Long-term use of Novinet. Birth control pills Novinet: instructions for use
“Novineta” are the following diseases and disorders:
Migraine accompanied by neurological symptoms;
Diabetes mellitus with angiopathy;
Cardiovascular diseases and venous thromboembolism;
Hepatitis, serious illnesses and liver tumors;
Cholestatic jaundice, including those caused by taking glucocorticosteroid drugs;
Pancreatitis;
Dyslipidemia;
Cholelithiasis;
Otosclerosis or severe itching observed during a previous pregnancy or taking glucocorticosteroids;
Malignant neoplasms of the mammary glands and genital organs, accompanied by hormonal disorders;
Rotor, Dubin-Johnson or Gilbert syndrome;
Vaginal bleeding of unknown origin.
In addition, Novinet is contraindicated during pregnancy or if pregnancy is suspected, during breastfeeding and with hypersensitivity to components. Also this hormonal contraceptive not prescribed to women over 35 years of age who have a nicotine addiction.
Side effects of Novinet
Side effects of Novinet are divided into two main groups. The first includes adverse reactions, the occurrence of which requires immediate discontinuation of the drug, and the second includes less serious negative effects.
Side effects due to which the use of Novinet should be discontinued include:
Arterial hypertension, arterial and venous thromboembolism;
Exacerbation of otosclerosis leading to hearing loss;
Hemolytic uremic syndrome;
Porphyria.
Less severe side effects of Novinet may appear as:
Nausea, vomiting, ulcerative colitis, jaundice, itching, cholelithiasis;
Headache and migraine;
Depression, sudden mood changes;
Vaginal bleeding;
Development of inflammatory processes in the vagina;
Amenorrhea;
Enlarged mammary glands;
Galactorrhea;
Candidiasis;
Development of erythema, chloasma or rash;
Increased body weight and fluid retention in the body.
In women who use contact lenses, Novinet may cause increased sensitivity of the cornea. In patients with hypersensitivity to artificially synthesized estrogen and gestagen, the drug can provoke the development of allergic reactions.
Tip 2: "Novinet": instructions for use, reviews of the drug
Novinet is a monophasic oral contraceptive. The drug suppresses ovulation by changing the endometrium, as a result of which the mucus produced by the cervix thickens, and it becomes impermeable to sperm.
Instructions for use of "Novinet"
"Novinet" is used to prevent unwanted messages. The drug is started on the first day of menstruation and continues to drink one tablet daily for 21 days. At the end of the course, you need to take a week break, after which the course of taking Novinet is resumed. During the week's break, menstrual bleeding should begin. The drug continues to be taken regardless of whether menstruation has ended or not. After Novinet they start drinking from the first day after the operation.
"Novinet" contains the hormones estrogen ethinyl estradiol and progestogen desogestrel.
Take the drug at the same time of day, do not allow a break of more than 12 hours. In this case, they take two "Novineta" at once and use other methods of contraception during the week. If the drug was missed on the first day of menstruation, the course begins on the second or fifth day. However, in this case, the drug exhibits a low contraceptive effect, so it should be used for a week additional methods protection from .
Except contraceptive action, the drug has therapeutic effect: it evens out the menstrual cycle, reduces blood loss, reduces inflammatory processes in the female genitals. According to reviews, after using Novinet, the condition of the skin improves, the risk of developing tumors in the breast is reduced.
Catad_pgroup Combined oral contraceptives
The most physiological contraceptive that maintains quality sex life. For the treatment of heavy and/or prolonged menstrual bleeding without organic pathology.
INFORMATION IS PROVIDED STRICTLY
FOR HEALTH PROFESSIONALS
Novinet - official instructions by application
Registration number: P N014994/01
Tradename: Novinet ®
International nonproprietary or generic name:
ethinyl estradiol + desogestrel
Dosage form:
film-coated tablets.]
Compound:
Active substances: ethinyl estradiol - 0.020 mg, desogestrel - 0.150 mg;Excipients: quinoline yellow dye E 104, α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate;
Film casing: propylene glycol, macrogol 6000, hypromellose.
Description
Round, biconvex, light yellow tablets marked “P9” on one side and “RG” on the other.
Pharmacotherapeutic group:
contraceptive (estrogen + progestogen)
ATX Code: G03AA09
Pharmacological properties
Pharmacodynamics
Novinet ® is a combined oral contraceptive drug, the main contraceptive effect of which is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, by increasing the viscosity of cervical mucus, the movement of spermatozoa through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg. Ethinyl estradiol is a synthetic analogue of endogenous estradiol; desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, and weak androgenic and anabolic activity. Novinet ® has a beneficial effect on lipid metabolism: increases the concentration of lipoproteins high density(HDL) in the blood plasma, without affecting the content of low-density lipoproteins (LDL). With the use of the drug, there is a significant decrease in the amount of monthly blood lost (with initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted (especially in the presence of acne vulgaris).
