Trade name of the drug: Fetalston Active ingredient (INN): progesterone Dosage form: capsules Composition: One capsule contains: Active substance: progesterone (natural micronized progesterone) 100 or 200 mg. Auxiliary substances: Gelatin, Glycerin, Sorbitol 70%, Sodium methylparaben, Sodium propylparaben, Purified water, Titanium dioxide, BHA, BHT, Soybean oil, Soy lecithin. Description: capsules 100 mg - oval, capsules 200 mg - oval, soft shiny gelatin capsules of yellowish color, containing an oily whitish homogeneous suspension (without visible phase separation). Pharmacotherapeutic group: gestagen ATX Code:G03DA04
Pharmacological properties Gestagen, a hormone of the corpus luteum. By binding to receptors on the surface of target organ cells, it penetrates into the nucleus, where, by activating DNA, it stimulates RNA synthesis. Promotes the transition of the uterine mucosa from the phase of proliferation caused by follicular hormone to the secretory phase, and after fertilization - to the state necessary for the development of a fertilized egg. Reduces excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the end elements of the breast. Stimulating protein lipase increases fat reserves; increases glucose utilization; increases the concentration of basal and stimulated insulin, promotes the accumulation of glycogen in the liver; increases the production of pituitary gonadotropins; reduces azotemia, increases the excretion of nitrogen in the urine. Activates the growth of the secretory department of the acinuses of the mammary glands and induces lactation. Promotes the formation of a normal endometrium.
Pharmacokinetics When ingested Suction Micronized progesterone is absorbed from the gastrointestinal tract. The concentration of progesterone in the blood plasma gradually increases during the first hour, the maximum concentration in the blood (Cmax) is noted 1-3 hours after administration. The concentration of progesterone in blood plasma increases from 0.13 ng / ml to 4.25 ng / ml after 1 hour, to 11.75 ng / ml after 2 hours and is 8.37 ng / ml after 3 hours, 2 ng / ml after 6 hours and 1.64 ng / ml 8 hours after administration. Metabolism The main metabolites that are detected in blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. Withdrawal It is excreted in the urine in the form of metabolites, 95% of them are glucuronjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnanedione). These metabolites, which are determined in blood plasma and urine, are similar to substances formed during the physiological secretion of the corpus luteum. With vaginal administration Suction Absorption occurs quickly, progesterone accumulates in the uterus, a high level of progesterone in the blood plasma is observed 1 hour after administration. The cmax of progesterone in blood plasma is reached 2-6 hours after administration. When the drug is administered 100 mg 2 times / day, the average concentration remains at 9.7 ng / ml for 24 hours. When administered in doses of more than 200 mg / day, the concentration of progesterone corresponds to the 1st trimester of pregnancy. Metabolism It is metabolized to form mainly 3-alpha, 5-beta-pregnanediol. The level of 5-beta-pregnanolone in plasma does not increase. Withdrawal It is excreted in the urine in the form of metabolites, the main part is 3-alpha, 5-beta-pregnanediol (pregnanedione). This is confirmed by a constant increase in its concentration (Cmax 142 ng / ml after 6 hours).
Indications for use Progesterone-deficient conditions in women. Oral route of administration: - the threat of spontaneous abortion or the prevention of habitual miscarriage due to established luteal insufficiency - the threat of premature birth - infertility due to luteal insufficiency - premenstrual syndrome - menstrual cycle disorders due to ovulation or anovulation disorders - fibrocystic mastopathy - premenopause - hormone replacement therapy of peri- and postmenopause (in combination with estrogenic drugs). Vaginal route of administration: - hormone replacement therapy in case of progesterone deficiency in non-functioning (absent) ovaries (egg donation) - support of the luteal phase during preparation for in vitro fertilization - support of the luteal phase in the spontaneous or induced menstrual cycle - premature menopause - hormone replacement therapy (in combination with estrogenic drugs) - infertility due to luteal insufficiency - prevention of habitual and threatening abortion due to progestin deficiency - prevention of uterine fibroids - prevention of endometriosis.
