Femoston

Femoston is an antimycotactic preparation of the estrogen-gestagen type, which has a "calendar" scheme of admission.

[1], [2]

Indications of the femoston

It is used in HRT to get rid of symptoms caused by estrogen deficiency in women who are in the menopause period . The drug is prescribed at least 6 months after the last menstruation.

In case of prevention, the medication is used to prevent osteoporosis during the menopause. The medicine is used for women who have a high probability of fractures, and who should not take other drugs prescribed to prevent bone loss.

[3], [4], [5]

Release form

The release is carried out in tablets. The form of LS Femoston 1/5 is made for 28 pieces inside the "calendar" pack.

Femoston 1/10 is packed into "calendar" packs of 14 tablets with a volume of 1 mg + 14 tablets with a volume of 1 mg + 10 mg.

Femoston 2/10 is packed in "calendar" packs in the amount of 14 pieces in volume 2 mg + 14 pieces in volume 2 mg + 10 mg.

[6]

Pharmacodynamics

Femoston is a complex hormonal drug used to get rid of signs of estrogen deficiency, and in addition to therapy for bleeding from the uterus that are dysfunctional.

Medicinal estradiol is similar to estradiol, produced by the body. The drug is used to compensate for the lack of estrogen, which develops with menopause, and besides it eliminates psychoemotional and vegetative disorders that arise during menopause, against which such problems are noted:

• hyperhidrosis with hot flashes;
• involution of the epidermis with mucous membranes (in particular, the mucocutaneous urinary tract, among which vaginal mucosa - because of this a woman feels uncomfortable with sexual contact);
• increased nervous excitability;
• dizziness along with headaches;
• sleep disorders;
• loss of bone mass or osteoporosis (especially if there are various risk factors - such as recent long-term therapy with SCS, early onset of menopause, smoking, and addition, having an asthenic type, etc.).

Together with this, estradiol is able to lower the values of total cholesterol, as well as LP, having a low density, while increasing the indices of LPs having a high density.

The gestagenic element of the drug (dydrogesterone) stimulates the development of the secretory stage of the endometrial cycle, and besides it reduces the likelihood of carcinogenesis or endometrial hyperplasia, which are associated with the action of estrogen.

Dydrogesterone does not possess estrogenic, androgenic anabolic or glucocorticosteroid properties.

To ensure the strongest prophylactic effect of HRT, therapy should begin as soon as possible after the onset of menopause.

[7]

Pharmacokinetics

When you take the medicine inside, there is a rapid absorption of estradiol. The process of its biotransformation takes place inside the liver. Its decay products are estrone, and besides estrone in the form of sulphate. Elimination of estrone together with estrone glucuronides occurs mainly along with urine.

The substance of dydrogesterone is also absorbed at high speed from the digestive tract after oral administration of the drug. It is completely biotransformed, and the main product of decomposition is 20-dihydrodidrogesterone. Excretion of metabolic products mainly occurs together with urine.

The half-life of dydrogesterone is about 5-7 hours, and the main decay product is approximately 14-17 hours. Complete excretion of these elements occurs after 72 hours.

[8], [9], [10], [11]

Dosing and administration

Femoston is often used only in strictly prescribed for this doctor's days, taking into account the individual features of the menstrual cycle of the patient. If menstruation is absent, the pill should be taken on the days when it was supposed to occur. With amenorrhea observed for 12 months, you can start using drugs any day.

Use of drugs in the form of 1/5.

The medicine should be taken continuously - on the 1st pill once a day (it is recommended to do it at the same time), without binding to eating. One cycle continues for a full 4 weeks (1 pack of the drug contains 28 tablets). Breaks between the cycles of treatment do not need to.

To eliminate manifestations of menopause, drug use begins with a minimum effective portion size. To begin therapy follows from application of 1/5 forms of a medicine. Taking into account the time of the onset of menopause, the degree of manifestation of developing signs and therapeutic effectiveness, the dosage regimen can be adjusted.

If a change from another drug containing estrogen-progestagenic elements is required, the patient must first complete the complete 4-week treatment cycle for cyclic use, and then begin the use of Femoston (this is suitable for any day). A break between the courses is not needed.

The mode of using the medicine in the form of 1/10.

The drug in the form of 1/10 taken without reference to the time of eating. The estrogen contained in it is intended for everyday use during the first 2 weeks of the course. The progestagenic element should be added in the last 14 days of each 4-week cycle.

Therapy begins with this scheme - a single dose of the first (white) pill per day (at the same time) during the first 14 days of the course. After this, in accordance with the instructions, the reception of gray tablets begins (according to a similar scheme). Observe interruptions between such 4-week cycles is not required.

Consecutive HRT of the combined type should begin with the reception of the form 1/10, and then the dosage is adjusted if necessary (taking into account the clinical effectiveness of the treatment).

To switch from a similar medication, it is necessary to complete a complete treatment course, and then to begin taking Femoston 1/10. The transition can be made on any of the days.

The scheme of application of the form LS 2/10.

