Novinet - Instructions For The Use Of Tablets, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Novinet

Novinet: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. With impaired renal function
10. 10. For violations of liver function
11. 11. Use in the elderly
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Novynette

ATX code: G03AA09

Active ingredient: Desogestrel (Desogoestrelum) + Ethinylestradiol (Aethinyloestradiolum)

Manufacturer: Gedeon Richter, Hungary

Description and photo update: 2019-09-08

Prices in pharmacies: from 448 rubles.

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Novinet is a monophasic oral contraceptive.

Release form and composition

Dosage form - film-coated tablets: round, biconvex, light yellow, marked "RG" on one side, "P9" - on the other (21 pcs. In blisters, in a cardboard box 1 or 3 blisters).

Content of active ingredients in 1 tablet Novineta:

• Ethinylestradiol - 20 mcg;
• Desogestrel - 150 mcg.

Auxiliary components: alpha-tocopherol, colloidal silicon dioxide, magnesium stearate, stearic acid, potato starch, povidone, lactose monohydrate, quinoline yellow dye (E104).

The composition of the film shell: hypromellose, macrogol 6000, propylene glycol.

Pharmacological properties

Pharmacodynamics

Novinet belongs to the combined oral contraceptive drugs. Its main contraceptive action is to reduce the production of gonadotropins and suppress ovulation. Also, when using it, the viscosity of cervical mucus increases, which makes it difficult for sperm to move through the cervical canal, and the state of the endometrium changes, as a result of which the implantation of a fertilized egg into the wall of the uterus does not occur.

Ethinylestradiol is a synthetic analogue of endogenous estradiol. Desogestrel is characterized by a pronounced gestagenic and antiestrogenic effect, reminiscent of that of endogenous progesterone, as well as insignificant anabolic and androgenic activity. Novinet has a beneficial effect on lipid metabolism: it increases the content of high density lipoproteins in the blood plasma, while not changing the concentration of low density lipoproteins. During the use of the drug, there is a significant decrease in the amount of blood lost monthly during menstruation (with the initial diagnosis of menorrhagia), normalization of the menstrual cycle, improvement in skin condition (especially in the presence of acne vulgaris).

Pharmacokinetics

When taken orally, desogestrel is almost completely and at a significant rate absorbed from the gastrointestinal tract. The biologically active metabolite of this compound is 3-keto-desogestrel. The average maximum level of desogestrel in serum is 2 ng / ml and is recorded 1.5 hours after taking the pill. The bioavailability of the substance is 62–81%.

3-keto-desogestrel binds to blood plasma proteins, mainly to sex hormone-binding globulin and albumin. The volume of distribution is 1.5 l / kg.

In addition to 3-keto-desogestrel, which forms in the intestinal wall and liver, other metabolites of desogestrel are known: 3β-OH-desogestrel, 3α-OH-desogestrel, and 3α-OH-5α-H-desogestrel, which are the first phase metabolites. They are not characterized by pharmacological activity and partly, through conjugation (the second stage of metabolism), pass into the form of polar metabolites (glucuronates and sulfates). Plasma clearance is approximately 2 ml / min per 1 kg of body weight.

On average, the half-life of 3-keto-desogestrel is 30 hours. Metabolites are excreted through the intestines and kidneys in a 6: 4 ratio. A stable concentration of desogestrel in the body is observed in the second half of the cycle. During this period, the level of this substance increases 2-3 times.

Ethinylestradiol is absorbed from the gastrointestinal tract rather quickly and completely. On average, the maximum concentration in the serum is 80 pg / ml and is reached 1-2 hours after taking the tablet. Due to the "first pass" effect and presystemic conjugation, the bioavailability of the substance reaches 60%.

Ethinylestradiol is 100% bound to plasma proteins, mainly albumin. The volume of distribution is 5 l / kg.

The pre-systemic conjugation of this compound is quite significant. After passing through the intestinal wall (first phase of metabolism), ethinylestradiol is involved in the process of conjugation in the liver (second phase of metabolism). The substance and its conjugates, formed in the first phase of metabolism (glucuronides and sulfates), are excreted into bile and become elements of enterohepatic circulation. The clearance of ethinyl estradiol from blood plasma is approximately 5 ml / min per 1 kg of body weight. Its average half-life is approximately 24 hours. About 60% of the substance is excreted through the intestines and about 40% through the kidneys.

A stable level of ethinyl estradiol in the body is established on the 3-4th day after the start of taking Novinet. At the same time, the content of the substance in the blood serum is 30-40% higher than after taking a single dose.

Indications for use

The use of Novinet is indicated for women for oral contraception.

