testosterone suspension

International nonproprietary name:

testosterone suspension

Dosage Form:

pills

Composition per tablet.

Active substance:
testosterone suspension -0.0005 g

Excipients:
– to obtain tablets with a weight of 0.15 g
potato starch -0.0340 g
sucrose (sugar) -0.1140 g
Starinov acid -0.0015 g

Description

Tablets of white color, Valium chamfered.

Pharmacological group:

glucocorticosteroid.

Indications for use:

Systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, periarteritis nodosa. Dermatomyositis, rheumatoid arthritis).

Acute and chronic inflammatory joint diseases: gout and psoriatic arthritis, osteoarthritis (including post-traumatic), arthritis, frozen shoulder, ankylosing spondylitis (ankylosing spondylitis), juvenile arthritis, Still’s syndrome in adults, bursitis, nonspecific tenosynovitis, synovitis and epicondylitis .

Rheumatic fever, acute rheumatic heart disease.

Acute and chronic allergic diseases: allergic reactions to medicines and foods, serum sickness, urticaria, allergic rhinitis, angioedema, drug rash, hay fever.

Skin diseases: pemphigus, psoriasis, eczema, atopic dermatitis, atopic dermatitis. contact dermatitis (with damage to a large surface of the skin), drug reaction, seborrheic dermatitis, exfoliative dermatitis, toxic epidermal necrolysis (Lyell’s syndrome), bullous dermatitis herpetiformis, malignant exudative erythema (Stevens-Johnson syndrome).

Brain edema (including on the background or brain tumors associated with surgery, radiotherapy or head trauma) after pre parenteral use.

Allergic eye diseases: allergic corneal ulcers, allergic form of conjunctivitis.

Inflammatory eye diseases: sympathetic ophthalmia, severe lingering front and rear uveitis, optic neuritis.

Primary or secondary adrenocortical insufficiency (including the state after the removal of the adrenal glands).

Congenital adrenal hyperplasia.

Kidney disease of autoimmune origin (including acute glomerulonephritis): nephrotic syndrome.

Subacute thyroiditis.

Diseases of the blood – agranulocytosis, panmielopatiya, autoimmune hemolytic anemia, acute myeloid leukemia and lymphoma, Hodgkin’s disease, thrombocytopenic purpura, secondary thrombocytopenia in adults, erythroblastopenia (erythrocytic anemia), congenital (erythroid) hypoplastic anemia.

Lung disease: acute alveolitis. lung fibrosis, sarcoidosis stage II-III. Bronchial asthma (bronchial asthma drug is only indicated for severe, inefficiency or inability to take inhaled corticosteroids).

TB meningitis, pulmonary tuberculosis, aspiration pneumonia (in combination with a specific chemotherapy).

Beryllium, Loeffler’s syndrome (not amenable to other therapy).

Lung cancer (in combination with cytostatics).

Multiple sclerosis.

Gastrointestinal disease: ulcerative colitis, Crohn’s disease, a local enteritis.

Hepatitis.

Prophylaxis of transplant rejection reactions in the complex therapy.

Hypercalcemia on the background of cancer, nausea and vomiting during cytostatic therapy.

Multiple myeloma.

Conducting tests in the differential diagnosis of hyperplasia (hyperfunction) and tumors of the adrenal cortex.

Contraindications

For short-term use in the “real life” testimony only contraindication is hypersensitivity. Children under 3 years old.

Carefully

Parasitic and infectious diseases of viral, fungal or bacterial origin (currently or recently transferred, including the recent contact with a patient) – herpes simplex, herpes zoster (viremicheskaya phase), chicken pox, measles: amoebiasis, strongyloidiasis (or suspected); systemic mycosis; active or latent tuberculosis. Application for serious infectious diseases is admissible only against the background of specific antimicrobial therapy.

Pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (incl, acquired immune deficiency syndrome or the human immunodeficiency virus (HIV infection).