Pharmacokinetics
Desogestrel
Suction
At orally desogestrel is absorbed from the gastrointestinal tract (GIT) quickly and almost completely. Metabolized to 3-keto-desogestrel, which is a biologically active metabolite of desogestrel. Medium maximum concentration in blood serum (C max) 2 ng / ml, achieved 1.5 hours (Tmax) after taking the pill. Bioavailability of the drug is 62-81%.
Distribution in the body
3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone-binding globulin (SHBG). The volume of distribution is 1.5 l/kg.
Metabolism
In addition to 3-keto-desogestrel, which is formed in the liver and in the intestinal wall, other metabolites are formed: Zα-OH-desogestrel, Zβ-OH-desogestrel, Zα-OH-5α-N-desogestrel (first phase metabolites). They do not have pharmacological activity, and are partially converted into polar metabolites (sulfates and glucuronates) through conjugation (the second phase of metabolization). Clearance from blood plasma is about 2 ml/min per 1 kg of body weight.
Excretion from the body
The average half-life of 3-keto-desogestrel is 30 hours. Metabolites are excreted by the kidneys and through the intestines (in a ratio of 6:4).
A stable concentration is established by the second half of the cycle. At this time, the level of ketogestrel increases 2-3 times.
Ethinyl estradiol
Suction
Ethinyl estradiol is absorbed from the gastrointestinal tract quickly and completely. The average maximum concentration in the blood serum (Cmax) is 80 pg/ml - 1-2 hours (Tmax) after taking the tablet. Bioavailability due to presystemic conjugation and the first pass effect is about 60%.
Distribution in the body
Ethinyl estradiol is completely bound to plasma proteins, mainly albumin. The volume of distribution is 5 l/kg.
Metabolism
Presystemic conjugation of ethinyl estradiol is significant. Bypassing the intestinal wall, (the first phase of metabolism) it undergoes conjugation in the liver (the second phase of metabolism). Ethinyl estradiol and its conjugates of the first phase of metabolism (sulfates and glucuronides) are excreted into bile and enter the enterohepatic circulation.
Clearance from blood plasma is about 5 ml/min per 1 kg of body weight.
Excretion from the body
The mean elimination half-life of ethinyl estradiol is approximately 24 hours. About 40% is excreted by the kidneys and about 60% through the intestines.
A stable concentration is established by 3-4 days, while the level of ethinylestradiol in serum is 30-40% higher than after a single dose.
Indications for use
Contraception
Contraindications
Carefully
Conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, fibrillation atria, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, presence of severe depression, incl. history, changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant).
Diabetes mellitus, uncomplicated vascular disorders, systemic lupus erythematosus (SLE), Crohn's disease, ulcerative colitis, sickle cell anemia; hypertriglyceridemia (including family history), acute and chronic diseases liver.
Pregnancy and lactation
The use of the drug during pregnancy and breastfeeding is contraindicated.
Dosage and administration
Inside. Taking pills starts from the first day menstrual cycle and take 1 tablet per day for 21 days, if possible at the same time of day.
After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal.
The next day after a 7-day break (four weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break. First dose of the drug
The first tablet should be taken on the first day of the menstrual cycle. In this case, it is not necessary to use additional methods of contraception.
You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills.
If more than 5 days have passed since the start of menstruation, you should postpone the start of use until the next menstruation. Taking the drug after childbirth
Women who are not breastfeeding can start taking the pill no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception.
If you have already had sexual intercourse after giving birth, then you should wait until your first menstruation to take the pills.
If a decision is made 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
After an abortion, in the absence of contraindications, you should start taking the pills from the first day, and in this case there is no need to use additional methods of contraception. Switching from another oral contraceptive
Taking Novinet ® after using another hormonal oral contraceptive containing 30 mcg ethinyl estradiol, according to a 21-day regimen:
It is recommended to take the first Novinet ® tablet the day after completing the course of the previous drug. There is no need to take a 7-day break or wait for the start of menstruation. There is no need to use additional methods of contraception.
When switching to Novinet ® from a drug containing 28 tablets, you should start a new package of Novinet ® the next day after the tablets in the package run out. Switching to Novinet ® after using oral hormonal drugs containing only progestogen (so-called “mini-pills”):
The first Novinet ® tablet should be taken on the first day of the cycle. There is no need to use additional methods of contraception.
If menstruation does not occur while taking the mini-pill, then after excluding pregnancy, you can start taking Novinet ® on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days.
In the above cases, the following non-hormonal methods are recommended as additional methods of contraception: use cervical cap with spermicidal gel, a condom, or abstaining from sexual intercourse. Application calendar method in these cases it is not recommended. 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. When menstruation is delayed, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular use of Novinet ® can be resumed after the usual 7-day break. Missed pills
If a woman forgot to take the pill on time, and no more than 12 hours have passed since the omission, she just needs to take forgotten pill, and then continue taking it at the usual time. If more than 12 hours have passed between taking pills, this is considered a missed pill, the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.