Contraindications

• Angina pectoris, transient ischemic attack and other precursors of thrombosis (including when indicated in anamnesis);
• Moderate or severe arterial hypertension (arterial pressure (BP) 160/100 mm Hg or more) and other multiple and / or severe risk factors for arterial or venous thrombosis;
• Migraine with focal neurological symptoms, including a history;
• History of venous thromboembolism;
• Myocardial infarction, deep vein thrombosis of the leg, stroke, pulmonary embolism and other forms of venous or arterial thrombosis or thromboembolism, currently and in history;
• Dyslipidemia;
• Diabetes mellitus (with angiopathy);
• Gallstone disease, including history;
• Liver neoplasms, including history;
• Severe liver disease, cholestatic jaundice (including pregnancy), hepatitis, including a history (before the normalization of laboratory and functional parameters and within 3 months after it);
• Pancreatitis (including history), proceeding with severe hypertriglyceridemia;
• Jaundice on the background of glucocorticosteroids (GCS);
• Dubin-Johnson syndrome, Gilbert's syndrome, Rotor syndrome;
• Severe pruritus, otosclerosis and its progression while taking GCS or during a previous pregnancy;
• Vaginal bleeding of unknown origin;
• Hormone-dependent malignant tumors of the mammary glands and genitals or suspicions of them;
• Breast-feeding;
• The period of pregnancy, including suspicion of it;
• Smoking more than 15 cigarettes a day over the age of 35;
• Hypersensitivity to drug components.

Caution must be exercised with women states contributing to increased risk of arterial and venous thrombosis, thromboembolism and obesity (body mass index greater than 30 kg / m ²), smoking, age over 35 years, family history, dyslipoproteinemia, migraine, hypertension, epilepsy, atrial fibrillation, valvular heart disease, ulcerative colitis, Crohn's disease, sickle cell anemia, chronic and acute liver pathologies, hypertriglyceride family anemia (including), prolonged immobilization, major surgery, lower limb surgery, superficial thrombophlebitis, varicose veins, severe trauma, postpartum period, severe depression (including history), systemic lupus erythematosus (SLE), diabetes mellitus (without vascular complications), change biochemical parameters, including hyperhomocysteinemia, activated protein C resistance, antithrombin III and protein S or C deficiency, antiphospholipid antibodies, including antibodies to cardiolipin,lupus anticoagulant.

Instructions for use of Novinet: method and dosage

Novinet is taken within 21 days, starting from the first day of menstrual bleeding, inside 1 tablet at the same time of day. Having taken all the tablets from the blister, they take a 7-day break, during which menstrual bleeding passes. Taking pills from the next blister should be started the next day after the break, even with continued bleeding. This regimen of the drug provides the effect of contraception as long as there is a need for it.

If a woman starts taking the first pill on the first day of her menstrual cycle, no additional contraceptive measures are required. When starting to use from the second to the fifth day of menstruation in the first cycle, it is necessary to use barrier methods of contraception during the first 7 days. If more than 5 days have passed since the start of menstruation, you should not start taking pills in this cycle.

After childbirth, taking the drug can begin no earlier than 21 days without additional contraceptive measures, subject to prior consultation with a doctor and the absence of breastfeeding. If during the specified period the woman had sexual contact, the start of therapy should be postponed until the beginning of the first menstruation. If you start using it in a period longer than 21 days after childbirth, during the first 7 days, you should use barrier contraception at the same time.

In the absence of contraindications, taking pills after an abortion should be started on the day of surgery without using additional contraceptive measures.

When switching from an oral hormonal contraceptive with an ethinylestradiol content of 30 μg and taken on a 21-day schedule, Novinet is taken the next day after taking the last pill of the previous contraceptive without a seven-day break and using additional contraception.

When switching from funds containing 28 tablets, Novinet is used the next day after taking the last tablet from the package of the previous contraceptive.

After the previous use of oral hormonal mini-pili preparations containing only progestogen, it is recommended to start switching to Novinet on the 1st day of the cycle without using additional methods of contraception.

In the absence of menstruation while taking mini-pills, it is necessary to exclude the presence of pregnancy and only then switch to taking Novinet on any day of the menstrual cycle using additional methods of contraception during the first 7 days. It is recommended to use a condom, cervical cap with spermicidal gel, or sexual abstinence as additional contraceptive methods during this period. It is not recommended to use the calendar method of protection during the first 7 days of taking the drug.

If a woman wants to postpone the onset of menstruation, then taking pills from the next blister must be started immediately, according to the usual scheme, without taking a 7-day break. During this period, breakthrough or spotting bleeding may occur, which does not reduce the contraceptive effect of the drug. After the prescribed 7-day break, the regular intake of the drug is restored.

If you accidentally skip the appointment at the set time, the pill should be taken as soon as you remember. If the period of delay is less than 12 hours, the contraceptive effect of the drug is not violated, further administration can be continued as usual. A delay of more than 12 hours is considered a missed pill and violates the reliability of contraception in this cycle (additional methods of contraception are required).