Estrogen should be consumed continuously, and the progestogen is taken during the 15-28th day of the course. In the first 14 days, pink tablets are consumed, one for each day, and then, from the 15th day, following the instructions, take yellow tablets.

Often, the size of the initial dosage of estradiol is 1 mg, which means that a sequential complex HRT is required to begin with form 1/10, and then, if necessary, gradually increase the dose.

To switch from other drugs to the drug in the form of 2/10, you must first complete a full 28-day cycle of therapy (the transition can be performed on any of the days).

Use of the drug in case of accidental skipping of the next portion.

If you miss a dose of the next dosage, you need to drink the tablet as quickly as possible. After the passage of more than 12 hours, it is necessary to continue the course, taking the next dose from the pack (do not take the missed one).

The use of a double dose to compensate for previously missed is not recommended, because this will increase the likelihood of bleeding and the emergence of smearing discharge from the vagina.

[16], [17], [18]

Use of the femoston during pregnancy

It is forbidden to use Femoston if the pregnancy was accurately established, and besides this, if there is a suspicion of its onset. In addition, it can not be prescribed to women during lactation.

Sometimes the drug is used during the planning of pregnancy. Among the indications for this purpose:

• conditions caused by a lack of estrogen, and developing in the form of insufficiency of the first stage (these are the conditions during which at the end of the 1st stage (follicular) cycle of menstruation the thickness of the endometrial layer is a maximum of 7-8 mm);
• caused by an imbalance of hormones infertility.

Too thin endometrium may be a factor leading to a disorder of the luteal stage, as a result of which the woman also fails to become pregnant.

Often when planning a doctor, prescribe a medication in the form of 2/10.

The level of estradiol inside the tablets used during the first 2 weeks of the menstrual cycle is such that Femoston does not inhibit ovulation (this distinguishes it from other contraceptives), while simulating the 1st stage of the menstrual cycle, and in addition stimulating growth and proliferation of endometrial cells.

The use of drugs containing estradiol in combination with dydrogesterone, helps secretory transformation of the internal uterine layer, which is required to ensure normal implantation of a fertilized egg with the subsequent onset of pregnancy. This suggests that Femoston 2/10 is able to stabilize the menstrual cycle.

The drug in the form of 2/10 during pregnancy planning should be consumed from the 1st day of the cycle of menstruation - in the amount of 1 tablet / day, in the period of 4 full weeks. It is forbidden to stop the course until the end of the pack of medicines - because it can lead to an imbalance of hormones, the symptoms of which are bleeding, having different intensity, and interfering with the onset of pregnancy.

If you use drugs at the planning stage, you should also increase the activity of the second stage of the cycle (lutein). For this, from the 14th day of the course, the use of the drug in combination with Dufaston (or its analogue) is prescribed.

The gestagenic element in Dufaston is dydrogesterone, which makes it possible to potentiate the positive medicinal effect on the organism of the woman as a whole and on the state of the endometrium. Take the medicine on the first pill twice a day, for 2 full weeks.

The onset of pregnancy during the reception of Femoston occurs only in exceptional cases. Usually a more realistic option is to initiate it after using drugs for several separate cycles, but mostly still after the completion of therapy.

Only one is allowed to use the drug at the stage of pre-existing pregnancy - if a woman needs support of the endometrium. But this decision can be made only by an experienced and qualified doctor.

Contraindications

Among the contraindications:

• women who have previously been diagnosed with a malignant neoplasm of a progestogen-or estrogen-dependent type, or if there is a suspicion of having this pathology;
• suspected or already diagnosed breast cancer;
• bleeding from the vagina, having an unexplained nature;
• untreated endometrial hyperplasia (pathological proliferation of lesion);
• present in the history or diagnosed in this period venous thromboembolism (this includes PE with a DVT);
• the presence of various thrombophilic disorders in a woman (this includes thrombophilia associated with a lack of antithrombin, and in addition a type C coagulation protein or protein S, which is its cofactor);
• thromboembolic arterial pathologies, including angina pectoris or myocardial infarction (its active phase or cases when the disease was transferred recently);
• active forms of hepatic pathologies, and in addition cases when the patient has not recovered the biochemical values of the liver after the disease has been eliminated;
• hematoporphyria;
• presence of high sensitivity for estradiol with dydrogesterone or auxiliary elements of the drug;
• teenagers, as well as children who are not yet 18 years of age.

[12]

Side effects of the femoston

Among the side symptoms that most often arise due to taking medication: various pain sensations (abdominal, head, and also in the pelvic region), migraine attacks, nausea, bloating, metrorrhagia. In addition, cramps in the legs, severe sensitivity or tenderness in the area of the mammary glands, asthenia, the appearance of bloody discharge from the vagina during the menopause, as well as increase or decrease in weight.

Quite often during clinical trials, the following manifestations were noted:

• thrush, an increase in uterine fibroids in size, ulcers in the uterine neck, changes in libido, as well as cervical fluid and dysmenorrhea;
• the state of depression, increased feelings of nervousness and dizziness;
• pain in the back;
• DVT and PE;
• pathologies affecting the operation of the gallbladder;
• an allergy that manifests itself in the form of urticaria, itching and rash, and in addition the appearance of peripheral edemas.

