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Proginova and Cyclo-Proginova - instructions for use, reviews, analogs and forms of release (pills or tablets of 2 mg) of the drug for the treatment of menopause and pregnancy planning in women, including breastfeeding. Composition

Proginova and Cyclo-Proginova - instructions for use, reviews, analogs and forms of release (pills or tablets of 2 mg) of the drug for the treatment of menopause and pregnancy planning in women, including breastfeeding. Composition

In this article, you can read the instructions for using the drug Proginova. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Proginova in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Proginova in the presence of existing structural analogues. Use to treat menopause, amenorrhea and pregnancy planning in women, including breastfeeding. Composition and interaction of the drug with alcohol.

 

Proginova - contains estrogen - estradiol valerate, which in the human body turns into a natural 17beta-estradiol. Against the background of taking Proginova there is no suppression of ovulation, and the production of hormones in the body practically does not change.

 

Estradiol replenishes the estrogen deficiency in the female body after the onset of menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms (such as hot flashes, increased sweating, sleep disturbances, increased nervous excitability, irritability, palpitations, cardialgia, dizziness, headache, decreased libido, muscular and joint pain); involution of the skin and mucous membranes, especially the mucosal genitourinary system (urinary incontinence, dryness and irritation of the vaginal mucosa, tenderness in sexual intercourse).

 

HRT with an adequate dose of estrogen, such as occurs in Proginova, reduces bone resorption and delays or stops the loss of bone mass in postmenopausal women. Long-term use of hormone replacement therapy (HRT) has been shown to reduce the risk of fracture of peripheral bones in women after menopause.With the abolition of HRT, the rate of bone mass reduction is comparable to that characteristic for the period immediately after menopause. It is not proven that using HRT, it is possible to achieve bone mass recovery to the pre-menopausal level.

 

HRT also has a beneficial effect on the content of collagen in the skin, as well as on its density, and can also slow the process of wrinkle formation.

 

HRT leads to a reduction in total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol, and an increase in triglyceride levels. The addition of a progestogen can to a certain extent inhibit the effect of estradiol on metabolism. In general, the metabolic effects of HRT are considered positive and are believed to be involved in reducing the risk of cardiovascular disease in postmenopausal women.

 

For women with a non-removed uterus, when applying Proginova it is recommended to take an extra gestagen for at least 10 days in each cycle. This reduces the risk of developing endometrial hyperplasia and the concomitant risk of adenocarcinoma in women in this group.

 

Composition

 

Estradiol valerate + auxiliary substances (Proginova).

 

Estradiol valerate + Norgestrel + auxiliary substances (Cyclo-Proginova).

 

Pharmacokinetics

 

After ingestion of estradiol valerate is quickly and completely absorbed. During the absorption and the first passage through the liver, the steroid ester is split into estradiol and valeric acid. At the same time, estradiol is largely subjected to further metabolization, for example, to estrone, estriol and estrone sulfate. After oral administration, only about 3% of estradiol becomes bioavailable. The intake of food on the bioavailability of estradiol has no effect. Estradiol is metabolized predominantly in the liver, and also partially in the intestines, kidneys, skeletal muscles and target organs. These processes are accompanied by the formation of estrone, estriol, catecholestrogens, as well as sulfate and glucuronide conjugates of these compounds, all of which have significantly less estrogenic activity or none have estrogenic activity. A certain part of estradiol is excreted with bile and is subjected to intestinal-hepatic recirculation.Metabolites of estradiol are mainly excreted in the urine in the form of sulfates and glucuronides.

 

After discontinuation of Proginova's intake, the concentrations of estradiol and estrone return to their initial values ​​within 2-3 days.

