LOETTE ® 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 LOETTE ® - Contraceptive Pill
LOETTE ® is used as an oral contraceptive.
Mode of action LOETTE ® - Contraceptive Pill
The presence of levonorgestrel as a progestin allows the classification of LOETTE ® among second-generation oral contraceptives.
Widespread for more than twenty years, they have been subjected to different studies and characterized both by the contraceptive potential, estimated at around 99.9%, and by the numerous side effects.
The contraceptive action is carried out mainly through the inhibition of the secretion of gonadotropins, which prevents the correct process of follicular maturation and the subsequent ovulation, but also through the induction of changes at the endometrial and uterine mucus level, useful for prevent the progression of the spermatozoa in the female genital apparatus and at the same time the eventual nesting of the embryo.
Both active ingredients, once taken and orally absorbed, undergo a first-pass metabolism, which results in a reduction of bioavailability, and after a half-life of about 20 hours they are eliminated in the form of inactive metabolites through feces and urine.
Studies carried out and clinical efficacy
1. ACCOUNTS AND MENTAL HEALTH
An important epidemiological study that shows how the implementation of simple and effective contraceptive methods can have a positive impact on the mental health status of women, reducing the incidence of deviant conditions such as alcoholism.
2. ORAL LOW-DOSE PULSES AND TOLERABILITY
The formulation of low-dose oral contraceptives with only 20 mcg of estrogen has guaranteed a reduction in the classic side effects of contraceptive therapy. The main objective of these innovations is oriented towards obtaining a contraceptive method that is well tolerated by women and successful.
3. CONTINUOUS LOW DOSAGE CONTRACEPTIVES
Study comparing the efficacy and safety of continuous administration of contraceptives with 90 mcg of levonorgestrel and 20 mcg of ethinyl estradiol with cyclical for 21 days of contraceptives based on levonorgestrel / ethinyl estradiol at 100mcg and 20mcg respectively. From the first results the contraceptive efficacy and safety seems to be similar between the two dosage schemes.
Method of use and dosage
LOETTE ® 20 mcg coated tablets of ethinyl estradiol and 100 mcg of levonorgestrel:
even second-generation oral contraceptives follow the classic dosing schedule which involves taking one tablet a day, possibly at the same time for 21 days, followed by a free one-week interval.
The suspension determines the detachment of the superficial endometrial wall followed then by a suspension hemorrhage, which resembles the duration and type of the physiological menstruation.
The aforementioned modality of assumption allows to reach in a short time (about 1 month) and maintain the maximum contraceptive capacity, which tends to decrease in case of forgetfulness for over 36 hours, to gradually disappear with the resumption of normal hormonal control after about one week of suspension.
The dosing schedule, and in particular the beginning of the contraceptive plan, could vary according to medical indications, in case of previous abortions, pregnancies or alternative contraception.
LOETTE ® warnings - Contraceptive Pill
Treatment with oral contraceptives must necessarily be preceded by a careful medical examination to assess the appropriateness of the therapy and the possible presence of factors capable of increasing the risk of side effects.
Patients suffering from 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 should carefully evaluate the relationship between risks and benefits with your doctor and choose the possible start of therapy by mutual agreement.
In the latter case the doctor should periodically check the patient's health status, through physical examination and more accurate investigation methods such as laboratory tests, and the patient promptly inform the doctor about the appearance of potentially indicative signs and symptoms of a morbid process in progress.
LOETTE ® 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 scientific literature is to what has been debated on the side effects of the contraceptive pill on fetal health, the intake of this drug is contraindicated both in pregnancy and in the subsequent stage of lactation, given also the ability of the active ingredients to pass through the breast filter and concentrate in breast milk.
Interactions
The intense hepatic metabolism to which both ethinylestradiol and levonorgestrel are exposed exposes LOETTE ® to an increased risk of pharmacologically relevant interactions.
In fact the concomitant intake of rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort, modulators of cytochrome p450 enzymatic activity, could alter the pharmacokinetic properties of the hormones contained in LOETTE ® and reduce their contraceptive abilities .
It is also useful to consider the mutual effect exerted by ethinylestradiol and levonorgestrel on numerous active ingredients, capable of altering their biological activity and therapeutic efficacy.
In these cases the correct reading of the illustrative leaflet and the request for a medical opinion are fundamental.
Contraindications LOETTE ® - Contraceptive Pill
LOETTE ® is contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, liver and kidney function changes, 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 use of second-generation oral contraceptives has often been associated with the appearance of side effects, some of which are so severe that they need to be stopped.
More precisely, among the clinically significant adverse reactions it has been possible to describe the presence of: nausea, headache, weight gain, irritability, nervousness, increased breast tension with tenderness to the touch and skin disorders of various nature.
Increased incidence of thromboembolic and neoplastic events, hypertension, coronary heart disease and hyperlipidemia represent the most serious, but fortunately less frequent, side effects, for which it may be necessary to suspend the intake of LOETTE ®
Note
LOETTE ® is salable only under medical prescription.
