Actions of Uniteston in details
Pharmacology: Pharmacodynamics: Uniteston is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life, Uniteston 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 Uniteston results in a clinically significant rise of plasma concentrations of Uniteston, dihydrotestosterone and androstenedione, as well as a decrease of sex hormone-binding globulin (SHBG). In males with primary (hypergonadotropic) hypogonadism, treatment with Uniteston results in a normalization of gonadotropin levels.
Pharmacokinetics: Following oral administration of Uniteston, an important part of Uniteston 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, Uniteston undecanoate is partly reduced to dihydrotestosterone undecanoate. From the lymphatic system, it is released into the plasma. In plasma and tissues, both Uniteston undecanoate and dihydrotestosterone undecanoate are hydrolyzed to yield the natural male androgens Uniteston and dihydrotestosterone. Single administration of Uniteston 80-160 mg leads to a clinically significant increase of total plasma Uniteston with peak-levels of approximately 40 nmol/L (Cmax), reached approximately 4-5 hrs (Tmax) after administration. Plasma Uniteston levels remain elevated for at least 8 hrs. Uniteston 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 Uniteston?
Uniteston 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 Uniteston will depend on the condition being treated.
Uniteston 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 Uniteston or start taking blood pressure medication.
You will need frequent blood tests.
Uniteston 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.
Uniteston can affect the results of certain medical tests. Tell any doctor who treats you that you are using Uniteston.
Misuse of Uniteston 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 Uniteston, stopping the medicine may caused unpleasant withdrawal symptoms, such as depression, tiredness, irritability, loss of appetite, sleep problems, or decreased libido.
Uniteston 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 Uniteston 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 Uniteston 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 Uniteston gel to your penis or your scrotum. The Uniteston brand of Uniteston gel should also not be applied to your stomach area.
It is best to cover treated skin areas with clothing while using Uniteston 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 Uniteston 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.
Uniteston pharmacology
Mechanism of Action
Endogenous androgens, including Uniteston 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. Uniteston and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of Uniteston, 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 Uniteston Gel 1%.
Pharmacokinetics
AbsorptionUniteston Gel 1% delivers physiologic amounts of Uniteston, producing circulating Uniteston concentrations that approximate normal concentrations (298 to 1043 ng/dL) seen in healthy men. Uniteston Gel 1% provides continuous transdermal delivery of Uniteston for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen.
Uniteston 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 Uniteston into the systemic circulation. Approximately 10% of the Uniteston dose applied on the skin surface from Uniteston Gel is absorbed into systemic circulation. In a study with Uniteston Gel 1% 100 mg, all patients showed an increase in serum Uniteston within 30 minutes, and eight of nine patients had a serum Uniteston concentration within normal range by 4 hours after the initial application. Absorption of Uniteston 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 Uniteston Gel 1%, follow-up measurements 30, 90 and 180 days after starting treatment have confirmed that serum Uniteston concentrations are generally maintained within the eugonadal range. Figure 1 summarizes the 24-hour pharmacokinetic profiles of Uniteston for hypogonadal men (less than 300 ng/dL) maintained on Uniteston Gel 1% 50 mg or 100 mg for 30 days. The average (± SD) daily Uniteston concentration produced by Uniteston Gel 1% 100 mg on Day 30 was 792 (± 294) ng/dL and by Uniteston Gel 1% 50 mg 566 (± 262) ng/dL.
Figure 1: Mean (± SD) Steady-State Serum Uniteston Concentrations on Day 30 in Patients Applying Uniteston Gel 1% Once Daily
Distribution
Circulating Uniteston is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of Uniteston in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins.
Metabolism
Uniteston is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of Uniteston are estradiol and dihydrotestosterone (DHT).
DHT concentrations increased in parallel with Uniteston concentrations during Uniteston Gel 1% treatment. The mean steady-state DHT/T ratio during 180 days of Uniteston Gel treatment ranged from 0.23 to 0.29 (50 mg of Uniteston Gel 1%/day) and from 0.27 to 0.33 (100 mg of Uniteston Gel 1%/day).
Excretion
There is considerable variation in the half-life of Uniteston concentration as reported in the literature, ranging from 10 to 100 minutes. About 90% of a dose of Uniteston given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of Uniteston and its metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of Uniteston occurs primarily in the liver.
When Uniteston Gel 1% treatment is discontinued after achieving steady state, serum Uniteston 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.
Uniteston Transfer from Male Patients to Female Partners
The potential for dermal Uniteston transfer following Uniteston Gel 1% use was evaluated in a clinical study between males dosed with Uniteston Gel 1% and their untreated female partners. Two (2) to 12 hours after application of 100 mg of Uniteston administered as Uniteston 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 Uniteston Gel 1% application sites. Under these study conditions, all unprotected female partners had a serum Uniteston concentration >2 times the baseline value at some time during the study. When a shirt covered the application site(s), the transfer of Uniteston from the males to the female partners was completely prevented.
References
- 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. "Therapeutic Testosterone: 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).
- EPA DSStox. "Testosterone: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