 

After ingestion, norgestrel is rapidly and almost completely absorbed from the digestive tract. The maximum concentration of levonorgestrel in the serum, about 7-8 pg / ml, is usually achieved 1-1.5 h after taking the pills. Levonorgestrel binds with albumin and globulin, binding sex hormones (SHGG). About 1-1.5% of the total concentration of levonorgestrel in the serum is not associated with protein. With a half-life of approximately 1 day, the metabolites of norgestrel are excreted in the urine and bile.

 

Indications

  • Hormone replacement therapy (HRT) for climacteric disorders, involutional changes of the skin and the urogenital tract, depressive states in climacteric and symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with a uterus unremoved;
  • prevention of postmenopausal osteoporosis;
  • normalization of irregular menstrual cycles;
  • treatment of primary or secondary amenorrhea.

 

Forms of release

 

Dragee 2 mg (sometimes mistakenly called a pill).

 

Instructions for use and reception scheme

 

Proginova

 

Dragee is taken entirely with a small amount of liquid.

 

If the patient has not removed the uterus and the menstruation is still continuing, Proginova should be taken in conjunction with any gestagen in the first 5 days of the menstrual cycle. However, patients with very rare menstruation, as well as postmenopausal women, can start taking the drug at any time, provided that pregnancy is excluded.

 

Each package is designed for 21-day pritm. Every day take one dragee. After each 21-day course, you can take a break in taking the drug, usually for a week or less (cyclic hormone replacement therapy (HRT)), or continue taking the pills daily (continuous HRT). In the latter case, the dragees from the new package are taken as soon as the dragee is finished in the previous package.

 

Combined treatment regimen

 

Women with a non-removed uterus are advised to take an additionalgestagen for 10-14 days every 4 weeks (cyclically combined HRT) or together with each estrogen tablet (continuous combined HRT).

 

The time of day when the woman takes the drug does not matter, but if she started taking the pills at any particular time, then you should stick to this time and continue. If the woman forgot to take the pills, she can take it within the next 12-24 hours. If the treatment is interrupted for a longer time, bleeding may occur.

 

Cyclo-Proginova

 

If the patient still has menstruation, the treatment should begin on the 5th day of the menstrual cycle (the 1st day of menstrual bleeding corresponds to the 1st day of the menstrual cycle).

 

Patients with amenorrhea or very rare menstruation, as well as postmenopausal women, can start taking the drug at any time, provided that pregnancy is excluded. Each package is designed for a 21-day reception.

 

Daily for the first 11 days take one white pellet, and then for 10 days - every day, one light brown pellet. After 21 days of taking the drug, a 7-day break in taking the drug follows, during which menstrual bleeding occurs,caused by cancellation of the drug (usually 2-3 days after receiving the last pills).

 

After a 7-day break in taking the drug, they begin a new package of CyclO-Proginova, taking the first pills on the same day of the week as the first pills from the previous package.

 

Dragee swallowed whole, squeezed a small amount of liquid. The time of day when a woman takes the drug does not matter, however, if she starts taking the pills at any particular time, she should stick to this time and on. If the woman forgot to take the pills, she can take it within the next 12-24 hours. If the treatment is interrupted for a longer time, vaginal bleeding may occur.

 

Side effect

  • changes in the frequency and intensity of uterine bleeding;
  • breakthrough bleeding;
  • intermenstrual bloody discharge (usually weakened during therapy);
  • dysmenorrhea;
  • changes in vaginal discharge;
  • tenderness, tension and / or enlargement of the mammary glands;
  • dyspepsia;
  • bloating;
  • nausea, vomiting;
  • abdominal pain;
  • skin rash;
  • itching;
  • Chloasma;
  • erythema nodosum;
  • headache;
  • migraine;
  • dizziness;
  • increased fatigue;
  • cardiopalmus;
  • edema;
  • increased blood pressure;
  • venous thrombosis and thromboembolism;
  • muscle cramps;
  • changes in body weight;
  • changes in libido;
  • visual impairment;
  • intolerance to contact lenses;
  • allergic reactions;
  • with prolonged monotherapy with estrogen, the risk of developing hyperplasia or endometrial cancer increases.

