NuvaRing - instructions for use, analogs, reviews and release form (hormonal contraceptive vaginal ring №1 and 3) a medicament for contraception and prevention of pregnancy in women. Side effects

In this article, you can read the instructions for using the drug Novaring. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Novargin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Novarying in the presence of existing structural analogs. Use of the contraceptive hormonal ring to prevent pregnancy in women, as well as during pregnancy and lactation.Probability of conception after use of the drug. Composition.

Novaring - a combined hormonal contraceptive for intravaginal use. Contains etonogestrel, a progestogen, a derivative of 19-nortestosterone, and ethinyl estradiol, which is an estrogen.

The main mechanism of contraceptive action of NovaRing is inhibition of ovulation. The gestagen component (etonogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and, thus, prevents the maturation of the follicle (blocks ovulation).

The Perl index, an indicator that reflects the frequency of pregnancy in 100 women during a year of contraception, when NovaRing is used, is 0.96.

Against the background of the drug, the pain and intensity of menstrual bleeding decreases, the frequency of acyclic bleeding and the probability of the development of iron-deficiency conditions decrease. In addition, there is evidence of a reduction in the risk of endometrial and ovarian cancer during the use of the drug. NovaRing does not reduce the bone mineral density.

Composition

Ethinyl estradiol + Ethonogestrel + auxiliary substances.

Pharmacokinetics

Etonogestrel

Etonogestrel, released from NovaRing, is quickly absorbed by the vaginal mucosa. Absolute bioavailability is about 100%. Etonogestrel binds to serum albumin and sex hormone binding globulin (SHBG). Etonogestrel and its metabolites are excreted in the urine and bile in a ratio of 1.7: 1. T1 / 2 metabolites are approximately 6 days.

Ethinylestradiol

Ethinyl estradiol, released from NovaRing, is rapidly absorbed by the vaginal mucosa. Absolute bioavailability is about 56%, which is comparable with the bioavailability of oral ethinyl estradiol. Ethinyl estradiol binds to serum albumin. Ethinyl estradiol is not excreted unchanged; its metabolites are excreted in the urine and bile in a ratio of 1.3: 1.

Indications

• contraception.

Forms of release

Vaginal ring number 1 and number 3 (the number in the package).

Instructions for use and how to use them

NovaRing is injected into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks, and then it is removed on the same day of the week in which it was placed in the vagina; after a week break, a new ring is introduced.For example: if the NovaRing ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday 3 weeks later at about 22.00; on the following Wednesday, a new ring is inserted.

Bleeding associated with the cessation of the drug usually begins 2-3 days after the removal of NovaRing and may not completely cease until the time when a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NovaRing should be entered on the first day of the cycle (ie on the first day of menstruation). It is allowed to install the ring on the 2nd-5th days of the cycle, however, in the first cycle, in the first 7 days of NovaRing use, additional use of barrier methods of contraception is recommended.

Transition from reception of the combined oral contraceptives

NovaRing should be administered on the last day of the free interval in the intake of combined hormonal contraceptives (tablets or plaster). If a woman correctly and regularly took a combined hormonal contraceptive and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle.

The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Transition from progestational contraception (mini-pili, implant or injection contraception) or gestagen-releasing intrauterine devices (IUDs)

A woman who takes a mini-drip can switch to using NovaRing on any day (the ring is administered on the day of removal of the implant or the IUD or on the day of the next injection). In all these cases, a woman should use the barrier method of contraception within the first 7 days after the introduction of the ring.

After an abortion in the first trimester of pregnancy

Use NovaRing can begin immediately after the abortion. In this case, there is no need for additional use of other contraceptives. If the use of NovaRing immediately after abortion is undesirable, the use of the ring should be carried out in the same way as if the hormonal contraceptives were not used in the previous cycle. In the interval, a woman is recommended an alternative method of contraception.

After childbirth or abortion, produced in the 2nd trimester of pregnancy

Use NovaRing should start within the 4th week after childbirth (if the woman does not breast-feed) or abortion in the 2nd trimester.If the NovaRing application is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of NovaRing application. However, if during this period, sexual intercourse has already occurred, you must first exclude pregnancy or wait for the first menstruation before using NovaRing.

Deviations from the recommended mode

Contraceptive effect and cycle control may be impaired if the patient does not follow the recommended regimen. To avoid losing the contraceptive effect in the event of a deviation from the regime, the following recommendations should be followed.

Lengthening the break in using the ring

If during interruption of the use of the ring there were sexual contacts, pregnancy should be excluded. The longer the break, the higher the probability of pregnancy. With the exception of pregnancy should, as soon as possible, as soon as possible to introduce a new ring in the vagina. For the next 7 days, an additional barrier method of contraception, for example, a condom, can be used.