If you miss one tablet in the first or second week of the cycle, you must take 2 tablets the next day and then continue regular use, using additional methods of contraception until the end of the cycle.
If you miss a pill in the third week of the cycle, you should take the forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and/or bloody discharge if you miss a pill and therefore the use of additional methods of contraception is recommended. What to do if you have vomiting or diarrhea?
If vomiting or diarrhea occurs after taking the drug, then absorption of the drug may be inadequate. If the symptoms stop within 12 hours, then you need to take one more tablet. After this, you should continue taking the pills in the usual way. If symptoms continue for more than 12 hours, then it is necessary to use additional methods of contraception during vomiting or diarrhea and for the next 7 days.
Side effect
Side effects that require immediate discontinuation of the drug:
- arterial hypertension;
- hemolytic-uremic syndrome;
- porphyria;
- hearing loss caused by otosclerosis.
Rarely found:
arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis lower limbs, pulmonary embolism); exacerbation of reactive systemic lupus erythematosus.
Very rare:
arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins; Sydenham's chorea (passing after discontinuation of the drug). Other side effects, less severe, but more common. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.
- Reproductive system:
acyclic bleeding/ bloody vaginal discharge, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina (eg candidiasis).
- Mammary gland: tension, pain, breast enlargement, galactorrhea.
- Gastrointestinal tract and hepato-biliary system: nausea, vomiting, Crohn's disease, ulcerative colitis, occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.
- Leather: nodal/ exudative erythema, rash, chloasma.
- Central nervous system:
headache, migraine, mood changes, depressive states.
- Metabolic changes: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.
- Eyes: increased sensitivity of the cornea when worn contact lenses.
- Others: allergic reactions
Overdose
Possible nausea, vomiting, and in girls, bleeding from the vagina.
The drug does not have a specific antidote; treatment is symptomatic.
If symptoms of overdose occur in the first 2-3 hours after taking the drug, gastric lavage is possible.
Interaction with others medicines
Medicines that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, drugs containing St. John's wort reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. Maximum level induction is usually achieved no earlier than 2-3 weeks, but can last up to 4 weeks. after drug withdrawal.
Ampicillin, tetracycline - reduce effectiveness (the mechanism of interaction has not been established).
If necessary joint reception, it is recommended to use additional barrier method contraception throughout the course of treatment and for 7 days (for rifampicin - for 28 days) after discontinuation of the drug.
Oral contraception may reduce carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.
special instructions
Before starting to use the drug and every 6 months thereafter. It is recommended to collect a detailed family or personal history and undergo a general medical and gynecological examination (examination by a gynecologist, taking a cytological smear, examination of the mammary glands and liver function, monitoring blood pressure(BP), blood cholesterol concentrations, urine analysis). These studies must be repeated periodically, due to the need for timely identification of risk factors or contraindications that have arisen.
The drug is a reliable contraceptive medicine: Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) with correct use is about 0.05.
In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects their reception. This issue should be discussed with the patient, who, after receiving necessary information will make the final decision on the preference for hormonal or any other method of contraception. The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:
- diseases of the hemostatic system.
- conditions/diseases predisposing to the development of cardiovascular disease, renal failure.
- epilepsy
- migraine
- risk of development estrogen-dependent tumor or estrogen dependent gynecological diseases;
- diabetes mellitus, not complicated by vascular disorders;
- severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction);
- epilepsy that suddenly appeared or worsened,
- sickle cell anemia, since in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism.
- migraine that suddenly appeared or worsened,
- the appearance of abnormalities in laboratory tests assessing liver function.
Thromboembolic diseases
Epidemiological studies have shown that there is an association between taking oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies).
When using oral contraceptive drugs very rarely, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is observed.
The risk of arterial or venous thromboembolic disease increases:
- with age;
- when smoking (heavy smoking and age over 35 are risk factors);
- if there is a family history of thromboembolic diseases (for example, in parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug.
- for obesity (body mass index above 30 kg/m2);
- for dislipoproteinemia;
- for arterial hypertension;
- in diseases of the heart valves, complicated by hemodynamic disorders,
- with atrial fibrillation;
- at diabetes mellitus, complicated vascular lesions;
- with prolonged immobilization, after a major surgical intervention, after surgery on the lower extremities, after a severe injury.
In these cases, a temporary discontinuation of the course of the drug is expected: it is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization.
There is an increased risk of venous thromboembolic disease in women after childbirth.
Diseases such as diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.
Biochemical abnormalities such as resistance to activated protein C, hyperchromocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases.
