NUVARING ® a drug based on ethinyl estradiol + etonogestrel
THERAPEUTIC GROUP: Hormonal contraceptives for topical use - Vaginal release system
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications NUVARING ® - Intravaginal ring
NUVARING ® a hormonal contraceptive in the form of an intravaginal ring.
NUVARING ® action mechanism - Intravaginal ring
NUVARING ® a silastic ring capable of gradually releasing active ingredients such as ethinyl estradiol and etonogestrel in the vaginal environment.
Both hormones, first absorbed by the vaginal mucosa, are distributed through the venous circulation of the vagina and uterus, first in the various peripheral districts, and then bound to plasma proteins.
Comparable to what has been described for oral contraceptives, they act both at the endometrial level where they induce changes affecting the endometrium and cervical mucus, useful for preventing spermatozoa from rising along the female genital tract, and at the central level where they inhibit the endogenous gonadotropin secretion, blocking follicular maturation and ovulation.
The particular hormone release system allows the frequency of ring changes to be reduced to a minimum while maintaining excellent contraceptive efficacy.
Studies carried out and clinical efficacy
1. THE COMPLIANCE OF THE VAGINAL RING
The ease of application, the reduction of possible errors associated with the dosing schedule and the excellent compliance of the medical device, make the intravaginal ring a particularly effective and well tolerated contraceptive method especially in the lower age groups.
2. NUVARING EFFECTIVENESS AND SAFETY
Work that demonstrates how the use of the vaginal contraceptive ring seems to be very effective and characterized by a favorable side effect profile that significantly increases its acceptability among the patient patients
3. NUVARING AND DIABETES OF THE FIRST TYPE
An interesting clinical study that demonstrates how the use of NUVARING in young patients suffering from first-type diabetes, can guarantee better glycemic control than classic contraceptive methods such as oral methods.
Method of use and dosage
NUVARING ® flexible ring with 54 mm external diameter and 4 mm transverse, containing 11.7 mg of etonogestrel and 2.7 mg of ethinyl estradiol:
studies on the pharmacokinetics of the active ingredients contained in NUVARING ® have shown how this medical device can guarantee an average daily release of about 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol for about 3 weeks.
The ring is inserted into the vagina for the first time, on the first day of the menstrual cycle, and held for 3 weeks, after which it is removed and suspended for a week, in which classic bleeding should occur.
Following the week of suspension the ring can be reinserted, on the same day and at the same time in which it was removed.
The application of the ring must be carried out in such a way that it does not create discomfort and does not come off easily.
The detachment and the absence of the ring for a period of more than 3 hours, could determine a reduction of the blood concentrations of the two hormones, therefore a lowering of the contraceptive efficacy of NUVARING ®
Consequently it is essential to reintroduce the lost ring, clearly after careful washing, and to use a covering contraception for the first few days.
Before applying NUVARING ® in case of particular conditions, it is essential to consult your doctor.
Warnings NUVARING ® - Intravaginal ring
Even the application of NUVARING ® must be preceded by a careful medical-gynecological examination to assess the appropriateness of the contraceptive method used and the possible presence of conditions capable of increasing the incidence of potential side effects.
In this case it should be understood as: the presence of risk factors such as smoking; diabetes; overweight; hypertension; heart valve defects or some heart rhythm disorders; superficial phlebitis (venous inflammation), varicose veins; migraine; depression; epilepsy; high levels of cholesterol and triglycerides in the blood, present or past, even in close family members; breast lumps; previous, in next family members, of breast cancer; liver or gallbladder disease; Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease); systemic lupus erythematosus (pathology that affects the skin of the whole body); hemolytic-uremic syndrome (blood clotting disorder that causes renal failure); sickle cell disease; porphyria; Chloasma, present or past, may cause a significant increase in the incidence of adverse reactions, especially those with the worst clinical course.
It is also essential to apply the intravaginal ring correctly, thus minimizing the risk of expulsion during sexual intercourse or in the case of chronic and severe constipation, safeguarding the contraceptive efficacy of the device.
PREGNANCY AND BREASTFEEDING
NUVARING ® contraindicated both during pregnancy and in the subsequent period of breastfeeding.
This contraindication is justified by the presence of studies that show how the active ingredients contained in it can induce problems in the fetus and at the same time modify the chemical-physical properties of breast milk, concentrating in it.
Interactions
The vaginal application of NUVARING ® does not spare the ethinylestradiol and etonogestrel it contains, from the hepatic metabolism supported by the cytochrome enzymatic class.
Consequently, the concomitant intake of active ingredients capable of modulating the activity of the aforementioned enzymes could alter the normal pharmacokinetic characteristics of the two hormones, varying their contraceptive efficacy.
For example the concomitant intake of primidone, phenytoin, barbiturates, carbamazepine (used to treat epilepsy), rifampicin (used to treat tuberculosis), ampicillin, tetracycline, griseofulvin (antibiotics used to treat infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), could cause a drop in blood concentrations of ethinyl estradiol and etonogestrel, reducing the contraceptive efficacy of NUVARING ®
The estrogens and progestogens contained in this medicine could lead to a significant alteration of some laboratory values related to liver, thyroid, adrenal and renal function.
Contraindications NUVARING ® - Intravaginal ring
NUVARING ® contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, alterations of liver and kidney function, malignant pathologies, neuro-psychiatric disorders, motor disorders, undiagnosed gynecological disorders and in case of hypersensitivity to the active ingredient or to one of its excipients.
Undesirable effects - Side effects
Different clinical trials and careful post-marketing monitoring show how the use of vaginal rings for hormonal contraception can be associated with:
- Frequent side effects such as vaginal infections, mood changes, headache and migraine, skin diseases, increased breast tension with tenderness, weight gain and alterations of the normal hydro-electrolyte balance;
- Less frequent but clinically more significant side effects such as: hypertension, alterations of the normal menstrual flow, dysuria, muscular pains, alopecia, eczema, abdominal cramps, nausea, vomiting, hot flushes, vision disorders, urinary tract infections, cystitis and cervicitis.
It is always useful to remember how the use of hormonal contraceptives, especially in predisposed patients, can increase the number of venous, arterial embolic thrombus events, vascular thrombus events and estrogen dependent tumors.
Note
NUVARING ® sold only under medical prescription.