If the ring was temporarily removed from the vagina

If the ring remained outside the vagina for less than 3 hours, the contraceptive effect will not decrease. Re-insert the ring in the vagina as soon as possible.

If the ring was outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. Place the ring in the vagina as soon as possible. During the next 7 days, it is necessary to use the barrier method of contraception, for example, a condom. The longer the ring was outside the vagina and the closer this time to a 7-day break in using the ring, the higher the probability of pregnancy.

If the ring was outside the vagina for more than 3 hours during the third week of its use, then the contraceptive effect may be reduced. A woman should throw this ring and choose one of two methods:

1. Immediately install a new ring. It should be borne in mind that the new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with discontinuation of the drug. However, smearing of blood or bleeding in the middle of the cycle is possible.

2. Wait for bleeding related to the cessation of the drug, and introduce a new ring no later than 7 days after the removal of the previous ring.This option should be selected only if the mode of using the ring was not violated in the first 2 weeks.

Extended use of the ring

If the drug NovaRing was used no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can make a week break in using the ring, and then enter a new ring. If NovaRing remained in the vagina for more than 4 weeks, the contraceptive effect may worsen, so before the introduction of a new ring, pregnancy should be excluded.

If the patient does not follow the recommended scheme of use, and after a week-long break in the use of the ring does not cause bleeding, then before the introduction of a new ring, pregnancy should be excluded.

To change the timing of menstrual bleeding

To postpone the menstrual-like withdrawal bleeding, you can introduce a new ring without a one-week break. The next ring should be used within 3 weeks. In this case, bleeding or spotting may occur. Next, after a normal weekly break, you should return to the regular application of NovaRing.

To postpone the onset of bleeding for another day of the week, you can recommend a shorter break in using the ring (for as many days as needed). The shorter the break in the use of the ring, the higher the probability of no bleeding that occurs after removal of the ring, and the occurrence of bleeding or spotting discharge during the use of the next ring.

Damage to the ring

In rare cases, when using NovaRing, a rupture of the ring was observed. The core of the NovaRing ring is solid, so its contents remain intact, and the release of hormones does not change significantly. In the case of rupture of the ring, it usually falls out of the vagina. When the ring is broken, a new ring must be inserted.

Fallout of the ring

Occasionally, NovaRing was dropped from the vagina, for example, if it was injected incorrectly, when the tampon was removed, during intercourse or against a background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women unintentionally injected NovaRing into the urethra.When there are symptoms of cystitis, you must consider the likelihood of improper insertion of the ring.

Rules for using NovaRing

The patient can independently introduce NovaRing into the vagina. To insert a ring, the woman should choose the most convenient position for her, for example, standing, lifting one leg, squatting, or lying down. NovaRing must be squeezed and held in the vagina until the ring's position is comfortable. The exact position of NovaRing in the vagina is not decisive for the contraceptive effect.

After the introduction, the ring should be kept in the vagina continuously for 3 weeks. If the ring was accidentally removed, it should be rinsed with warm (not hot) water and immediately inserted into the vagina.

To remove the ring, it can be picked up by the index finger or by squeezing between the index and middle fingers, pull out of the vagina.

Side effect

• vaginal infection (candidiasis, vaginitis);
• cystitis, cervicitis, urinary tract infections;
• increase in body weight;
• increased appetite;
• depression;
• decreased libido;
• mood change;
• headache;
• migraine;
• dizziness;
• impaired vision;
• tides;
• abdominal pain;
• nausea, vomiting;
• bloating;
• diarrhea;
• constipation;
• acne;
• alopecia;
• eczema;
• itching;
• skin rash;
• pain in the lumbar region;
• muscle spasms;
• pain in the limbs;
• dysuria;
• nagrabanie and soreness of mammary glands;
• genital itching;
• pain in the pelvis;
• vaginal discharge;
• amenorrhea;
• ectropion of the uterus;
• fibrocystic mastopathy;
• menorrhagia, metrorrhagia;
• premenstrual syndrome;
• dysmenorrhea;
• spasm of the uterus;
• burning in the vagina;
• dryness of the vulva and vaginal mucosa;
• local reactions from the penis (sensation of the foreign body partner during intercourse, irritation of the penis with increased sensitivity to the components of the drug);
• abaissement of the vaginal ring;
• fatigue;
• malaise;
• stomach ache;
• edema;
• sensation of foreign body in the vagina.