When assessing the benefit/risk ratio of taking a drug, it must be borne in mind that targeted treatment this state reduces the risk of thromboembolism. Signs of thromboembolism are:
- sudden chest pain that radiates to the left arm,
- sudden shortness of breath,
- any unusually severe headache that continues for a long time or appearing for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy), weakness or severe numbness of half the body, motor disorders, severe unilateral pain in calf muscle, acute stomach).
Tumor diseases
Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play an important role in the development of cervical cancer.
A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).
There are few reports of the development of benign or malignant tumor liver in women taking hormonal contraceptives for a long time. This should be kept in mind when differential diagnostic assessment of abdominal pain, which may be associated with an increase in the size of the liver or intra-abdominal bleeding.
The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
The effectiveness of the drug may decrease if following cases:
missed pills, vomiting and diarrhea, concomitant use of other drugs that reduce the effectiveness of birth control pills.
If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.
The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.
Chloasma
Chloasma may occasionally occur in women who have a history of it during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunbeams or ultraviolet light while taking pills.
Changes in laboratory parameters
Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters may change (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins).
After acute viral hepatitis should be taken after normalization of liver function (not earlier than 6 months). For diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods contraception). Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked. During lactation, milk secretion may decrease; in small quantities, the components of the drug are excreted in breast milk.
INeffect of the drug on the ability to drive a car and operate machinery
Research studies possible influence The drug was not tested on the ability to drive a car or use other machinery.
Release form
Film-coated tablets. 21 tablets in a blister (Al/PVC/PVDC). 1 or 3 blisters in a cardboard box with instructions for use.
Storage conditions.
Drug: NOVINET ®
Active substance: desogestrel, ethinylestradiol
ATX code: G03AA09
KFG: Monophasic oral contraceptive
Reg. number: P No. 014994/01-2003
Registration date: 05/23/03
Owner reg. cred.: GEDEON RICHTER Ltd. (Hungary)
DOSAGE FORM, COMPOSITION AND PACKAGING
Film-coated tablets pale yellow, biconvex, disc-shaped, marked "P9" on one side and "RG" on the other side.
Excipients: quinoline yellow (E104), β-tocopherol, magnesium stearate, colloidal anhydrous silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate.
Shell composition: propylene glycol, macrogol 6000, hypromellose.
21 pcs. - blisters (1) - cardboard boxes.
21 pcs. - blisters (3) - cardboard boxes.
The description of the drug is based on the officially approved instructions for use.
PHARMACHOLOGIC EFFECT
A monophasic hormonal contraceptive for oral administration containing a combination of estrogen (ethinyl estradiol) and a progestin (desogestrel). Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian system.
Desogestrel is a synthetic gestagen that, when taken orally, inhibits the synthesis of LH and FSH in the pituitary gland and, by preventing follicle maturation, effectively blocks ovulation. It has an antiestrogenic, weak androgenic (anabolic) effect, and does not have an estrogenic effect.
Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol, involved together with the hormone corpus luteum in the formation of the menstrual cycle. Prevents the maturation of an egg capable of fertilization.
The contraceptive effect is due, on the one hand, to a decrease in the susceptibility of the endometrium to the blastocyte, and on the other hand, to an increase in the viscosity of mucus in the cervix, which prevents the advancement of sperm.
The drug has a beneficial effect on lipid metabolism: it increases the HDL content in plasma without affecting the LDL content.
When taking the drug, losses are significantly reduced menstrual blood. Regular use of the drug normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including cancer.
Has a beneficial effect on skin, significantly improves the condition of the skin with acne vulgaris.
PHARMACOKINETICS
Desogestrel
Suction
Desogestrel is quickly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized in the liver and intestinal wall into 3-keto-desogestrel, which is a biologically active metabolite of desogestrel.
Cmax is reached after 1.5 hours and is 2 ng/ml. Bioavailability - 62-81%.
Distribution
3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone binding globulin (SHBG).
Vd is 5 l/kg. C ss is established by the second half of the menstrual cycle, when the level of 3-keto-desogestrel increases 2-3 times.
Metabolism
The products of further metabolism of ketodesogestrel are pharmacologically inactive; some of them are converted by conjugation into polar metabolites, primarily sulfates and glucuronides.
breeding
T1/2 is 38 hours. Metabolites are excreted in urine and feces (in a ratio of 6:4).
Ethinyl estradiol
Suction
Ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. Cmax is achieved 1-2 hours after taking the drug and is 80 pg/ml. The bioavailability of the drug due to presystemic conjugation and the “first pass” effect through the liver is about 60%.
Distribution
Ethinyl estradiol is almost completely bound to plasma proteins, mainly albumin.
Vd is 5 l/kg. C ss is established by the 3-4th day of administration, while the level of ethinyl estradiol in the serum is 30-40% higher than after a single dose of the drug.