 

Contraindications

 

It is not recommended to start hormone replacement therapy (HRT), in the presence of any of the conditions listed below. If any of these conditions occur during HRT, then immediately stop using the drug and inform the doctor about it:

  • pregnancy;
  • lactation period;
  • bleeding from the vagina of unknown origin;
  • confirmed or suspected breast cancer;
  • confirmed or suspected hormone-dependent precancerous diseases or hormone-dependent malignant tumors;
  • Liver tumors now or in the past (benign or malignant);
  • severe liver disease;
  • Acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke);
  • deep vein thrombosis in the acute stage, thromboembolism now or in the past;
  • the presence of a high risk of venous and arterial thrombosis;
  • severe hypertriglyceridemia;
  • congenital deficiency of lactase, sucrose / isomaltase, lactose intolerance, glucose-galactose malabsorption;
  • children and adolescents under 18;
  • hypersensitivity to the components of the drug Proginova.

 

Application in pregnancy and lactation

 

Hormone replacement therapy (HRT) is not prescribed during pregnancy or lactation.

 

If pregnancy is detected during the administration of Proginova, the drug should be discontinued.

 

Application in elderly patients

 

There is no data on the need for dose adjustment in women up to 65 years of age. There are limited data showing an increased likelihood of dementia risk in women starting hormone replacement therapy at the age of 65 and older. Tell your doctor if you start taking Proginova's drug over the age of 65.

 

Use in children

 

Contraindicated in children under 18 years.

 

special instructions

 

When prescribing hormone replacement therapy (HRT) for women,having several risk factors for the development of thrombosis or a high degree of severity of one of the risk factors, the possibility of mutual strengthening of the effect of risk factors and prescribed treatment on the development of thrombosis should be taken into account. In such cases, the total value of the available risk factors is increased. If there is a high risk, Proginova is contraindicated.

 

Medical examination

 

Prior to the use of the drug, and then at certain intervals during treatment (at least 1 time in 6 months), gynecological examinations, mammary glands, blood pressure measurement and other necessary examinations should be performed.

 

Medical examination (including periodic determination of prolactin concentration) is necessary if the patient has prolactinoma.

 

If hormone replacement therapy is performed in one of the diseases or conditions listed below, you may need to have careful medical supervision. Therefore, if you have one of these conditions, tell your doctor before you start taking Proginova:

  • uterine fibroids;
  • endometriosis at present or in the past;
  • diseases of the liver or gallbladder.After the transferred hepatitis, the administration of the drug is possible not earlier than in 6 months (before the normalization of the liver function);
  • jaundice during a previous pregnancy or previous reception of sex hormones;
  • diabetes;
  • arterial hypertension (high blood pressure);
  • Chloasma (areas of discolored skin) now or in the past. If available, avoid prolonged exposure to sunlight or ultraviolet radiation;
  • epilepsy;
  • benign diseases of mammary glands (mastopathy);
  • bronchial asthma;
  • migraine;
  • increased content of triglycerides in the blood;
  • porphyria;
  • otosclerosis;
  • systemic lupus erythematosus;
  • chorea;
  • increased risk of vein thrombosis. The risk rises with age. It can also increase in the case of existing thrombosis in you or your relatives, with varicose veins, excessive body weight.

 

The risk of deep vein thrombosis is temporarily increased as a result of surgery, serious injuries or prolonged immobility. If you are taking Proginova, tell your doctor about any planned hospitalization or surgery (4-6 weeks).

 

Do not use hormone replacement therapy to prevent heart attack or stroke.

 

The following warnings regarding the use of HRT should be considered when using Proginova.

 

Endometrial cancer

 

With prolonged use of estrogens in monotherapy, the probability of cancer of the uterine mucosa (endometrial cancer) increases. If you have a uterus, you will need an additional method of progestogen. The addition of gestagens reduces the risk of endometrial cancer.

