Depo-Testosterone 100 mg/ml is a naturally occurring sex hormone produced in a man's testicles. Small amounts of Depo-Testosterone 100 mg/ml are also produced in a woman's ovaries and adrenal system.
Depo-Testosterone 100 mg/ml is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty, impotence, or other hormonal imbalances. This medicine is not for use in treating low Depo-Testosterone 100 mg/ml without certain medical conditions or due to getting older.
Depo-Testosterone 100 mg/ml enanthate is used in women to treat breast cancer that has spread to other parts of the body (metastatic) and cannot be treated with surgery.
Depo-Testosterone 100 mg/ml will not enhance athletic performance and should not be used for that purpose.
Depo-Testosterone 100 mg/ml may also be used for purposes not listed in this medication guide.
Depo-Testosterone 100 mg/ml indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Depo-Testosterone 100 mg/ml Gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Depo-Testosterone 100 mg/ml:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum Depo-Testosterone 100 mg/ml concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low Depo-Testosterone 100 mg/ml serum concentrations, but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of Depo-Testosterone 100 mg/ml Gel 1% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of Depo-Testosterone 100 mg/ml Gel 1% in males less than 18 years old have not been established.
Topical Depo-Testosterone 100 mg/ml products may have different doses, strengths or application instructions that may result in different systemic exposure (1, 12.3).
How should I use Depo-Testosterone 100 mg/ml?
Use Depo-Testosterone 100 mg/ml solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Depo-Testosterone 100 mg/ml solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Depo-Testosterone 100 mg/ml solution refilled.
Prime this product before the first use. To prime it, depress the pump 3 times and wash any product that is dispensed down the sink.
Depress the pump once to fill the applicator cup. Holding the applicator upright, wipe Depo-Testosterone 100 mg/ml solution steadily up and down onto clean, dry skin in the armpit. If Depo-Testosterone 100 mg/ml solution drips or runs, it can be wiped back up with the applicator cup. Do NOT apply Depo-Testosterone 100 mg/ml solution to other parts of your body (eg, scrotum, penis, stomach, shoulders, upper arms). Do NOT apply it over open sores, wounds, or irritated skin.
Do NOT use your fingers or hand to rub the medicine into the skin.
You may need to alternate between armpits when applying Depo-Testosterone 100 mg/ml solution. Be sure you understand how to apply Depo-Testosterone 100 mg/ml solution. Contact your doctor or pharmacist if you have questions or concerns about how to apply Depo-Testosterone 100 mg/ml solution.
Wash your hands with soap and water immediately after using Depo-Testosterone 100 mg/ml solution.
Allow Depo-Testosterone 100 mg/ml solution to dry completely before dressing.
After Depo-Testosterone 100 mg/ml solution has dried, cover the application site (eg, with a shirt) to prevent others from coming into contact with Depo-Testosterone 100 mg/ml solution. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
After using Depo-Testosterone 100 mg/ml solution, rinse the applicator with room temperature water and pat it dry with a tissue. Replace the applicator and cap on the bottle for storage.
Do NOT get Depo-Testosterone 100 mg/ml solution in your eyes. If you do, rinse thoroughly with water. If eye irritation persists, contact your doctor.
Apply Depo-Testosterone 100 mg/ml solution at the same time every morning after showering or bathing, unless your doctor tells you otherwise.
If you are also using an antiperspirant or deodorant (stick or roll-on), apply it at least 2 minutes before you apply Depo-Testosterone 100 mg/ml solution.
For best results, wait 2 hours after applying Depo-Testosterone 100 mg/ml solution before you wash the application site or swim.
If you miss a dose of Depo-Testosterone 100 mg/ml solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Depo-Testosterone 100 mg/ml solution.
Uses of Depo-Testosterone 100 mg/ml in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Depo-Testosterone 100 mg/ml is a male hormone primarily used to treat deficiency or absence of naturally produced hormone Depo-Testosterone 100 mg/ml in men (hypogonadal disorders). The conditions include,
Testicular diseases (primary hypogonadism) - diseases or conditions of testes, the organ that produces Depo-Testosterone 100 mg/ml affecting secretion of Depo-Testosterone 100 mg/ml.
Pituitary diseases (secondary hypogonadism) - diseases or conditions of pituitary gland or hypothalamus that produce hormones (gonadotropins) which stimulate release of Depo-Testosterone 100 mg/ml.
In women, Depo-Testosterone 100 mg/ml may be used as a treatment to improve quality of life in women with advanced breast cancer.