Diseases of the gastrointestinal tract: stomach ulcer and 12 duodenal ulcer. esophagitis, gastritis, acute or latent peptic ulcer, recently established intestinal anastomosis, ulcerative colitis, with the threat of perforation or abscess formation, divertiku-

Diseases of the cardiovascular system, including recent myocardial infarction (in patients with acute and subacute myocardial infarction may spread necrosis, slowing the formation of scar tissue, and as a consequence – the gap of the heart muscle), decompensated chronic heart failure, hypertension, hyperlipidemia.

Endocrine diseases – diabetes mellitus (including breach of tolerance to carbohydrates), hyperthyroidism, hypothyroidism, Cushing’s disease. obesity (1II-1V step).

Severe chronic renal and / or hepatic insufficiency, nefrourolitiaz.

Hypoalbuminemia and conditions predisposing to its occurrence.

Systemic osteoporosis, myasthenia gravis, acute psychosis, polio (excluding the bulbar form of encephalitis), open-and-closure glaucoma, the period of lactation.

Application of pregnancy and during breastfeeding

In pregnancy, the drug is used only in cases where the potential benefit to the mother outweighs the potential risk to the fetus. When long-term therapy in pregnancy does not exclude the possibility of fetal growth. In case of application in the III trimester of pregnancy there is a risk of atrophy of the fetal adrenal cortex, which may necessitate replacement therapy in the newborn. If you want to treat drug but during breastfeeding, the breast-feeding should be discontinued.

Dosage and administration:

Inside, in individually selected doses, the magnitude of which is determined by the kind of disease. its activity and the degree of patient response character.

The average daily dose – 0.75-9 mg. In severe cases, there may be used and higher doses separated by 3-4 reception. The maximum daily dose – usually 15 mg. After achieving a therapeutic effect dose was gradually reduced (usually 0.5 mg to 3 days) to maintenance – 2-4.5 mg / day. The minimum effective dose – 0.5-1 mg / day.

Babies (depending on age) designate 83.3-333.3 mg / kg or 2.5-10 mg / sq. m / day in 3-4 divided doses.

The time of application depends on the nature of testosterone suspension pathologic process and the effectiveness of treatment, ranging from several days to several months or more. Treatment stopped gradually (after multiple injections administered corticotropin).

In bronchial asthma, rheumatoid arthritis, ulcerative colitis – 1.5-3 mg / day; in systemic lupus erythematosus – 2-4.5 mg / day; in hematologic malignancies -7,5-10 mg.

For treatment of acute allergic diseases is expedient to combine parenteral and oral administration: 1 day – 4-8 mg parenterally; Day 2 – inside. 4 mg 3 times per day; 3, Day 4 – inside. 4 mg 2 times a day; 5. Day 6 – 4 mg / day. inside; Day 7 – removal of the drug.

Test with testosterone suspension (Liddle test). It held in the form of small and large tests. When small test patient testosterone suspension give 0.5 mg every 6 hours during the day (i.e., 8 a.m., 14 hours. 2 hours and 20 am). Urine to determine the 17-hydroxycorticosteroids or free cortisol was collected from 8 a.m. to 8 a.m. two days before the destination as testosterone suspension and 2 days in the same time intervals after administration of said doses of testosterone suspension. These dose testosterone suspension inhibits the formation of corticosteroids in almost all healthy individuals. After 6 hours after the last dose of testosterone suspension cortisol plasma levels below 135-138 nmol / l (less than 4.5-5 g / 100 ml). Reduced clearance 17 oxycorticosteroids below 3 mg / day. and free cortisol below 54-55 nmol / day (less than 19-20 mg / day) excludes the hyperactivity of the adrenal cortex. In individuals. suffering from a disease or syndrome, Cushing’s is not observed during the small changes in the secretion of corticosteroids test.

During the test a large testosterone suspension administered 2 mg every 6 hours for 2 days (i.e., 8 mg testosterone suspension per day). Also conduct urine collection to determine the 17-oxycorticosteroids or free cortisol (if necessary define free cortisol in plasma). In Cushing’s disease there is a decrease excretion 17 glucocorticoids or free cortisol by 50% or more, while for tumors of the adrenal glands or ectopic adrenocorticotropic, (or corticotropin-zktopirovannom) syndrome excretion of corticosteroids is not changed. In some patients with ectopic ACTH syndrome, reducing the excretion of corticosteroids is not detected even after receiving testosterone suspension at a dose of 32 mg / day.

