YASMINELLE ® 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 YASMINELLE ® - Contraceptive Pill
YASMINELLE ® is used as an oral contraceptive.
Mechanism of action YASMINELLE ® - Contraceptive Pill
YASMINELLE ® is an oral contraceptive consisting of an estrogenic hormone such as ethinyl estradiol and a progestogen such as drospirenone. This drug is characterized by the analogue YASMIN for the ethinylestradiol dosage, which is reduced by 1 microgram with the aim of increasing tolerability to the drug, while maintaining the contraceptive power unchanged.
The latter is guaranteed by the synergistic action between estrogens and progestins, which at the doses used guarantee, respectively, the inhibition of the hypothalamic-pituitary-gonadal axis, thus preventing both follicular maturation and subsequent ovulation, and alterations of the mucosa uterine and related mucus, able to counteract sperm growth and correct embryo nesting.
Furthermore, the dosage used drospirenone presents a modest antimineralocorticoid activity, able to decrease the retention of sodium and water reducing the risk of hypertension and clinically less serious aesthetic problems.
For both active ingredients the half life is around 24 hours, at the end of which they are metabolised to the liver level and subsequently eliminated through feces and urine.
Studies carried out and clinical efficacy
1. ARGININE AND ORAL ACCEPTANCE: REDUCTION OF CADIOVASCULAR RISK
Interesting study that has shown how the addition of Arginine to the oral contraceptive can reduce the long-term cardiovascular risk, improving the dependent endothelial vasodilation, therefore also the blood pressure levels.
2. COMBINED ORAL CONTRACTS AND FEMALE WELFARE
Long-term study that evaluated the effects of different oral contraceptives on the general state of psycho-physical well-being of patients. The data show that the administration of ethinyl estradiol and drospirenone based contraceptives can improve some important parameters such as: feeling of emotional well-being, acne and water retention.
3. YASMINELLE AND PATTERN OF BLOOD
YASMINELLE is a combined low dose oral contraceptive. Useful to reduce the side effects of classic contraceptives, however, it seemed to present an unreliable and prolonged bleeding pattern even during the intake phase. However, this study showed that YASMINELLE has a standard bleeding profile with reliable control of the cycle.
Method of use and dosage
YASMINELLE ® 0.02 mg coated tablets of ethinyl estradiol and 3 mg of drospirenone:
the assumption of YASMINELLE ® must necessarily be preceded by a careful gynecological examination useful to clarify the adequacy of the prescription.
In these cases the intake cycle should start on the first day of menstruation for a total duration of 21 days, after which it would be necessary to suspend therapy for a week, before starting with a new cycle.
Around the second third day of suspension is the appearance of a suspension hemorrhage.
Given the half-life of the two active ingredients, to maintain maximum contraceptive coverage it would be useful to take the tablet every day at the same time, considering that the contraceptive efficacy decreases after about 36 hours, while the inhibition of the hypothalamic-pituitary-ovary axis it disappears about 7 days after stopping therapy.
In case of forgetfulness or if you come from a previous contraceptive method it would be necessary to consult your doctor and scrupulously follow his instructions.
Warnings YASMINELLE ® - Contraceptive Pill
Before taking any oral contraceptive you should consult your doctor and undergo a careful gynecological examination, correlated by the appropriate laboratory tests, to evaluate the therapeutic appropriateness and the possible presence of potentially dangerous conditions.
For example, patients suffering from coagulation disorders, cardiovascular pathologies, neoplastic pathologies, liver and kidney diseases, neurological and psychiatric disorders, metabolic pathologies such as diabetes and predisposing conditions to the aforementioned conditions should evaluate the cost / benefit ratio with their doctor. if you decide to take the contraceptive, undergo periodic checks, carefully monitoring what may be the early signs of therapy-related disorders.
YASMINELLE ® contains lactose therefore its administration in patients with lactase enzyme deficiency, poor glucose / galactose absorption or lactose intolerance could be combined with gastro-intestinal side effects.
PREGNANCY AND BREASTFEEDING
Despite the scientific literature has not yet observed mutagenic or teratogenic effects on human fetuses exposed to estroprogestinici, the intake of YASMINELLE ® in pregnancy is contraindicated.
In the event of an unexpected pregnancy while taking a combined oral contraceptive it is necessary to stop taking the pill immediately.
Moreover, given the ability of the active ingredients to permeate the mammary filter and concentrate in breast milk, the aforementioned contraindications also extend to the period of breastfeeding.
Interactions
The hepatic metabolism of the hormones contained in YASMINELLE ® exposes the patient to potential risks in terms of frequency of side effects and effectiveness of contraceptive coverage, in case of concomitant intake of active ingredients capable of modulating the activity of liver enzymes.
Rifampicin, phenytoin, barbiturates, antiretrovirals, herbal remedies such as St. John's wort, represent only some of the active ingredients capable of significantly varying the pharmacokinetic characteristics of ethinyl estradiol and drospirenone.
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 YASMINELLE ® - Contraceptive Pill
The use of YASMINELLE ® is contraindicated in patients with existing or previous venous thrombosis, stroke, hypertension, metabolic disorders 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
Estro-progestin-based oral contraceptive therapy is often associated with the appearance of different side effects.
More precisely, clinical trials show how the administration of YASMINELLE ® can determine adverse reactions such as emotional lability, headache, abdominal pain, increased breast tension with relative pain, metrorrhagia and weight gain with good frequency.
Fortunately, clinically more significant adverse reactions such as depression, cardiovascular changes, nausea, vomiting, cystitis and edema have been observed quite rarely.
However, the possible correlation between the use of combined oral contraceptives and the increase in embolic and neoplastic thrombus events remains to be investigated.
Note
YASMINELLE ® is salable only under medical prescription.