Occasionally, taking drugs leads to the appearance of such violations:

• increased sensitivity to contact lenses;
• problems in the liver, often manifested in the form of malaise, abdominal pain and asthenia with jaundice;
• increased curvature of the eye cornea;
• increase in the size of the mammary glands;
• development of PMS.

There are isolated disorders such as stroke, hemolytic form of anemia, vomiting, choreic hyperkinesia, myocardial infarction or vascular purpura. In addition, the appearance of nodular or multiform erythema, melanosis or chloasma (sometimes they persist after discontinuation of drug use), symptoms of intolerance and edema of Quincke, as well as worsening of the course of hematoporphyria.

At the same time, at times, therapy using estrogen-progestogen drugs in women leads to the development of tumors (either good or malignant or of unknown origin), an increase in the size of neoplasms of a progestogen-dependent nature, an increase in the plasma values of triglycerides and the level of thyroid hormones, and in addition to the appearance fibrocystic lesions in the thoracic region. The blood pressure index can also increase, acute blockage occurs in the arteries, varicose veins, peripheral vascular pathology, pancreatitis (accompanied by already existing hypertriglyceridermia), dyspepsia, SLE, incontinence and cystitis-like syndrome. In addition, symptoms of dementia may appear and exacerbate existing epilepsy.

[13], [14], [15]

Overdose

Data on the poisoning of the medicine was not recorded.

Both estrogen and progestogen are substances with a low level of toxicity.

In theory, intoxication can intensify the intensity of such side effects, such as vomiting, a feeling of drowsiness, nausea and dizziness.

To prescribe any specific symptomatic procedures in such cases, most likely, it will not be necessary (even with intoxication in the child).

[19], [20]

Interactions with other drugs

Tests regarding the therapeutic interactions of the drug have not been conducted, but there is evidence that individual drugs can affect the effectiveness of progesterones with estrogens.

Anticonvulsants (such as phenobarbital or phenytoin) and antimicrobial drugs (this includes rifampicin with nevirapine or efavirenz) potentiates the biotransformation of these elements. This effect is developing in connection with the ability to induce enzymes of hemoprotein P450 participating in the metabolic processes of the drug.

Ritonavir, together with nevivinavir, are drugs that have a powerful retarding effect on the activity of the isoenzymes CYP3A4, and in addition A5 with A7. When combined with steroid hormones, they cause activation of these hemoproteins.

Phytopreparations, the main element of which is St. John's wort, are able to stimulate the process of progestagenic and estrogenic biotransformation - by affecting the isoenzyme CYP 3A4.

There are facts confirming that the activity of the metabolic processes of progestogens with estrogens is increased due to a decrease in the drug efficacy of these elements, and also affects the profile of bleeding from the uterus.

In this case, estrogens are able to destroy the biotransformation of other components, competing inhibiting the hemoproteins of the P450 system involved in biotransformation of the active elements of these drugs.

It should be taken into account when appointing estrogens in combination with medications that have a narrow drug index (among them tacrolimus with cyclosporin and theophylline with fentanyl). Such ligaments can lead to an increase in plasma values of these components to a toxic level. As a result, careful monitoring of the drug over a long period of time, and at the same time reducing the dose of the above medicines, may be required.

[21], [22]

Storage conditions

Femoston is required to be kept out of the reach of small children. The temperature level for such storage should be a maximum of 30 ^of C.

[23], [24]

Shelf life

Femoston is allowed to be used for 3 years from the date of manufacture of the therapeutic agent.

Analogues

The analogues of the drug are drugs Climonorm, Triesquens and Cleigoest with Divina.

Reviews

Femoston receives many comments on medical forums (they apply to all its forms of release), which have conflicting assessments. Usually such reviews describe the experience of using drugs at the stage of pregnancy planning or with menopause.

Women who have been helped by the drug, among the benefits, are good tolerability and a low incidence of negative symptoms. It is noted that it quickly stabilizes the condition, eliminating unpleasant menopausal manifestations, generally improves well-being, and also positively influences the state of the epidermis and helps to restore the cycle if it has been disturbed. In addition, note the convenience of the drug in use.

Negative opinions are associated with the development of negative symptoms in patients (rashes, swelling, depression, weight gain, decreased activity, joint pain, etc.), and in addition to lack of the necessary result.

If we consider the feedback of specialists based on the data of clinical tests, we can summarize that the drug has a high medicinal effectiveness both in therapy and in the prevention of various conditions arising from early depletion of ovarian activity.

At the same time, all patients treated have good tolerability of drugs. Tests revealed that the treatment positively affects the well-being of patients (for example, lipid blood counts).

During the therapy, a significant increase in the values of the maximum oxygen consumption was noted, and in addition, the dydrogesterone enhanced the protective action of estrogen against the bones.

This allows us to conclude that doctors confirm the need for early onset, as well as differentiated selection of HRT type in women with ovarian problems.

[25], [26]