Buy Progesterone solution 1%, 1 ml, 10 pcs
  • Buy Progesterone solution 1%, 1 ml, 10 pcs

Progesterone

Dalkhimpharm
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2019-09-19
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Clinical Pharmacology

Progesterone - gestagen. Hormone yellow body. Causes the transition of the mucous membrane of the uterus from the phase of proliferation caused by follicular hormone to the secretory phase, and after fertilization promotes its transition to the state necessary for the development of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of end elements of the mammary gland. Does not possess androgenic activity. Progesterone has a weak effect on protein metabolism, contributes to the deposition of fat and the accumulation of glucose in the liver, and also reduces the reabsorption of sodium in the renal tubules.

Progesterone has a blocking effect on the secretion of hypothalamic factors releasing LH and FSH, inhibits the formation in the pituitary gonadotropic hormones and inhibits ovulation.

Pharmacokinetics

After the i / m injection is absorbed quickly and almost completely. Metabolized in the liver, most metabolites form conjugates with glucuronic and sulfuric acids.

T1 / 2 of plasma is a few minutes. Excreted in the urine - 50-60% and with the feces - more than 10%. The number of metabolites that are excreted in the urine varies depending on the phase of the corpus luteum.

Indications

Dysfunctional uterine bleeding, metrorrhagia, amenorrhea, habitual miscarriage. Contraception.

Composition

1 ml of solution in olive oil contains

Active substance: progesterone.

Progesterone is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Progesterone Dalkhimpharm Russia solution
Pragisun Sun Pharmaceutical Industries Ltd India capsules
Iprozhin Italfarmaco Italy capsules
Utrogestan Bezen Healthca SA Belgium capsules

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Progesterone

Dosage and Administration

Orally

The drug is taken orally in the evening before bedtime, drinking water.

In most cases, with progesterone deficiency, the daily dose of Utrogestan® is 200-300 mg, divided into 2 doses (200 mg in the evening before bedtime and 100 mg in the morning, if necessary).

With threatened abortion or to prevent habitual abortion due to progesterone deficiency: 200-600 mg per day daily in the first and second trimesters of pregnancy. Further use of the drug Utrogestan® may be prescribed by the attending physician on the basis of an assessment of the clinical data of a pregnant woman.

In case of insufficiency of the luteal phase (premenstrual syndrome,

fibrocystic mastopathy, dysmenorrhea, menopausal transition period) the daily dose is 200 or 400 mg taken within 10 days (usually from the 17th to the 26th day of the cycle).

With MGT in perimenopause with estrogen therapy, the drug Utrogestan®

applied at 200 mg per day for 12 days.

When MGT in postmenopause in continuous mode drug Utrogestan®

used in a dose of 100-200 mg from the first day of estrogen preparations. Selection of the dose is carried out individually.

Intravaginal

Capsules are inserted deep into the vagina.

Prevention (prevention) of premature birth in women

from the risk group (with shortening of the cervix of the uterus and / or availability of anamnestic data of preterm labor and / or premature rupture of the membranes): the usual dose is 200 mg before bedtime, from the 22nd to the 34th week of pregnancy.

The complete absence of progesterone in women with non-functioning

(absent) ovaries (egg donation): during estrogen therapy, 100 mg per day on the 13th and 14th days of the cycle, then 100 mg twice a day from the 15th to the 25th day of the cycle, from the 26th day, and in the case of determining the pregnancy dose increases by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. This dose may be applied for 60 days.

Support of the luteal phase during the extracorporal cycle

fertilization: it is recommended to use from 200 to 600 mg per day, starting from the day of injection of chorionic gonadotropin during the first and second trimester of pregnancy.

Support of the luteal phase in spontaneous or induced menstrual

cycle for infertility associated with dysfunction of the corpus luteum: it is recommended to use 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 threatened abortion or to prevent habitual abortion,

arising on the background of progesterone deficiency: 200-400 mg per day in 2 divided doses daily in the first and second trimesters of pregnancy.

Adverse reactions

The adverse events listed below, noted during oral administration of the drug, are distributed according to the frequency of occurrence according to the following gradation: often:> 1/100, <1/10; infrequently:> 1/1000, <1/100; rarely:> 1/10000, <1/1000; very rarely: <1/10000.