Contraindications

• venous thrombosis (including in the anamnesis), including deep vein thrombosis, pulmonary thromboembolism;
• arterial thrombosis (including history), including stroke, transient cerebral circulatory disorders, myocardial infarction and / or thrombosis precursors, including angina pectoris, transient ischemic attack;
• heart defects with thrombogenic complications;
• changes in blood indicators indicating a predisposition to the development of venous or arterial thrombosis, including resistance to activated protein C, antithrombin 3 deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and anti-phospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
• migraine with focal neurological symptoms;
• arterial hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mmHg);
• diabetes mellitus with vascular lesions;
• pancreatitis incl. in the anamnesis, in a combination with the expressed hypertriglyceridemia;
• severe liver disease, before the normalization of its function;
• liver tumors (including in the anamnesis);
• hormone-dependent malignant tumors (eg, breast cancer), presumed, presumed or in history;
• bleeding from the vagina of an unclear etiology;
• pregnancy (including alleged);
• lactation period;
• surgical interventions followed by prolonged immobilization;
• Smoking (15 or more cigarettes a day) in women 35 years of age or older;
• hypersensitivity to the components of the drug.

Caution should be given to the drug in the presence of any of the following conditions of disease or risk factors; in such cases, the physician must carefully weigh the ratio of the benefits and risks of using NovaRing:

• venous or arterial thrombosis (in the case of brothers and sisters and / or parents);
• Obesity (body mass index more than 30 kg / m2);
• dyslipoproteinemia;
• Varicose disease (in combination with thrombophlebitis of superficial veins);
• atrial fibrillation;
• diabetes;
• systemic lupus erythematosus;
• hemolytic-uremic syndrome;
• epilepsy;
• chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
• sickle-cell anemia;
• congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson, Rotor);
• Chloasma;
• uterine fibroids;
• fibrocystic mastopathy;
• conditions that complicate the use of the vaginal ring: prolapse of the cervix, bladder hernia, hernia of the rectum, severe chronic constipation;
• spikes in the vagina;
• Smoking (less than 15 cigarettes a day) in women 35 years of age or older.

In case of aggravation of diseases, deterioration or other risk factors, a woman should alsoconsult a doctor and, possibly, cancel the drug.

Application in pregnancy and lactation

Contraindications NovaRing use in pregnancy, suspected pregnancy and lactation.

NovaRing is contraindicated in the period of breastfeeding. NovaRing is able to influence lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and / or their metabolites can be excreted with milk.

special instructions

Prior to the appointment or resumption of NovaRing, a medical examination should be conducted: to analyze the history (including family history) and to exclude pregnancy; to measure blood pressure; to conduct a survey of mammary glands, pelvic organs, including cytological examination of smears from the cervix; conduct some laboratory tests to exclude contraindications and reduce the risk of possible side effects of NovaRing. The frequency and nature of medical examinations are carried out by a specialist, taking into account the individual characteristics of each woman, but at least once every 6 months.

The patient should become familiar with the instructions for using NovaRing and follow all recommendations.

It should be noted that NovaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Women aged 40 years and over, women with cervical intraepithelial neoplasia, as well as women who smoke at any age, require additional consultation of the gynecologist before the appointment of NovaRing.

The effectiveness of the NovaRing preparation may decrease when the regimen is not implemented.

During the use of NovaRing, there may be acyclic bleeding (spotting or sudden bleeding). If such bleeding is observed after regular cycles against the background of the NovaRing application in accordance with the instructions, you should contact your doctor-gynecologist for the necessary diagnostic tests, incl. to exclude a malignant tumor and pregnancy. Diagnostic curettage may be required.

Some women do not bleed after removing the ring. If NovaRing was used in accordance with the instructions, it is unlikely that a woman is pregnant.If the instructions are not followed and there is no bleeding after removing the ring, and if there is no bleeding in two consecutive cycles, pregnancy should be excluded.

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that prolonged use of combined hormonal contraceptives leads to an additional increase in the degree of such risk, but it remains unclear how far this is related to other factors. The positive role of regular examinations of a woman in a gynecologist and the use of barrier methods of contraception are evident. There is no information about the increased risk of cervical cancer in HPV-infected women using NovaRing.

The studies showed a slight increase in the relative risk (1.24) of breast cancer in women taking combined hormonal oral contraceptives, but this risk gradually decreases within 10 years after drug withdrawal. Breast cancer is rare in women under the age of 40, so an additional number of cases of breast cancer in women,or continued use of combined oral contraceptives, is small compared with the overall risk of developing breast cancer. Data have been obtained that in women taking oral combined contraceptives, breast cancer is less common than in women who have never used such drugs. The possibility of NovaRing's influence on the incidence of breast cancer is being studied.