Depo-Testosterone 100 mg/ml description
Depo-Testosterone 100 mg/ml is a steroid sex hormone found in both men and women. In men, Depo-Testosterone 100 mg/ml is produced primarily by the Leydig (interstitial) cells of the testes when stimulated by luteinizing hormone (LH). It functions to stimulate spermatogenesis, promote physical and functional maturation of spermatozoa, maintain accessory organs of the male reproductive tract, support development of secondary sexual characteristics, stimulate growth and metabolism throughout the body and influence brain development by stimulating sexual behaviors and sexual drive. In women, Depo-Testosterone 100 mg/ml is produced by the ovaries (25%), adrenals (25%) and via peripheral conversion from androstenedione (50%). Testerone in women functions to maintain libido and general wellbeing. Depo-Testosterone 100 mg/ml exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Depo-Testosterone 100 mg/ml may be further converted to dihydrotestosterone or estradiol depending on the tissue.
One system is applied at about the same time each day. The adhesive side of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS system should be placed on a clean, dry area of skin on the arm, back or upper buttocks immediately upon removal from the protective pouch. DO NOT APPLY TO THE SCROTUM. The area selected should not be oily, damaged, or irritated. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the system comes off after it has been worn for more than 12 hours and it cannot be reapplied, a new system may be applied at the next routine application time. In either case, the daily treatment schedule should be continued. The Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS system should be worn approximately 24 hours and then replaced. To ensure proper dosing, serum Depo-Testosterone 100 mg/ml concentration may be measured 2-4 hours after an application of Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS. If the serum Depo-Testosterone 100 mg/ml concentrations are low, the dosing regimen may be increased to 2 systems. Because of variability in analytical values among diagnostic laboratories, all Depo-Testosterone 100 mg/ml measurements should be performed at the same laboratory.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE
Patients should start therapy with a 6 mg/d system of either Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) or Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE applied daily; if the scrotal area cannot accommodate a 6 mg/d system, a 4 mg/d Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) system should be used. One Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) or Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE system should be placed on clean, dry, scrotal skin. Scrotal hair should be dry-shaved for optimal skin contact. Chemical depilatories should not be used. Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) or Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE should be worn 22-24 hours.
After 3-4 weeks of daily system use, blood should be drawn 2-4 hours after system application for determination of serum total Depo-Testosterone 100 mg/ml. Because of variability in analytical values among diagnostic laboratories, this laboratory work and later analyses for assessing the effect of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE therapy should be performed at the same laboratory.
If patients have not achieved desired results by the end of 6-8 weeks of treatment with any of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products, another form of Depo-Testosterone 100 mg/ml replacement therapy should be considered.
How supplied
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS, Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)), and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE Depo-Testosterone 100 mg/ml transdermal systems contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE systems are supplied as individually pouched systems, 30 per carton.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) 4 mg/d (Depo-Testosterone 100 mg/ml Transdermal System) -- each 40 cm2 system contains 10 mg Depo-Testosterone 100 mg/ml USP for nominal delivery of 4 mg for one day.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE
6 mg/d (Depo-Testosterone 100 mg/ml Transdermal System) -- each 60 cm2 system contains 15 mg Depo-Testosterone 100 mg/ml USP for nominal delivery of 6 mg for one day.
Store at controlled room temperature below 25oC (77oF).
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE
Store at room temperature 15-30oC (59-86oF).
Disposal
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.
Caution: Federal law prohibits dispensing without prescription.
REFERENCE
1. Matsumoto AM, Sandblom RE, Schoene RB et al. Depo-Testosterone 100 mg/ml replacement in hypogonadal men: Effects on obstructive sleep apnoea, respiratory drives, and sleep. Clin Endocrinol (1985) 22: 713-721.
2. Schneider BK, Pickett CK, Zwillich CW et al. Influence of Depo-Testosterone 100 mg/ml on breathing during sleep. J Appl Physiol (1986) 61: 618-623.
3. Matsumoto AM. Hormonal therapy of male hypogonadism. Endocrinol Metab Clin North Am. (1994) 23: 857-875.
5. Nieschlag E, Wang CCL. Guidelines for the use of androgens in men. Geneva: World Health Organization (1992); 1-16.
6. Walle T, Walle UK, Mathur RS et al. Propranolol metabolism in normal subjects: Association with sex steroid hormones. Curr Pharmacol Ther (1994) 56:127-132.
7. Physicians Generic Rx: The Complete Drug Reference. (1996); II-1972
Anticoagulants: C-17 substituted derivatives of Depo-Testosterone 100 mg/ml, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.
Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.
Propranolol: In a published pharmacokinetic study of an injectable Depo-Testosterone 100 mg/ml product, administration of Depo-Testosterone 100 mg/ml cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of Depo-Testosterone 100 mg/ml with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.7
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
The Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Depo-Testosterone 100 mg/ml than other skin sites, Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) or Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE will not produce adequate serum Depo-Testosterone 100 mg/ml concentrations if applied to non-scrotalskin.
Ingestion of Depo-Testosterone 100 mg/ml, or the contents of any of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products will not result in clinically significant serum Depo-Testosterone 100 mg/ml concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Depo-Testosterone 100 mg/ml from any of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products will not produce adequate serum Depo-Testosterone 100 mg/ml levels due to its short half-life (about 10 minutes).
Adverse events are reported in this section by product. Adverse events reported during use of a given product may occur in patients who are treated with any Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) product.
In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS, the most commonly reported adverse events were application site reactions of transient itching (12%) and moderate or severe erythema (3%).
Adverse events reported by less than 1% of Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS users in clinical trials that were of probable or unknown relationship to drug were:
Body as a Whole: abdominal pain, back pain, infection;
Urogenital System: abnormal ejaculation, breast pain, dysuria, urinary tract infection, and impaired urination.
Topical Reactions
Of 457 study participants, 3 men (1%) discontinued prematurely because of application site reactions.
There were no clinically significant differences in skin tolerability in younger (<65 years old) and older (³ 65 years old) subjects.
A contact sensitization rate of 0.5% for Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS was observed in a 6-week study of 233 normal male volunteers.
In one study with 14 days of daily use, 42% of patients reported 3 or more detachments of their Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS; of these detachments, 33% occurred during exercise.
In clinical studies of 104 patients treated with Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)), the most common adverse effects reported were local effects. In US clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort, or irritation at some time during therapy. Of all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation. All topical reactions decreased with duration of use.
The following adverse effects (greater than 1%) were reported in association with Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) therapy in 104 patients using the product for up to three years. These effects are listed in decreasing frequency of occurrence with the percentages of patients reporting the effect in parentheses: Gynecomastia (5%), acne (4%), prostatitis/urinary tract infection (4%), breast tenderness (3%), stroke (2%). For this same patient population, the following adverse effects were reported by 1% of users: memory loss, pupillary dilation, abnormal liver enzymes, scrotal cellulitis, deep vein phlebitis, benign prostatic hyperplasia, rectal mucosal lesion over prostate, hematuria/bladder cancer, papilloma on scrotum, and congestive heart failure.
Adverse Events with Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE
In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)). Other adverse events reported during the study were headache (6%), dizziness (6%), back pain, pain, nausea, and pustular rash (1% each).
General Adverse Events with Androgen Replacement Therapy
Skin and Appendages: Hirsutism, male pattern baldness, seborrhea, and acne.
Endocrine and Urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high doses.
Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests. Rare instances of hepatocellular neoplasms and peliosis hepatis have occurred.
Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic: Increased serum cholesterol.
Miscellaneous:Rarely, anaphylactoid reactions.
DRUG ABUSE AND DEPENDENCE
The Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.
Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) and Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Depo-Testosterone 100 mg/ml than other skin sites, Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) or Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) WITH ADHESIVE will not produce adequate serum Depo-Testosterone 100 mg/ml concentrations if applied to non-scrotalskin.
Ingestion of Depo-Testosterone 100 mg/ml, or the contents of any of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products will not result in clinically significant serum Depo-Testosterone 100 mg/ml concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Depo-Testosterone 100 mg/ml from any of the Depo-Testosterone 100 mg/ml (Depo-Testosterone 100 mg/ml (transdermal)) products will not produce adequate serum Depo-Testosterone 100 mg/ml levels due to its short half-life (about 10 minutes).
Depo-Testosterone 100 mg/ml Gel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
Depo-Testosterone 100 mg/ml Gel 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Depo-Testosterone 100 mg/ml Gel 1% may cause fetal harm when administered to a pregnant woman. Depo-Testosterone 100 mg/ml Gel 1% may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of Depo-Testosterone 100 mg/ml from men treated with Depo-Testosterone 100 mg/ml Gel 1%. If a pregnant woman is exposed to Depo-Testosterone 100 mg/ml Gel 1%, she should be apprised of the potential hazard to the fetus.
Active ingredient matches for Depo-Testosterone 100 mg/ml:
DailyMed. "TESTOSTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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