Generic Medicine Info
Known or suspected carcinoma of the breast (in males) or prostate; current or history of liver tumours, hypercalcaemia or hypercalciuria; men with hypogonadal conditions which are not associated with genetic or structural etiologies (e.g. age-related hypogonadism). Serious cardiac, hepatic and renal disease (cypionate inj). Pregnancy and lactation.
Special Precautions
Patient with CV disease, ischaemic heart disease, coronary artery disease, hypertension, thrombophilia or risk factors for venous thromboembolism (VTE); epilepsy, migraine, existing or at risk of sleep apnoea (e.g. obesity, chronic lung diseases), depression; diabetes mellitus, benign prostatic hyperplasia; cancer patients at risk of hypercalcaemia or hypercalciuria (e.g. hypernephroma, bronchial carcinoma, skeletal metastases). Avoid treatment in men with previous MI or stroke within the past 6 months. Not indicated for use in women. Nasal gel: Not recommended for use in patients with history of nasal disorders, nasal or sinus surgery, nasal fracture (within the previous 6 months or which caused a deviated anterior nasal septum), mucosal inflammatory disorders (e.g. Sjogren's syndrome) and sinus disease. Renal and hepatic impairment. Elderly. Patient Counselling Transdermal gel: Do not wash the site or shower for at least 2-6 hours after application. Cover application site(s) with clothing after the gel has dried. Before any situation where direct skin-to-skin contact with another person is anticipated, wash or cover application site thoroughly (e.g. shower before sexual contact). Do not apply to genitals. Avoid fire, flame, or smoking until the gel has dried out. Patch: Avoid showering, swimming, or washing the site of administration for at least 3 hours after application. Do not apply on the scrotum. Monitoring Parameters Local guidelines for safety monitoring must be considered during therapy. Before starting treatment, ensure adequate blood pressure control and patient's baseline CV risk. Monitor serum total testosterone level at baseline and regularly during treatment; PSA and prostate examination (in men aged >40 years), haematocrit, and Hb prior to therapy, quarterly for the 1st 12 months of treatment, then yearly thereafter; LFTs and lipid profile; blood pressure prior to therapy, 3-6 weeks after initiation or dose adjustments then periodically thereafter; urine and serum Ca; bone mineral density after 1-2 years of therapy (in hypogonadal men with osteoporosis or low trauma fracture). After each inj, observe patients for 30 minutes to check for the occurrence of POME reactions or anaphylaxis (undecanoate IM inj). Assess patients for CV events, new-onset or worsening hypertension, depression, anxiety, mood changes, or suicidal ideation or behaviour.
Adverse Reactions
Significant: Hypercalcaemia, hypercalciuria; may increase risk of breast or prostate cancer; exacerbated benign prostatic hyperplasia, sleep apnoea; hepatic neoplasm, cholestatic hepatitis, jaundice (prolonged use); oedema with or without CHF, increased blood pressure which increases the risk of major CV events (e.g. MI, stroke), changes in serum lipid profile, VTE (e.g. pulmonary embolism, DVT, ocular thrombosis), polycythaemia, gynaecomastia, priapism, oligospermia, azoospermia; drug abuse resulting in CV and psychiatric events, drug dependence and withdrawal symptoms; depression, suicidal ideation; severe rhinitis (nasal gel); virilisation in secondarily exposed children (transdermal gel). Gastrointestinal disorders: Nausea, diarrhoea, abdominal pain or discomfort. General disorders and administration site conditions: Inj site reactions (e.g. pain, discomfort, pruritus, erythema, haematoma, irritation), fatigue, asthenia; transdermal gel and patch: application site reactions (e.g. rash, erythema, pruritus, vesicles). Immune system disorders: Hypersensitivity reactions. Investigations: Increased haematocrit, weight, RBC count, Hb, prostate-specific antigen (PSA), blood creatine phosphokinase, estradiol, testosterone; decreased serum LDL-C, HDL-C, triglycerides. Metabolism and nutrition disorders: Electrolyte changes; hypercholesterolaemia. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia; back pain (patch). Nervous system disorders: Headache, migraine, tremor, dizziness. Psychiatric disorders: Mood altered, nervousness. Renal and urinary disorders: Urinary obstruction or retention, nocturia, dysuria. Reproductive system and breast disorders: Prostate or breast induration, prostatitis, testicular pain, increased or decreased libido. Respiratory, thoracic and mediastinal disorders: Cough, sinusitis; nasopharyngitis, rhinorrhoea, epistaxis, nasal discomfort and scabbing, bronchitis, upper respiratory tract infection (nasal gel). Skin and subcutaneous tissue disorders: Pruritus, acne. Vascular disorders: Hypertension, hot flush.
Potentially Fatal: Benign and malignant liver tumours leading to intraabdominal haemorrhage (IM); pulmonary oil microembolism (POME) and anaphylaxis (IM esters particularly undecanoate inj); peliosis hepatis (prolonged use).
Drug Interactions
May decrease effect with enzyme inducers (e.g. rifampicin, barbiturates, carbamazepine, phenytoin, primidone, phenylbutazone, dichloralphenazone). May enhance the effect of coumarin-type anticoagulants (e.g. warfarin). May increase risk of oedema with corticosteroids or ACTH. May cause improved glucose tolerance; dose adjustment of insulins and other antidiabetic agents may be necessary. May decrease the total testosterone concentration with oxymetazoline (nasal gel).
ATC Classification
G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.
Disclaimer: This information is independently developed by CIMS based on testosterone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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