 

Tell your healthcare provider if, on the background of taking Proginova, you often have irregular or breakthrough bleeding.

 

Mammary cancer

 

The results of several studies have shown that in women who have used hormone replacement therapy (HRT) for several years, breast cancer (BC) is observed somewhat more often than their peers who have never used it.

 

The relative risk increases with the duration of estrogen monotherapy, but may be absent or decreased. This increase is comparable to the increased risk of breast cancer in women with a later onset of natural menopause, as well as obesity and alcohol abuse.The increased risk gradually decreases to the usual level during the first few years after discontinuation of HRT.

 

HRT increases the mammographic density of the mammary glands, which in some cases may have a negative impact on the radiographic detection of breast cancer. In this regard, your doctor can use other research methods for screening for breast cancer.

 

Ovarian Cancer

 

During the epidemiological study, there was a slight increase in the risk of ovarian cancer in women who use estrogen replacement therapy (EST) for a long time (more than 10 years). At the same time, a mea- analysis of 15 studies did not reveal an increased risk in the use of EST. However, these data are currently controversial.

 

Liver tumors

 

In rare cases, the use of sex hormones observed the development of benign, and even less often, malignant liver tumors. In some cases, bleeding from such tumors into the abdominal cavity posed a threat to life. Communication with HRT is not proven. Although such cases are extremely unlikely, you should inform your doctor if you experience unusual sensations in the upper abdomen,which do not pass for a short period of time.

 

The reasons for the immediate discontinuation of the drug Proginova

 

You should immediately stop treatment and consult a doctor if you experience any of the following conditions:

  • the first occurrence of a migraine attack (characterized by a throbbing headache and nausea, which is preceded by a visual impairment);
  • exacerbation of existing migraines; any unusually frequent or unusually severe headaches;
  • sudden visual or hearing impairment;
  • inflammation of the veins (phlebitis).

 

If you have a thrombosis in the presence of Proginova or if you suspect that this could happen, you should stop taking the drug immediately and see a doctor. The warning signs of a possible thrombosis are:

  • coughing up blood;
  • unusual pain in the hands or feet or puffiness;
  • sudden lack of air;
  • loss of consciousness.

 

The administration of Proginova should also be stopped immediately in case of pregnancy or jaundice.

 

Influence on the results of laboratory studies

 

Admission of sex hormones can affect the results of some laboratory studies.Always inform your doctor if you are taking Proginova.

 

Proginova is not used for contraception.

 

If contraception is necessary, non-hormonal methods should be used (with the exception of calendar and temperature methods). If you suspect a pregnancy, you should stop taking the drug until pregnancy is not ruled out.

 

Additional Information

 

There is no data on the need for dose adjustment in women up to 65 years of age. There are limited data showing an increased likelihood of dementia risk in women starting hormone replacement therapy at the age of 65 and older. Tell your doctor if you start taking Proginova's drug over the age of 65.

 

The use of Proginova in patients with impaired liver function has not been studied.

 

The use of Proginova in patients with impaired renal function has not been studied. The available data indicate that there is no need to adjust the dose when the drug is used in this category of patients.

 

Impact on the ability to drive vehicles and manage mechanisms

 

Does not affect.

 

Drug Interactions

 

At the beginning of hormone replacement therapy (HRT), it is necessary to stop the use of hormonal contraceptives. If necessary, the patient should recommend non-hormonal contraceptives.

 

Long-term treatment with drugs that induce liver enzymes (for example, some anticonvulsant and antimicrobial drugs) can increase the clearance of sex hormones and reduce their clinical effectiveness. A similar property of inducing liver enzymes was found in hydantoids, barbiturates, primidon, Carbamazepine and rifampicin, the presence of this feature is also assumed in oxcarbazepine, topiramate, felbamate and griseofulvin. The maximum induction of enzymes is usually observed not earlier than 2-3 weeks, but then it can persist for at least 4 weeks after discontinuation of the drug.

