drugs

CERAZETTE ® - Desogestrel

CERAZETTE ® is a drug based on desogestrel

THERAPEUTIC GROUP: Systemic hormonal contraceptives based on progestins

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications CERAZETTE ® - Minipillola

CERAZETTE® is used as an oral contraceptive.

Action mechanism CERAZETTE ® - Mini-pill

Oral contraceptives such as CERAZETTE ® characterized by the presence of a single progestogen hormone, are commonly defined as mini-pill due to the absence of estrogen.

Despite this significant difference in the overall composition, the contraceptive efficacy is comparable to that of the most common progestin estrous, with mechanisms of action active both at the uterine level (variation of the fluidity of cervical mucus) and at the ovarian level (suppression of induced ovulation from the inhibition of gonadotropin secretion and in particular of luteinizing hormone).

The absence of estrogen, although it does not affect the contraceptive efficacy of the drug, significantly reduces some side effects such as nausea, vomiting, increased breast tension and tenderness, significantly increasing the placemant of the therapy and its tolerability.

Furthermore, from a pharmacokinetic point of view, taking desogestrel alone allows steady state to be reached only after 4-5 days of intake, making oral contraception immediately effective.

The elimination, active through feces and urine, occurs after about 30 hours, following a predominantly hepatic metabolism.

Studies carried out and clinical efficacy

1. CERAZETTE AND MIGRAINE

Interesting study that demonstrates how the use of oral progestogen-only contraceptives can significantly improve the symptoms of migraine with aurea especially in patients coming from combined oral contraception.

2. CERAZETTE IN THE PREMESTRUAL SYNDROME

Case report, in which it was shown how the use of progestins alone can be important in the treatment of premenstrual syndrome in young patients with a family history of thrombophilia.

3. CERAZETTE: EFFECTIVENESS AND TOLERABILITY

An important study that demonstrates how the administration of progestogen-only contraceptives even for prolonged periods of time can provide good contraceptive efficacy with a marked increase in tolerability.

Method of use and dosage

CERAZETTE ® desogestrel 75 mcg tablets;

the dosing schedule envisaged for mini-pills like CERAZETTE ® differs from the classic dosage of oral hormonal contraceptives.

In this case in fact the maximum contraceptive efficacy, which is observed only after about 7 days of treatment, is obtained through the continuous intake of one tablet a day, every day at the same time.

Treatment should be started on the first day of menstruation, except for patients with recent history of abortions or pregnancies or alternative hormonal contraception, who should strictly adhere to medical indications.

In case of forgetfulness, especially when 36 hours elapse after taking the last tablet, it may be necessary to resort to contraceptive methods of coverage, given the reduction in the contraceptive efficacy of CERAZETTE ®

Warnings CERAZETTE ® - Minipillola

The intake of CERAZETTE ® must necessarily be preceded by a careful medical-gynecological examination useful for verifying the possible presence of conditions incompatible with oral contraception based on progestogens alone or capable of increasing the incidence of clinically significant side effects . Diabetes; overweight; smoke; 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 past, represent some of the potential risk factors for the onset of embolic or neoplastic thrombus events following the use of oral contraceptives.

Consequently, in the planning phase of contraception, the doctor should carefully evaluate the cost / benefit ratio, informing the patient of the potential risks and the signs that accompany and precede the appearance of more serious pathologies.

CERAZETTE ® 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

The intake of CERAZETTE ® is contraindicated in pregnancy due to the presence of experimental studies showing side effects related to the massive intake of progestins on fetal health and given the absence of clinical trials able to characterize the safety profile of the drug when taken pregnant.

CERAZETTE ® seems to be used during the breastfeeding phase, always under medical indication, given the low capacity of the desogestrel to concentrate in breast milk at concentrations potentially dangerous for the infant.

Interactions

Given the hepatic metabolism to which desogestrel is subjected, the same pharmacological interactions described for combined oral contraceptives are also envisaged for drugs such as CERAZETTE ®.

Consequently the simultaneous intake of active ingredients such as primidone, phenytoin, barbiturates, carbamazepine, (used for the treatment of epilepsy), rifampicin (used for the treatment of tuberculosis), ampicillin, tetracyclines, la griseofulvin (antibiotics used for the treatment of infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), capable of inducing cytochrome enzymatic activity, could reduce the plasma concentrations of the progestogen compromising the effectiveness contraceptive of the drug.

Different studies also show that taking oral contraceptives can cause a significant variation in laboratory parameters related to hepatic, thyroid, adrenal and renal function.

Contraindications CERAZETTE ® - Minipillola

CERAZETTE ® contraindicated in case of current or previous venous thrombosis, stroke, hypertension, malignant pathologies, undiagnosed vaginal bleeding, undiagnosed gynecological diseases, in case of hypersensitivity to the active ingredient or to one of its excipients and during the entire period of pregnancy.

Undesirable effects - Side effects

The absence of ethinylestradiol in the formulation of CERAZETTE ® allows to significantly reduce the frequency and intensity of the side effects commonly related to hormonal contraception.

Among these the most frequent undoubtedly remains irregular bleeding, observed in about 50% of women undergoing treatment.

On the other hand, there have been fewer cases of headaches, changes in mood, acne and dermatological diseases, breast pain and weight gain.

The effects of progestogen-only pills on the incidence of embolic, cardiovascular and tumor thrombus events (especially breast) remain to be characterized more precisely.

Note

CERAZETTE ® is salable only under medical prescription