Femoston

Фемостон Drug photo

The description is actual on 11.03.2015

  • Latin name: Femoston
  • ATH code: G03FB08
  • Active ingredient: Didrogesteron + Oestradiol (Dydrogesteronum + Oestradiolum)
  • Producer: Abbott Laboratories S.A. (USA), Solvay Pharmaceuticals (Netherlands)

Structure

1 and 5 mg are a part of one tablet Femoston 1/5 oestradiol and didrogesteron concentration, respectively. As auxiliary components are used: lactose in the form of monohydrate, methylhydroxypropyl cellulose, anhydrous colloid silicon dioxide, corn starch, a macrogoal 400, magnesium stearate, iron dyes (oxide yellow E172 and red E172), dioxide of titanium (E171), Opadry orange.

Also tablets Femoston Conti 1/5 have similar structure.

In tablets Femoston 1/10 white colors as active component oestradiol is used. Concentration of substance — 1 mg / tab. Femoston 1/10 oestradiol and didrogesteron contain in each gray tablet in the ratio 1:10 (1 mg of oestradiol on 10 mg of a didrogesteron).

In pink tablets Femoston 2/10 as active component contains oestradiol in concentration of 2 mg / tab. Oestradiol and didrogesteron contain in light yellow tablets in the ratio 2:10 (2 mg of oestradiol on 10 mg of a didrogesteron). Auxiliary components: lactose in the form of monohydrate, a gipromelloza, magnesium stearate, corn starch, silicon dioxide colloid, Opadry (respectively, white, gray, pink and yellow).

Release form

Dosage form of drug — film coated round, a biconvex form of a tablet with a diameter of 0,7 cm. Tablets differ on color depending on concentration of active substance / substances, on each of them on one of the parties there is a marking "379".

On tablets Femoston 1/5 on the other hand is engraved the letter "S". Tablets are issued in calendar packagings on 28 pieces.

Tablets with bigger concentration of active agents are packaged in calendar packagings as follows:

  • 14 white tablets of 1 mg + 14 gray tablets of 1 mg +10 mg (Femoston 1/10);
  • 14 pink tablets of 2 mg + 14 light yellow tablets of 2 mg +10 mg (Femoston 2/10).

Pharmacological action

Anticlimacteric estrogen-gestagennoye means for "calendar" (consecutive) reception.

Pharmacodynamics and pharmacokinetics

Femoston represents the combined hormonal means applied to elimination of symptoms of oestrogenic insufficiency and treatment of DMK — dysfunctional uterine bleedings.

The oestradiol which is contained in drug is identical to endogenous oestradiol. Drug is used for completion of deficit of estrogen after approach of a climax and effectively treats the vegetative and psychoemotional frustration connected with a menopause which are followed:

  • hyperhidrosis;
  • inflow;
  • involution mucous and skin and especially mucous an urogenital path (in particular, mucous vaginas because of which the woman begins to feel discomfort during sexual contact);
  • increase of nervous irritability;
  • headaches and dizzinesses;
  • sleep disorders;
  • loss of mass of a bone tissue or osteoporosis (in particular if these or those risk factors are noted — prolonged treatment by glucocorticosteroids in the recent past, early approach of a climax, asthenic type of addition, smoking, etc.).

Also oestradiol promotes decrease in concentration of the general cholesterol and LP of low density, at the same time increasing at the same time concentration of LP of high density.

Action of a gestagenny component of drug — a didrogesteron — is directed to stimulation of approach of a secretory phase of an endometrial cycle, and also reduces risk of carcinogenesis and the hyperplasia of an endometria associated with estrogen influence.

Didrogesteron does not render androgenic oestrogenic, glucocorticosteroid or anabolic action. For ensuring the maximum preventive effect of replaceable hormonal therapy (ZGT), treatment is recommended to be begun as soon as possible after approach of a climax.

After reception of p/os oestradiol is easily absorbed. Biotransformation of substance is carried out in a liver, products of a metabolism are estrone and estrone in the form of sulfate. Oestradiol and glucuronides of estrone eliminirutsya from an organism mainly with urine.

Didrogesteron is also quickly absorbed from a digestive tract after reception of p/os. Substance biotransformirutsya completely, a key product of a metabolism — 20-digidrodidrogesteron. Removal of metabolites is carried out mainly with urine.

