Progynova 2mg Bayer drugs treat deficiency estrogen (1 blister x 28 tablets)

Dosage form Box of 1 blister x 28 tablets
Specifications Estradiol Valerate

Ingredient

Composition information	Content
Estradiol Valerate	2mg

Uses

indications

Progynova drug are indicated in the following cases:

Hormone -replacement hormone (HRT) is indicated for patients with signs and symptoms of deficiency of estrogen due to natural menopause or reducing genital gland function.

Prevent osteoporosis in the postmenopausal period. In the process of using progynova, the ovaries are not inhibited and the production of endogenous hormones is not much affected.

During menopause, the decline and loss of estradiol production process of the ovaries can lead to changes in body temperature causing hark accompanied by insomnia and sweating, atrophy of the urinary organs with vaginal dryness syndrome, intercourse pain and uncontrolled urination.

There are some signs that are not specific but also in menopausal symptoms of angina, tachycardia, irritability, nervous breakdown, capacity and concentration, or forgetfulness, decrease in sexual desire, muscle pain. Using hormone replacement therapy (HRT) will reduce the above symptoms due to estrogen deficiency in menopausal women.

HRT with sufficient amount of estrogen in progynova reduces bone resorption and slows down or stops bone loss after menopause. When the HRT stops, the bone mass drops immediately with the proportion equivalent to the postmenopausal period.

There is no evidence that HRT is treated with bone mass as in the premenopausal stage. HRT also has a good influence on collagen and skin thickness, so it can slow down the process of creating wrinkles on the skin.

HRT changes lipid components: reduces total cholesterol and LDL-cholesterol; Increases HDL-Cholesterol and Triglycerides. The effect on metabolic can be reduced if supplemented with progesterone.

Additional progesterone to estrogen replacement therapy as progynova for at least 10 days for each cycle is recommended for women with intact uterus. This measure reduces the risk of endometrial hyperplasia and avoids the risk of glandular carcinoma in these women. The addition of progesterone to HRT does not affect the effectiveness of estrogen for approved indications.

Observing and research studies of the Women's Health Association (WHI) on the conjugated Equine Estrogen (CEE) combined with Medroxyprogesterone Acetate (MPA) suggests the risk of death of colon cancer in menopausal women using HRT. In WHI's study on mere CEE therapy, there is no report on reducing the risk of disease. However, these findings have not been proved related to other HRT drugs.

Pharmacokinetics

absorption

Estradiol Valerate is absorbed quickly and completely. This steroid ester is split into valeric acid during the first absorption and metabolism through the liver. At the same time, Estradiol undergo many metabolic processes later, such as converting into estrogen, estriol and estronesulfate.

Only about 3% of estradiol becomes a form of active activity after taking estrogen valeate. Food does not affect the bioavailability of Estradiol.

Distribution

Estradiol's maximum concentration in serum is approximately 15 PG/ml (or 30 PG/ml), usually achieved within 4-9 hours after drinking. Within 24 hours after drinking, the concentration of estradiol in serum drops to 8 PG/ml (or 15 PG/ml).

Estradiol is in association with albumin and binds to globulin associated with sex hormones (SHBG). The estradiol part does not bind to the serum protein in about 1 - 1.5% and the estradiol part is connected to SHBG at about 30-40%.

Estradiol's distribution volume after intravenous dosage injection is about 1 l/kg.

Metabolism

After the exile estradiol is separated the ester, the drug is metabolized through the biological transformation path of endogenous estradiol. Estradiol is metabolized in the liver, but it is also metabolized in other organs other than the liver such as intestines, kidneys, muscular systems and other target organs. These processes are involved in the formation of Estrone, Estriol, Catecholestrogen and sulfate and glucuronide links, which are weak estrogenic activity or no estrogenic activity.

Elimination

The total serum clearance of estradiol after taking a single dose by vein, very different from 10 to 30 ml/min/kg. A large amount of Estradiol's metabolites are issued into bile fluid and participate in the liver -intestinal cycle round.