System

Undesirable effects

bodies

often

infrequently

seldom

very rarely

Disorders of the genitals and breast

Violations

menstrual

cycle

Amenorrhea

Acyclic

bleeding

Mammalgia

   

Mental Disorders

     

Depression

Nervous system disorders

Headache

Drowsiness

Transient

dizziness

   

Disorders of the gastrointestinal tract

Bloating

Vomiting

Diarrhea

Constipation

Nausea

 

Disorders of the liver and biliary tract

 

Cholestatic

jaundice

   

Immune system disorders

     

Hives

Violations of the skin and subcutaneous tissue

 

Itching

Acne

 

Chloasma

Drowsiness, transient dizziness are possible, as a rule, 1-3 h after oral administration of the drug. These adverse reactions can be reduced by reducing the dose, using the drug at bedtime or switching to a vaginal route of administration.

These unwanted reactions are usually the first signs of an overdose.

Drowsiness and / or transient dizziness are observed, in particular, in the case of concomitant hypoestrogenism.Reducing the dose or restoring higher estrogenation immediately eliminates these phenomena, without reducing the therapeutic effect of progesterone.

If the treatment starts too early (in the first half of the menstrual cycle, especially before the 15th day), shortening of the menstrual cycle or acyclic bleeding is possible.

Registered changes in the menstrual cycle, amenorrhea or acyclic bleeding are characteristic of all gestagens.

Application in clinical practice

When used in clinical practice, the following adverse events were noted with oral progesterone administration: insomnia; premenstrual syndrome; tension in the mammary glands; vaginal discharge; joint pain; hyperthermia; excessive sweating at night; fluid retention; change in body weight; acute pancreatitis; alopecia, hirsutism; libido changes; thrombosis and thromboembolic complications (when MHT is performed in combination with estrogen preparations); increase blood pressure.

The drug contains soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

When vaginal application

It was reported about individual cases of development of reactions of local intolerance to the components of the drug (in particular, soy lecithin) in the form of hyperemia of the vaginal mucosa, burning, itching, oily discharge.

Systemic side effects with intravaginal use of the drug in the recommended doses, in particular, drowsiness or dizziness (observed with oral administration of the drug), were not observed.

Hypersensitivity to progesterone or any of the excipients of the drug; deep vein thrombosis, thrombophlebitis; thromboembolic disorders (thromboembolism of the pulmonary artery, myocardial infarction, stroke), intracranial hemorrhage, or a history of these conditions / diseases; bleeding from the vagina of unknown origin; incomplete abortion; porphyria; established or suspected malignant neoplasms of the mammary gland and genitals; severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson's syndrome, Rotor, malignant liver tumors) currently or in history; children's age up to 18 years (efficiency and safety are not established); breastfeeding period.

CAREFULLY

Cardiovascular diseases, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia, dysfunction of the liver of mild and moderate severity; photosensitivity.

The drug should be used with caution in the II and III trimesters of pregnancy.

Drug interactions

Oral administration

Progesterone enhances the action of diuretics, antihypertensive drugs, immunosuppressants, anticoagulants. Reduces the lactogenic effect of oxytocin. Simultaneous use of CYP3A4 liver microsomal enzymes with inducer drugs, such as barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, phenylbutazone, spironolactone, griseofulvin, is accompanied by an acceleration of progesterone metabolism in the liver.

Simultaneous administration of progesterone with certain antibiotics (penicillins, tetracyclines) can lead to a decrease in its effectiveness due to a violation of the enterohepatic recirculation of sex hormones due to changes in the intestinal microflora.

The severity of these interactions can vary in different patients, so the prognosis of the clinical effects of these interactions is difficult.

Ketoconazole may increase the bioavailability of progesterone.

Progesterone can increase the concentration of ketoconazole and cyclosporine.

Progesterone may decrease the effectiveness of bromocriptine.

Progesterone can cause a decrease in glucose tolerance, as a result of which - to increase the need for insulin or other hypoglycemic drugs in patients with diabetes mellitus.

Bioavailability of progesterone can be reduced in patients who smoke and with excessive use of alcohol.

