NovaRing
Active material: Ethinylestradiol, Etonogestrel
When ATH: G02BB01
CCF: Hormonal contraceptive for intravaginal administration
ICD-10 codes (testimony): Z30.0
Manufacturer: N.V. ORGAN (Netherlands)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Vaginal ring smooth, clear, colorless or nearly colorless, without much visible damage, with transparent or nearly transparent area at the junction of.
| 1 ring | |
| ethinylestradiol | 2.7 mg |
| etonogestrel | 11.7 mg |
Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate, Purified water.
1 PC. – package of aluminum foil (1) – cardboard boxes.
1 PC. – package of aluminum foil (3) – cardboard boxes.
Pharmacological action
Hormonal contraceptive for intravaginal application, containing estrogen – ethinyl estradiol and progestogen – etonogestrel, will release the ethinyl estradiol – 15 µg/day and ètonogestreda 120 mg / day. Etonogestrel, a derivative of 19-nortestosterone, It binds to the progesterone receptor in target organs.
The principal mechanism of action of the preparation of the vaginal Nuvaring® is inhibition of ovulation.
Pearl Index drug Nuvaring® is equal to 0.765.
In addition to the contraceptive drug activity has a positive effect on the menstrual cycle. Against the background of its application cycle becomes more regular, menstruation occur less painful, with a lower intensity of bleeding, which in turn can help reduce the frequency of iron deficiency. Besides, there is evidence of reducing the risk of endometrial cancer and ovarian cancer.
Pharmacokinetics
Etonogestrel
Absorption
Etonogestrel, disposable of Nuvaring®, rapidly absorbed mucosa of the vagina. Cmax etonogestrel, approximately equal to 1700 pg / ml, It is achieved after about a week after the introduction of the ring. Serum is subject to small fluctuations and slowly reaches 1400 pg / ml after 3 weeks. The absolute bioavailability of approximately 100%.
Distribution
Etonogestrel binds to serum albumin and globulin, sex hormone binding (SHBG). Vd etonogestrel 2.3 l / kg.
Metabolism
Etonogestrel metabolized by hydroxylation to form and recover sulfate and glucuronide conjugates. The serum clearance is approximately 3.5 l /.
Deduction
Reducing the concentration of serum etonogestrel is biphasic. T1/2 β-phase is about 29 no. Etonogestrel and its metabolites are excreted in urine and bile in the ratio 1.7:1. T1/2 metabolites about 6 days.
Ethinylestradiol
Absorption
Ethinylestradiol, disposable of Nuvaring®, rapidly absorbed mucosa of the vagina. Cmax is about 35 pg / ml, It is achieved by 3 the day after the introduction of the rings and decreases to 18 pg / ml after 3 weeks. The absolute bioavailability of approximately 56%, that compares with biodostupnostthew when administered.
Metabolism
Ethinyl estradiol initially metabolized during aromatic hydroxylation with formation of various gidroksilirovannyh and methylated metabolites, which are present both in the free State, and in the form of glucuronid and sulphate conjugates. Serum clearance around 3.5 l /.
Deduction
Reducing the concentration of ethinyl estradiol in serum is two-phase nature. T1/2 β-phase is characterized by large individual differences, and, average, is about 34 no. Ethinyl estradiol is not excreted unchanged; its metabolites are excreted in urine and jelchew in proportion 1.3:1. T1/2 metabolites is approximately 1.5 days.
Testimony
- Contraception.
Dosage regimen
NovaRing® misleading vagina 1 once every 4 of the week. The ring is in the vagina 3 of the week, and then deleted on the same day of the week, in which it was placed in the vagina. After a week's break, introduces a new ring. Bleeding, associated with the termination of the drug, typically begins in 2-3 the day after removing Nuvaring® and can not fully end until, When you want to begin using the next ring.
Hormonal contraceptives were not applied during the previous menstrual cycle
NovaRing® should be between 1 and 5 day of the menstrual cycle, but no later than 5 day cycle, even if women did not complete menstrual bleeding. For the first 7 days of the first cycle of the Nuvaring®, It is recommended that additional use of barrier methods of contraception.
The transition from receiving combined oral contraceptives
NovaRing® must be entered no later than the day, following the interval in the employment drug. If the combined oral contraceptive device also contains inactive tablets (placebo), the Nuvaring® must be entered no later than the day, following the reception of the latest placebo tablets.
The transition from gestagennoj contraception (minipill, implant or injectable contraception) or progestogen-fission intrauterine device (Navy)
The Introduction Of The Nuvaring® should any day (If the patient has mini-Pili), on the day of the implant or IUD removal, and when the contraceptive injection – in a day, When a next injection. In all these cases, you should use an additional barrier method of contraception during the first 7 days of use Nuvaring®.