The period of semi-life of a didrogesteron — from 5 to 7 hours, its main metabolite — from 14 to 17 hours, completely substances are removed in 72 hours.

Indications to use

Femoston's use is shown at replaceable hormonal therapy for elimination of the phenomena caused by oestrogenic insufficiency at women in the postclimacteric period.

Medicine is appointed not earlier than later half a year after the last menstrual bleeding.

Preventive administration of drug is reasonable for the prevention of development of osteoporosis after approach of a climax. Means is appointed to women at whom the risk of changes is increased and to which use of other drugs intended for prevention of loss of bone weight is contraindicated.

Contraindications

Drug is not appointed:

  • to women for whom in the past malignant were diagnosed it is oestrogenic - or progestagenzavisimy tumors, and also in the presence of suspicions on these diseases;
  • to patients with the diagnosed or suspected breast cancer;
  • at vaginal bleedings of not specified origin nature;
  • at not cured hyperplasia (pathological growth) of an endometria;
  • at the venous thromboembolism found at the moment or noted in the anamnesis (including including TGV and TELA);
  • if these or those trombofilichesky frustration (are found in the patient including at the thrombophilia associated with deficit of antithrombin, coagulative protein C or its cofactor — S protein);
  • at clotting diseases of arteries, including including stenocardia or a myocardial infarction (both in an active stage, and in cases when the disease was postponed in the recent past);
  • at active diseases of a liver, and also if at the patient after the postponed disease biochemical indicators of a liver were not recovered;
  • at a porphyrinic illness;
  • if it is known of individual intolerance of oestradiol, a didrogesteron or auxiliary components of Femoston;
  • to children and teenagers till 18 flyings;
  • at pregnancy (as at established, and if pregnancy expected);
  • at a lactation.

Side effects

Belong to the category of the side effects which are often arising in connection with Femoston's use: pains (head, in a stomach, in the field of a basin), nausea, migrenozny attacks, a meteorism, spasms of legs, hypersensitivity and/or morbidity of mammary glands, a metrorrhagia, emergence of bloody vulval bleedings after approach of a menopause, an adynamy, decrease/increase in body weight.

With a frequency of 1/1000-1/100 during clinical trials there were such phenomena as:

  • vaginal candidiasis;
  • depression;
  • increase in the sizes of fibroma of a uterus;
  • change of a libido;
  • nervousness increase;
  • TGV, TELA;
  • dizzinesses;
  • diseases of a gall bladder;
  • dorsodynia;
  • the allergic reactions on skin which are followed by an itch, urticaria, rashes;
  • dysmenorrhea;
  • ulcer defects on a neck of uterus;
  • emergence of cervical allocations;
  • peripheral hypostases.

In rare instances (with a frequency of 1/10000-1/1000) therapy by drug was followed:

  • intolerance of contact lenses;
  • functional disorders of a liver which are quite often shown in the form of an adynamy, an indisposition, abdominal pains, jaundice;
  • increase in curvature of a cornea of an eye;
  • increase in mammary glands;
  • syndrome of premenstrual tension.

In isolated cases medicine is capable to provoke development of a chorea, hemolitic anemia, a stroke, a myocardial infarction, the vascular purpura, vomiting, a nodular or polymorphic erythema, a melanopathy or a hloazma (which are quite often remaining and after drug withdrawal), a Quincke's disease, hypersensitivity reactions, deterioration in a course of a porphyrinic illness.

Besides, in connection with treatment estrogen-progestagenovymi drugs women sometimes have new growths (high-quality, malignant or an unspecified etiology), the sizes of progestagenzavisimy tumors increase, there are fibrous and cystous damages of mammary glands, concentration of triglycerides in a blood plasma and concentration of hormones of a thyroid gland increases; arterial hypertension, acute obstruction of arteries, an illness of peripheral vessels, a varicosis, dyspepsia, pancreatitis (against already existing gipertriglitseridermiya), a system lupus erythematosus, a tsistitopodobny syndrome, an urine incontience develop; epilepsy becomes aggravated, there are symptoms of dementia.

Tablets Femoston: application instruction

Most often Femoston accept in the days which are strictly determined by the attending physician, taking into account features of a specific menstrual cycle. In the absence of menstrual bleedings, tablets should be drunk in expected days when they would have to begin. At the amenorrhea which is noted within a year, administration of drug can be begun at any time.