Side effect

The frequency and severity of side effects depend on the duration of application, size of the dosage used and the possibility of compliance circadian rhythm of destination. Usually testosterone suspension was well tolerated. It has low mineralocorticoid activity, i.e. its effect on water and electrolyte metabolism is low. Typically, the low and medium dose of testosterone suspension did not cause the delay of sodium and water in the body, increased excretion of potassium. We describe the following side effects:

From endocrine system: reduction of glucose tolerance, “steroid” diabetes or a manifestation of latent diabetes mellitus, adrenal suppression, Cushing’s syndrome (moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae ). delayed sexual development in children.

From the digestive system: nausea, vomiting, pancreatitis, “steroid” stomach ulcers and 12 duodenal ulcer, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups in rare cases – increase in the activity of “liver. “transaminase and alkaline phosphatase.

Cardio-vascular system: arrhythmia, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of chronic heart failure, electrocardiographic changes typical of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. Patients with acute and subacute myocardial infarction – the spread necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, ver th. pseudotumor cerebellum, headache, convulsions.

From the senses: posterior subcapsular cataracts, increased intraocular pressure with possible damage to the optic nerve, the propensity to develop secondary bacterial, fungal or viral eye infections, trophic changes of the cornea, exophthalmos.

On the part of metabolism: increased excretion of calcium ions, hypocalcemia. increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating.

Conditional mineralokortikosteroidnoy activity – Fluid retention and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue.).

From the musculoskeletal system: slowing growth and ossification processes in children (premature closure of epiphyseal growth zones), ostsoporoz (rarely -patologicheskie fractures, aseptic necrosis of the humeral head and femur), rupture of tendons of muscles, “steroid” myopathy, reduced muscle mass (atrophy).

For the skin and mucous membranes: delayed wound healing, petechiae, ecchymosis. thinning of the skin, atrophy of the skin and subcutaneous tissue, hyper- or hypopigmentation, “steroid” acne, striae. the tendency to the development of pyoderma and candidiasis.

Allergic reactions: generalized (skin rash, itching skin, anaphylactic shock), local allergic reactions.

Other: development or exacerbation of infection (the appearance of this side effect contribute jointly used immunosuppressants and vaccination), leucocyturia. “cancellation” syndrome.

Overdose

Perhaps increased dose-related side effects, except for allergic reactions. It is necessary to reduce the dose of testosterone suspension. Treatment is symptomatic.

Interaction with other drugs

testosterone suspension increases the toxicity of cardiac glycosides (because of the emerging hypokalemia increases the risk of arrhythmias).

Accelerating the elimination of acetylsalicylic acid, reduces its concentration in the blood (with the abolition of testosterone suspension concentration of salicylates in the blood increases, and increases the risk of side effects).

While the use of live virus vaccines, and in comparison with other types of immunization increases the risk of activation of viruses and the development of infections.

Increases isoniazid metabolism, mexiletine (especially for “fast acetylators”), which leads to a decrease in their plasma concentrations.

It increases the risk of hepatotoxic action of paracetamol (induction of “liver” enzymes and formation of toxic metabolite of paracetamol).

Increases (long-term therapy) folic acid content.

Hypokalemia caused by corticosteroids may increase the severity and duration of muscle blockade on the background of muscle relaxants,

In high doses, it reduces the effect of somatropin.

Antacids reduce the absorption of glucocorticosteroid agents.

testosterone suspension reduces the effect of hypoglycemic drugs: increases the anticoagulant effect of coumarin derivatives.

Reduces the impact of vitamin D on the absorption of calcium ions into the lumen of the intestine. Ergocalciferol and parathyroid hormone hinder the development of osteopathy caused by corticosteroids.

Reduces prazikvantsla concentration in the blood.

