SECURGIN ® is a drug based on ethinyl estradiol + desogestrel
THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestin and estrogens, fixed combination
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications SECURGIN ® - Contraceptive Pill
SECURGIN® is used as an oral contraceptive.
Mechanism of action SECURGIN ® - Contraceptive Pill
The contraceptive action of SECURGIN ® is guaranteed by the presence of ethinyl estradiol and desogestrel at concentrations such as to induce effects both at the central and local level.
More precisely the aforementioned hormones are able to inhibit the hypophysial secretion of gonadotropins, FSH and LH, thus interfering with the oocyte maturation processes and with ovulation itself, and at the same time inducing chemical-physical variations of the cervical mucus such as to counteract the ascent of sperm into the female genital tract and the possible nesting of the embryo in the uterine mucosa.
The estrogens contained in SECURGIN ® make it possible to classify this medicine as a third generation oral contraceptive, which, born with the intent to reduce some side effects such as weight gain and skin disorders, has unfortunately been associated with an increased risk of developing thromboembolic events.
Studies carried out and clinical efficacy
1. DESOGESTREL-BASED CONTRACEPTIVES AND LDL METABOLISM
An extremely interesting in vitro study demonstrating that ethinyl estradiol and desogestrel based oral contraceptives are able to induce the expression of LDL receptors in placental trophoblast cells. This study could partly justify the effects of desogestrel on lipid metabolism observed in vivo.
2. EFFECTS OF DESOGESTREL ON THE MICROCIRCLE
Study demonstrating how desogesterl and ethinyl estradiol-based contraceptives can induce dependent endothelial vasodilation thanks to the differential expression of eNOS, a producer of nitric oxide. This action appears to be mediated above all by the progestin action of the desogestrel
3. THIRD GENERATION CONTRACTS AND COLLATERL EFFECTS
A one-year clinical trial conducted on 100 healthy women who showed that desogestrel and ethinyl estradiol-based contraceptives are safer than those containing levonorgestrel with regard to the incidence and severity of acne, hirsutism and weight variations.
Method of use and dosage
SECURGIN ® tablets coated with 20 mcg of ethnyl estradiol and 150 mcg of desogestrel:
taking oral contraceptives such as SECURGIN ® should follow the classic cyclical pattern, characterized by the continuous administration of one tablet a day for 21 days, alternated with periods of 7-day suspension, in which suspension bleeding should be observed due to changes induced at the endometrial level.
The half-life of both active ingredients, estimated at around 24 hours, allows maximum contraceptive coverage to be maintained by simply taking one tablet a day at the same time, considering that a reduction of the tablet is observed after 36 hours. contraceptive efficacy that gradually tends to disappear around the seventh day of suspension, in which the physiological hormonal control is resumed.
Changes to the normal dosing schedule may be necessary during particular pathologies, recent abortions or pregnancies, forgetfulness of the daily intake or in case of variation of the contraceptive used.
Warnings SECURGIN ® - Contraceptive Pill
Given the biological complexity of hormonal contraception and the potential long-term risks of the same, before undertaking an oral contraceptive it would be necessary to undergo a careful medical examination useful to exclude the presence of conditions able to increase the incidence of the aforementioned risks.
In fact, women with existing or previous cardiovascular and neoplastic diseases, 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 undergo periodic useful tests to assess one's health status.
Especially in these cases the doctor / patient relationship is necessary in order to carefully consider the risk-benefit ratio of oral contraception, clarifying both the potential side effects and the first signs with which these occur, so that they can be recognized promptly and properly controlled.
SECURGIN ® contains lactose so that its intake in patients with lactase enzyme deficiency, glucose / galactose malabsorption or lactose intolerance, may be associated with severe gastrointestinal disorders.
PREGNANCY AND BREASTFEEDING
The absence of studies such as to fully characterize the safety profile of SECURGIN ® when taken during pregnancy and the scarce need to use a contraceptive method during the same period, do not allow the use of oral contraceptives during the gestational period.
Furthermore, the ability of estrogens and progestogens contained in these drugs to permeate the breast filter and concentrate in breast milk also extends this contraindication to the subsequent breastfeeding phase.
Interactions
The hepatic metabolism to which both ethinylestradiol and desogestrel are subjected, significantly increases the risk of drug interactions capable of altering the pharmacokinetic properties of SECURGIN ® reducing its contraceptive efficacy.
More precisely the contextual assumption of metabolic inducers of citrochromial enzymes such as rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort could increase the metabolism of the hormones contained in SECURGIN ® thus reducing blood concentrations and biological efficacy.
Consequently, before taking any drug, it would be advisable to seek the advice of your doctor and possibly resort to contraceptive methods of coverage.
Contraindications SECURGIN ® - Contraceptive Pill
SECURGIN ® 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 third-generation oral contraceptives have been designed to reduce some side effects of hormonal contraceptive therapy such as weight gain and skin disorders, taking SECURGIN ® has often been associated with side effects such as nausea, headaches, and mood changes, eye irritation, haemorrhagic spotting, increased breast tension and tenderness.
Particularly relevant from the clinical point of view, both in some cases requiring immediate drug withdrawal, were some long-term adverse reactions responsible for increasing the frequency of arterial and venous thromboembolic accidents, hypertension and coronary artery disease, hyperlipidemia and cholestatic jaundice.
Note
SECURGIN ® is salable only under medical prescription.
