TRIMINULET ® - Ethinyl estradiol + Gestodene

TRIMINULET ® 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 TRIMINULET ® - Contraceptive Pill

TRIMINULET® is used as an oral contraceptive.

Mechanism of action TRIMINULET ® - Contraceptive Pill

TRIMINULET ® is a triphasic oral contraceptive, therefore the tablets containing ethinyl estradiol as estrogen and gestodene as progestin, will have different dosages.

More precisely, the intake scheme will involve increasing the concentrations of ethinyl estradiol during the middle of the cycle and then falling again, and a gradual increase in the quantities of progestin until the end of the cycle.

These variations, which seem to follow in part those of the normal endogenous hormonal balance, should, thanks also to the use of innovative progestins such as gestodene, reduce some important side effects such as bleeding spotting.

From a pharmacodynamic point of view, triphasic contraceptives perform their anti-conventional function by inhibiting the production and secretion of gondatropins, useful for follicular maturation and ovulation, and by inducing a series of changes in the cervical mucus and in the endometrium necessary to counteract the ascent spermatozoa in the female genital tract and at the same time the eventual embryo nesting.

Studies carried out and clinical efficacy

1. THE CONTRACEPTIVE EFFECTIVENESS OF THREE-PHASE ORAL CONTRACEPTIVES

Study that characterizes the contraceptive activity of three-phase oral contraceptives, demonstrating how these drugs can guarantee an excellent inhibition of follicologenesis, therefore an excellent contraceptive efficacy

2. THREE-PHASE ORAL CONTRACEPTIVES AND COAGULATION

Work that shows how the intake of low-dose three-phase oral contraceptives, while determining a slight variation of some blood parameters, does not result in significant alterations affecting the coagulation system, lipid metabolism and blood viscosity.

3. LONG-TERM TOLERABILITY

Studies that show how the long-term (3 years) intake of triphasic oral contraceptives can guarantee excellent contraceptive efficacy without inducing significant changes in blood pressure and body weight.

Method of use and dosage

TRIMINULET ®

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;

the dosing schedule includes the uninterrupted intake of one tablet per day for 21 days, more or less at the same time, interspersed with a period of weekly suspension, in which suspension bleeding should be carried out similar to that which occurs with menstruation.

Although the intake of these tablets is decidedly simplified by the presence of a calendar associated with the blister, the beige tablets are numbered from 1 to 6, the brown ones from 7 to 11 and the white ones from 12 to 21, with a numbering that defines the day of employment.

In case of forgetfulness, recent abortions or pregnancies or if you came from alternative methods or contraceptive drugs, it would be advisable to contact your doctor immediately and follow his instructions, before starting the intake of TRIMINULET ®

Warnings TRIMINULET ® - Contraceptive Pill

Given the numerous side effects associated with the use of oral contraceptives, the administration of drugs such as TRIMINULET ® must necessarily be preceded by a careful medical-gynecological examination capable of excluding some potential risk factors for the patient's health.

In fact 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 TRIMINULET ® should be carefully evaluated

Should the patient and doctor opt for the feasibility of contraception in the above cases, the need for periodic medical checks would become a necessity in order to avoid the appearance of unpleasant side effects.

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.

TRIMINULET ® 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

Although there are studies in the literature showing that the accidental exposure of the fetus to estroprogestinici, the absence of significant clinical trials able to demonstrate its total safety does not allow the free use of oral contraceptives during pregnancy.

Furthermore, the ability of ethinyl estradiol and gestodene to pass through the breast filter concentrating in breast milk, extends the aforementioned contraindication also to the subsequent breastfeeding period.

Interactions

Active ingredients such as primidone, phenytoin, barbiturates, carbamazepine, (used to treat epilepsy), rifampicin (used to treat tuberculosis), ampicillin, tetracyclines, griseofulvin (antibiotics used for the treatment of infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), capable of altering the functionality of cytochromial enzymes, could induce activity, thus reducing the contraceptive efficacy of TRIMINULET ®.

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 TRIMINULET ® - Contraceptive Pill

TRIMINULET ® 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

Different clinical trials and careful post-marketing monitoring show that taking estrogen and progestin-based oral contraceptives is often associated with the appearance of side effects.

These, although characterized by a different clinical course, interest:

The gastrointestinal system with nausea, vomiting, diarrhea and abdominal cramps;
The neuro-psychiatric sphere with alterations in mood, irritability, depression, headache and migraine;
The skin exposed to rash, hives, eczema and various types of inflammation;
The breast with increased breast tenderness associated with pain;
The genital apparatus with oligomenorrhea, dysmenorrhea and spotting intermenstrual bleeding;
The cardiovascular system more subject to embolic thrombus, hypetension and coronorapotaia events;
The metabolic sphere with the appearance of hyperlipidemia and altered control of glucose metabolism;
The liver undergoes a greater workload, the risk of gall bladder disease with relative pancreatitis and neoplastic transformation.