Gel Applying the 0.06% besins skin treatment, anti -osteoporosis (80g)

Dosage form Tube x 80g
Specifications Estradiol

Ingredient

Composition information	Content
Estradiol	0.06%

Uses

indications

The galogel besins is indicated in the following cases:

replaced hormone therapy used to treat deficiency of estrogen and symptoms due to deficiency of estrogen, especially symptoms related to natural or artificial menopause: symptoms of vascular vasoconstriction (hot flashes, night sweat), symptoms of urinary - sex (vulva - vaginal atrophy, painless urination) and symptoms of psychological disorders, etc.). After menopause bones in women are at high risk of fractures and do not tolerate transplanted drugs, to prevent osteoporosis or for women to be contraindicated with these drugs. The active ingredient is similar in chemical and biological with endogenous estradiol. This allows 17 β estradiol to enter the body by applying on healthy skin. This substance will overcome the deficiencies in estrogen production in menopause women or women who have cut the fallopian tubes and reduce the symptoms of menopause. Estrogen prevents bone loss due to menopause or fallopian tube.

With a specific receptor, estrogen forms a complex that stimulates DNA synthesis and protein in the spaces; These substances have the effect of metabolic at the target agency. The most active estrogen in the receptor is Estradiol, produced mainly by ovarian cysts, from menstruation to menopause.

In this way, the estrogel has the effect of estrogen on the main organs, not only in the ovaries, endometrium and breasts but also in the hypothalamus, pituitary, vagina, uterus and liver in the same way often seen in the follicle stage. Using the oestrogel by penetrating the skin will avoid the first liver effect, which is the cause of increasing the synthesis of angiotensinogen, lipoprotein lipoproteins (VLDL - Triglycerides) and some coagulation factors.

Dynamic pharmacokinetics

In the early hours after applying the gel (from 2 to 12 hours), the estradiol level reached proportional to the dosage and area of the drug area.

On experimental, the esteriol concentration in serum measured 24 hours after applying the drug a day a daily amount of 2.5 g or 5g gel, applying over 750 cm2 of the skin: The concentration achieved average corresponding to 75 PG/ml or 98 PG/ml (changing between minimum individuals is 42 and maximum 122 PG/mL when using 2.5 g gel; minimum 670 PG/mL when using 5g gel). These concentrations are usually stable and equivalent for 72 hours after applying the drug every day, even in 6 consecutive cycles in other experiments.

The esteriol concentration does not change on the same individual for many months (changes between individuals about 11%). Using Estradiol through the skin will avoid the first liver effect: a physiological report of E2 and E2 concentrations during the circulation ranges from 0.78 to 0.97; And so it is maintained and equivalent to the observation concentration before menopause. When stopping treatment, the serum concentration returns to the basic level within 76 hours, as the concentration of the conjugated ester is eliminated through the urine.

estradiol

Estradiol absorbs through the skin, equivalent to about 10% of the dose.

Estradiol's waste time in plasma is about 1 hour. The clearance of its metabolites in plasma is from 650 - 900 liters/day/m2.

The amount of estradiol goes into the blood every 24 hours after applying the drug a day a day of 2.5 g and 5 g of gel is 75 mcg/day and 100 mcg/day.

Estradiol is metabolized mainly through the liver in the form of estron and its combined form (glucoromid and sulphat). These are poor active substances and are eliminated mostly in the form of glucoronid and sulphat. The metabolic substances also undergo gut cycle.

Before taking Gel Applying the 0.06% besins skin treatment, anti -osteoporosis (80g)

How to use

Use topical.

Patients are recommended to apply medicine on the skin as wide as possible, preferably on the forearm, arms and/or shoulders or wide skin. Should avoid applying medication directly on the breast, on vulva or vaginal mucosa.

Eadrogel should be used as follows:

Patients apply themselves on clean skin in the evening or in the morning, it is best after bathing and at the same time every day.

Treatment of postmenopausal symptoms, minimum doses effectively is 1.25 g gel per day (= 0.75 mg estradiol) and should be used from 21 to 28 days per month. Dosage changes according to patient needs. The average dose is 2.5 g gel per day. To start and continue treating symptoms related to menopause, the lowest dose should be used in the shortest possible treatment.

