YASMIN ® is a drug based on ethinyl estradiol + drospirenone
THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestin and estrogens, fixed combination
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications YASMIN ® - Contraceptive Pill
YASMIN ® is used as an oral contraceptive.
Action mechanism YASMIN ® - Contraceptive Pill
The contraceptive effect of YASMIN ® is guaranteed by the particular combination of an estrogen, ethinyl estradiol, and a progestin, drospirenone.
Taken orally both active ingredients are rapidly absorbed at the intestinal level, reaching maximum plasma concentration within two hours of oral administration with bioavailability of 45% for ethinyl estradiol and 80% for drospirenone.
Linked to specific plasma proteins, they are distributed to the target organs and then, after about a half-life of 20 hours for the estrogen and 40 hours for the progestin, they are metabolized to the liver level and eliminated both through the urine and through the faeces.
The contraceptive action is essentially performed through the inhibition of the ovulatory process conducted by the constant and high concentrations of estrogens, taken through the drug, which inhibit the hypothalamic-pituitary axis from feedback, preventing the secretion of gonadotropins responsible for maturation and subsequent maturation ovulation of the mature oocyte.
The presence of the progestin instead guarantees endometrial variations that culminate with menstruation once the contraceptive pill is suspended, and changes in the chemical-physical properties of the uterine mucus able to counteract the spermatozoa.
Drospirenone, in addition to guaranteeing the appropriate changes in the endometrium, has a modest anti-mineralocorticoid activity, which prevents the accumulation of sodium and water, responsible for the increase in water retention that is often accompanied by the use of these contraceptives.
Studies carried out and clinical efficacy
1. COMBINED ORAL CONTRACEPTIVES AND VASCULAR STIFFNESS
The ENIGMA study carried out on young women using combined oral contraceptives demonstrated a significant increase in systolic pressure combined with greater rigidity of the large arteries. These two conditions represent important cardiovascular risk factors.
2. YASMINE AND POLYCHISTIC OVEN SYNDROME
Oral contraceptives containing drospirenone have been shown to be more effective in patients with polycystic ovarian syndrome while preserving the metabolic and hormonal health status. Important successes were also achieved in the reduction of pain associated with the menstrual cycle.
3. THE EFFECTIVENESS OF YASMINE
The use of YASMIN as a contraceptive method has proved to be very effective and well tolerated on a large number of women enrolled in this study. Respect other contraceptives YASMIN has ensured better control of body weight and premenstrual symptoms.
Method of use and dosage
YASMIN ® ethinyl estradiol 0.03 mg coated tablets and drospirenone 3 mg:
as simple as it may seem to take a contraceptive pill, this cannot do without a careful medical examination and the scrupulous supervision of your gynecologist.
In principle, the intake of YASMIN ® should begin on the first day of menstruation, if it is not from a previous contraceptive therapy, and continue for the next 20 days, taking the tablet preferably at the same time every day.
The next cycle must necessarily begin 7 days after suspension, an interval in which there will be bleeding from suspension.
In the case of previous contraceptive therapies, abortions or recent pregnancy, the start of taking YASMIN ® must be established by your gynecologist.
The forgetting of taking a tablet over 12 hours from the normal established time could lead to a reduction in the contraceptive capacity of the drug, while the suspension of therapy for over seven days would result in a recovery of the normal hypothalamic, pituitary, and therefore gonadal function.
It should be remembered that in the case of vomiting, within 3-4 hours of taking YASMIN ® it would be advisable to take another tablet to maintain contraceptive coverage.
Warnings YASMIN ® - Contraceptive Pill
The administration of YASMIN ® must be preceded by a careful gynecological examination to assess the possible presence / absence of conditions incompatible with the use of a combined oral contraceptive.
More precisely, the presence of cardiovascular disorders, or familiarity with cardiovascular events, neoplasms or family history of neoplastic diseases are some of the conditions for which it is particularly important to assess the risk / benefit ratio associated with the administration of YASMIN ® with your doctor
The use of oral contraceptives is often associated with an increase in pressure, with the appearance of depressive symptoms capable of aggravating an already existing clinical picture, with an increase in peripheral resistance to insulin which is particularly dangerous in diabetic women for whom the intake of YASMIN ® must necessarily be combined with continuous medical supervision.
YASMIN ® contains lactose therefore its administration in patients with lactase enzyme deficiency, glucose / galactose malabsorption or lactose intolerance could be combined with gastro-intestinal side effects.
PREGNANCY AND BREASTFEEDING
The scientific literature proposes numerous studies related to the safety of the administration of combined oral contraceptives on the health of the fetus, observing the presence of significant side effects in animal models.
However, the clinical trial did not detect any type of teratogenic or mutagenic effect on the human fetus.
Nevertheless, the intake of YASMIN ® in pregnancy is contraindicated, and this contraindication also extends to the subsequent period of breastfeeding given the ability of the active ingredients to pass through the breast filter and concentrate in breast milk.
Interactions
The complex biological role of these hormones, combined with significant hepatic metabolism, exposes YASMIN ® to numerous possible drug interactions capable of significantly altering both the pharmacokinetic and therapeutic properties of the active ingredients contained therein.
More precisely, the concomitant intake of phenytoin, barbiturates, primidone, antiretrovirals, antibiotics and various active ingredients capable of altering the normal activity of liver enzymes could vary the metabolism of YASMIN ® reducing its contraceptive efficacy.
For this reason it would be useful in such conditions to resort to contraceptive methods of coverage.
It is also necessary to consider that the same drug could induce a series of variations on the pharmacokinetics and on the biological efficacy of other active ingredients, so it is essential to consult the package insert and consult your doctor.
Contraindications YASMIN ® - Contraceptive Pill
The use of YASMIN ® is contraindicated in patients suffering from current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, alterations in liver and kidney function, malignancies, undiagnosed gynecological diseases and in case of hypersensitivity to the active substance or to one of its excipients.
Undesirable effects - Side effects
The administration of YASMIN ® is often accompanied, especially in the initial phase of the cycle, by side effects such as: headache, altered mood, migraine, nausea, increased breast tension and breast pain.
Vascular changes are more rare, such as hypertension and hypotension, genitals such as vaginitis, skin problems such as acne, eczema and itching.
Further studies are instead evaluating the long-term effects of oral contraception, probably related to some serious reactions such as thromboembolic disorders and liver changes.
Note
YASMIN ® is salable only under medical prescription.
