MINESSE ® - Ethinyl estradiol + Gestodene

MINESSE ® is a drug based on ethinyl estradiol and gestodene

THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestin and estrogens, fixed combination

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications MINESSE ® - Ethinyl estradiol + Gestodene

MINESSE ® is used as an oral contraceptive.

Mechanism of action MINESSE ® - Ethinyl estradiol + Gestodene

Oral contraception with fixed combination estrogens and progestins is based on the ability of these two hormones to modulate hormonal balance and to induce chemical-physical variations of some parameters useful to prevent both ovulation and fertilization.

More precisely estro-progestins such as ethinyl estradiol and gestodene are able to act on the hypothalamic hypophyseal axis, modulating the endogenous secretion of gonadotropins such as LH and FSH necessary to guarantee correct follicular maturation and subsequent ovulation, and at the same time on consistency of cervical mucus, thus making sperm ascent more difficult along the female genital tract.

The excellent intestinal absorption and the good bioavailability of both active ingredients contained in MINESSE ® allow their oral intake, while their half-life, estimated around 24 h, allows to maintain the maximum contraceptive coverage through the ingestion of a single tablet per day.

Studies carried out and clinical efficacy

1. ORAL CONTRACEPTION AND COAGULATION

Study that tested the effects of oral contraceptives at different doses on the coagulative characteristics of 46 women, without observing clinically significant changes. In the light of these data, there is a need for more substantial studies that can also discriminate the effects of hormonal contraception on those related to ethnic characteristics.

2. PHARMACOLOGICAL INTERACTIONS

Very important systematic work that lists all the known potential active ingredients, able to interfere with the activity of cytochrome p450 enzymes by altering the anti-conventional efficacy of oral contraceptives.

3. EFFICIENCY AND SECURITY OF MINESSE

Study that observed the efficacy and safety of MINESSE on 163 women with a maximum age of 59 years. In particular the continuous intake for six months did not result in the appearance of clinically relevant side effects, also providing good control of the cycle and premenstrual symptoms.

Method of use and dosage

MINESSE ® pale yellow coated tablets of 15 mcg of ethinyl estradiol 60 mcg of gestodene; white coated tablets with no active ingredient: the particular formulation used for MINESSE ® allows the intake of one tablet per day continuously, thus reducing the risk of forgetting the normal timing of employment.

In this case, in fact, you should start the contraception cycle on the first day of your oestrus by taking a yellow tablet and prolonging it for the next 24 days, immediately followed by taking the white tablet for the next 4 days .

During this last period, the appearance of suspension bleeding induced by histological changes in the endometrium is physiological.

This dosing schedule, especially in relation to the initial phase of treatment, could undergo important variations in the case of recent abortion or pregnancy, forgetfulness or change in the contraceptive used.

The maximum contraceptive coverage is obtained during the second treatment cycle, while this tends to decrease after about 36 hours from taking the last tablet to disappear after 7 days, given the restoration of normal hormonal control.

Warnings MINESSE ® - Ethinyl estradiol + Gestodene

The biological complexity of hormonal contraception and the presence of even serious side effects requires a careful gynecological and medical examination, aimed at assessing the possible prescriptive appropriateness and the presence of conditions such as to increase the risk of adverse reactions.

More precisely, patients suffering from cardiovascular and neoplastic diseases in progress or past, liver and kidney diseases, neurological and psychiatric disorders, metabolic pathologies such as diabetes and risk factors for cardiovascular diseases such as obesity or smoking, should seriously consider the cost / benefit ratio that would result from taking an oral contraceptive and at the same time the possible need to undergo periodic medical checks.

In these cases the patient must be appropriately informed by the doctor on the short and long term effects related to the use of hormonal contraceptives, and on the typical signs of such reactions, so that they can be recognized promptly.

MINESSE ® 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

Despite the accidental exposure of estrogens and progestins, in pregnant women, has not caused the appearance of side effects on the fetus, the intake of MINESSE ® is contraindicated during the whole gestation.

This contraindication also extends to the subsequent period of breastfeeding given the ability of ethinyl estradiol and gestodene to permeate the breast filter, concentrating in breast milk.

Interactions

As is known, the hepatic metabolism to which both ethinylestradiol and gestodene are subjected, significantly increases the risk of potentially dangerous drug interactions.

More precisely, the simultaneous intake of enzyme inducers such as phenobarbital, phenytoin, primidone, carbamazepine, topiramate, rifabutin, rifampicin, griseofulvin, ritonavir, some antibiotics and sometimes St. John's wort (hypericum perforatum), could increase the metabolism of the two hormones, thus reducing both blood concentrations and the contraceptive effect.

In this case, therefore, it would be particularly advisable to consult your doctor, possibly considering taking a method of contraception.

Contraindications MINESSE ® - Ethinyl estradiol + Gestodene

MINESSE ® 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

Although MINESSE ® has low-dose hormones and a new-generation synthetic progestin such as gestodene, the use of this contraceptive is often accompanied by short and long-term side effects.

Fortunately, those that occur more frequently are clinically not very relevant, including vaginitis, mood changes, irritability, dizziness, nausea and vomiting, skin disorders and increased breast tension with tenderness.

However, the aforementioned effects are combined with others, much more rare but of greater clinical interest, such as eye problems, embolic thrombus diseases, hypertension, coronary heart disease, biliary lithiasis and pancreatitis, hyperlipidemia and other metabolic disorders, for which the immediate suspension of contraceptive therapy.