It is not recommended for continuous estrogen treatment without using the same at the same time as progestin due to the risk of endometrials (hyperplugs, dysplasia may have high risk of endometrial cancer). The treatment should be continued for at least 3 consecutive weeks, then stopped treating for a week in combination with oral progestin for 12 to 14 rights every month. The treatment can be applied from the day 1 to 25 of the month, combined with drinking progestin. Hemorrhage due to suspension of medication may occur during the week of interruption of treatment. Only the licensed progestin should be used to combine with an recommended estrogen.

However, continuous estrogen treatment can be proposed in cases where women have removed uterus or whenever estrogen deficiency symptoms clearly reappear when interrupting treatment. In this case, progesterone can be used for the first 12 to 14 days of each month. If previously diagnosed with endometriosis, it is not recommended to use progestin for women who have removed the uterus.

If necessary, the dose can be adjusted after 2 or 3 treatment cycles, depending on the clinical symptoms. This may be related to:

Dosage in case of symptoms of estrogen secretion such as breast tension, abdominal and pelvic swelling, anxiety, restlessness or irritability. 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 using overdose?

No report.

What to do when forgetting a dose? If the next dose time is less than 12 hours, wait until the next application. If the next dose time is over 12 hours, apply the dosage immediately and continue to use the next dose as usual. Forgetting a dose may increase the likelihood of bleeding or bleeding.

Side Effects

When using the besins oestrogel, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Genital: Dysmenorrhea, menstrual bleeding, hemorrhage (bleeding), menstrual disorders, white blood.

digestive: abdominal pain, abdominal spasms, abdominal swelling, nausea, vomiting. nerve: headache.

Muscle muscle: Muscle cramps, pain.

Mental: Stress, depression syndrome.

Uncommon, 1/1000

Genital: benign breast tumor, uterine polyps, increase the volume of smooth muscle tumors in the uterus, endometriosis, breast pain, worsen than estrogen -dependent tumors.

nerve: migraine, dizziness, drowsiness.

Muscle muscle: joint pain.

blood vessel: Shallow or deep vein thrombosis, intravenous inflammation. overall: peripheral edema, sodium stasis, swelling, weight change.

Skin and soft tissue: skin rash, itching, skin tip. liver: Change liver functions, liver glands, gallstones.

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

anti -contraindications gamel besins in the following cases:

Known breast cancer or a history of breast cancer.

Known or suspected that there is a malignant tumor dependent estrogen (such as endometrial cancer).

Vaginal hemorrhage has not been diagnosed.

Endometrial hyperplasia has not been treated.

History or having a sterile vascular abscess (such as deep vein thrombosis, pulmonary embolism).

Recent venous thromboembolism or progress (such as angina, myocardial infarction).

Severe liver disease or liver damage when liver function tests are still abnormal.

Hypersensitivity to the active ingredient or any ingredient of the drug.

Porphyrin metabolic disorders.

Be cautious when using

While treating postmenopausal symptoms, hormone therapy should not be started if it affects the quality of life. In each case, it is necessary to evaluate the risks and benefits at least each year and should only continue hormonal therapy instead when benefits are greater than the risk.

Clinical examination and monitoring

Before the beginning or continued hormone therapy, should proceed to fully learn a history of personal and family diseases. Body examination should be examined (especially pelvic and breast), and at the same time pay attention to the contraindications, special warnings and cautiousness when used. During treatment, it is also recommended that regular examination should be conducted with frequency and properties of adaptation to each patient.

Women will be notified of the abnormalities of the mammary gland they must notify the doctor or nurse. Regular examination includes mammography, in accordance with the clinical requirements of each patient; At the same time should be done depending on current screening practice.

Statuses to be monitored

If one of the following conditions is happening, it has occurred before and/or becomes worse during pregnancy or previous hormone treatment, patients should be closely monitored. It is important to note that these conditions are more likely to recur or worsen during estrogen treatment, especially smooth muscle tumors (uterine fibroids) or endometriosis.

Pre -history or have blood thromboembolism. bile.

migraine or severe headache.

In case of simultaneous use with a progestin, it is important to pay attention to the possible contraindications of progestin: pregnancy for progestin with androgen activity, breast or ovarian cancer or endometrium for progestin actrogen activity.

Patients should be cautious when there are risks of cardiovascular disease, coronary artery disease and/or cerebrovascular disease due to increased hypertension or tobacco use.

Recognize a change at the time of breast examination requires additional gynecological examination during treatment.

Similarly, it is necessary to consult a doctor when there is an abnormal vaginal bleeding (in addition to the monthly interruption time), headache and visual damage, swelling in the lower limel or abdomen.

