Androgel topical gel 50mg/5g besins support the treatment of male gonads (30 packs x 5g)

Dosage form Box of 30 packs x 5g
Specifications Testosteron
Ingredient Besins healthcare

Ingredient

Thành phần cho 5g

Composition information	Content
Testosteron	50mg

Uses

indications

Androgel® drugs are indicated in the following cases:

This drug is a testosterone replacement therapy for gonads reduction in men due to the deficiency of testosterone has been determined through clinical symptoms and biochemical tests. The endogenous androgen, mainly testosterone, is secreted by the testes and DHT is its main metabolites responsible for the development of external and internal genitalia, maintaining secondary genital characteristics (stimulating hair development, broken voice, sexual development), general effects on protein assimilation, skeletal muscle development and body fat distribution, nitrogen, sodium, sodium, sodium, sodium Chlorid, phosphate and water secretion in urine.

testosterone does not develop testes: it reduces the gonadotropin secretion of the pituitary gland.

The effects of (estocsterone in some target organs increasing after converting testosterone in the periphery into estradiol is the substance that can be connected to the estrogen receptor in the target cell nucleus for example, yen, fat, brain, bone and leydig cell of the testes.

Dynamic pharmacokinetics

The absorption of testosterone via skin varies from about 9% to 14% of the dose used.

After absorbing through the skin, testosterone diffuses in the whole body completely at relatively stable concentrations in the 24 -hour cycle.

Serum testosterone levels increased from the first hour after applying the drug and reaching a stable state from the second day. After that, the change of daily testosterone concentration has the same amplitude as the amplitude observed in the day and night (Circadian Rhythm) of endogenous testosterone. Therefore, the cross -skin line avoids the peaks distributed in the blood created when using the injection. The skin through the skin does not cause steroid concentration in the liver above the physiological level, in contrast to oral androgen therapy.

Using 5 g androgel® produces an average increase in testosterone levels about 2.5 ng/ml (8.7 nmol/l) in plasma.

When stopping treatment, testosterone levels start to drop to about 24 hours after the last dose. Testosterone concentration will return to the basic level about 72 hours after the last dose.

The main metabolites of testosterone are dihydrotestosterone and estradiol.

Testosterone is excreted mainly in urine and feces in the form of conjugated testosterone metabolites.

Clinical safety data

testosterone is found without In vitro mutation using a backward mutation model (AMES test) or Hamster mouse ovaries. The relationship between Androgen treatment and some cancer has been found, in experimental animal studies. Experimental data on rats has shown an increase in the rate of prostate cancer after treatment with Testerone.

Genital hormones are known to facilitate the development of some tumors caused by known cancer drugs. No correlation has been established between these findings and real risks in humans.

Before taking Androgel topical gel 50mg/5g besins support the treatment of male gonads (30 packs x 5g)

How to use

drugs used on the skin.

Dosage

Adults and elderly patients

The recommended dose is 5 g of gel (equivalent to 50 mg of testosterone) applied 1 time/day, at the same time, preferably in the morning. The daily dose is adjusted by the doctor, depending on the clinical response or testing on each patient, but not more than 10 g of gel/day. Should adjust the dose each time 2.5 g gel.

Applying the drug should be done by the patient on the healthy, clean and dry skin area on both shoulders or both arms or abdomen.

After opening the package, you must remove all the medicine inside the package and apply immediately to the skin. Apply gently on the skin into a thin layer. No, need to rub on the skin. Let dry for at least 3-5 minutes before wearing clothes. Wash your hands with water and soap after applying the drug.

Do not apply medicine to the genital area because high alcohol content has a on -site irritating card.

Testosterone concentration, plasma in a stable state reached about the second day of Androgel® treatment. To adjust the testosterone dose, serum testosterone levels must be measured in the morning. Before applying the drug from the third day onwards after the beginning of treatment (reasonable is 1 week). The dose can be reduced if the plasma testosterone levels increase above the desired level. If the plasma testosterone levels may increase the dose, no more than 10 g of gel/day.

