the mini-pill, you can start taking Novinet on any day of the cycle, but be sure to use additional methods of contraception in the first 7 days. As additional methods of contraception in these cases, it is recommended to use non-hormonal methods (cervical cap with spermicidal gel, condom). The calendar method is not recommended in this case. Delay of the menstrual cycle If there is a need to delay menstruation, you must continue taking the tablets from the new package without a 7-day break according to the usual regimen. If menstruation is delayed, breakthrough and spotting bleeding may occur, which is not evidence of a decrease in the contraceptive effect of the drug. Regular use of Novinet can be resumed after the usual 7-day break.
Compound
The basis of the drug is 20 mcg ethinyl estradiol and 150 mcg desogestrel .
The auxiliary components of Novinet include: E 104 (quinoline yellow dye), α-tocopherol, magnesium stearate, povidone, colloidal silicon dioxide, potato starch, stearic acid, lactose monohydrate.
Composition p/o: hypromellose, macrogol 6000, propylene glycol.
Contraindications to the use of the drug Novinet
Absolute contraindications: pregnancy or suspicion of it, hypertension (arterial hypertension) of moderate or severe degree, lipid metabolism disorders, the presence or 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 in anamnesis of severe liver disease, cholestatic jaundice, hepatitis, jaundice during pregnancy, when using steroid drugs, with Dubin-Johnson syndrome or Rotor syndrome, with liver tumors, porphyria; hepatitis (within 3 months from the moment of normalization of laboratory parameters), cholelithiasis, the presence of estrogen-dependent tumors or suspicion of them, endometrial hyperplasia, genital bleeding of unknown etiology; presence or history of systemic lupus erythematosus, previously noted pruritus, genital herpes, otosclerosis, or progression of otosclerosis during a previous pregnancy or while taking steroids; hypersensitivity to the components of the drug. Relative contraindications (in the presence of any of the following conditions, the benefits or possible negative effects of taking oral contraceptives are assessed individually): disorders of the blood coagulation system, all diseases in which there is a possibility of circulatory disorders: heart failure, renal failure, as well as a history of these diseases ; epilepsy or a history of it; migraine or a history of it; history of cholelithiasis; the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases; diabetes; presence of severe depression, including a history of depression; sickle cell anemia.
Novineta price
The price of Novinet in pharmacies depends on the number of tablets in the package.
The price for Novinet birth control pills in Ukraine ranges from 220 UAH for package No. 21 and from 750 UAH for package No. 63.
You can buy package No. 21 in Russian pharmacies for 280-460 rubles, the cost of package No. 63 varies from 1100 to 2500 rubles.
- Online pharmacies in RussiaRussia
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Novinet tablets 21 pcs. JSC Gedeon Richter
RUB 513 order - Novinet tablets p.p.o. 63 pcs. JSC Gedeon Richter
RUB 1,188 order
Pharmacy Dialogue
- Novinet (tab.p.pl/rev. No. 21x3)Gedeon-Richter
RUB 1,231 order
- Novinet (tab.p.pl/rev. No. 21) Gedeon-Richter
RUB 487 order
show more
Side effects of the drug Novinet
Intermenstrual bleeding, amenorrhea after discontinuation of the drug, changes in vaginal mucus, growth of uterine fibroids, the occurrence of vaginal infections; feeling of tension, soreness and enlargement of the mammary glands, galactorrhea; nausea, vomiting, cholelithiasis, cholestatic jaundice; erythema nodosum, rash, chloasma; increased sensitivity of the cornea when using contact lenses; headache, migraine, mood changes, depression; fluid retention in the body, changes in body weight, decreased tolerance to carbohydrates. The drug should be stopped immediately if such severe side effects occur as thrombosis and thromboembolism (myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism of the pulmonary, hepatic, mesenteric, renal arteries or retinal vessels), hypertension (arterial hypertension) severe or moderate severity, the occurrence of hormone-dependent tumors, breast cancer, reactive systemic lupus erythematosus, Sydenham chorea. It is possible to develop a benign or malignant liver tumor in women who have been taking hormonal contraceptives for a long time.
Interaction
The effectiveness of COCs for oral administration is reduced in combination with drugs that induce liver enzymes: drugs Hypericum perforatum, Carbamazepine , Griseofulvin , barbiturates , Hydantoin , Rifampicin , Primidone , Felbamate , Topiramate , Oxcarbazepine .
In addition, these drugs increase the risk of breakthrough bleeding.
The level of induction reaches a maximum within 14-20 days, but can also persist for up to 4 weeks after discontinuation of the drug.
If it is necessary to use Novinet in combination with Tetracycline and Ampicillin during the entire course of treatment and for another week after its completion, additional contraception is required (these drugs reduce the effectiveness of the drug).