Method of administration and dosage The duration of treatment is determined by the nature and characteristics of the disease. Oral route of administration The drug is taken orally, washed down with water. In most cases, with progesterone deficiency, the daily dose of Fetalston is 200-300 mg, divided into 2 doses (morning and evening). With the threat of spontaneous abortion or for the prevention of habitual miscarriage: 200-600 mg per day. With the threat of premature birth: 400 mg of progesterone every 6-8 hours, depending on the clinical results obtained during the acute phase, then in a maintenance dosage of 600 mg per daya day divided into 3 doses up to the 36th week of pregnancy. With insufficiency of the luteal phase (premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, premenopause) the daily dose is 200 or 400 mg, taken for 10 days (usually from the 17th to the 26th day of the cycle). With hormone replacement therapy in peri- and postmenopause against the background of estrogen intake, Fetalston is used 200 mg per day for 10-12 days. Vaginal route of administration Complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy, 200 mg per day on the 13th and 14th days of the cycle, then 100 mg 2 times a day from the 15th to the 25th day of the cycle, from the 26th day, and in the case of pregnancy determination, the dose increases by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. This dosage can be applied for 60 days. Support of the luteal phase during the in vitro fertilization cycle: it is recommended to take from 200 to 600 mg per day, starting from the day of injection of chorionic gonadotropin during the I and II trimester of pregnancy. Support of the luteal phase in the spontaneous or induced menstrual cycle, with infertility associated with impaired function of the corpus luteum, it is recommended to take 200-300 mg per day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and pregnancy diagnosis, treatment should be continued. In cases of threat of abortion or in order to prevent habitual abortions that occur against the background of progesterone deficiency: 200-400 mg daily in 2 doses in the I and II trimesters of pregnancy. Capsules are injected deep into the vagina.
Side effects - Allergic reactions. - When ingested - drowsiness, transient dizziness (1-3 hours after taking the drug), extremely rarely - intermenstrual bleeding.
Contraindications Hypersensitivity to the components of the drug, a tendency to thrombosis, acute forms of phlebitis or thromboembolic diseases; bleeding from the genital tract of unknown origin; incomplete abortion, porphyria. Established or suspected malignant neoplasms of the mammary glands and genitals. The oral route of administration is for severe liver dysfunction. With caution Diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression; hyperlipoproteinemia, lactation.
Drug interactions Enhances the effect of diuretics, antihypertensive drugs, immunosuppressants, anticoagulants. Reduces the lactogenic effect of oxytocin. Co-administration of Fetalstone with barbiturates, phenytoin, rifampicin, phenylbutazone, spironolactone, griseofulvin, ampicillin, tetracycline may lead to a change in the effect of the drug. Fetalstone and other progestogens can cause a decrease in glucose tolerance and increase the need for insulin or other hypoglycemic drugs in diabetic patients.
Special instructions The drug should not be used for the purpose of contraception. Use during pregnancy and lactation It should be used with caution orally during pregnancy in patients with impaired liver function. Influence on the ability to drive a car and complex mechanisms When taken orally, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions. The drug should not be used after the expiration date and should be stored out of the reach of children.
Overdose The undesirable effects listed above most often indicate an overdose. They spontaneously disappear when the dose of the drug is reduced.
Release form Capsules 100 mg, 7 capsules in a blister, 4 blisters in a cardboard pack together with instructions for use. Capsules 200 mg, 7 capsules in a blister, 2 blisters in a cardboard pack together with instructions for use.
Storage conditions Store at a temperature not exceeding 25 ° C.
Expiration date 2 years.
Conditions of release from pharmacies By prescription.
Name and address of the legal entity in whose name the registration certificate was issued HARASHA PHARMA PVT. LTD.DG-II/159 A, Vikaspuri, D-Block, NewDeli, India
Manufacturer's name and address APPLIED COMMUNICATIONS & CONTROLS, 122, Selaqui, Industrial Area, Dehradun,Uttarakhand, India
Produced by order of HARASHA PHARMA PVT. LTD, India
Consumer complaints should be sent to HARASHA PHARMA PVT. LTD. DG-II/159 A, Vikaspuri, D-Block, New Delhi, India
