What Is a Testosterone Patch?
Testosterone. Chemical name: 17-hydroxyandrost-4-en-3-one. The main auxiliary material of this product is: acrylic pressure-sensitive adhesive.
Chemical name: 17-hydroxyandrost-4-en-3-one Molecular formula: C 19 H 28 O 2
Molecular weight: 288.42
- Testosterone patch, this product is suitable for testosterone replacement therapy for hypogonadism in men, such as after testectomy, no testis, orchitis, Creutzfeldt-Jakob syndrome, hypopituitarism, and endocrine impotence; some androgen deficiency Syndrome and so on.
- Drug Name
- Testosterone patch
- Hanyu Pinyin
- Gao Tong Tie Ji
- Drug type
- Doping
- Use classification
- Other antianemia drugs
Testosterone patch ingredients
- Testosterone. Chemical name: 17-hydroxyandrost-4-en-3-one. The main auxiliary material of this product is: acrylic pressure-sensitive adhesive.
Chemical name: 17-hydroxyandrost-4-en-3-one Molecular formula: C 19 H 28 O 2
Molecular weight: 288.42
Testosterone patch properties
- This product is a colorless adhesive coated on a white backing film.
Testosterone patch indications
- This product is suitable for testosterone replacement therapy for hypogonadism in men, such as testicular resection, a testis-free disease, orchitis, Creutzfeldt-Jacob syndrome, hypopituitarism, endocrine impotence, androgen deficiency syndrome in middle and old men.
Testosterone patch specifications
- 16.3 mg (3.3 cm x 3.03 cm).
Testosterone patch usage dosage
- Use it at about 10pm every night at the same time. Immediately after removing the protective film of the patch, apply it on the clean, dry, and non-traumatic skin of the back, abdomen, upper arms, or both strands, and press with your palm for about ten seconds to ensure good contact, especially the edges.
Dosage of this product is once a day, two sticks at a time, or increased to 3-4 sticks according to the doctor's advice. Each stick can provide about 2.5mg / day of testosterone, and the sticks can be replaced for 24 hours.
To ensure an appropriate dose, serum testosterone concentrations should be monitored regularly in the morning.
In order to avoid or reduce local skin irritation, the application site is changed daily.
Testosterone patch adverse reactions
- In a randomized, double-blind, placebo-parallel, multicenter clinical trial, 69 patients were treated with this product for eight weeks, with an adverse event rate of 23.19%. Clinical studies have shown that this product is well tolerated and no serious adverse events have occurred. The most frequent adverse events were: local skin irritation.
Sixty-nine patients received this product for eight weeks, and the incidence was more than 1%.
Adverse event.
Incidence (%).
The local drug reaction was 13.04%.
The rash was 1.45%.
Pustular rash is 1.45%.
Testicular pain was 1.45%.
Night sweats were 1.45%.
Lower limb pain was 1.45%.
Hearing loss was 1.45%.
Upper respiratory tract infection was 1.45%.
A total of 23.19%.
Applying hydrocortisone ointment at the site after application can improve mild skin irritation.
Foreign literature reports that 104 patients treated with a testosterone transdermal patch for a three-year clinical study have adverse reactions with a incidence of more than 1% as follows:
Percentage of patients with adverse event.
Male breasts feminize 5%.
Acne 4%.
Prostate / urethral infections 4%.
Breast tenderness 3%.
Stroke 2%.
Among the above patient population, 1% of users reported the following symptoms: memory loss, pupil dilation, abnormal liver enzymes, scrotal cellulitis, deep phlebitis, benign prostatic hypertrophy, rectal mucosal damage above the prostate, hematuria / bladder cancer, scrotum Papilloma and congestive heart failure.
Testosterone patches contraindications
- Patients who are allergic to any ingredient in the drug delivery system are contraindicated.
It is contraindicated for breast cancer and men who have known or suspected prostate cancer.
This product has not been evaluated for female patients, and it is forbidden to use it for women. Testosterone can be harmful to the fetus.
Testosterone patches considerations
- 1. Please report to the doctor in time when the patient has any of the following conditions:
Excessive or long penile erections Nausea, vomiting, jaundice, or swelling of the ankles Dyspnea, including sleep-related breathing disorders
2. For patients with previous heart, kidney or liver disease, edema may or may not occur with or without congestive heart failure. In this case, in addition to stopping the patient from taking the medication, diuretics may be required for treatment.
3. The literature reports that men who use testosterone solutions topically can cause virilization of female partners. Transdermal creams can leave testosterone on the skin. If this product is inadvertently transferred to a female partner, the contacted skin should be removed and washed immediately. If your female partner's body hair distribution changes or acne increases significantly, you should go to the hospital for treatment.
4. Laboratory inspection:
(1) For patients receiving long-term androgen therapy, the hemoglobin and hematocrit should be checked periodically (detecting erythrocytosis).
(2) Liver function, prostate specific antigen (PSA), total cholesterol and high-density lipoprotein should be tested periodically. If PSA rises too quickly or PSA> 4ng / mL, the drug should be stopped.
(3) In order to ensure an appropriate dose, the serum testosterone concentration should be measured regularly.
5. Use with caution by athletes
Testosterone patch for pregnant and lactating women
- Female use is prohibited.
Testosterone patch for children
- The safety and effectiveness of testosterone patches in children have not been established at home and abroad.
Testosterone patch for the elderly
- Elderly patients should be evaluated for prostate cancer before receiving testosterone replacement therapy. Elderly patients receiving androgen therapy increase their risk of prostate hyperplasia and prostate cancer.