When taking Rifampicin, additional precautions are required for 4 weeks after stopping treatment with the drug.
COCs reduce carbohydrate tolerance and increase the need for oral antidiabetic agents or insulin .
Novinet should be used with caution in combination with:
- tricyclic antidepressants;
- anticoagulants of the indanedione or coumarin series ;
- β-adrenergic receptor blockers;
- bromocriptine;
- hepatotoxic agents (in particular, with Dantrolene ).
Special instructions for the use of the drug Novinet
Before prescribing the drug, you should collect a detailed family and personal history, conduct a general and gynecological examination (measurement of blood pressure, laboratory tests, examination of the mammary glands and pelvic organs, cytological examination of smears) to exclude diseases, the risk of which increases with the use of oral contraceptives. Examinations must be repeated periodically. When deciding whether to prescribe oral contraceptives, one should evaluate the ratio of potential risks and benefits of their use, in particular, oncoprotective properties against ovarian and endometrial cancer. If liver function test results change, the drug should be discontinued. If any of the above conditions occur or progress while using the drug, it must be stopped and switched to using a non-hormonal method of contraception. Taking oral contraceptives may be accompanied by changes in some laboratory test parameters (functional tests of the liver, kidneys, adrenal glands, thyroid gland, blood coagulation and fibrinolytic activity, levels of lipoproteins and transport proteins). The risk of developing arterial or venous thromboembolic complications increases with age, smoking (heavy smoking is considered an increased risk factor in women over 35 years of age), the presence of thromboembolic diseases in personal and family history (parents, brother or sister), and obesity (index body weight 30 kg/m2), dyslipoproteinemia, hypertension (arterial hypertension), heart valve diseases, atrial fibrillation, diabetes mellitus, prolonged immobilization, after extensive surgical interventions, interventions on the lower extremities, severe injuries. It is recommended to stop taking the drug 4 weeks before surgery and resume 2 weeks after remobilization. The risk of developing thromboembolic complications is increased in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell anemia. If a dose is missed, but no more than 12 hours have passed since the missed dose, you should take the missed tablet and then continue taking the drug at the usual time. If more than 12 hours have passed since the missed period, the reliability of contraception in this cycle is not guaranteed, the use of additional methods of contraception is recommended. If a dose is missed in the 1st or 2nd week of the cycle, you must take 2 tablets the next day, and then continue taking the drug regularly, using additional methods of contraception until the end of the cycle. If a dose is missed in the 3rd week of the cycle, you should take the missed tablet and continue taking the drug regularly without a 7-day break. Due to the minimal dose of estrogen, the risk of ovulation and/or spotting if a dose is missed is increased, so the use of additional methods of contraception is recommended. If vomiting or diarrhea was noted after taking the drug, absorption of its components may be incomplete. If these symptoms disappear within 12 hours, you must take 1 additional tablet. After this, taking the drug should continue as usual. If vomiting and diarrhea continue for more than 12 hours, additional methods of contraception must be used that day and for the next 7 days. The appearance of irregular, spotting or breakthrough bleeding after several months of using the drug may indicate a decrease in its effectiveness. If menstrual-like bleeding does not begin at the end of the second cycle, taking the pills should be stopped and resumed only after possible pregnancy has been ruled out. The drug did not have a teratogenic effect when taken accidentally at the beginning of pregnancy. The use of combined oral contraceptives during breastfeeding is not recommended as they can reduce the secretion of breast milk.
Reviews about Novinet
Reviews about birth control pills Novinet are mostly positive: the majority of women who have taken the drug note its main advantages as high efficiency, ease of use and affordable price.
However, there is a certain percentage of patients who are dissatisfied with the drug. Negative reviews about Novinet are mainly due to the fact that the tablets provoke side effects (in particular, they reduce libido) and provoke hormonal imbalance in the body.
As for pregnancy after Novinet, reviews differ here - some women write that they took the drug in small courses in order to stimulate pregnancy, and became pregnant already in the first or second cycle, while others complain that after taking the drug, their periods disappeared for quite some time. a long period, and the eggs did not mature for a year or more.
Analyzing doctors' reviews of Novinet, we can conclude that the reaction to taking COCs is always unpredictable and very individual, so opinions about these drugs are often opposite.
Due to the minimal concentration of hormones in the drug, doctors recommend taking it to young women who have not given birth. But for women with children, the dose of active substances may be insufficient.
Another positive aspect of using Novinet is its ability to stop the growth of fibroids . For fibroids, the drug is prescribed if the size of the node is small, as well as in situations where it is necessary to preserve the woman’s reproductive function.