With intravaginal use

The interaction of progesterone with other drugs with intravaginal use was not evaluated. It is necessary to avoid the simultaneous use of other drugs used intravaginally, in order to avoid impaired release and absorption of progesterone.

Pregnancy and Lactation

The drug should be used with caution in the II and III trimesters of pregnancy due to the risk of cholestasis.

Progesterone penetrates into breast milk, so the use of the drug is contraindicated during breastfeeding.

Special instructions

The drug Utrogestan® can not be used for contraception.

The drug can not be taken with food, as the food intake increases the bioavailability of progesterone.

The drug Utrogestan® should be taken with caution in patients with diseases and conditions that can be exacerbated by fluid retention (arterial hypertension, cardiovascular diseases, chronic renal failure, epilepsy, migraine, bronchial asthma); in patients with diabetes; impaired liver function mild and moderate severity; photosensitivity.

Patients with a history of depression should be monitored, and if severe depression develops, the drug should be withdrawn.

The composition of the drug Utrogestan® includes soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

Patients with concomitant cardiovascular diseases or their history should also be observed periodically by a doctor.

Use of the drug Utrogestan® after the I trimester of pregnancy can cause the development of cholestasis.

With prolonged treatment with progesterone, regular medical examinations (including liver function tests) should be carried out; treatment should be canceled in case of deviations from normal indicators of functional liver tests or cholestatic jaundice.

When using progesterone, a decrease in glucose tolerance and an increased need for insulin and other hypoglycemic drugs in patients with diabetes mellitus is possible.

In the case of amenorrhea in the treatment process, it is necessary to exclude the presence of pregnancy.

If treatment begins too early at the beginning of the menstrual cycle, especially before the 15th day of the cycle, shortening of the cycle and / or acyclic bleeding are possible. In the case of acyclic bleeding should not use the drug to determine their causes, including the histological examination of the endometrium.

If you have a history of chloasma or a tendency to its development, patients are advised to avoid UV exposure.

More than 50% of cases of spontaneous abortions in early pregnancy are due to genetic disorders. In addition, the cause of spontaneous abortions in early pregnancy can be infectious processes and mechanical damage. Use of the drug Utrogestan® in these cases can lead only to a delay of rejection and evacuation of a non-viable ovum. Use of the drug Utrogestan® for the purpose of the prevention of the threatening abortion is justified only in cases of insufficiency of progesterone.

When conducting MGT by estrogen during the period of perimenopause, the use of the drug Utrogestan® is recommended for at least 12 days of the menstrual cycle.

In the continuous mode of MHT in postmenopausal use of the drug is recommended from the first day of estrogen.

When conducting MGT increases the risk of venous thromboembolism (deep vein thrombosis or pulmonary thromboembolism), the risk of ischemic stroke, coronary heart disease.

Due to the risk of thromboembolic complications, use of the drug should be discontinued in case of: visual impairment, such as loss of vision, exophthalmos, double vision, vascular lesions of the retina; migraine; venous thromboembolism or thrombotic complications, regardless of their location.

If there is a history of thrombophlebitis, the patient should be closely monitored.

When using Utrogestan® with estrogen-containing preparations, refer to the instructions for their use regarding the risks of venous thromboembolism.

The results of the clinical study of the Women Health Initiative Study (WHI) indicate a slight increase in the risk of breast cancer with a long, more than 5 years, combined use of estrogen-containing drugs with synthetic gestagens. It is not known whether there is an increase in the risk of breast cancer in postmenopausal women with MHT estrogen preparations in combination with progesterone.

The results of the WHI study also revealed an increased risk of developing dementia with the onset of MHT over 65 years of age.

Before the onset of MGT and regularly during her conduct, a woman should be examined to identify contraindications for her. In the presence of clinical indications, an examination of the mammary glands and gynecological examination should be conducted.

The use of progesterone may affect the results of some laboratory tests, including indicators of the function of the liver, thyroid gland; coagulation parameters; the concentration of pregnandiol.

Impact on the ability to drive vehicles and mechanisms

When using the drug orally, care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Overdosage

Symptoms: drowsiness, transient dizziness, euphoria, shortening of the menstrual cycle, dysmenorrhea.