Testosterone patch drug interactions
- Anticoagulants:
It has been reported that C-17 substituted testosterone derivatives, such as dehydrotestosterone, can reduce patients' need for oral anticoagulants. Patients using oral anticoagulants need close monitoring, especially when they start or stop using androgens.
Hydroxybutacon:
The simultaneous use of hydroxybutaxone and androgens can lead to an increase in serum concentration of hydroxybutaxone.
insulin:
For diabetic patients, metabolism of androgens can lower blood sugar, thus reducing insulin requirements.
Propranolol:
A study on the pharmacokinetics of testosterone products for injection reported that administration of testosterone cyclopentapropionate can lead to an increase in propranolol clearance in most patients tested.
Cortisol:
The combination of testosterone and corticotropin (ACTH) or cortisol can increase the formation of edema. Therefore, these drugs must be used with caution, especially for patients with heart or liver disease.
Testosterone patch overdose
- There is a report on acute injection of testosterone enanthate in patients with testosterone concentrations as high as 11,400ng / dL, which may cause cerebrovascular accidents.
Testosterone patch pharmacology and toxicology
- Pharmacological effects This product is an androgen drug, which is used to provide male physiologically required testosterone. Testosterone is the main endogenous androgen, which can promote the normal growth and development of male sexual organs and maintain male secondary sexual characteristics; can maintain nitrogen, sodium, potassium and phosphorus levels, reduce the excretion of calcium in urine; promote protein synthesis and reduce decomposition , Enhance immune function, promote bone growth; promote the generation of red blood cells, feedback inhibition of gonadotropin secretion.
Animal test data reported in the toxicity study literature: Tests were performed by subcutaneous injection or implantation of testosterone in mice and rats. Implants cause cervical tumors in mice, which sometimes metastasize. Evidence suggests that testosterone injection in female mice of some species increases susceptibility to hepatocellular carcinoma. In addition, testosterone can increase the number of tumors and reduce the degree of differentiation of rat livers to carcinogenic chemicals.
Testosterone patch pharmacokinetics
- Testosterone can be continuously absorbed during the 24-hour administration of this product. After use at 10 o'clock every night, the total serum testosterone level can simulate the periodic change of serum testosterone in young healthy men. The blood drug concentration reaches the peak in the early morning, and the lowest in the evening .
Twelve patients with hypogonadism had an average baseline serum total testosterone concentration of 2.43 nmol / L before administration.
Each night at 10:00, use 2, 4, or 6 patches of this product, for seven days of continuous medication, the steady-state pharmacokinetic parameters are as follows:
dose
AUCss0 ~ tn (hr * nmol / L)
Cssmax (nmol / L)
Cav
(nmol / L)
Cssmin
(nmol / L)
tmax (hr)
2 stickers (n = 12)
110.94 ± 54.89
7.67 ± 6.14
4.62 ± 2.29
3.86 ± 1.65
10.50 ± 5.05
4 stickers (n = 8)
245.06 ± 98.19
20.84 ± 15.23
10.21 ± 4.09
6.53 ± 2.27
6.25 ± 3.11
6 stickers (n = 7)
416.62 ± 278.66
36.13 ± 44.32
17.36 ± 11.61
12.26 ± 8.09
7.71 ± 2.43
AUCss0 ~ tn = area under the curve during steady state drug Cssmax = steady peak concentration Cav = average steady state blood drug concentration
Cssmin = steady-state trough concentration tmax = peaking time shows that after topical application of this product, the main system exposure parameters increase with increasing dose.
Applying this product topically every day, the Cmax (7.67nmol / L) and Cav (4.62 nmol / L) of serum total testosterone at steady state compared with the baseline total serum testosterone concentration of 2.43nmol / L, which are 3.16 times and 1.90 times the baseline mean, respectively. Times, showing a significant increase in total testosterone concentration in the body (P 0.05), and the serum total testosterone concentration in 33.3% of patients could reach the normal range.
Applying this product topically every day, the peak concentration and the average serum total testosterone concentration (Cmax and Cav) on the first day of administration reached the reference normal range (8.40 ~ 34.7 nmol / L). The average Cmax and Cav values were 34.28 nmol / L, respectively. L and 9.08 nmol / L, the average serum total testosterone Cmax and Cav at steady state were also in the normal range, which were 20.84 nmol / L and 10.21 nmol / L, respectively.
In serum, testosterone is mainly tightly bound to sex hormone-binding globulin (SHBG) and loosely bound to albumin. Testosterone bound to albumin is easily dissociated and is presumed to be biologically active. Testosterone bound to SHBG is considered to have Biological activity. The amount of SHBG in serum and the concentration of total testosterone determine the distribution of biologically active and inactive male hormones in the body.
Testosterone is mainly inactivated by the liver metabolism in the body. Testosterone is metabolized into a variety of 17-ketosteroid hormones through two different pathways. The most active metabolites are estradiol and dihydrotestosterone. Compared with testosterone, dihydrotestosterone has higher binding power with SHBG. In the reproductive tissue, DHT is further metabolized to 3 and 3 androsterol.
After intramuscular administration, approximately 90% of a testosterone dose is excreted from the urine as glucuronic acid and sulfuric acid conjugates of testosterone and testosterone metabolites, and approximately 6% is excreted mainly from feces in unbound form.
Testosterone Patch Storage
- Shaded, sealed and stored at room temperature (15-30 ° C).
Testosterone Patch Packaging
- Composite aluminum plastic bag, 2 stickers / bag.
Testosterone patch expiration date
- 24 months