HARMONET ® - Ethinyl estradiol + Gestodene

HARMONET ® is a drug based on ethinyl estradiol + gestodene

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

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

Indications HARMONET ® - Contraceptive Pill

HARMONET ® is used as an oral contraceptive.

Mechanism of action HARMONET ® - Contraceptive Pill

Thanks to the presence of a synthetic progestogen such as gestodene, HARMONET ® is one of the third generation oral contraceptives, launched around 1990 with the aim of minimizing some of the side effects of classical contraception such as water retention, weight gain and various skin disorders.

Taken orally, it releases its active ingredients at the intestinal level where they are rapidly absorbed and distributed thanks to the use of plasma proteins to the different target tissues.

As sex hormones, they interact with specific intracellular receptors, thus modulating gene expression and cellular activation status, determining:

Ovulation inhibition, mediated by the arrest of pituitary production of gonadotropins through negative feedback processes;
Alterations of the endometrial and uterine mucus features, useful to counteract the spermatozoa in the female genital tract and the eventual embryo nesting.

After their activity, after about 24 hours, they are metabolized to the liver level and excreted through feces and urine.

Studies carried out and clinical efficacy

1. THIRD GENERATION AND AND HEMOSTASIS CONTRACEPTIVES

The administration of oral contraceptives containing gestodene turned out to be able to increase the pro coagulant activity but at the same time to increase the fibrinolytic activity by balancing the two processes. It therefore appears that the increased incidence of embolic thrombus events cannot be associated with changes in hemostasis processes.

2. THIRD GENERATION ORAL CONTRECECTIVES AND INFLAMMATORY STATE

The intake of third-generation oral contraceptives has been shown to induce a low-grade inflammatory state measured with the increase in blood concentrations of high-sensitivity reactive C protein and homocysteine. These conditions could be associated with the increased risk of developing embolic thrombus events.

3. THIRD GENERATION AND CLASSIC SONG CONTRACEPTIVES

Curious study that tries to give scientific value to the usual belief that the hormonal balances and the various phases of the cycle can modulate the vocal abilities of classical singers. In this work the administration of third-generation oral contraceptives, capable of stabilizing the hormonal profile, has led to a reduction in vocal fluctuations during the period of recruitment.

Method of use and dosage

HARMONET ® 20 mcg coated tablets of ethinyl estradiol and 75 mcg of gestodene:

the therapeutic scheme for oral contraceptives such as HARMONET ® involves the continuous intake of one tablet a day for 21 days, possibly at the same time, followed by a 7-day withdrawal period, in which a suspension bleeding due to structural changes should occur. 'endometrium.

This mode of intake guarantees the maximum possible contraceptive capacity, which would tend to decrease following the failure to take a tablet to disappear almost completely following the resumption of the normal hormonal control observed after about 7 days of suspension.

In any case, the administration of HARMONET ® must be preceded by a careful medical evaluation and accompanied by all the indications useful in the event of the appearance of side effects or unexpected events of various kinds.

Warnings HARMONET ® - Contraceptive Pill

The intake of HARMONET ® should be preceded by a careful gynecological examination useful for verifying the appropriateness of the chosen contraceptive method and the possible presence of factors predisposing to the development of serious side effects, especially embolic thrombus.

In fact the presence of cardiovascular and neoplastic pathologies in progress or past, liver and kidney diseases, disorders of the neurological and psychiatric sphere, metabolic pathologies such as diabetes and risk factors for cardiovascular diseases such as obesity or smoking, would require particular attention in the evaluation the cost / benefit ratio and the need for periodic checks.

In this regard, the patient should be informed of the potential risks and the warning signs of these diseases, so as to be able to put timely remedies, always under a medical indication.

HARMONET ® 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 use of oral contraceptives is not indicated during the pregnancy period, both for the preventive uselessness and for the lack of a particularly characterized safety profile.

The contraindications also extend to the next stage of breastfeeding, given the ability of the hormones contained in HARMONET ® to permeate the breast filter and concentrate in breast milk.

Interactions

The concomitant intake of rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort may alter the pharmacokinetic properties of ethinyl estradiol and gestodene, reducing the contraceptive abilities of HARMONET ®

This interaction is due to the modulating role of the aforementioned active ingredients in the activity of cytochromial enzymes responsible for the metabolism of the hormones contained in HARMONET ®

The effect of oral contraceptives on the activity of numerous drugs should also be considered.

In light of these considerations, the importance of medical consultation is evident before undertaking the assumption of any active ingredient.

Contraindications HARMONET ® - Contraceptive Pill

HARMONET ® 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

Different clinical trials and long-term post-marketing monitoring have characterized the most common side effects observed following the administration of combined oral contraceptives.

Headache, depression, nausea, vomiting, abdominal pain, rash, urticaria, increased breast tension and associated pain were the most frequently observed side effects but fortunately clinically not very relevant and promptly returned once the intake was suspended.

On the contrary, more serious adverse reactions such as hypertension, hepatic adenomas and embolic thrombus events have fortunately only been observed in a few cases and especially in predisposed patients.