Metabolism
Presystemic conjugation of ethinyl estradiol is significant. Ethinyl estradiol and its metabolites in the form of sulfates and glucuronides are excreted into bile and enter the enterohepatic circulation. Clearance from blood plasma is about 5 ml/min/kg body weight.
breeding
T1/2 of ethinyl estradiol averages about 26 hours. About 40% is excreted in the urine and about 60% in feces.
INDICATIONS
Per oral contraception.
DOSING REGIME
The tablets are taken orally, at the same time of day, without chewing and with a small amount of liquid.
The drug is prescribed 1 tablet/day (if possible at the same time of day), starting from the 1st day of the menstrual cycle for 21 days. This is followed by a 7-day break, during which menstrual-like bleeding occurs. On the eighth day, resume taking tablets from the next package (even if the bleeding has not stopped yet). If the rules of administration are followed, the contraceptive effect is maintained during the 7-day break.
If the first tablet is taken on day 1 of the menstrual cycle, then additional methods of contraception are not required. You can start taking pills from the 2-5th 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, you should delay starting the drug until your next menstruation.
After childbirth For non-lactating women, the drug can be prescribed after 21 days. In this case, there is no need to use other methods of contraception. If the drug is prescribed later than 21 days after birth, then additional methods of contraception must be used in the first 7 days of administration. If in postpartum period sexual contact preceded oral contraception, then you need to wait until your first menstruation to take the pills. For women who continue breastfeeding, the use of combined oral contraceptives is not recommended, as taking the drug may reduce milk production.
At transition to Novinet after taking another estrogen-progestogen hormonal contraceptive (calculated for 21 or 28 days of use), the first Novinet tablet should be taken the next day after completing the course of the previous drug. There is no need to use additional methods of contraception.
When switching to Novinet after taking a hormonal contraceptive containing only gestagen, the first Novinet tablet should be taken on the first day of the menstrual cycle; there is no need to use additional methods of contraception. If menstruation does not occur while taking the previous drug, you can start taking Novinet on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days of use.
As additional methods of contraception, it is recommended to use a cervical cap with spermicidal gel, a condom, or abstain from sexual intercourse. The use of the calendar method as an additional method of contraception is less reliable.
At need to delay menstruation Taking the tablets should be continued without a 7-day break. In this case, intermenstrual bleeding may appear, but this does not reduce the contraceptive effect of the drug. Regular use of Novinet can be resumed after the usual 7-day break.
When skipping a drug dose, if no more than 12 hours have passed since the last dose, then you need to take the missed tablet and then continue taking it at the usual time. If more than 12 hours have passed since the last pill was taken, then the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.
If you miss 1 tab. in the first or second week of the cycle you need to take 2 tablets. the next day and then continue regular use using additional methods of contraception until the end of the cycle. If you miss 1 tab. in the third week of the cycle, in addition to the listed measures, a 7-day break is excluded.
Due to the intake of a smaller dose of estrogen into the body due to missing a pill(s), the likelihood of ovulation and/or spotting increases, so in such cases the use of additional methods of contraception is recommended.
If vomiting or diarrhea occurs after taking the drug, then absorption of the drug may be inadequate. If the symptoms stop within 12 hours, then you need to take 1 additional tablet from another package. After this, you should continue taking the tablets as usual. If symptoms continue for more than 12 hours, then it is necessary to use additional methods of contraception in the next 7 days.
SIDE EFFECT
Heavy side effects, which are extremely rare and require discontinuation of the drug
From the outside of cardio-vascular system: myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism, increased blood pressure.
cholestatic jaundice, cholelithiasis.
Others: exacerbation of systemic lupus erythematosus; in some cases - Sydenham's chorea, which disappears after discontinuation of the drug.
Other side effects are more common, but do not require discontinuation of the drug
From the reproductive system: intermenstrual bleeding, amenorrhea after discontinuation of the drug, changes in the nature of vaginal mucus, vaginal candidiasis, changes in the size of uterine fibroids, worsening of endometriosis, tension, pain, enlarged mammary glands, milk secretion, changes in libido.
From the outside digestive system: nausea, vomiting, gastralgia, hepatocellular adenoma.
Dermatological reactions: Erythema nodosum, rash, generalized itching, chloasma (with long-term use).
From the side of the central nervous system: headache, migraine, mood lability, depression, hearing loss.
From the side of the organ of vision: swelling of the eyelids, conjunctivitis, blurred vision, flickering before the eyes, increased sensitivity of the cornea (when wearing contact lenses).
From the side of metabolism: fluid retention in the body, changes in body weight, decreased tolerance to carbohydrates.
From the laboratory parameters: the estrogenic component of Novinet tablets can change some indicators of the function of the liver, kidneys, adrenal glands, thyroid gland, the level of blood clotting factors and fibrinolysis, lipoproteins and transport proteins.