Children

Androgel® is not indicated for children and has no clinical assessment in male children under 18 years old.
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 do

do when overdose? This is a case of a stroke in a patient with a high plasma testosterone level of 114 ng/ml (395 nmol/l). Very few are likely to achieve such high plasma testosferone levels when using sugar through the skin.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Androgel®, you may experience unwanted effects (ADR).

The most common side effects of the drug are observed in the recommended dose of 5 g of gel/day is the skin reaction (10%): The reaction at the position of topical, erythema, acne, dry skin.

The side effects of the drug are reported at 1 -

Common (1/100

Blood disorders and lymphatic systems: Changes in testing values (increased red blood cells, lipids).

Systemic disorders and medication: headache.

Kind and urinary disorders: Prostate disorders.

Reproductive disorders and mammary glands: Men's breast enlargement, breast pain.

Disorders of the body: dizziness, abnormalities, forgetting, increasing sensation.

Disrestation: Disorders of mood.

Pentecology: Hypertension.

Gastrointestinal disorders: diarrhea.

Skin and subcutaneous tissue: Hair loss, urticaria.

Men's breast enlargement, persistent, is a common finding in patients with genital gland reduction treatment.

According to the literature, unwanted effects have known to be reported after testosterone treatment or oral or injected and listed as follows:

Metabolic and nutrient disorders: weight gain, electrolyte changes (holding sodium, chlorid, potassium, calcium, calcium, inorganic and water phosphate) during high doses and/or prolonged treatment.

Muscle system: Muscle spasticity.

Sutras: restlessness, depression, hostility.

Respiratory system: sleep apnea.

Gifting liver: jaundice and abnormal liver function tests in very rare cases.

Skin and auxiliary parts: Different skin reactions may occur including acne, increased sebum secretion and baldness.

Reproductive and mammary disorders: Changes in sexual energy, increasing the frequency of erection, treatment with high doses of testosterone preparations often interrupt or reduce sperm production, thus reducing the size of the testicular recovery; Testosterone replacement therapy in reducing genital gland function in rare cases can cause erections, prolonged pain (penis pain), abnormal prostate, prostate cancer, urinary tract obstruction.

Systemic disorders and medication in place: Testosterone is high doses or prolonged occasional increasing water stasis and edema; Hypersensitivity reaction can occur.

Data on the risk of prostate cancer associated with indeterminate testosterone therapy.

The unwanted effects rarely related to excessive testosterone dose include the liver tumor.

Due to the alcohol content contained in the product, apply regularly to the skin can cause irritation and dryness.

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

Androgel® drug contraindicated in the following cases:

In case of knowing or resting in prostate cancer or breast carcinoma.

In case of hypersensitivity to testosterone or any ingredient of the drug.

for children under 18 years old.

Be cautious when used

Androgel® is only used if it is determined to reduce the energy of gonads (reducing the gonads due to increased and decreased gonadotropine) and has been eliminated other causes of symptoms before starting treatment. The deficiency of Estosterone must be clearly shown by the signs of the sexual properties (the development of secondary sexual characteristics, changes in body composition, weakness, reduced sexual, erection dysfunction, etc.) and is determined by two separate blood testosterone measurements. Currently, there is no consensus of specific reference testosterone value by age. However, it should be noted that the level of physiological testosterone is lower when age increases.

Due to the variation of testing values, all testosterone measurements should be done in the same laboratory.

Androgel® is not a medication for infertility in men or helplessly.

Before conducting testosterone treatment, all patients must be examined meticulously to eliminate the risk of prostate cancer in the past. Careful and regular monitoring of prostate and breasts must be monitored according to the recommended methods (rectal examination with fingers and estimates about prostate -specific antigens (PSA) in serum) at least once/year in patients taking testosterone therapy and 2 times/year in elderly patients and risk patients (those who have clinical or family -clinical elements).

Androgen can accelerate the progression of subclinical prostate cancer and hyperplasia.

Be cautious when taking Androgel® in patients with breast cancer in danger of hypercalcemia (and coordinated calcium hypercalcium), due to bone metastasis. Recommendations regularly monitor serum calcium concentration in these patients.

In patients with heart failure, liver failure or severe renal failure, Androgel® treatment can cause serious complications that manifest with edema, with or without congestion, in this case, it must be stopped immediately. In addition, may need diuretic therapy.

