Actions of Testoviron Depot 100 in details
Pharmacology: Pharmacodynamics: Testoviron Depot 100 is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life, Testoviron Depot 100 is essential for the functioning of the testes and accessory structures, and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function.
Treatment of hypogonadal men with Testoviron Depot 100 results in a clinically significant rise of plasma concentrations of Testoviron Depot 100, dihydrotestosterone and androstenedione, as well as a decrease of sex hormone-binding globulin (SHBG). In males with primary (hypergonadotropic) hypogonadism, treatment with Testoviron Depot 100 results in a normalization of gonadotropin levels.
Pharmacokinetics: Following oral administration of Testoviron Depot 100, an important part of Testoviron Depot 100 undecanoate is co-absorbed with the lipophilic solvent from the intestine into the lymphatic system, thus circumventing the first-pass inactivation by the liver. During absorption, Testoviron Depot 100 undecanoate is partly reduced to dihydrotestosterone undecanoate. From the lymphatic system, it is released into the plasma. In plasma and tissues, both Testoviron Depot 100 undecanoate and dihydrotestosterone undecanoate are hydrolyzed to yield the natural male androgens Testoviron Depot 100 and dihydrotestosterone. Single administration of Testoviron Depot 100 80-160 mg leads to a clinically significant increase of total plasma Testoviron Depot 100 with peak-levels of approximately 40 nmol/L (Cmax), reached approximately 4-5 hrs (Tmax) after administration. Plasma Testoviron Depot 100 levels remain elevated for at least 8 hrs. Testoviron Depot 100 and dihydrotestosterone are metabolized via the normal pathways. Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.
Toxicology: Preclinical Safety Data: Preclinical data reveal no hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
How should I take Testoviron Depot 100?
Testoviron Depot 100 is injected under the skin or into a muscle, usually given every 2 to 4 weeks. Xyosteds should be given only by a healthcare professional.
The length of treatment with Testoviron Depot 100 will depend on the condition being treated.
Testoviron Depot 100 can raise your blood pressure, which could increase your risk of heart attack, stroke, or death. Your blood pressure will need to be checked often. You may need to stop using Testoviron Depot 100 or start taking blood pressure medication.
You will need frequent blood tests.
Testoviron Depot 100 can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.
Testoviron Depot 100 can affect the results of certain medical tests. Tell any doctor who treats you that you are using Testoviron Depot 100.
Misuse of Testoviron Depot 100 can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence. Stealing, selling, or giving away this medicine is against the law.
If you have used too much Testoviron Depot 100, stopping the medicine may caused unpleasant withdrawal symptoms, such as depression, tiredness, irritability, loss of appetite, sleep problems, or decreased libido.
Testoviron Depot 100 administration
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Apply the Testoviron Depot 100 topical (transdermal) patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Apply your patch at the same time each evening.
Choose a different skin area to wear each new patch you put on. You should not use the same skin area twice in a 7-day period.
After removing a patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.
Apply the Testoviron Depot 100 gel at the same time each day (preferably in the morning) to clean, dry, unbroken skin on the shoulders or upper arms. Open the gel pouch, and squeeze the entire contents onto the palm of your hand. Apply the gel right away and allow it to dry for at least 5 minutes before you dress. Wash your hands with soap and water after applying the gel.
Do not apply Testoviron Depot 100 gel to your penis or your scrotum. The Testoviron Depot 100 brand of Testoviron Depot 100 gel should also not be applied to your stomach area.
It is best to cover treated skin areas with clothing while using Testoviron Depot 100 gel. This will help prevent getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.
To be sure this medicine is helping your condition, your blood will need to be tested often. Your prostate or liver function may also need to be tested. Visit your doctor regularly.
Use Testoviron Depot 100 topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture and heat. Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged.
Testoviron Depot 100 pharmacology
Mechanism of Action
Endogenous androgens, including Testoviron Depot 100 and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal chord thickening, alterations in body musculature and fat distribution. Testoviron Depot 100 and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of Testoviron Depot 100, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
Pharmacodynamics
No specific pharmacodynamic studies were conducted using Testoviron Depot 100 Gel 1%.