CONTRAINDICATIONS
Pregnancy or suspicion of it;
Arterial hypertension is severe or medium degree heaviness;
Familial forms of hyperlipidemia;
Thromboembolism (including a history) or predisposition to it (myocardial infarction, cerebrovascular diseases (ischemic and hemorrhagic stroke), pronounced form atherosclerosis);
IHD, decompensated heart defects, myocarditis;
Diabetic angiopathy (including retinopathy);
Severe liver diseases (including a history), cholestatic jaundice, hepatitis (before normalization of laboratory parameters and in the first 6 months after their normalization), jaundice during pregnancy or while taking corticosteroids, Dubin-Johnson syndrome, Rotor syndrome, cholelithiasis disease, liver tumor, porphyria;
Estrogen-dependent tumors or suspicion of them, breast and endometrial cancer, endometrial hyperplasia, endometriosis, breast fibroadenoma;
Genital bleeding of unknown etiology;
Systemic lupus erythematosus (including history);
Genital herpes, pregnancy herpes;
Severe skin itching;
Otosclerosis (aggravated during a previous pregnancy or while taking corticosteroids);
Hypersensitivity to the components of the drug.
WITH caution and only after a thorough assessment of the benefits and risks of use the drug should be prescribed for diseases of the hemostatic system, heart failure (including a history), renal failure (including a history), epilepsy, migraine, with the risk of developing an estrogen-dependent tumor, diabetes mellitus, sickle cell anemia ( during infections or conditions of hypoxia, taking an estrogen-containing drug can provoke the occurrence of thromboembolism), with severe depression (including a history of depression).
PREGNANCY AND LACTATION
Novinet is contraindicated for use during pregnancy. Taking Novinet should be stopped 3 months before the planned pregnancy. If pregnancy occurs, the drug should be discontinued.
Epidemiological studies have shown that among children, born by women who took hormonal contraceptives before pregnancy, the incidence of malformations does not increase. In cases of taking the drug for early stages No teratogenic effects were detected during pregnancy.
The use of Novinet is contraindicated during lactation (breastfeeding), because the drug reduces secretion breast milk, changes its composition. Besides, active substances small amounts are excreted in breast milk.
SPECIAL INSTRUCTIONS
Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory research) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis cervical smear). A similar study during the period of taking the drug is carried out regularly, every 6 months.
The effectiveness of the drug Novinet is reduced if pills are missed, with vomiting and diarrhea, as well as with simultaneous reception with other medicines.
The effectiveness of Novinet may decrease if intermenstrual bleeding appears after several months of its use. If at the same time menstrual-like bleeding does not appear during the break, taking the pills can be continued only after the exclusion of pregnancy.
The risk of arterial or venous thromboembolic diseases increases with age, with smoking, with a family history of thromboembolic diseases, with obesity (body mass index above 30 kg / m 2), with dyslipoproteinemia, with arterial hypertension, with valvular heart disease, with fibrillation atria, with diabetes mellitus, with prolonged immobilization.
If depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used to correct it.
In the presence of resistance to activated protein C, hyperchromocysteinemia, deficiency of proteins C, S, deficiency of antithrombin III, the presence of antiphospholipid antibodies (anticardiolipins, lupus anticoagulants), the risk of developing thromboembolic diseases increases. Targeted treatment of the above conditions reduces the risk of thrombosis.
Pregnancy poses a greater risk of thrombosis than taking hormonal contraceptives.
Reception of Novinet should be stopped immediately in the following cases:
The onset of a severe headache for the first time or an increase in common migraines;
Acute deterioration in visual acuity;
Suspicion of myocardial infarction or thrombosis;
A sharp increase in blood pressure;
The appearance of jaundice or hepatitis without jaundice, intense generalized itching;
The occurrence of epilepsy or an increase in epileptic seizures;
4 weeks before the planned surgical intervention and in case of prolonged immobilization (taking Novinet can be resumed after 2 weeks from the moment of remobilization);
Development of pregnancy.
Impact on the ability to drive vehicles and operate machinery
No studies have been conducted to study the effect of Novinet on the abilities necessary to drive a car and operate machinery.
OVERDOSE
Symptoms: metrorrhagia. Taking the drug in high doses was not accompanied by the appearance of severe symptoms.
Treatment: In the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.
DRUG INTERACTIONS
With simultaneous use of Novinet with antispasmodics, phenobarbital derivatives, antibiotics (tetracycline, ampicillin, rifampicin, isoniazid, neomycin, penicillin, chloramphenicol), carbamazepine, phenylbutazone, analgesics, anxiolytics, activated carbon, sulfonamides, nitrofurans, antimigraine drugs, griseofulvin, laxatives and some medicinal plants(for example, St. John's wort) it is possible to change the nature of menstruation and reduce the contraceptive effect of Novinet.