Be careful when taking Androgel® in patients with ischemic heart disease.

Testosterone can cause hypertension and need to be cautious when taking Androgel® in hamlet hypertension.

In addition to testosterone levels in patients treated with long -term androgen, periodic tests should be checked for the following test parameters: hemoglobin, hematocrit (to detect the possibility of witness, increase red blood cells), test liver function and determine the parameters of lipids.

Be cautious when taking Androgel® in patients with epilepsy and migraine (migraine) because it can be worse than these diseases.

There are reports published on increased risk of sleep apnea in subjects who are reduced gonads treated with testosterone esters, especially in people with risk factors such as obesity and chronic respiratory diseases.

Insulin sensitivity can be improved in patients treated with androgen are people with plasma testosterone levels at a normal level after treatment with alternative therapy.

Some clinical signs: easily stimulated, restless, weight gain, prolonged or regularly cans that show excessive use androgen, need to adjust the dose. If the patient has a severe reaction at the injection site, the treatment should be reviewed and stopped using the drug if necessary. Athletes should be noted that this separation contains active ingredients (testosterone) that can give false positive reactions in anti -doping tests.

Androgel® is not used for women because it can cause masculinity.

The potential shift of testosterone

If not cautious, Testosterone Gel can be transmitted to others during close skin exposure, resulting in increased serum testosterone levels and may have side effects (e.g. hair development in the face and/or body, broken voice, menstrual disorders) in the case of repeated contact (masculinated by chance).

Doctors need to notify patients on the risk of testosterone transmission and safety instructions. Androgel® is not prescribed for patients with a great risk of refusing to follow safety instructions (for example, severe alcoholism, drug abuse, severe mental disorders).

Wearing topical skin -covered clothes or bathing before contact allows to avoid this shift.

Recommendations for prudent measures

for patients

Wash your hands with water and soap after applying the gel.

When the gel is dry, wearing topical skin.

Shower bath before any case is expected to have this type of contact.

For people who are not treated with Androgel®

In case of contact with an over topical skin that has not been washed or not covered with clothes, it is necessary to wash immediately the skin that can testosterone transmitted as soon as possible, using water and soap.

Report on the appearance of masculinized signs such as acne or changing hair.

According to In vitro studies on the absorption of testosterone conducted with Androgel®, it is better for patients to wait at least 6 hours after applying the gel to bathe. Sometimes the patient bathes for a period of 1 to 6 hours after applying the gel, does not affect the treatment results.

To ensure the safety of your partner, advise patients to a long time from applying Androgel® until sex, wearing clothes to cover the drug area during contact or bathing before sex.

Moreover, it is recommended to wear clothes that cover the topical area during contact with children to avoid the risk of infection into children's skin.

Pregnant women must avoid any contact with Androgel®. In the case of a pregnant partner, the patient must pay more attention to caution.

The ability to drive and operate machinery

No research has been conducted on impact on the ability to drive and operate machinery.

pregnancy

Androgel® is only used for men.

Pregnant women must avoid any contact with topical places androgel®.

This drug may have side effects that cause fetal masculinity. In case of contact, washing with water and soap as soon as possible.

Breastfeeding period

No report.

Interactive drug

Oral anticoagulants

Change anticoagulant activity (increasing the effect of oral anticoagulant drugs due to changing holistic coagulation factors in the liver and inhibiting competition in cohesion with plasma proteins).

Recommended increased monitoring of prothrombin time and determining international standardized ratio (INR). Patients who are taking oral anticoagulant need to have close monitoring, especially when starting or stopping treatment with Androgen.

Simultaneous use of testosterone and acth or corticosteroid may increase the risk of edema. As a result, it is necessary to be cautious when using these drugs, especially in patients with heart, kidney or liver disease.

Interaction with tests

Androgen may reduce globulin concentration with thyroxin, resulting in a decrease in serum T4 concentration and increase the absorption of T3 and T4 plastic. However, the concentration of free armor hormone does not change and has no clinical evidence in terms of disability and thyroid.

Storage

Storage below 30 ° C.

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