Application instruction Femoston 1/5

Drug is intended for continuous reception: a pill is taken by p/os, on one in days (it is optimum — at the same time), without becoming attached by the time of meal. Duration of one cycle — 4 full weeks (1 packaging No. 28 is expected one cycle). It is not necessary to maintain a break between cycles.

For stopping of symptoms of a climax drug begins to be accepted with minimum effective dose. Treatment is begun with appointment Femoston 1/5. Considering time of approach of a climax, expressiveness of the symptoms accompanying it and efficiency of therapy amendments can be introduced in the mode of dosing.

In need of transition from other drug incorporating estrogenic and progestagenny components for consecutive (or cyclic) reception, the patient should finish a full four-week course and only after that to pass to treatment by Femoston 1/5 (reception can be begun in any day). The break between cycles is not done.

The scheme of use of drug of Femoston 1/5 Conti is similar to above described.

Application instruction Femoston 1/10

Tablets Femoston 1/10 should be drunk regardless of meal time. Estrogen as a part of drug is intended for continuous daily reception within the first two weeks of a cycle.

The Progestagenny component is added in the last 14 days of each four-week course.

Treatment is begun with reception of white tablets according to the scheme: 1 tablet once a day (at the same time) within the first 2 weeks of a cycle. Further, following instructions on packaging, begin to take a gray pill (also, on one in days).

It is not necessary to do breaks between 28-day cycles.

The consecutive combined ZGT is begun with Femoston's 1/10 appointment, further if necessary the dose is adjusted taking into account clinical results of therapy.

For transition from similar drug it is necessary to complete a full cycle of treatment and only then to begin to take a pill Femoston 1/10. It is possible to do it in any day.

Application instruction Femoston 2/10

The estrogenic component of drug should be accepted continuously, the progestagenny component is entered from the 15th day of a 28-day cycle.

It means that in the first 2 weeks of a cycle the patient should accept on 1 pink tablet a day, and, since 15 in the afternoon, following instructions on drug packaging, to pass to reception of tablets of yellow color.

Usually starting dose of oestradiol — 1 mg therefore the consecutive combined ZGT is begun with Femoston 1/10 and if in it there is a need, pass to reception of higher dose over time.

Transition from other drugs on Femoston 2/10 is carried out only upon completion of a full four-week cycle (in any day).

How it is correct to accept Femoston in case of the admission of the next dose?

If the woman missed reception of the next dose of drug, the medicine should be taken as soon as possible. If after the admission there passed more than 12 hours, then the course is continued, having taken the following pill (passed from packaging it is not necessary to drink).

Reception of a double dose for compensation missed is not reasonable as it is accompanied by probability of increase of risk of bleedings of break and emergence of the smearing vulval allocations.

How to accept drug to patients of different age groups?

For treatment of patients 65 years are more senior than sufficient experience of use of Femoston is not present.

Indications to purpose of drug to children and teenagers do not exist.

Overdose

Overdose cases Femoston were not fixed by drug.

Both oestrogenic, and progestagenny components of tablets belong to the category of low-toxics.

Theoretically overdose can provoke strengthening of expressiveness of such side effects as: nausea, vomiting, dizziness, drowsiness.

It is improbable that owing to overdose purpose of any specific symptomatic treatment can be required (including at overdose at children).

Interaction

Researches of medicinal interactions of Femoston were not conducted.

Nevertheless, it is known that some means can exert impact on efficiency of estrogen and progesteron.

So, anticonvulsant (for example, Phenytoinum or phenobarbital) and antimicrobic (including not Virapinum, rifampicin or efavirenz) drugs strengthen biotransformation of these substances that is connected with their ability to induce the enzymes of system of P450 cytochrome which are taking part in a medicine metabolism.

Ritonavir and nelvinavir which are powerful inhibitors of isoenzymes of CYP 3A4, A5 and A7, in a combination with steroid hormones promote activation of the specified tsitokhrom.

Phytodrugs which basis is made by a St. John's Wort (Hypericum) which is made a hole can stimulate biotransformation of estrogen and progestogens due to ability to influence CYP 3A4 isoenzyme.

There are proofs that more actively proceeding metabolism of estrogen and progestogens provokes reduction of clinical performance of these substances and influences a profile of uterine bleedings.