 

In rare cases, along with the concomitant use of certain types of antibiotics (for example, penicillin and Tetracycline groups), a decrease in the level of estradiol was observed.

 

Substances that are highly conjugated (for example, paracetamol) can increase the bioavailability of estradiol due to competitive inhibition of the conjugation system during absorption.

 

Due to the effect of HRT on glucose tolerance, in some cases, the need for oral antidiabetics or insulin may change.

 

Excessive consumption of alcohol during HRT may lead to an increase in the level of circulating estradiol.

 

Analogues of the drug Proginova and Cyclo-Proginova

 

Structural analogs for the active substance, as well as estrogens and gestagens in combinations:

  • Agesta;
  • Aromasine;
  • Aromeston;
  • Biel;
  • Veldedien;
  • Veraplex;
  • Vero Tamoxifen;
  • Byzanne;
  • Ginepristone;
  • Gynestrel;
  • Hormoplex;
  • Depot Provera;
  • Derremiril;
  • The Divigel;
  • Duphaston;
  • Wife;
  • Zitazonium;
  • Implanon;
  • Iprozhin;
  • Climadinone;
  • Climara;
  • Clomid;
  • Clomiphene;
  • Clostilbite;
  • Krajonon;
  • Lactineth;
  • Levonorgestrel;
  • Ledibon;
  • Livial;
  • Loveston;
  • Megeis;
  • Microlus;
  • Microfolline;
  • Miniziston;
  • Mirell;
  • Mirena;
  • Miropristone;
  • Mifegin;
  • Mifeprex;
  • Mifepristone;
  • Novofen;
  • Nolvadex;
  • Norkolut;
  • Norplant;
  • Ovestin;
  • Ovipol Clio;
  • Organometr;
  • Pencrofton;
  • Postinor;
  • Prajisan;
  • Premarin;
  • Prim is Nor;
  • Provera;
  • Progesterone;
  • Cyclo Proginova;
  • Projest;
  • Serofen;
  • Serpafar;
  • Synphase;
  • Tamoxen;
  • Tamoxifen;
  • Turinal;
  • Utrozhestan;
  • Charozette;
  • Evista;
  • Exemestane;
  • Exluent;
  • Elvagin;
  • Escapel;
  • Estradurine;
  • Estimax;
  • Estriol;
  • Estrovagin;
  • Estrogele;
  • Estrofem.

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Reviews (5):
Guests
gynecologist
In our countries, the drug Proginova is undeservedly unpopular, although in all of Europe hormone replacement therapy with this type of drugs is the standard for keeping women young and prolonging their longevity. A pill, if there is - this is probably the only reason why the drug may not be prescribed to women in menopause and after age. There is no danger in this kind of therapy, except that it is financially necessary to spend money. But on the elderly granny will not be like.
Guests
Nick
A good drug, it helps me.
Visitors
Alina
In 2007, there was an operation, the right ovary was removed and partially left for endometriosis cysts. FSH ranged from 45 to 110 after cycloprogin 72. Saw courses are no more than 5 months. I do not carry much.At the moment, the sixth day I drink, accompanied by a swelling, pain in the abdomen and in the lower back, little urine is released. How do you think to continue the reception?
Administrators
admin
Alina, I'm more concerned about your oliguria (a small amount of excreted urine). If you associate these symptoms with taking Cyclo Proginova, then you should contact your doctor as soon as possible, since it is possible to cancel the drug and replace it with another. Independently to cancel, not knowing your diagnosis, I can not remotely, but the complication is frightening. Well remember, that preceded deterioration, can some external factor (which also need to be eliminated) or another medication (its reception will also need to be discontinued). This is all serious, do not put off going to the doctor.
Guests
Louise
I've been drinking Pig Cycloo Proginova for about 10 years. Assigned with an early menopause. I feel fine.

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