If one tablet is missed during the first two weeks of the cycle, the next day you need to take 2 tablets and continue taking it using additional methods of contraception until the end of the cycle.

If the tablet is missed in the third week of the cycle, you should take it and continue taking Novinet without a 7-day break in this cycle. Since the content of estrogen is minimal, when the next dose is skipped, the risk of bleeding and / or ovulation increases, therefore the use of additional methods of contraception is mandatory.

In case of vomiting or diarrhea immediately after taking the next Novinet tablet, the absorption process may be incomplete. If the stomach upset has stopped within 12 hours, an additional pill should be taken and your normal contraceptive regimen continued. If the duration of vomiting or diarrhea exceeds 12 hours, the woman should use barrier methods of contraception during the period of discomfort and for the next 7 days.

Side effects

• Reproductive system: amenorrhea against the background of drug withdrawal, vaginal spotting or acyclic bleeding, changes in the state of vaginal mucus, candidiasis, development of vaginal inflammation, galactorrhea, pain, tension, enlargement of the mammary glands;
• Nervous system: headache, mood instability, depression, migraine;
• Digestive system: nausea, vomiting, ulcerative colitis, Crohn's disease, exacerbation or development of jaundice and / or pruritus caused by cholestasis, cholelithiasis;
• Metabolism: an increase in body weight, fluid retention in the body, a decrease in carbohydrate tolerance;
• Organ of vision: in patients with contact lenses - increased sensitivity of the cornea;
• Dermatological reactions: rash, erythema nodosum, chloasma, exudative erythema;
• Others: the development of allergic reactions.

The use of the drug can cause side effects that require immediate discontinuation of the drug:

• Cardiovascular system: arterial hypertension; rarely - venous and arterial thromboembolism (including pulmonary embolism, stroke, myocardial infarction, deep vein thrombosis of the legs); very rarely - venous or arterial thromboembolism of the renal, hepatic, mesenteric, retinal veins and arteries;
• Sense organs: hearing loss caused by otosclerosis;
• Others: porphyria, hemolytic uremic syndrome; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - transient chorea of Sydenham.

Overdose

According to the instructions, Novinet in high doses can cause symptoms such as nausea and vomiting, as well as bloody vaginal discharge in girls. The drug does not have a specific antidote, so symptomatic treatment is prescribed. If signs of an overdose are noted in the first 2-3 hours after taking the pills, gastric lavage may be effective.

special instructions

Novinet is a reliable hormonal contraception.

The use of the drug should be started after a complete general medical and gynecological examination, including a detailed personal and family history, laboratory tests, blood pressure measurement, examination of the pelvic organs, mammary glands, cytological analysis of a cervical smear. The conclusion of the gynecologist about the possibility of using the drug is made on the basis of the data obtained. After informing the patient about the possible negative effects and benefits of hormonal contraception, the doctor gives her the right to make the final decision.

The use of the drug should take place with a regular (once every 6 months) examination by a gynecologist and careful individual monitoring of the state of health. A woman should know that the reason for the immediate withdrawal of the drug is the appearance of one of the following deviations:

• Diseases or conditions that contribute to the development of renal, cardiovascular failure;
• Abnormalities in laboratory tests to assess liver function;
• Pathology of the hemostatic system;
• Migraine;
• Epilepsy;
• The threat of developing estrogen-dependent gynecological diseases or estrogen-dependent neoplasms;
• Severe depression (it is recommended to take vitamin B6 to correct the condition associated with the pathology of tryptophan metabolism);
• Diabetes mellitus without vascular complications;
• Sickle cell anemia.

While taking oral hormonal contraceptives, the risk of developing venous and arterial thromboembolic pathologies increases, especially in women aged or with a family history of thromboembolic diseases (parents, sister, brother). The risk increases with heavy smoking, dyslipoproteinemia, obesity, diabetes mellitus with vascular lesions, heart valve disease with hemodynamic disturbances, arterial hypertension, atrial fibrillation, during prolonged immobilization associated with major surgery (including surgery on the lower extremities) or after severe trauma …

The use of the contraceptive should be discontinued 4 weeks before elective surgery and resumed 2 weeks after remobilization.

After childbirth, the likelihood of venous thromboembolic disease increases.

Diabetes mellitus, hemolytic uremic syndrome, systemic lupus erythematosus, Crohn's disease, sickle cell anemia, ulcerative colitis increase the risk of developing venous thromboembolic diseases.

With a deficiency of proteins C and S, resistance to activated protein C, hyperhomocysteinemia, the presence of antiphospholipid antibodies, a lack of antithrombin III, the likelihood of developing venous or arterial thromboembolic pathologies increases.