After abortion, produced in the first trimester of pregnancy
Use Nuvaring® You can start immediately after an abortion. In this case, there is no need for additional use of other contraceptives. However, if you use Nuvaring® immediately after abortion is undesirable, the use of rings should produce the same, as if hormonal contraceptives were not applied during the previous cycle.
After childbirth or abortion, produced in the II trimester
Use Nuvaring® should begin within 4 weeks after delivery or abortion. If you use Nuvaring® launched at a later date, the additional use of barrier methods of contraception in the first 7 days of Nuvaring®. But, If sexual intercourse during this period have already occurred, You must first rule out pregnancy or wait for the first menstruation to begin using Nuvaring®.
Contraceptive effect and cycle control can be broken, If the patient breaks the recommended mode. To avoid loss of contraceptive effect in case of deviation from the mode, the following guidelines must be followed:
- when extended interruption in the use of rings you want to put the new ring in the vagina as soon as possible. Additionally, over the next 7 days, you must use a barrier method. If during a break to use the ring had sexual intercourse, should take into account the possibility of pregnancy. The longer break, the higher the risk of pregnancy.
- when, if the ring was accidentally removed and remained outside of the vagina less 3 no, contraceptive effect is reduced. Should again put the ring into the vagina as possible. If the ring was out of the vagina for more than 3 no, contraceptive efficacy may be reduced. You should put the ring into the vagina as possible, after which it must be in the vagina constantly for at least 7 days, It is necessary to additionally use a barrier method during these 7 days. If the ring was outside the vagina more 3 no during the third week of its use, It should extend its application over lay three weeks (before the end of the 7 days after re-introduction of rings). After that you should remove the ring and put a new after a week's break. If removing the rings from the vagina for a period of more than 3 h occurred during the first week of using the rings, the likelihood of pregnancy.
- when the extended use of rings, but no longer 4 weeks, contraceptive effect lasts. You can make a one-week break and then put a new ring. If Nuvaring® the vagina was more 4 weeks, contraceptive efficacy may be reduced, and before applying the new ring Nuvaring® Pregnancy must be excluded.
If the patient does not follow the recommended regimen and then during the week-long break to use the rings don't comes bleeding, caused by the removal of rings, before using a new vaginal ring should be deleted pregnancy.
That postpone the time of menstruation, You can start using the new rings without a week's break. The next ring should be used for 3 weeks. This can occur because bleeding or mazhushchie selection. Then put a week's break should return to regular use Nuvaring®.
To move the onset of menstruation to another day of the week from the date of, that falls on the current schema use rings, You can make shorter the coming break to use the ring on so many days, how much you want to. The shorter break to use rings, the higher the probability of non-bleeding, coming after the removal of the rings, and the emergence of the late bleeding or spotting during the use of the following ring.
Rules for using Nuvaring®
The patient may independently enter Nuvaring® vagina. For the introduction of the woman should be rings choose the most convenient position for it, eg, Standing, lifting one leg, squatting, or lying down. NovaRing® you need to squeeze and hold the vagina to convenient situation rings. The exact position of the Nuvaring® the vagina is not decisive for the contraceptive effect rings.
After the introduction of the ring should be vagina constantly throughout 3 weeks. If it was accidentally deleted (eg, When you remove a tampon), the ring should be washed with warm water and immediately place in the vagina. To remove the rings you can pick up an index finger or pinching between the index and middle fingers, pull from the vagina.
Side effect
CNS: headache, migraine, depression, emotional lability, dizziness, anxiety, feeling tired.
From the digestive system: nausea, stomach ache, diarrhea, vomiting.
On the part of the reproductive system: vaginal discharge (“white”), vaginitis, cervicitis, soreness, stress and breast augmentation, dysmenorrhoea, decreased libido.
From the urinary system: urinary tract infection (incl. cystitis).
Local reactions: drop ring, discomfort during sexual intercourse in women and men, foreign body sensation in the vagina.
Other: increase or decrease in body weight.
Contraindications
- Venoznыy or arteryalnыy thrombosis / tromboэmbolyya (incl. history);
-risk factors for thrombosis (incl. history);
- Migraine with focal neurological symptoms;
- Diabetic angiopathy;
- Pancreatitis (incl. history) in combination with a high degree of hypertriglyceridemia (the concentration of LDL more 500 mg / dL);
- Severe liver disease (to normalize function indicators);
- Liver tumors (benign or malignant, incl. history);
-dependant malignant tumors (installed or projected, eg, tumors of the genital organs or mammary glands);
is vaginal bleeding unclear etiology;
- Pregnancy or suspected it;
- Lactation;
- Hypersensitivity to the drug.