The metabolism of estradiol in the final stage is mainly excreted into sulphate and glucuronides in urine.

Stable state

Compared to a single dose, estradiol's concentration in plasma is approximately 2 times higher when taking multiple consecutive doses. On average, the concentration of estradiol changes in the range of 15 (or 30 pg/ml) (minimum) and 30 (or 60 PG/mL) (maximum level).

Estrone, a less active metabolic substance, achieves 8 times higher serum concentration, estrone sulfate reaches serum concentration about 150 times higher. After stopping treatment, the concentration of Estradiol and Estrone returned as before treatment within 2-3 days.

Before taking Progynova 2mg Bayer drugs treat deficiency estrogen (1 blister x 28 tablets)

How to use

Patients who have been removed from the uterus

Can be used at any time.

If the patient has intact uterus and still has menstruation, it is advisable to start treatment according to the combination of Progynova and Progestogen mode within the first 5 days of the cycle (see combined treatment).

Patients who have run out of menstrual periods or have irregular menstruation or postmenopausal patients may begin treatment according to combined mode at any time (see combined treatment section), need to eliminate the possibility of pregnancy during treatment.

Transferred from treatment with other hormone replacement therapies (cycle, continuous use or continuous combination)

Women who change from other HRT treatment regimen should use up the dose of treatment before starting progynova.

Progynova 28 tablets

Each blister consists of 28 tablets for 28 days of treatment. Continuous treatment, which means that after using all the old blisters, continue to use a new blister without time to rest.

combining mode

In women who are intact uterine intact, should combine a suitable progestogen for 10-14 days, each 4 -week cycle (continuous or cycle HRT mode) or drink at the same time progestogen with each tablet containing estrogen (continuous HRT mode).

For successful treatment, the doctor must find a way to explain for patients to understand how to use combination and ensure patients comply with the recommended combination treatment regime.

How to take medicine: Swallow whole tablet with a little water.

Should take medicine at a fixed daily time.

Dosage

A progynova, daily drink.

More information about special object groups:

Children and adolescents: Progynova is not indicated for adolescents and adolescents. In women aged 65 and older. Progynova contraindicated in women with severe liver failure. The existing data does not suggest the need to adjust the dose in this object group.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

What to do when you forget 1 dose? If more than 24 hours, do not take the tablet for forgotten. If you forget to take several pills, abnormal bleeding can occur.

Side Effects

When using progynova drugs , you may experience unwanted effects (ADR).

Common

weight gain or weight loss, headache, abdominal pain, nausea, rash, itching, uterine bleeding and vagina including bleeding.

Hypersensitivity reaction, depression state, dizziness, visual effects, fast heartbeat, indigestion, erythema, urticaria, breast pain, breast tightness, edema.

rare

Anxiety, increase or decrease in Libido, migraine, dislike contact lenses, bloating, vomiting, him, acne, cramps, menstruation, vaginal discharge, premenstrual syndrome, big breast, fatigue.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Progynova drug contraindicated in the following cases:

Do not use HRT for the following cases. Need to stop the drug immediately if any phenomenon appears below during the treatment period:

Pregnant and lactating women.

Vaginal bleeding of unknown causes.

There is or suspected breast cancer.

There is or suspected a benign or malignant uterine tumor, due to the effects of sex hormones.

Currently or a history of liver tumor (healed or malignant).

Severe liver diseases.

Aortic thrombosis (such as myocardial infarction , stroke). deep vein thrombosis, thrombosis or a history of these diseases.

High risk of arterial thrombosis or veins.

Increase blood triglycerides.

There is a history of hypersensitivity to any ingredients of the drug.

Be cautious when using

Before starting treatment, it is necessary to consider the conditions and risks listed below to decide on the benefits and the risk of treatment for each patient.
When being treated with this therapy, it is necessary to stop the drug immediately if the control is detected or when the situation appears:

There is migraine or occasional occasional pain; Serious headache appears for the first time or other progresses to warn the risk of cerebral embolism.

