PLANUM ® 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 PLANUM ® - Contraceptive Pill
PLANUM ® is used as an oral contraceptive.
Action mechanism PLANUM ® - Contraceptive Pill
PLANUM ® falls into the category of combined oral contraceptives thanks to the simultaneous presence of an estrogen such as ethinyl estradiol and a progestin like desogestrel.
The synergistic biological activity of the aforementioned hormones guarantees coverage against unwanted pregnancies through the simultaneous realization of anatomo-functional modulation processes.
More precisely, on the one hand we are witnessing a reduction in the secretion of gonadotropins, responsible for the process of follicular maturation and ovulation through feedback inhibition of the hypothalamic-pituitary activity, and on the other hand for modifications of the consistency of the mucus and of the endometrium, useful to counteract the spermatozoa in the female genital tract, and also the eventual embryo nesting in the uterine mucosa.
Although PLANUM ® is included among third-generation contraceptives, using limited dosages and synthetic progestogens such as desogestrel, while reducing some of the more common side effects of classic oral contraception, such as androgenic effects, it does not have the antimineralocorticoid activity, guaranteed by progestogens such as drospirenone, useful to reduce problems of water-based retention at the base of hypertension and weight gain.
Studies carried out and clinical efficacy
1. TOLERABILITY OF COMBINED ORAL CONTRACTS
A reassuring study, however dated, which shows that ethinyl estradiol-based and desogestrel oral contraceptives taken by over 1600 women have not determined any significant side effects related to weight gain, blood pressure increase and variation in laboratory parameters. It is necessary to remember that all these evidences have been questioned by later works.
2. ETINILESTRADIOLO + DESOGESTREL AND ACNE
Work that shows how oral contraceptives based on desogestrel and ethinyl estradiol, besides being effective and well tolerated, also show a preventive action against skin diseases such as acne
3. CONTRACEPTIVES AND EMATOCRITUS
Improved control of menstrual flow following the use of combined oral contraceptives has proved to be important in safeguarding some important parameters such as sideremia and hematocrit. These general effects could contribute to maintaining a woman's good health
Method of use and dosage
PLANUM ® tablets coated with 30 mcg of ethnyl estradiol and 150 mcg of desogestrel:
the correct intake of PLANUM ® involves the formulation of intake cycles of 21 consecutive days alternated with a suspension period of about 7 days in which a suspension bleeding similar to the physiological menstruation should take place.
The intake of these tablets must be carried out every day at the same time, in order to keep the contraceptive coverage high, which is reduced already after about 36 hours from the last tablet taken with a complete recovery of the physiological hormonal control after about 7 days of suspension .
If the tablet is regurgitated 3-4 hours after taking it, a new one should be swallowed immediately to preserve the contraceptive properties of the cycle.
Particular indications regarding the beginning of the therapy are necessary in case of previous pregnancy or abortion or in case of variation of the oral contraceptive used.
Warnings PLANUM ® - Contraceptive Pill
The numerous side effects linked to the administration of oral progestagens require a particular scrupulousness in the definition of therapeutic appropriateness and a careful evaluation of the potential conditions predisposing to the development of adverse reactions.
Conditions such as current 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 be carefully evaluated, and in the case in which it was decided to take PLANUM ® monitored periodically throughout the therapeutic process.
It is also necessary to establish a productive relationship between doctor and patient, useful to ascertain the possible appearance of warning signs of more serious pathologies and to promptly place all the necessary remedies.
PLANUM ® 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
Despite the accidental exposure during pregnancy to progestin-related estrus has not determined any type of fetal malformation, taking PLANUM ® during the whole pregnancy is strongly contraindicated.
This contraindication also extends to the subsequent lactation period given the ability of both active ingredients to permeate the breast filter and concentrate in breast milk.
Interactions
Given the hepatic metabolism conducted by the cytochromial enzymes of ethinyl estradiol and desogestrel, the concomitant intake of inducers of the aforementioned enzymes, such as rifampicin, phenytoin, barbiturates, antiretrovirals, antibiotics, herbal remedies such as St. John's wort may alter the characteristics pharmacokinetics of PLANUM ® reducing its contraceptive efficacy.
In this regard it is necessary to use an alternative contraceptive method.
In any case, it would be advisable to consult your doctor and the package insert of the medicine before taking any medication together with the combined oral contraceptive therapy.
Contraindications PLANUM ® - Contraceptive Pill
PLANUM ® 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
The administration of combined oral contraceptives like PLANUM ® is evidently associated with different side effects with a more or less severe course.
Weight gain, water retention, headache, depression, nausea, vomiting, abdominal pain, rash, urticaria, increased breast tension and associated pain are the most common but fortunately transient side effects.
Hypertension, increased cardiovascular risk and embolic thrombus events, increased incidence of hepatic and uterine neoplastic diseases are the most clinically significant adverse reactions for which the correct evaluation of the cost-benefit ratio is usually necessary.
Note
PLANUM ® is salable only under medical prescription.
