BELARA ® - Ethinyl estradiol + Clormadinone

BELARA ® is a drug based on ethinyl estradiol + Clormadinone acetate

THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestin and estrogens, fixed combination

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

Directions BELARA ® - Contraceptive Pill

BELARA ® is used as an oral contraceptive.

Action mechanism BELARA ® - Contraceptive Pill

BELARA ® is an oral contraceptive consisting of low-dose estrogen (ethinyl estradiol) and a progestin (chlormadinone) at concentrations useful both to safeguard the contraceptive characteristics and to reduce some unpleasant effects of combined oral contraception.

The anti-contraceptive effect is guaranteed by the synergistic action of the two hormones useful to inhibit the hypothalamic-pituitary axis, reducing the endogenous secretion of gonadotropins responsible for follicular maturation and subsequent ovulation, and to guarantee endometrial and cervical mucus changes such as complicate the spermatozoa in the female genital tract and the eventual embryo nesting.

Chloradinone is also attributed a strong antiandrogenic action useful in avoiding some particularly annoying pill-related reactions such as acne, hirsutism and alopecia.

Both active ingredients, taken orally, are absorbed at the intestinal level reaching maximum plasma concentration in about 2 hours, and persisting in circulation for over 20 hours, allowing the drug to be administered once a day.

Once its action is over, the two hormones contained in BELARA ® undergo first a hepatic metabolism and then an elimination through urine and faeces.

Studies carried out and clinical efficacy

1. ORAL CONTRACEPTION AND MESTRUAL PAIN

Study demonstrating that long-term use of oral contraceptives may be useful in reducing the pain symptoms associated with the cycle. Important property that demonstrates the therapeutic utility of oral contraception.

2. BELARA AND ACNE

The antiandrogenic action of chlormadinone acetate has proved useful in improving moderate acne in patients undergoing contraceptive therapy. This work demonstrates the beneficial effects on the skin of contraceptives such as BELARA.

3. BELARA AND METABOLIC PROFILE

Administration of BELARA has been shown to be safer than that of other oral contraceptives on maintaining metabolic health. In fact, this study has shown that taking the aforementioned contraceptive can preserve the lipidemic profile of the patient by not contributing to the increase in atherosclerotic risk, as done instead by other oral contraceptives.

Method of use and dosage

BELARA ® 0.03 mg coated tablets of ethnyl estradiol and 2 mg of chlormadinone acetate:

Before taking an oral contraceptive it would be necessary to consult your gynecologist and undergo a careful check-up.

In cases where the administration of BELARA ® is indicated, one tablet should be taken daily for 21 days, followed by suspension for 7 days in which suspension bleeding similar to the physiological menstruation should occur.

The half-life of the two active ingredients allows you to maintain maximum contraceptive activity by ingesting one tablet every day at the same time.

The contraceptive coverage therefore tends to decrease at 36 hours from the last tablet taken while the hypothalamic-pituitary axis recovers its physiological activity after about 7 days of interruption.

If the tablet is vomited within 3-4 hours of taking it, it would be necessary to resort to a new administration.

In case of forgetfulness, recent pregnancy or transition from a different contraceptive therapy it is useful to consult your gynecologist and scrupulously follow his instructions.

Warnings BELARA ® - Contraceptive Pill

The biological complexity of oral contraception, the numerous side effects and the increased risk of onset of serious pathologies such as neoplastic and thromboembolic ones require a careful preliminary control visit, useful to verify the therapeutic appropriateness and the absence of incompatible conditions .

It should in fact be taken into account that in addition to coagulation disorders, cardiovascular pathologies, neoplastic pathologies, liver and kidney diseases, disorders of the neurological and psychiatric sphere and metabolic pathologies such as diabetes, predisposing conditions such as obesity or smoking, can significantly affect the onset of thromboembolic events especially in conjunction with the administration of combined oral contraceptives.

In these cases, therefore, careful medical supervision and periodic checks are necessary.

BELARA ® contains lactose so that its intake in patients with lactase enzyme deficiency, glucose / galactose or lactose intolerance, may be associated with severe gastrointestinal disorders.

PREGNANCY AND BREASTFEEDING

The use of BELARA ® in pregnancy is contraindicated although the scientific literature has not yet found clinical correlations capable of associating teratogenic effects on the fetus with the administration of combined oral contraceptives.

On the contrary pharmacokinetic studies have shown that both active ingredients can easily pass the breast filter and concentrate in breast milk, thus extending the contraindication also to the period of breastfeeding.

Interactions

Despite the fact that chlormadinone does not undergo a first-pass metabolism, both active ingredients are metabolized by liver enzymes at the end of their life, and in particular by the family of cytochromes.

This type of metabolism exposes the two hormones to particular pharmacokinetic variations, given the high susceptibility of the aforementioned enzymes to exogenous modulators.

In fact rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort, represent only some of the active ingredients capable of modulating the activity of cytochromial enzymes, thus varying the pharmacokinetic properties and contraceptive efficacy of BELARA ®

At the same time it must be considered that ethinylestradiol is able to modify the biological activity of other active ingredients

Given the complexity of possible interactions, it would be useful to consult your doctor in case of concomitant administration of more drugs and carefully read the package leaflet ..

Contraindications BELARA ® - Contraceptive Pill

BELARA ® is contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, changes 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

The assumption of BELARA ® is accompanied above all in the initial phase of the contraceptive cycle by side effects of:

nervous system such as headache, dizziness, migraine and behavioral state alterations;
gastro-intestinal system with nausea, vomiting and abdominal pain;
cardiovascular system with a significant increase in blood pressure;
genital apparatus with spotting hemorrhagic, vaginal discharge and pelvic pain;
breast with increased breast tenderness and pain.

Clinically relevant side effects have been observed in rare cases, while the association between combined oral contraceptives and increased risk of thromboembolic and neoplastic diseases remains to be elucidated.