The reasons to immediately stop the treatment

Should stop treatment immediately if one of the following contraindications:

jaundice or impaired liver function

significant hypertension

The recurrent headache of migraine form

Doubt or pregnancy

Endometrial hyperplasia

The risk of increased endometrium or carcinoma increases when using single estrogen for a long time. Combined with a progestin for at least 12 days in each cycle for women who have not had surgery to remove the uterus significantly reducing this risk.

Bleeding and bleeding due to interrupting treatment may appear in the first months of treatment. If these symptoms appear after a period of treatment or prolonged after the end of treatment, it is advisable to find the cause, maybe through the endometrial biopsy to eliminate malignant diseases.

Using monomers of a single therapy can cause malignant tumor or malignant transformation of the remaining endometrial cells. A supplementation of a progestin and estrogen replacement therapy should be considered for women to remove the uterus after endometriosis and know the rest of the endothelial tissue.

Breast cancer

The risk of increased breast cancer in women is treated with estrogen, combining estrogen and progestin or tibolones in hormone therapy for replacement for many years. With all replacement hormone therapies, the risk of increasing increasing is clearer after many years of use and increasing over time of treatment. However, this risk returns to the basic level after many years (maximum 5 years) ending treatment.

Venous thrombosis

Alternative hormone therapy is associated with a relative risk of increased risk of the development of venous thrombosis (VTE), such as deep vein thrombosis or pulmonary embolism.

Contact your doctor as soon as possible when the symptoms of thrombosis occur (such as swelling in one leg, sudden chest pain, shortness of breath ...).

coronary artery disease

Randomly controlled studies do not show cardiovascular benefits when continuous coordination treatment estrogen and medroxyprogesterone acetate (MPA).

Stroke (stroke)

A large random study (WHI research) shows that increased risk of ischemic stroke (CVA) in women with good health during the continuous treatment of combined Esrogen and MPA.

Ovarian cancer

Long -term use (at least 5-10 years) hormone therapy instead. Using only estrogen for women who have removed uterus is related to an increase in the risk of ovarian cancer under some epidemiological studies.

Other conditions

The estrogen can cause salt water, so it is recommended to monitor patients with heart or kidney dysfunction. At end -stage renal failure patients with estradiol concentration in the circulation are likely to increase. Because, it is observed that during the treatment with estrogen, rare cases of increased glycerides in plasma may be the cause of pancreatitis.

The ability to drive and operate machinery

does not affect.

pregnancy

estrogel is not indicated for pregnant women. Should stop taking the drug right in the case of pregnancy or suspicion of pregnancy. The risk of miscarriage and inhibiting milk secretion is not indicated for estrogen therapy. So far, epidemiological studies have not proven the effect of teratogenic or toxic to fetuses in pregnant women accidentally exposed to estrogen treatment.

The period of breastfeeding

does not only prescribe this drug during breastfeeding.

Drug interaction

estrogel does not cause excessive liver irritation at the usual dosage: no harmful effects on lipids, blood clotting factors (fibrinogen, hq antithrombin activity, the concentration of revering substances during circulation or on globulin associated with sex hormones). Therefore, the drug has no effect on increasing blood triglycerides, diabetes or hypertension.

On the other hand, the metabolism of estrogen may increase when used simultaneously with enzyme induction substances, especially cytochrom P450 enzymes, such as anti -convulsions (phenobarbital, phenyltoin, carbamazepin, meprobamat, phenylbutazon) or anti -infection drugs (rifampicin, rifabutin, nevirapin, nevirapin, nevirapin, nevirapin, nevirapin, nevirapin, nevirapin, nevirapin, nevirapin, nevirapin Efavirenz).

Ritonavir and Nelfinavir, although known as strong enamel inhibitors, has the same effect as the enzyme when used simultaneously with steroid hormones.

Preparations from pharmaceuticals containing St. Jonh (Hypericum Perforatum) can stimulate the metabolism of estrogen and progestin.

Use the skin to penetrate the skin to avoid the liver effect for the first time. Therefore, the metabolism of estrogen used in this sugar may be less affected by more enzyme induction by oral use.

Clinically, an increase in metabolism of estrogen and progestin can lead to a decrease in the effectiveness of the drug and change the uterine bleeding.

Storage

Do not use overdue drugs stated on the packaging, stored at temperatures below 300C.

Expiry date: 36 months, from the date of production.

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