In some patients, the average therapeutic dose may be excessive due to the present or unstable endogenous progesterone secretion, particular drug sensitivity or too low estradiol concentration.

Treatment:

in case of drowsiness or dizziness, it is necessary to reduce the daily dose or prescribe the drug at bedtime for 10 days of the menstrual cycle;

in case of shortening of the menstrual cycle or "bloody" bleeding, it is recommended to transfer the treatment to a later day of the cycle (for example, on the 19th instead of the 17th);

in perimenopause and in MHT in postmenopause it is necessary to make sure that the estradiol concentration is optimal.

In case of overdose, symptomatic treatment is carried out if necessary.

  • Active ingredient: Progesterone

Studies and clinical trials of Progesterone (Click to expand)

  1. Estrogen and progesterone receptor status determined by the Ventana ES 320 automated immunohistochemical stainer and the CAS 200 image analyzer in 236 early-stage breast carcinomas: Prognostic significance
  2. Progesterone receptor immunoreactivity in aromatic L-amino acid decarboxylase-containing neurons of the guinea pig hypothalamus and preoptic area
  3. Nitric oxide synthase in the Guinea pig preoptic area and hypothalamus: Distribution, effect of estrogen, and colocalization with progesterone receptor
  4. Bcl-2 EXPRESSION IS CORRELATED WITH A LOW APOPTOTIC INDEX AND ASSOCIATED WITH PROGESTERONE RECEPTOR IMMUNOREACTIVITY IN ENDOMETRIAL CARCINOMAS
  5. Metastatic lesions from prostate cancer do not express oestrogen and progesterone receptors
  6. Down-regulation of bcl-2 expression is closely related to squamous differentiation and progesterone therapy in endometrial carcinomas
  7. Variation of bcl-2 expression in breast ducts and lobules in relation to plasma progesterone levels: overexpression and absence of variation in fibroadenomas
  8. New monoclonal antibodies to oestrogen and progesterone receptors effective for paraffin section immunohistochemistry
  9. Metastatic lesions from prostate cancer do not express oestrogen and progesterone receptors
  10. Up-regulation of pS2 expression during the development of adenocarcinomas but not squamous cell carcinomas of the uterine cervix, independently of expression of c-jun or oestrogen and progesterone receptors
  11. Involvement of chloride channels in progesterone production during meiotic maturation of follicle-enclosed oocytes ofRana temporaria andXenopus laevis
  12. Evidence of a progesterone receptor in the liver of the green frogRana esculenta and its down-regulation by 17? estradiol and progesterone
  13. Interferon-β can induce progesterone receptors in human endometrial adenocarcinoma
  14. Adenocarcinoma of the cervix : Expression and clinical significance of estrogen and progesterone receptors
  15. Progesterone induces apoptosis and up-regulation of p53 expression in human ovarian carcinoma cell lines
  16. Histochemical analysis of estrogen and progesterone receptors and gastric-type mucin in mucinous ovarian tumors with reference to their pathogenesis
  17. Immunohistochemical analysis of progesterone receptor and ki-67 labeling index in astrocytic tumors
  18. Changing estrogen and progesterone receptor patterns in breast carcinoma during the menstrual cycle and menopause
  19. The stability of estrogen and progesterone receptor expression on breast carcinoma cells stored as preservCyt suspensions and as thinPrep slides
  20. Survival of premenopausal breast carcinoma patients in relation to menstrual cycle timing of surgery and estrogen receptor/progesterone receptor status of the primary tumor
  21. Constitutive co-expression of estrogen and progesterone receptor mRNA in human meningiomas by RT-PCR and response of in vitro cell cultures to steroid hormones
  22. Estrogen receptor (ER) and progesterone receptor (PgR), by ligand-binding assay compared with ER, PgR and pS2, by immuno-histochemistry in predicting response to tamoxifen in metastatic breast cancer: A Southwest Oncology Group study
  23. Second-trimester maternal serum progesterone levels in Turner syndrome with and without hydrops and in trisomy 18
  24. Estrogen and progesterone receptors in breast cancer: Comparison between enzyme immunoassay and computer-assisted image analysis of immunocytochemical assay

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