NOVYNETTE ® is a drug based on ethinyl estradiol + desogestrel.
THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestin and estrogens, fixed combination
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications NOVYNETTE ® - Contraceptive Pill
NOVYNETTE ® is used as an oral contraceptive.
Action mechanism NOVYNETTE ® - Contraceptive Pill
NOVYNETTE ® is a fixed combination estro-progestin used as a contraceptive method.
Its biological action is guaranteed by the combination of ethinyl estradiol, an estrogen also used in hormone substitute therapy, and desogestrel, a synthetic progestin with a significant anti-estrogenic action.
From the biological point of view contraceptive activity is performed through the inhibition to feedback of the hypothalamic-pituitary axis exerted by both hormones, useful to reduce the secretion of gonadotropins and the consequent oocyte maturation with attached ovulation, and through induction of variations in the chemical and physical characteristics of mucus and endometrium such as to counteract both the ascent of the spermatozoa and the eventual embryo nesting.
The hormonal dosages used in NOVYNETTE ® allow both the accomplishment of the aforementioned contraceptive activities and the reduction of some side effects such as hirsutism and skin problems often associated with the use of first and second generation contraceptives.
The pharmacokinetic characteristics of the two active ingredients also allow the daily intake of a tablet, given the half-life that is around for both around 24-30 hours.
Studies carried out and clinical efficacy
1. THE EFFECTIVENESS OF COMBINED ORAL CONTRACTS
A pioneer study that demonstrated the efficacy of low-dose oral contraceptives in ensuring excellent contraceptive coverage while reducing some unpleasant side effects, including androgenic ones in particular.
2. THE TOLERABILITY OF NOVYNETTE
Study conducted on 25 women undergoing contraceptive treatment with Novynette, which shows that this drug is well tolerated, producing transient and clinically insignificant side effects.
3. COMPARISONS AGAINST
Work demonstrating that the efficacy and safety profile of oral contraceptives based on ethinyl estradiol and gestodene or of ethinyl estradiol and desogestrel are practically overlapping. Both therapies proved to be very well tolerated.
Method of use and dosage
NOVYNETTE ® tablets coated with 20 mcg of ethnyl estradiol and 150 mcg of desogestrel:
like most oral contraceptives, NOVYNETTE ® also follows the classic intake scheme, characterized by the daily intake of one tablet a day for 21 days, interrupted by a suspension period of about a week, in which bleeding similar to physiological occurs menstruation.
The contraceptive protocol should be started on the first day of menstruation and continued for the next 20 days through daily intakes carried out at the same time, in order to keep the contraceptive power high, which tends to fall around the thirtieth hour from suspension.
The biological action of inhibition to feedback carried out by the contraceptive instead tends to spontaneously regress around the seventh day of suspension, significantly reducing the contraceptive coverage.
The medical opinion before and during the therapy is necessary both in the evaluation of the real necessity of the same one, than in the monitoring of possible side effects.
This supervision becomes fundamental in case of forgetting about taking a tablet or in the eventual variation of the oral contraceptive used.
Warnings NOVYNETTE ® - Contraceptive Pill
Before undertaking any oral contraceptive it is necessary to undergo a careful gynecological examination useful to evaluate the therapeutic appropriateness and the possible presence of factors capable of increasing the incidence of side effects.
In fact, the presence of cardiovascular and neoplastic pathologies in progress or past, liver and kidney diseases, disorders of the neurological and psychiatric sphere, metabolic pathologies such as diabetes and risk factors for cardiovascular diseases such as obesity or smoking could significantly increase the incidence of the side effects related to NOVYNETTE ® therapy
It is also important to remember that different epidemiological studies have described the increased incidence of pancreatitis, thromboembolic and cardiovascular events, neoplastic diseases of the uterine cervix, inflammatory and nerve pathologies, following the use of combined oral contraceptives in predisposed patients.
NOVYNETTE ® contains lactose so that its intake in patients with lactase enzyme deficiency, glucose / galactose malabsorption or lactose intolerance, could be associated with severe gastrointestinal disorders.
PREGNANCY AND BREASTFEEDING
Although the scientific literature has not yet demonstrated a connection between progestogen estrogen intake and fetal developmental alterations, NOVYNETTE ® intake is severely contraindicated throughout pregnancy.
Furthermore, the ability of both active ingredients to pass through the breast filter and to concentrate in breast milk widens the aforementioned contraindication also to the subsequent period of breastfeeding.
Interactions
The hepatic metabolism to which both active ingredients are subjected significantly increases the risk of clinically significant drug interactions.
Different active ingredients including rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort may in fact modulate the activity of cytochromial enzymes responsible for the metabolism of ethinyl estradiol and desogestrel, varying the relative pharmacokinetic properties, therefore also the contraceptive efficacy.
This explains why it is necessary to use alternative contraceptive methods during any treatment period.
It is good to remember that the active ingredients contained in NOVYNETTE ® could induce changes in the therapeutic efficacy of different drugs, so it would be useful to consult your doctor and read the package leaflet carefully before taking any medicine.
Contraindications NOVYNETTE ® - Contraceptive Pill
NOVYNETTE ® is contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic disorders such as diabetes mellitus, hypertension and dyslipidemia, liver and kidney function changes, 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 have observed that NOVYNETTE ® therapy can be associated with different side effects such as irregular bleeding, migraine, nausea, vomiting, weight gain, depression and mood changes.
More rare but clinically more significant side effects have affected the cardiovascular system with hypertension and thromboembolism, and the liver with increased risk of liver carcinomas.
Note
NOVYNETTE ® is salable only under medical prescription.