Novinet reduces effectiveness when used simultaneously oral anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, guanethidine, theophylline, caffeine, vitamins, clofibrate, glucocorticosteroids, paracetamol.
When Novinet is used simultaneously with oral hypoglycemic drugs or insulin, the condition may be impaired. carbohydrate metabolism, because Novinet may reduce carbohydrate tolerance and increase the need for insulin or oral hypoglycemic agents, which may require dose adjustment.
CONDITIONS OF VACATION FROM PHARMACIES
The drug is available with a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of 15° to 30°C. Shelf life - 3 years.
Novinet – oral monophasic combination drug with contraceptive effect.
Release form and composition of Novinet
Novinet is available in the form of round film-coated tablets.
Main active ingredients Novinet tablets are: desogestrel and ethinyl estradiol.
As excipients act: magnesium stearate, quinoline yellow dye, colloidal silicon dioxide, α-tocopherol, povidone, stearic acid, lactose monohydrate, potato starch.
Pharmacological action of Novinet
Novinet is a hormonal contraceptive that contains two hormones: estrogen and gestagen. The contraceptive effect of the drug is based on the inhibition of gonadotropins and suppression of the ovulation process. Due to the increased viscosity of the cervical fluid, the movement of sperm through cervical canal slows down, and the altered state of the endometrium prevents the implantation of a fertilized egg.
Desogestrel, which is part of Novinet tablets, has a pronounced antiestrogenic and gestagenic effect, weak anabolic and androgenic activity. Ethinyl estradiol is a synthetic analogue of follicular estradiol.
Reviews from doctors about Novinet are mostly positive, since the drug contains a small amount of hormones. In this regard, Novinet is widely used in gynecological practice.
During the period of taking Novinet, menstrual blood loss is greatly reduced, and the menstrual cycle returns to normal. In addition, according to doctors, Novinet has a beneficial effect on the skin, especially if it is prone to acne vulgaris.
Indications for use of Novinet
According to the instructions Novinet is used:
- as a means of oral contraception;
- for treatment functional disorders menstrual cycle;
- with premenstrual syndrome.
Contraindications
According to the instructions, Novinet is contraindicated for:
- severe and/or multiple risk factors for arterial or venous thrombosis;
- presence of precursors of thrombosis;
- migraine with neurological focal symptoms;
- diabetes mellitus;
- venous or arterial thrombosis/thromboembolism;
- pancreatitis;
- severe liver diseases;
- cholelithiasis;
- hormone dependent malignant neoplasms mammary glands and genitals;
- Dubin-Johnson, Gilbert, Rotor syndromes;
- vaginal bleeding of unknown etiology;
- pregnancy and lactation;
- hypersensitivity to Novinet components.
Directions for use and dosage
The drug is taken orally. Taking Novinet begins on the first day of the cycle. Novinet tablets are taken one per day for 21 days at the same time. Then there is a break of 7 days. The next day after the break, Novinet administration is resumed by starting the next package. This regimen of taking the drug must be followed as long as there is a need for contraception.
You can start taking Novinet tablets from the 2-5th day of menstruation, but in the first cycle of using Novinet you must use additional methods of contraception in the first week of use.
After childbirth, you can start taking the drug no earlier than 21 days after the birth of the child (for mothers who are not breastfeeding).
After an abortion, Novinet should be taken on the 1st day after surgery.
When switching from hormonal drugs that contain only progestogen, the first tablet is taken on the first day of the cycle.
If a woman needs to delay menstruation, then she must continue to take the pills from the new package according to the usual schedule without interruption.
If a woman does not take the Novinet tablet in a timely manner, it can be taken no later than 12 hours from the date of the missed dose. Next, taking the drug continues at the usual time. A missed pill is considered a break of more than 12 hours. In this case, the reliability of contraception in this cycle not guaranteed.
If a woman misses taking a Novinet tablet in the 1st or 2nd week, she should take 2 tablets the next day, and then continue taking it regularly, but should use additional methods of contraception until the end of the cycle.
If you miss a pill in the 3rd week, you need to take the forgotten pill and continue taking the drug. In this case, no break is taken.
If diarrhea or vomiting occurs after taking Novinet, the absorption of the contraceptive may not be complete. If symptoms stop within 12 hours, you need to take an additional tablet. Then, taking the pills continues as usual. If diarrhea or vomiting persists for more than 12 hours, additional contraceptive methods should be used during vomiting or diarrhea and for the next 7 days after they stop.
Side effects of Novinet
According to reviews of Novinet, it can cause certain side effects:
- cardiovascular system: venous and arterial thromboembolism - rare; arterial hypertension; venous or arterial thromboembolism of the renal, hepatic, retinal mesenteric veins and arteries;
- sense organs: hearing loss;
- others: porphyria, hemolytic-uremic syndrome, exacerbation of reactive systemic lupus erythematosus, Sydenham chorea.
