MIRANOVA ® is a drug based on ethinyl estradiol + levonorgestrel
THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestin and estrogens, fixed combination
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications MIRANOVA ® - Contraceptive Pill
MIRANOVA® is used as an oral contraceptive.
Mechanism of action MIRANOVA ® - Contraceptive Pill
Second-generation oral contraceptives, such as MIRANOVA ®, are characterized by the presence of an estrogen such as ethinyl estradiol and a synthetic progestin such as levonorgestrel, capable of partially reducing the collateral symptoms associated with oral contraception.
From the biological point of view both active ingredients guarantee the contraceptive action acting both at the nervous level, through the inhibition of hypothalamic secretion of gonadotropin useful for the correct oocyte maturation, and at the uterine level, modifying the physico-chemical properties of the cervical mucus and of the 'endometrium and at the same time making the spermatozoa in the female genital tract and the embryo nesting more complex.
The maximum contraceptive coverage, able to guarantee an efficacy of about 99.9%, is observed only after the first month of treatment and remains so through the assumption of one tablet per day according to the posology scheme.
This timing is evidently dictated by the pharmacokinetic properties of the two hormones such as to present a half-life close to 24 hours.
Studies carried out and clinical efficacy
1. EFFECTIVENESS AND SECURITY OF MIRANOVA
Study demonstrating the efficacy and safety profile of low-dose large-scale contraceptives. The work that collects data from over 13 thousand women shows that taking Miranova can guarantee good contraceptive coverage leading to a reduction in intermenstrual bleeding with advancing therapy.
2. CONTINUED OR CYCLIC THERAPY
It is known that therapeutic schemes have been proposed for a long time, different from the classical cyclic assumption that foresee the continuous use of the contraceptive. Studies such as these show that the contraceptive efficacy and safety profile of the two protocols are practically comparable.
3. ORAL CONTRACEPTIVES AND ANTI-DIABETIC DRUGS
Study that reassures many diabetic women in which it is shown that liraglutide, a drug similar to GLP-1 used for the treatment of type II diabetes, does not alter the pharmacokinetic profile of ethinyl estradiol / levonorgestre in any way, preserving its contraceptive efficacy.
Method of use and dosage
MIRANOVA ® 0.02 mg coated tablets of ethinyl estradiol and 0.1 mg of levonorgestrel:
if oral contraception is used for the first time as a contraceptive method, the use of these drugs should be started on the first day of menstruation and continued for the next 21 days.
This cycle should be followed by a 7-day withdrawal period in which a suspension bleeding similar to menstruation should generally take place and is linked to the effects of the absence of hormones on the endometrial mucosa.
The maximum contraceptive efficacy is achieved through the daily administration of MIRANOVA ® at the same time, given the half-life of both active ingredients, while this coverage tends to lose effectiveness 36 hours after taking the last tablet to reduce further in subsequent 7 days of suspension, in which the physiological hormonal balance tends to restore itself.
Warnings MIRANOVA ® - Contraceptive Pill
The intake of MIRANOVA ® must necessarily be preceded by a careful gynecological examination useful for evaluating the patient's state of health, the prescriptive appropriateness and the presence of conditions predisposing to the development of side effects.
More precisely, the presence of vascular and cardiac problems, risk factors for cardiovascular diseases such as smoking and obesity, changes in liver and kidney function, neurological and psychiatric disorders and metabolic pathologies such as diabetes, could increase the risk of developing serious adverse reactions seriously compromising the patient's state of health.
In these conditions, therefore, medical supervision and the presence of periodic controls are useful, in order to evaluate the possible onset of early warning signs of more important pathological events.
MIRANOVA ® 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 accidental exposure of human fetuses to estrogen-progestins has not led to particularly serious side effects, the intake of MIRANOVA ® in pregnancy remains contraindicated.
Furthermore, the ability of ethinylestradiol and levonorgestrel to pass through the breast filter and concentrate in breast milk could expose the breastfed infant to dangerous side effects.
In light of these data, MIRANOVA ® is contraindicated even during the period of breastfeeding.
Interactions
The hepatic metabolism to which both ethinylestradiol and levonorgestrel are subjected exposes MIRANOVA ® to the risk of pharmacokinetic variations that could compromise the contraceptive efficacy of the drug.
In fact, the simultaneous intake of active ingredients such as rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort, capable of altering the activity of cytochromial enzymes involved in estrogenic and progestin metabolism, could cause significant variations from the pharmacokinetic point of view to reduce the contraceptive efficacy of the drug.
Consequently the contextual taking of other drugs must necessarily be preceded by a medical consultation and possibly combined with other methods of contraception coverage.
Contraindications MIRANOVA ® - Contraceptive Pill
MIRANOVA ® is contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, alterations in 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
The administration of oral contraceptives is often accompanied by the appearance of side effects such as nausea, abdominal pain, weight gain, headache, migraine, mood alterations and increased breast tension with tenderness.
More rarely and especially in predisposed patients clinically more relevant adverse reactions such as thromboembolic events, hypertension, coronary heart disease, hyperlipidemia and cholestatic jaundice have been observed.
Note
MIRANOVA ® is salable only under medical prescription.