FROM caution should be prescribed for patients with diabetes, obesity (body mass index over 30 kg / m2), hypertension, Atrial Fibrillation, valvular heart disease, dyslipoproteinemia, diseases of the liver or gallbladder, Crohn's disease or ulcerative colitis, sickle-cell anemia, SLE, hemolytic uremic syndrome, epilepsy, smoking combined with age more 35 years, during prolonged immobilization, major surgical interventions, fibrocystic mastopathy, fibromiome uterus, congenital hyperbilirubinemia (Gilbert's syndrome, Dubin-Johnson and Rotor), hloazme (avoid exposure to UV rays), as well as the conditions, that make it difficult to use the vaginal ring (cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation).
Pregnancy and lactation
Contraindicated use Nuvaring® Pregnancy, suspicion, pregnancy and lactation.
Cautions
Before assigning the Nuvaring®, You should collect detailed medical history of the patient, a medical examination, taking into account contraindications and cautions. During the Nuvaring® the survey should be repeated at least 1 per year. Frequency and list of studies must be selected individually for each patient, but in any case, particular attention should be paid to the control of HELL, the exploration of the mammary glands, abdominal and small pelvis, including cervical cytology and relevant laboratory tests.
The Effectiveness Of The Nuvaring® can be reduced in case of a failure mode of application or concomitant use of other drugs.
Destination if necessary against the backdrop of Nuvaring® drugs, that can affect the contraceptive effect of the drug (phenytoin, phenobarbital, prymydon, Carbamazepine, rifampicin, okskarʙazepin, topiramate, felʙamat, ritonavir, griseofulvin, St. John's wort preparations), should use a barrier method in addition to use Nuvaring® or choose another method of contraception. When accepting induction mikrosomaionah liver enzymes on a background of application of the Nuvaring® should use a barrier method during the course of receiving concomitant drugs and for 28 days after the termination of their employment. While taking antibiotics (excluding the amoxicillin and doxycycline) You should use a barrier method is not less 7 days after the termination of the course of antimicrobial therapy. If concomitant therapy medicines continues over 3 weeks of use rings, the next ring is placed directly, without a week's break.
The use of contraceptive steroids may influence the results of certain laboratory tests, including the biochemical indicators of liver function, Thyroid, adrenal glands and kidneys, level of plasma transport proteins (eg, corticosteroid-binding globulin and globulin, sex hormone binding), fractions of lipid/lipoprotein, indicators of carbohydrate metabolism and performance of coagulation and fibrinolysis. Indicators, usually, change in the normal range.
The patient should be informed that, that Nuvaring® does not protect against HIV infection (AIDS) and other diseases, sexually transmitted.
While using the Nuvaring® You may experience irregular bleeding (minor selection or sudden bleeding).
Some of the women during a break to use the rings don't comes bleeding, caused by the removal of rings. If Nuvaring® made in accordance with the recommendations of the, unlikely, that a woman is pregnant. If you deviate from the recommended regime and the absence of bleeding from the preparation, or, in the absence of bleeding 2 times in a row should be deleted pregnancy.
The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on sexual partners through their absorption through the skin of the penis is not investigated.
Overdose
Cases overdose unknown.
Alleged symptoms: nausea, vomiting, vaginal bleeding.
Treatment: symptomatic therapy. There are no antidotes.
Drug Interactions
Interactions between hormonal contraceptives and other drugs can lead to bleeding “Breakthrough” and/or loss of contraceptive effect.
If you are applying to Nuvaring® with drugs, inducing hepatic microsomal enzymes (phenytoin, phenobarbital, prymydon, Carbamazepine, rifampicin, okskarʙazepin, topiramate, felʙamat, ritonavir, griseofulvin, St. John's wort preparations) intensifies the metabolism of sex hormones and decreases the contraceptive effect Nuvaring®.
The Effectiveness Of The Nuvaring® may also decrease while receiving some antibiotics, such as Penicillins and tetracyclines. These drugs reduce the circulation of ènteropečenočnuû estrogen, that leads to a decrease in the concentrations of ethinyl estradiol.
As a result of the studies of pharmacokinetics showed no impact on contraceptive efficacy and safety of Nuvaring® If it overlaps with anti-fungal drugs and spermicidnymi means.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
NovaRing® It should be kept out of the reach of children at a temperature from 2° to 8° c. Shelf life – 3 year.
