Androgel gel appearance. 1% 5g pack. 30 pc


Androgel gel appearance. 1% 5g pack. 30 pc


SKU: 466813276 Categories: , Tags: ,


Active substance:
Testosterone – 25 mg Excipients: isopropyl – 12.5 mg Carbomer 980 – 22.5 mg Sodium hydroxide – 118 mg, 96% ethanol – 1.785 g Purified water – 2.5 g
Transparent or slightly opalescent, colorless gel with alcohol odor.
Product form:
Gel for external use 10 mg / g.
2.5 or 5.0 g of gel in a single-dose packages of polyethylene laminated aluminum foil.
10 or 30 a package together with instructions for use in a cardboard box. 75 g of gel (60 doses of 1.25g of gel) in a plastic bottle with a pump-dispenser, provided with a protective cap.
1 bottle or vial 2 together with instructions for use in a cardboard box.
– the presence of breast carcinoma, prostate cancer or suspected of having it; – if available hypersensitivity to testosterone or to other components of the formulation. Experience in the use of AndroGel in women and children is missing.
Be wary – Malignant neoplasms (due to the risk of hypercalcemia and hypercalciuria). – Severe heart, liver or kidney failure. – Coronary artery disease. – Arterial hypertension. – Epilepsy. – Migraine.
1 %
Replacement therapy in endogenous testosterone deficiency.
Interaction with other drugs
Androgel® should be used with caution with oral anticoagulants, since it is possible potentiation of oral anticoagulants by synthesis modification hepatic coagulation factor and competitive inhibition of binding to plasma proteins. It is recommended to monitor the prothrombin time. Patients receiving oral anticoagulants require frequent monitoring, particularly at the beginning and / or end of a course of treatment with androgens.
Co-administration of testosterone and ACTH or corticosteroids may increase the risk of edema. These drugs must be administered with caution, especially in patients suffering from heart diseases, kidney or liver.
Effects on laboratory tests: androgens may reduce levels of thyroxine binding globulin, resulting in a decrease in serum concentrations of T4 and increase sensitivity to T3 and T4. Levels of free thyroid hormones, however, remain unchanged, while there are no clinical manifestations of hypothyroidism.
Cases of overdose when using Androgel is not fixed. Described only one case of overdose after application of testosterone administered by injection. It had a stroke in a patient with a high concentration of testosterone in the plasma 114 ng / ml (395 nmol / L). However, it is unlikely that such plasma testosterone concentrations can be achieved when applying the drug to the skin.
pharmachologic effect
Pharmacological group:
Pharmacological properties:
– Androgel® creates and maintains a steady level of testosterone within the physiological range, starting from the second day of treatment (for comparison – the equilibrium concentrations of testosterone when used in injectable form are established only between the 3rd and 5th injections, i.e., almost a year after initiation of therapy). – When using Androgel No adverse supraphysiological concentrations of testosterone peaks which inevitably arise in the appointment of injectables. This is reflected in the instructions to the drugs. Periods and hypogonadal supraphysiological concentrations of testosterone produced by injecting drugs increase the risk of adverse events (increased hematocrit, priapism, aggression, seizures, cardiovascular complications). – Androgel® can quickly cancel if necessary. After the cancellation of Androgel testosterone serum concentration returns to the values ​​that existed prior to the start of treatment, for a maximum of 4 days after the last application. (For comparison – the half-life prolonged injectables reaches 90 days.).
Endogenous androgens (mainly testosterone) secreted by the testes and its major metabolite dihydrotestosterone responsible for the development of external and internal genitals and for developing and maintaining secondary sexual characteristics (stimulating hair growth, deepening of the voice), libido; for the overall impact on protein anabolism; for the development of skeletal muscles and the distribution of subcutaneous fat; for reducing the excretion of nitrogen, sodium, potassium, chlorides, phosphates and water. Testosterone does not cause testicular development: it reduces the pituitary secretion of gonadotropins. Effects of testosterone on some target organs are shown after peripheral conversion of testosterone to estradiol, which then binds to the estrogen receptor in the nuclei of cells of target organs (such as the pituitary, adipose tissue, brain, bone, etc.).
The degree of absorption of testosterone through the skin ranges from about 9% to 14% of the applied dose. After absorption of testosterone through the skin enters the systemic circulation at relatively constant concentrations for 24 hours. testosterone concentration in serum increases with the first hour after administration of the drug Androgel®, reaching a constant value from the second day of treatment. Diurnal variation testosterone concentrations have the same amplitude as the observed changes in the circadian rhythms of endogenous testosterone. For external administration route of the drug are no peaks supraphysiological testosterone concentration in the blood resulting from the injection mode of administration. In contrast to oral androgen therapy, topical application of the preparation does not cause an increase in liver above physiological norms steroid concentrations. Application 5 g Androgel testosterone causes an average increase in plasma concentration of approximately 2.5 ng / ml (8.7 nmol / L). After the cessation of treatment testosterone concentration begins to decline after about 24 hours after the last dose. The concentration returned to baseline levels after about 72-96 hours after the last dose. The main active metabolites are dihydrotestosterone and testosterone estradiol. Androgel® excreted primarily in the urine and the faeces as conjugated testosterone metabolites.
Pregnancy and breast-feeding
Pregnant women should avoid all contact with the drug because of its possible virilizing effects on the fetus. In case of contact with the product must as a place of contact with soap can be cleaned more.
Conditions of supply of pharmacies