Cyclosporine (inhibits metabolism) and ketoconazole (reduced clearance) increases the toxicity.

Thiazide diuretics, carbonic anhydrase inhibitors. other glucocorticosteroids and amphotericin B increase the risk of hypokalemia. sodium-containing medicines – edema and high blood pressure.

Nonsteroidal anti-inflammatory drugs and ethanol increase the risk of ulceration of the mucous membrane of the gastrointestinal tract, bleeding, in combination with non-steroidal anti-inflammatory drugs to treat arthritis may reduce the dose of corticosteroids due terapevticheskog summation of effect.

Indomethacin, displacing testosterone suspension from its association with albumin, increases the risk of its side effects.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of gluco corticosteroid is reduced under the influence of phenytoin. barbiturates, ephedrine, theophylline, rifampicin and other inducers of “liver” microsomal enzymes (increased metabolic rate).

Mitotane and other inhibitors of adrenocortical function may necessitate increasing the dose of corticosteroids.

Clearance of glucocorticosteroids increases against the backdrop of shitovidnoy gland hormones.

Immunosuppressive drugs increase the risk of infections and lymphoma or other lymphoproliferative disorders caused by the Epstein-Barr virus.

Estrogens (including oral contraceptives estrogensoderzhaschie) glucocorticosteroids reduce clearance, half-life, and prolong their therapeutic and toxic effects.

The appearance of hirsutism and acne promotes the simultaneous use of other steroid hormonal drugs – androgens, estrogens, anabolic steroids, oral contraceptives.

Tricyclic antidepressants may enhance the severity of depression caused by taking corticosteroids (not shown for the treatment of side effects data).

The risk of developing cataracts increases with the use of the background of other glucocorticosteroids. antipsychotic drugs (neuroleptics) karbutamida and azathioprine.

Simultaneous with the appointment of m-holinoblokatorami (including antihistamine drugs, tricyclic antidepressants), nitrates promotes increased intraocular pressure.

special instructions

Before and during glucocorticosteroid therapy should be monitored blood count, blood glucose level and electrolyte content in the plasma.

Appointing testosterone suspension during intercurrent infections, septic conditions, and tuberculosis, it is necessary to treat at the same time bactericidal antibiotics.

With daily application to 5 months of treatment developed atrophy of the adrenal cortex.

May mask some signs of infections: during treatment useless immunize.

With the sudden cancellation of corticosteroids, especially in the case of the prior use of high doses. there is a syndrome of “cancellation” of glucocorticosteroids (not due gipokortitsizm): loss of appetite, nausea, lethargy, generalized musculoskeletal pain, fatigue, and may occur and acute adrenal insufficiency (decrease in blood pressure, arrhythmia, sweating, weakness, oligoanuria, vomiting. abdominal pain, diarrhea, hallucinations, fainting, coma).

After the cancellation within a few months is maintained relative adrenal insufficiency. If during this period there stressors administered (indicated) at the time of glucocorticoids, optionally in combination with mineralokortikosteroidami.

In children, during long-term treatment should be carefully monitored for the dynamics of growth and development. Children who during the treatment period were in contact with patients with measles or chickenpox, prophylaxis prescribe specific immunoglobulins.

During treatment with testosterone suspension (especially long) must be monitored ophthalmologist, control of blood pressure and fluid and electrolyte balance, as well as patterns of peripheral blood and the blood glucose level. In order to reduce the side effects can be prescribed anabolic steroids, antacids. and increase the flow of potassium ions in body (diet, potassium supplements). Food must be rich in potassium ions, proteins, vitamins, containing small amounts of fats, carbohydrates and salts.

The children in the growth period glyukokortikostsroidy should be used only if absolutely indicated and iodine especially careful supervision of a doctor.

Ability to influence the reaction rate when driving or working with other mechanisms.

Use caution when driving and busy with other potentially hazardous activities that require high concentration and speed of psychomotor reactions, because the drug can cause dizziness and others. Side effects that may affect these abilities. “ online anabolic steroids pharmacy

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