In rare cases, women who took combined oral contraceptives, observed benign liver tumors and even less often - malignant. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. If there is severe pain in the upper half of the abdomen, an increase in the liver or signs of intra-abdominal bleeding, a woman who uses NovaRing should exclude a liver tumor.

Although many women taking hormonal contraceptives, there is a slight increase in blood pressure, clinically significant hypertension is rare.A direct link between the use of hormonal contraceptives and the development of hypertension is not established. However, if the NovaRing preparation is used, there is a constant increase in blood pressure, the patient should contact the treating gynecologist; in such cases, it is necessary to remove the ring, prescribe antihypertensive therapy and decide on the choice of the most acceptable method of contraception, including. the possible resumption of NovaRing.

Although estrogens and progestogens are able to influence peripheral insulin resistance and tissue tolerance to glucose, there is no evidence for the need for a change in hypoglycemic therapy when hormonal contraceptives are used. However, women with diabetes should be under constant medical supervision with NovaRing, especially in the first months of contraception.

The use of contraceptive steroids can affect the results of certain laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function,the plasma content of transport proteins (eg, corticosteroid binding globulin and globulin binding sex hormones), lipid / lipoprotein fractions, carbohydrate metabolism and clotting and fibrinolysis parameters. Indicators, as a rule, vary within the limits of normal values.

Serious surgical intervention (including on the lower limbs) is a contraindication to the use of the drug. In the case of a routine operation, it is recommended to stop the use of the drug for at least 4 weeks, and resume not earlier than 2 weeks after complete recovery of the motor activity.

Women who are predisposed to the development of chloasma, during the application of NovaRing should avoid exposure to sunlight and ultraviolet radiation.

The degree of exposure and possible pharmacological effects of ethinylestradiol and etonogestrel on the mucous membrane of the head and skin of the penis have not been investigated.

Impact on the ability to drive vehicles and manage mechanisms

Given the pharmacodynamic properties of the drug NovaRing, it is not expected to affect its ability to drive and use complex equipment.

Drug Interactions

The interaction between hormonal contraceptives and other drugs can lead to the development of acyclic bleeding and / or inefficiency of contraception.

Possible interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones.

The effectiveness of NovaRing can decrease with the simultaneous use of antiepileptic drugs (phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate), antituberculosis drugs (rifampicin), antimicrobial drugs (ampicillin, tetracycline, griseofulvin), possibly antiviral drugs (ritonavir) and medicines containing St. John's wort.

When treating any of these listed drugs, a woman should temporarily use the barrier method of contraception in combination with the NovaRing drug or choose another method of contraception. In the treatment with drugs that induce the induction of hepatic enzymes, the barrier method (condom) should be applied against the background of treatment and within 28 days after the withdrawal of such drugs.

If concomitant therapy is to be continued after a 3-week application of the ring, the next ring should be injected immediately without the usual interval.

During antibiotic treatment (excluding Amoxicillin and doxycycline) it is necessary to use the barrier method of contraception (condom) during treatment and for 7 days after their withdrawal. If concomitant therapy should be continued after a 3-week application of the ring, the next ring should be injected immediately without the usual interval.

As a result of studies of pharmacokinetics, the effect on contraceptive efficacy and safety of NovaRing preparation when it was applied simultaneously with antifungal agents and spermicides was not detected. With the combined use of suppositories with antifungal agents, the risk of ring rupture is slightly increased.

Hormonal contraceptives can cause a metabolic disorder in other medicines. Accordingly, their concentrations in plasma and tissues may increase (eg, cyclosporine) or decrease (for example, lamotrigine).

To avoid possible interactions, it is necessary to study the instructions for the use of other drugs.

The use of tampons does not affect the effectiveness of NovaRing. In rare cases, the ring can be accidentally removed when removing the tampon.

Analogues of hormonal contraceptive Novary

Novaring does not have structural analogs for the active substance.

Analogues for the pharmacological group (estrogens and gestagens in combinations):

• Angelique;
• Antotevin;
• Belara;
• Daillah;
• Demulen;
• Jess;
• Divina;
• Evra;
• Janine;
• Genetten;
• Zoeli;
• The individual;
• Clira;
• Climadinone;
• Klimen;
• Clinonorm;
• Cliogest;
• Lindineth 20;
• Lyndyneth 30;
• Logest;
• Marvelon;
• Mersilon;
• Midian;
• Microinon;
• Novinet;
• Non-Ovlon;
• Ovidon;
• Regulon;
• Rigevidone;
• Silestus;
• Triaclim;
• Trigestrel;
• Trikwilar;
• Trisequence;
• Femaflor;
• Femoden;
• Femoston;
• Evian;
• Egestenol;
• Yarina;
• Yarina Plus.

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