Targeted therapy of the above conditions helps to reduce the risk of thromboembolism with characteristic symptoms of manifestation in the form of sudden chest pain radiating to the left arm, sudden shortness of breath, unusually severe headache that lasts a long time (especially if the headache appears for the first time in combination with dizziness, weakness, acute abdomen, partial or complete loss of vision, diplopia, aphasia, focal epilepsy, collapse, movement disorders, numbness of half of the body, severe one-sided pain in the calf muscle).

Taking a contraceptive can be considered one of the many risk factors for developing breast cancer.

Against the background of prolonged use of the drug, the development of benign or malignant neoplasms of the liver is possible. This should be taken into account in the differential diagnostic assessment of abdominal pain, which may be associated with intraperitoneal bleeding or an increase in liver size.

Women with a history of this pathology during pregnancy are at risk of developing chloasma, so they are advised to avoid direct sunlight or ultraviolet radiation.

The effectiveness of oral contraception may be affected by the simultaneous use of other drugs, in this case, the use of additional barrier contraceptive methods is required.

The effect of the drug is reduced against the background of irregular, smearing or breakthrough bleeding that appeared after several months of contraception. In this case, it is necessary to continue taking the pills until the end of the next cycle and in the absence of menstrual bleeding in the 7-day break or continuation of acyclic bleeding, stop taking the pills until pregnancy is excluded.

In addition, skipping the pill, vomiting or diarrhea can disrupt the effect of the drug.

The action of the tablets can cause a change in laboratory indicators of the function of the kidneys, adrenal glands, liver, thyroid gland, the level of transport proteins and lipoproteins, hemostasis indicators.

After acute viral hepatitis, the drug can be used after full recovery of liver function (6 months or more).

Novinet does not protect against sexually transmitted diseases, including HIV infection (AIDS).

The effect of the drug on the ability to drive vehicles and mechanisms has not been studied.

With impaired renal function

With renal failure (including a history), Novinet is prescribed with caution and only after a careful assessment of the balance of harm and benefit.

For violations of liver function

The drug should not be prescribed for hepatitis (including a history, before the normalization of laboratory and functional parameters and within 3 months after their normalization), cholestatic jaundice (including accompanying pregnancy) and severe liver dysfunctions. The contraceptive is used with caution in acute and chronic liver diseases.

Use in the elderly

Since Novinet is a contraceptive drug, it is not used in elderly patients.

Drug interactions

Simultaneous use of Novinet with drugs that induce liver enzymes (barbiturates, hydantoin, primidone, rifampicin, carbamazepine, oxcarbazepine, felbamate, St. John's wort, topiramate, griseofulvin) reduces the effectiveness of contraception bleeding and increases the risk of breakthrough. It should be borne in mind that the maximum degree of induction of any of these agents is achieved after 2-3 weeks of use, but can last up to 4 weeks after discontinuation of the drug.

Since tetracycline and ampicillin reduce the effectiveness of the drug, it is necessary to use additional barrier methods of contraception when combined with Novinet during the entire period of therapy and 7 (for rifampicin - 28) days after their cancellation.

Possible decreased carbohydrate tolerance, increased need for oral antidiabetic drugs or insulin.

Analogs

The analogues of Novinet are: Marvelon, Regulon, Mersilon, Tri-Mercy.

Terms and conditions of storage

Store at 15-30 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Novinet

According to reviews, Novinet is a good contraceptive. Most of the patients who took it, among its advantages, note the affordable cost, ease of use and high efficiency. However, some women still refused to take the drug due to significant side effects (for example, decreased libido) and hormonal imbalances in the body.

Reviews on the appointment of a contraceptive when planning pregnancy are controversial. Some patients claim that they took pills in a course for a short period of time to stimulate conception and became pregnant already in the first or second cycle after discontinuation, while other women complain that the drug provoked amenorrhea (disappearance of menstruation for a long time) and caused disruptions in maturation of eggs for 1 year or more.

The doctors' comments are both positive and negative, since taking contraceptives often causes unpredictable and strictly individual reactions. Since the drug contains a minimum amount of hormones, experts often prescribe it to young women who have not yet given birth. But women who have already become mothers may be faced with the fact that the concentration of substances that prevent pregnancy may be insufficient.

Another advantage of Novinet is its ability to inhibit the growth of uterine fibroids. In this case, it is prescribed for the small size of the node, and also if it is necessary to preserve the woman's reproductive function.

Price for Novinet in pharmacies

The price of Novinet for a pack containing 21 tablets is approximately 495–550 rubles. A package of the drug, containing 63 tablets, will cost 1200-1330 rubles.

Novinet: prices in online pharmacies

Drug name Price Pharmacy

Novinet 20 mcg + 150 mcg film-coated tablets 21 pcs. 448 r Buy

Novinet tablets 21 pcs. 461 r Buy

Novinet 20 mcg + 150 mcg film-coated tablets 63 pcs. 1147 RUB Buy

Novinet tablets p.p. 63 pcs. 1181 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!