Less severe side effects of Novinet reviews include:
- reproductive system: amenorrhea after discontinuation of a contraceptive, acyclic bleeding, changes in the state of vaginal mucus, inflammatory processes of the vagina, tension, candidiasis, pain, galactorrhea, enlarged mammary glands;
- digestive system: ulcerative colitis, nausea, vomiting, cholelithiasis, development or exacerbation of jaundice or itching due to cholestasis;
- central nervous system: migraine, depression, mood lability, headache;
- dermatological reactions: exudative and erythema nodosum, chloasma, rash;
- metabolism: decreased tolerance to carbohydrates, increased body weight, fluid retention in the body;
- organs of vision: when wearing contact lenses - increased sensitivity of the cornea;
- allergic reactions.
Use during pregnancy and lactation
According to the instructions, Novinet should not be used during pregnancy and breastfeeding.
In addition, doctors' reviews of Novinet indicate that the drug should be discontinued 3 months before the expected pregnancy.
Overdose
According to reviews of Novinet, an overdose of the drug manifests itself in the form of nausea, vomiting and bleeding from the vagina (in girls).
In this case, gastric lavage is performed in the first 2-3 hours after taking Novinet. Next – treatment is symptomatic.
Interaction with other drugs
According to the instructions for Novinet, hydantoin, carbamazepine, barbiturates, rifampicin, primidone, oxcarbazepine, felbamate, topiramate, griseofulvin reduce the effectiveness of Novinet and increase the risk of breakthrough bleeding.
The effectiveness of Novinet is also reduced by tetracycline and ampicillin.
Storage conditions for Novinet
The drug should be stored at a temperature of no more than 15-30º Celsius.
Today, oral contraception is the most popular among women. Firstly, it has a fairly high contraceptive effectiveness, secondly, it eliminates discomfort, unlike the use of mechanical ones, and thirdly, it allows women to control the entire situation. Every lady sees in this contraceptive method its additional benefits.
However, they are not without their disadvantages, but, according to most women, they still have more advantages. Now it remains to choose the most optimal tablets that would be quite effective and would not cause side effects. Their choice is so large that sometimes gynecologists cannot immediately navigate. Today we will talk about Novinet tablets. Reviews from doctors about this drug are ambiguous, but still most experts claim it high degree protection.
How does the drug "Novinet"
These tablets consist of synthetic analogues of natural and gestagen. Scientists have proven that it is synthetic hormones that have more strong effect. This drug blocks the production of certain hormones responsible for ovulation. As a result, the egg does not mature, and fertilization does not occur. Thickens under the influence of tablets cervical mucus which prevents the passage of spermatozoa.
Those suffering from dysmenorrhea and severe premenstrual syndrome it is shown to take the drug "Novinet". Reviews of doctors in such cases are only positive. Special benefits: restoration of the menstrual cycle (if it is irregular), reduction pain syndrome during menses, regulation heavy bleeding and getting rid of acne.
If we compare this contraceptive with other OCs, then the drug “Novinet” among this abundance is considered one of the most harmless and safe. The tablets contain a minimal level of estrogen, which can significantly reduce the risk of many side effects - especially weight gain.
Side effects caused by Novinet tablets
Reviews of gynecologists about the drug indicate the following adverse reactions: diarrhea, nausea, dizziness, headaches, changes in libido, jaundice, increased blood pressure, swelling of the mammary glands, decreased or increased body weight.
Other manifestations are possible: fatigue, amenorrhea, candidiasis, hair loss, erythema nodosum, thrombosis, hypertension, vaginal mycosis, skin pigmentation. Some manifestations disappear on their own after three months of regular use of the tablets.
Tablets "Novinet": how to take
Thanks to the convenient packaging, which indicates how to take the drug correctly, a woman can easily control her contraceptive intake. The first tablet is drunk on the day of the menstrual cycle. The next one is accepted at the same hours as the first one. The course lasts 21 days, then a seven-day break is taken, during which period menstruation begins.
After seven days we start drinking a new pack - 21 days. If the menstruation has not ended, and the week has expired, start drinking Novinet anyway. Reviews of doctors about the duration of use agree - it is not recommended to use it for more than two years.
It is necessary to take a break for at least six months so that the work of the ovaries is restored. You should stop taking it if:
- Pregnancy occurred while taking it.
- The next menstruation did not come.
- Hepatitis or jaundice has developed.
- Vision has decreased.
- Severe headaches began.
- Epileptic seizures appeared (increased).
- Hypertension developed.
- An operation is planned.
If you fail to take the next dose or you just forgot, take the pill as soon as you remember about it and then everything is on schedule. If you have not taken the drug for about a month, then you need to start the course again, just keep in mind that the effect of the pill is significantly reduced.
Contraindications for Novinet tablets