On prescription.
side effects
The most common adverse effects (about 10%) when using the recommended dose of 5 grams of gel per day were skin reactions at the site of application, erythema, acne, dry skin. In clinical trials Androgel following undesirable effects were observed (> 1/100
From the blood and lymphatic system: changes in the results of laboratory tests (polycythaemia, lipids level change).
With the genitourinary system: changes in the prostate gland, gynecomastia, mammalgia.
From the nervous system: dizziness, paraesthesia, amnesia, hyperaesthesia, mood changes.
Cardio-vascular system: increased blood pressure.
On the part of the gastrointestinal tract: diarrhea.
Of the skin and its appendages: alopecia, rash.
General disorders: headache. The drug contains alcohol, so when it is often applied to the skin may appear irritation and dryness.
special instructions
Androgel® be used only with testosterone deficiency accompanied by such clinical manifestations as hypoplasia or regression of secondary sexual characteristics, change body structure, impaired carbohydrate and lipid metabolism, obesity, asthenia, sexual dysfunction (decreased libido, erectile dysfunction, etc.) , decreased bone mineral density, mood swings, depression, hot flashes, etc. Before treatment should be excluded other possible causes underlying the above symptoms. Currently, there is no clear age norms testosterone values. However, it should be taken into account that physiological levels of serum testosterone levels begin to decline from 30-40 years, and the level of globulin binding sex steroids increases. This, accordingly, leads to a decrease in the level of biologically active testosterone.
Due to variability in laboratory values, determination of the concentration of testosterone must be carried out in the same laboratory.
Androgel® not used to treat infertility or male erectile dysfunction, the cause of which is not associated with testosterone deficiency.
Prior to the appointment of testosterone, all patients should be evaluated to rule out the risk of having prostate cancer, since androgens may accelerate the progression of sub-clinical prostate cancer and benign prostatic hyperplasia. Should be careful and regular monitoring of the condition of the prostate (digital rectal examination, determination of prostate-specific antigen (PSA) in serum) and the breast at least once a year, and in elderly patients and patients at risk (clinical or family factors) – twice a year.
testosterone drugs should be used with caution in patients with malignancies at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. In these patients, it is recommended to control calcium concentration in the serum.
In patients suffering from severe cardiac, hepatic or renal insufficiency, treatment with testosterone preparations can cause complications characterized by edema with congestive heart failure or without her. In this case, treatment should be discontinued immediately. In addition, you may need to diuretic therapy. Patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentration is necessary periodically to check the following laboratory findings: hemoglobin, hematocrit (to detect polycythemia), liver function tests and lipid profile.
Data were published to increase the risk of sleep apnea in hypogonadal patients treated with testosterone esters, especially in those who had risk factors such as obesity and chronic respiratory disease.
In patients with diabetes receiving androgens, when the normal concentration of testosterone in the blood plasma can be observed an increase in insulin sensitivity.
Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment. If the patient develops a severe local reaction, the treatment should be reviewed and, if necessary, discontinued. When using Androgel athletes need to take into account the fact that this drug contains an active substance (testosterone) which may produce a positive reaction in anti-doping tests.
Impact on the ability to drive a car and other mechanisms
There is currently no data on the effect of Androgel on ability to drive a car and to operate machinery.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children.
Dosing and Administration
The recommended dose of 5 grams of gel (i.e. 50 mg of testosterone) used 1 time per day at about the same time, preferably in the morning. Individual daily dose may be adjusted by the physician according to clinical and laboratory parameters in patients, but should not exceed 10 g of gel per day. Correction dosing regimen should be performed in steps of 2.5 g of gel per day.
The gel is applied to the clean, dry intact skin shoulders, shoulder girdle and / or abdomen. In applying the drug in the vial for a full dose of the extract must first fill capacity pump-dispenser. To do so, keep the container upright, slowly and fully depress the pump dispenser to 5 times. After the first five strokes throw the resulting gel with caution. Filling capacity pump-dispenser is necessary only to provide a first dose of the extract. After the procedure, the pump-dispenser container filling press the pump dispenser 1 time to release one dose of the extract of 1.25 g of gel, containing 12.5 mg of testosterone.
The gel must be removed from the vial or from the packet directly to the palm, and then applied to the appropriate application site. After opening the package, you must immediately put on your skin and all of its contents spread a thin layer.
Not necessarily Androgel® rubbed into the skin. Give the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap and water after application. Do not apply the gel on the genital area as a high content of ethanol in the product may cause local irritation.
Permanent testosterone plasma concentration is achieved approximately at the second day of treatment Androgel®. To adjust the testosterone dose necessary to determine the concentration of testosterone in the serum in the morning, before the use of the drug, from the third day after the start of treatment (within one week). The dosage may be reduced if the testosterone plasma levels increased. If low concentrations, the dose can be increased, but no more than up to 10 g of gel per day.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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