In turn estrogen can break process of biotransformation of other substances due to competitive suppression of tsitokhrom of the P450 system which take part in processes of biotransformation of active agents of drugs.

It is necessary to remember it, appointing estrogen in a combination with the drugs having a narrow therapeutic index including with fentanyl, takrolimusy, theophylline, cyclosporine.

Similar combinations can become the reason of increase of plasma concentration of the specified substances to level toxic. Therefore there can be a need of careful monitoring of medicine for an appreciable length of time, and also reduction of a dose of cyclosporine, a takrolimus, theophylline and fentanyl.

Terms of sale

According to the recipe.

Storage conditions

Optimal conditions of storage for tablets Femoston — maintenance of temperature no more than 30 degrees Celsius. Drug has to be stored in original packaging. To protect from children.

Period of validity

Drug is good for use within 36 months after a date of issue.

Special instructions

Drug is recommended to be used only in the presence of symptoms which exert adverse impact on quality of life. Treatment is continued until the advantage of use of means exceeds risk of emergence of by-effects.

Analogs

Coincidence on the ATH code of the 4th level:

Generic (structural analog) of Femoston ⅕ is drug Femoston Conti 1/5.

Drugs with the similar mechanism of action: Diwine, Klimonorm, Kliogest, Trisekvens.

Klimonorm or Femoston — what is better?

The decision on what drug should be chosen from group of the means combined estrogen-gestagennykh, the doctor on the basis of the data on the period of age hormonal changes obtained from the patient accepts.

It is considered that in drug Klimonorm a gestagenny component is present at the most optimum concentration that allows to control effectively a cycle and provides the necessary level of protection of an endometria against hyperplastic effect of estrogen.

Along with it it is possible to keep the favorable effects caused by influence of estrogen on a condition of cardiovascular system and a lipidic exchange. Besides, the levonorgestrel which is contained in Klimonorm potentsiirut the effect of oestradiol directed to treatment and prevention of osteoporosis.

One more important feature of levonorgestrel is its almost 100% bioavailability thanks to which it is possible to maintain stability of effects of drug.

And expressiveness of effects remains invariable irrespective of feeding habits of the woman, existence of diseases of a digestive tract at it, and also activity of hepatic system which plays a key role in processes of a presistemny metabolism of xenobiotics.

Bioavailability of a didrogesteron who is Femoston's part makes 28% in this connection its effects are subject to fluctuations (and as boundaries - and interindividualny).

Angélique or Femoston — what is better?

Specialists consider that there is no special difference between these means. The main difference of drug of Angélique from Femoston is what as a gestagenny component is its part drospirenon in concentration of 2 mg / tab.

Zdravzona

  • Femoston Conti 1mg/5mg No. 28 tabletkisolvay Pharma
  • Femoston 2mg/10mg No. 28 tabletkisolvay Pharma
  • Femoston 1mg/10mg No. 28 tabletkisolvay Pharma

Drugstore of IFC

  • Femoston 1/5 Conti tbl p / about No. 28, Solvay Pharmagermaniya
  • Femoston 2/10 tbl p / about No. 28, Solvay Pharmaniderlandy
  • Femoston 1/10 tbl p / about No. 28, Solvay Pharmaniderlandy
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Apteka24

  • Femostonanda)
  • Femoston kontisolvay Pharmaceuticals (Netherlands)
  • Femostonanda)
  • Femoston Conti pass the tab. 2.5mg +0.5mg No. 28abbot (Germany)

Paniapteka

  • Femoston Conti of the tab. of 1 mg +5mg No. 28solvey
  • Femoston Conti of the tab. of 1 mg +5mg No. 28solvey
  • Femoston Conti of the tab. of 1 mg +5mg No. 28solvey

BIOSPHERE

  • Femoston of 0,5/2,5 mg No. 28 tabl.p.p.o.
  • Femoston of 2/10 mg No. 28 tabl.p.o.solvay Pharmaceuticals B.V. (Netherlands)
  • Femoston of 1/10 mg No. 28 tabl.p.p.o.solvay Pharmaceuticals B.V. (Netherlands)
  • Femoston of 1/5 mg No. 28 tabl.p.o.solvay Pharmaceuticals B.V. (Netherlands)
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Section: Gynecologic Hormonal
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