The recurrence of jaundice; Or itching due to biliary obstruction appears for the first time during pregnancy or use of previous sex steroids.

Symptoms or suspicion.

In the case of these risks that first appeared or more progressive, the benefits and risks of therapy need to be analyzed. At the same time consider the possibility of stopping the use of hormones instead.
It is necessary to consider the ability to increase the risk of thrombosis in women with many risk factors or a severe risk factor. This will be much more serious, not simply the sum of risk factors. Do not apply hormone replacement therapy (HRT) to cases of superior risks.
venous thrombosis
Both random studies with control and epidemiological research show that HRT may be related to an increase in the risk of developing venous thrombosis (VTE), such as deep veins or pulmonary veins.
It is necessary to discuss with patients, carefully consider benefits/risks when prescribing hormone replacement therapy in patients with risk factors of venous thrombosis (VTE).
The main risk factors of VTE include a history of itself, the family history (if the person whose blood has directly suffered from VTE at a relatively young age proves that genetic factors) and serious obesity. The risk of VTE also increases with age. There is no agreement on the effects of vasodilation in VTE.
The risk of VTE can temporarily increase when the patient is prolonged, surgery after injury or surgery under the program or major injury. Depending on the nature of each case and the time of immobility, it is necessary to temporarily stop HRT.
arterial thrombosis
Two major clinical trials have been combined with combined estrogen (CEE) with Medroxyprogestogen Acetate (MPA), hormone used in hormone therapy instead. The results show that the risk of coronary artery disease (CHD) can increase slightly in the first year of use, then do not give any benefits. Clinical trials with CEE simply show the ability to reduce the rate of CHD in women aged 50 - 59 and absolutely no benefits for the total number of experiments.Another result is that, in two clinical trials with CEE used alone or in combination with MPA, the risk of stroke increases from 30% to 40%. It is not determined that these findings are related to other replacement hormones that are not used by oral.
Diseases of gallbladder
estrogen is thought to increase the risk of gallstones. Some women are likely to suffer from gallbladder diseases during the use of estrogen therapy.
Innovation
Clinical trials with cee -containing preparations show very little evidence to increase the risk of dementia if they start using this hormone in women over 65. This risk may be reduced if the treatment is started in the early stages of menopause. It is not determined whether these findings are related to other replacement hormones.
tumors
Breast cancer
Monitoring clinical studies and symptoms shows that the risk of breast cancer is determined to increase for women who have used hormone replacement therapy for several years.
General assessment of the correlation risk of breast cancer is determined on more than 50 epidemiological studies shows that most of the risk is recorded from risk factors from 1 to 2.
The risk of correlation increases over time of treatment and may be lower or not increased if treated with products containing only estrogen.
Two randomized trials of large sample size on CEE alone or in combination with MPa shows the corresponding risk of 0.77 (95% Cl; 0.59 - 1.01) or 1.24 (95% Cl; 1,01 - 1.54) after 6 years of using hormone therapy instead. It is also not known whether it is true for other hormone replacement preparations.
This increase is gone for a few years after stopping using HRT.
Most studies suggest that tumors are diagnosed in patients who are using or have just used HRT with much better prognosis than those who do not use this therapy. There are no data on metastatic phenomena out of the mammary gland.
HRT increases the density of the mammary X -ray image. In some cases, this may affect the detection of breast cancer from X -ray images.
Endometrial cancer
Long -term use estrogen increases the risk of endometrial hyperconders or endometrial cancer.
Ovarian cancer
A epidemiological study shows a slight increase in the risk of ovarian cancer in women who use hormone therapy for a long time (more than 10 years). Meanwhile, a widespread analysis conducted for 15 studies that did not detect the phenomenon of increasing risk in women using alternative estrogen therapy. Therefore, the effect of hormone therapy instead of ovarian cancer is unclear.
liver
In some rare cases, the liver has been encountered and more rare is the malignant tumor of the liver after using hormones containing hormones that are similar to progynova. In some special cases, hemorrhage may occur in the abdominal threat of patient life.
Other pathologies
The relationship between HRT and clinical hypertension use has not been determined. The mild hypertension in women who use HRT has also been reported. Often rarely have clinical manifestations. However, if in some cases the signs of clinical hypertension lasts continuously during HRT use, may need to stop using the drug.
Sacrimation liver dysfunctions, including hyperkemin with blood bilirubin such as dubin syndrome - Johnson or rotor syndrome. It is necessary to closely monitor and check the liver function periodically. In case the indicators of liver function increase, it is advisable to stop using HRT.
For women with triglycerides increasing in moderate levels, special monitoring. The use of HRT for these women can increase the triglyceride index, which can cause acute pancreatitis.
Although using HRT can affect peripheral insulin resistance and glucose tolerance, generally do not need to adjust the dose of diabetes treatment drugs during HRT use. However, women with diabetes should be carefully monitored during HRT use.
Some cases may appear unwanted estrogen stimulation during HRT use such as abnormal uterine bleeding. If the vaginal bleeding is abnormal or persistent during treatment, it is necessary to assess the condition of the endometrium.
The size of the uterus may increase due to the effect of estrogen. If this sign appears, HRT should be stopped.
If endometriosis reappears during treatment, it is advisable to stop using HRT.
Need to monitor strict medical (including periodic concentration test) in patients with prolactin secretion.
The tanning phenomenon is often very rare, common in patients with a history of tanning during pregnancy. Women who tend to be tanning should avoid direct contact with sunlight or ultraviolet rays during HRT use.
The following signs have also been reported as possible or worse when using HRT. However, it does not show a clear related to the use of HRT, these women need to be closely monitored during the use of HRT:

epilepsy .

Benopathes in the breast.

bronchial asthma .
migraine.
Porphyrinuria.

osteoporosis .
Systemic Red Reds.

Lightly dance.

In women with genetic angiography, external estrogen can be caused or increased the symptoms of angioedema.
The ability to drive and operate machinery

no.
Pregnancy

Do not use hormone replacement therapy for pregnant and lactating women. If pregnant during use of progynova, should stop treatment immediately.
The period of breastfeeding

Do not use hormone replacement therapy for pregnant and lactating women. If pregnant during use of progynova, should stop treatment immediately.
Small amount of sex hormones are exported into breast milk.
Drug interaction

Interaction with other drugs
The long -term treatment of liver fermentation effects (for example, some anti -convulsed or antibiotic drugs) may increase the clearance of sex hormones and reduce clinical effects. The drugs that affect the liver enzymes include HytanToins, Barbiturates, Primodone, Carbamazepine and Rifampicin, in addition, it may include oxcarbazepine, topiramate, felbamte and griseofulvin. The biggest effect of this drug to the liver enzymes is only noticed after 2 to 3 weeks and can last up to 4 weeks after stopping the above drugs.

Some rare cases, estradiol levels are reduced when used simultaneously some antibiotics (eg penicillin or tetracycline).

The active ingredients must undergo an important reception (eg Paracetamol) that can increase Estradiol's biodiversity with the competitive inhibition ability of the conscious system during absorption. In some cases, the demand for anti -diabetes or insulin or insulin may change due to the effects of glucose tolerance.

Interaction with alcohol

Use of alcohol during HRT treatment can lead to increased estradiol.

Interaction with subclinical test results

Using sexual steroids can affect biochemical indicators, for example: liver, thyroid, adrenal glands and kidney function, the content of proteins (transportation) in plasma such as globulin associated with corticosteroids and lipid/lipoprotein components, carbohydrate metabolism indicators, blood coagulation and fiber solubility indicators.

Storage

Store at room temperature below 30 ° C.

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