MILVANE ® is a drug based on ethinyl estradiol and gestodene
THERAPEUTIC GROUP: Three-phase systemic hormonal contraceptives based on progestins and estrogens.
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications MILVANE® - Contraceptive Pill
MILVANE ® is used as an oral contraceptive.
MILVANE® Action Mechanism - Contraceptive Pill
Triphasic oral contraceptives such as MILVANE ® are drugs based on estrogens and progestogens of variable, usually low concentration, useful for preventing conception while attempting to reduce the collateral symptoms classically associated with combined oral contraception.
The theoretical basis of the development of triphasic contraceptives consists in modulating the hormonal concentration assumed in a way dependent on the phase of the cycle, increasing the estrogen towards the middle of the cycle and increasing progestin concentrations gradually.
These slight fluctuations should partly reflect endogenous hormone balance, thereby reducing the frequency and extent of bleeding spotting.
The contraceptive properties instead remain almost identical to those of the monophasic contraceptives acting:
- At the central level, reducing the endogenous secretion of gonadotropins, useful for ensuring correct follicular maturation and subsequent ovulation;
- At the uterine level, inducing chemical-physical variations of the cervical and histological mucus of the endometrium, necessary to make the ascent of the spermatozoa in the female genital tract more difficult, and possibly even the embryo nesting.
From the pharmacokinetic point of view, both ethinylestradiol and gestodene are rapidly absorbed from the intestinal mucosa, metabolised at the hepatic level and eliminated mainly through the kidney, after a half-life of about 24 hours.
Studies carried out and clinical efficacy
1. THREE-PHASE ORAL CONTRACCEPTION AND LIPID METABOLISM
Work that compares the effect of three-phase contraceptives based on ethinyl estradiol and gestodene with those of monophasic contraceptives. The study showed that such contraception can increase HDL cholesterol concentrations by reducing those of LDL, thus preserving the patient from cardiovascular risk. However, these data seem to be questioned by other studies.
2. THREE-PHASE ORAL CONTRACEPTIVES AND ACNE
Interesting retrospective study that evaluated the efficacy of oral contraceptives containing progestins such as gestodene in reducing the incidence and severity of acne, significantly improving the state of inflammatory lesions related to this condition.
3. PHARMACOCINETICS
An interesting pharmacokinetic study that fully characterizes the kinetic properties of both ethinyl estradiol and gestodene when taken in the form of triphasic oral contraceptives, demonstrating that the half-life of these active ingredients is around 18 hours.
Method of use and dosage
MILVANE ®
6 beige-coated tablets of 30 mcg of ethinyl estradiol and 50 of gestodene;
5 dark brown coated tablets of 40 mcg of ethinyl estradiol and 70 mcg of gestodene;
10 white coated tablets of 30 mcg of ethinyl estradiol and 100 mcg of gestodene;
taking the 21 tablets in the MILVANE ® blister follows a very specific order indicated by the calendar on the package.
Starting the intake on the first day of the cycle, when you are not coming from other oral contraceptive methods, of the first pill marked in the package from the beginning START, you can proceed with the continuous intake of the next 20 tablets, one a day at the same time, completing thus the first treatment cycle.
Before embarking on the new contraceptive cycle, it will be necessary to interrupt the intake for about 7 days, in which a suspension bleeding similar to the physiological menstruation should take place.
The timing of recruitment, relative to the beginning of contraception, may change in the case of recent abortions or pregnancies, or if it came from a different hormonal contraceptive.
In the above cases and in case of forgetfulness it would be advisable to contact your doctor immediately and follow his instructions.
MILVANE® Warnings - Contraceptive Pill
The administration of MILVANE ® must necessarily be preceded by a careful gynecological examination useful for evaluating the possible presence of risk factors capable of increasing the incidence of side effects linked to contraceptive use.
Smoke; 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 previous (patches on the skin with yellowish-brown pigmentation, in particular on the face, represent only some of the conditions for which the risk / benefit ratio linked to the intake of MILVANE ® should be carefully evaluated, subjecting to periodic medical checks if necessary.
The reduction of the incidence of serious side effects also passes through the correct doctor / patient relationship, useful to clarify from the outset what are the potential risks and the first signs with which these occur.
MILVANE ® contains lactose, therefore its use in patients with lactase enzyme deficiency, glucose / galactose malabsorption or lactose intolerance, may be associated with severe gastrointestinal disorders.
PREGNANCY AND BREASTFEEDING
The use of oral contraceptives during pregnancy is contraindicated, given the absence of clinical trials able to characterize the safety profile of these drugs when taken during pregnancy.
This contraindication also extends to the subsequent breastfeeding period, given the ability of ethinylestradiol and gestodene to permeate the breast filter and concentrate in breast milk .
Interactions
The typical hepatic metabolism of ethinyl estradiol and gestodene, supported by cytochromial enzymes, exposes MILVANE ® to possible drug interactions.
For example the concomitant intake of primidone, phenytoin, barbiturates, carbamazepine, (used to treat epilepsy), rifampicin (used to treat tuberculosis), ampicillin, tetracyclines, griseofulvin (used antibiotics for the treatment of infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), could increase the metabolism of the two hormones, thereby reducing both the blood concentrations and the contraceptive effect of the drug.
In this case, therefore, it would be particularly advisable to consult your doctor, possibly considering taking a method of contraception.
Given the ability of ethinylestradiol and gestodene to modulate the activity and effectiveness of other active ingredients, one should always remind their doctor or other specialists about taking this drug, in order to avoid unpleasant consequences.
Contraindications MILVANE® - Contraceptive Pill
MILVANE ® is contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, changes 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 associated with the appearance of side effects of different clinical entities.
The less important adverse reactions, which tend to regress spontaneously once the therapy is suspended, involve the gastro-intestinal apparatus with vomiting, abdominal pain and cramps, the cutaneous one with acne, erythema, rash etc, the nervous one with depression, behavioral alterations, irritability, headache and migraine, genital irritation with oligomenorrhea, dysmenorrhea and intermenstrual bleeding and it is also possible to observe increased breast tension with tenderness and weight gain related to fluid retention and edema.
Clinically more important, but fortunately more rare, are the cases of thrombosis and accidents embolic thrombus, hypertension and coronary artery disease, hyperlipidemia, alterations in liver function, gall bladder lithiasis and pancreatitis, optimal neuritis and hepatocellular carcinomas, associated with the administration of combined oral contraceptives.
Note
MILVANE ® is salable only under medical prescription.