Pharmacokinetics
AbsorptionTestoviron Depot 100 Gel 1% delivers physiologic amounts of Testoviron Depot 100, producing circulating Testoviron Depot 100 concentrations that approximate normal concentrations (298 to 1043 ng/dL) seen in healthy men. Testoviron Depot 100 Gel 1% provides continuous transdermal delivery of Testoviron Depot 100 for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen.
Testoviron Depot 100 Gel 1% is a hydroalcoholic formulation that dries quickly when applied to the skin surface. The skin serves as a reservoir for the sustained release of Testoviron Depot 100 into the systemic circulation. Approximately 10% of the Testoviron Depot 100 dose applied on the skin surface from Testoviron Depot 100 Gel is absorbed into systemic circulation. In a study with Testoviron Depot 100 Gel 1% 100 mg, all patients showed an increase in serum Testoviron Depot 100 within 30 minutes, and eight of nine patients had a serum Testoviron Depot 100 concentration within normal range by 4 hours after the initial application. Absorption of Testoviron Depot 100 into the blood continues for the entire 24-hour dosing interval. Serum concentrations approximate the steady-state concentration by the end of the first 24 hours and are at steady state by the second or third day of dosing.
With single daily applications of Testoviron Depot 100 Gel 1%, follow-up measurements 30, 90 and 180 days after starting treatment have confirmed that serum Testoviron Depot 100 concentrations are generally maintained within the eugonadal range. Figure 1 summarizes the 24-hour pharmacokinetic profiles of Testoviron Depot 100 for hypogonadal men (less than 300 ng/dL) maintained on Testoviron Depot 100 Gel 1% 50 mg or 100 mg for 30 days. The average (± SD) daily Testoviron Depot 100 concentration produced by Testoviron Depot 100 Gel 1% 100 mg on Day 30 was 792 (± 294) ng/dL and by Testoviron Depot 100 Gel 1% 50 mg 566 (± 262) ng/dL.
Figure 1: Mean (± SD) Steady-State Serum Testoviron Depot 100 Concentrations on Day 30 in Patients Applying Testoviron Depot 100 Gel 1% Once Daily
Distribution
Circulating Testoviron Depot 100 is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of Testoviron Depot 100 in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins.
Metabolism
Testoviron Depot 100 is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of Testoviron Depot 100 are estradiol and dihydrotestosterone (DHT).
DHT concentrations increased in parallel with Testoviron Depot 100 concentrations during Testoviron Depot 100 Gel 1% treatment. The mean steady-state DHT/T ratio during 180 days of Testoviron Depot 100 Gel treatment ranged from 0.23 to 0.29 (50 mg of Testoviron Depot 100 Gel 1%/day) and from 0.27 to 0.33 (100 mg of Testoviron Depot 100 Gel 1%/day).
Excretion
There is considerable variation in the half-life of Testoviron Depot 100 concentration as reported in the literature, ranging from 10 to 100 minutes. About 90% of a dose of Testoviron Depot 100 given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of Testoviron Depot 100 and its metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of Testoviron Depot 100 occurs primarily in the liver.
When Testoviron Depot 100 Gel 1% treatment is discontinued after achieving steady state, serum Testoviron Depot 100 concentrations remain in the normal range for 24 to 48 hours but return to their pretreatment concentrations by the fifth day after the last application.
Testoviron Depot 100 Transfer from Male Patients to Female Partners
The potential for dermal Testoviron Depot 100 transfer following Testoviron Depot 100 Gel 1% use was evaluated in a clinical study between males dosed with Testoviron Depot 100 Gel 1% and their untreated female partners. Two (2) to 12 hours after application of 100 mg of Testoviron Depot 100 administered as Testoviron Depot 100 Gel 1% by the male subjects, the couples (N = 38 couples) engaged in daily, 15-minute sessions of vigorous skin-to-skin contact so that the female partners gained maximum exposure to the Testoviron Depot 100 Gel 1% application sites. Under these study conditions, all unprotected female partners had a serum Testoviron Depot 100 concentration >2 times the baseline value at some time during the study. When a shirt covered the application site(s), the transfer of Testoviron Depot 100 from the males to the female partners was completely prevented.
References
- DailyMed. "TESTOSTERONE PROPIONATE: 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).
- 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).
- NCIt. "Testosterone Propionate: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
