Manufacturer: Schering-Plough
Substance: Testosterone
Pack: 30 caps (40 mg/cap)
What is Virigen Andriol 40 mg 30 Caps Schering-Plough?
Pharmacological properties:
Pharmacodynamic properties
Testosterone is the main endogenous hormone in terms of growth and development of male sex organs and male sexual characteristics. During the adulthood, the functionality of testosterone testes and support structures and the preservation of libido are vital to maintaining healthy feeling, erectile potency, prostate and seminal vesicle functions. When hypogonadal men are given Virigen Testocaps, there is a clinically significant increase in testosterone, dihydrotestosterone and androstenedione plasma concentrations, as well as a decrease in SHBG (sex hormone binding globulin) level. The treatment of Virigen Testocaps for men with primary (hypergonadotropic) hypogonadism provides normalization of the gonadotropin level.
Pharmacokinetic properties
Following oral administration of Virigen's Testocaps, an important part of the active substance testosterone undecanoate is absorbed from the intestines with the lipophilic solvent into the lymphatic system and thus is disrupted by the liver from the first pass inactivation. During absorption, testosterone undecanoate is partially reduced to dihydrotestosterone undecanoate. It is released from the lymphatic system to the plasma. In plasma and tissues, both testosterone undecanoate and dihydrotestosterone undecanoate are hydrolyzed, and natural male androgens testosterone and dihydrotestosterone emerge.
Single administration of 80-160 mg of Virigen Testocaps leads to a clinically significant increase in total plasma testosterone level and reaches a maximum value of about 40 nmol / l (Cmax) approximately 4-5 hours after using (tmax). Plasma testosterone levels remain high for at least 8 hours. Testosterone and dihydrotestosterone are metabolized via hepatic pathways. The breakthrough is largely due to urine as the enocholanolone and androsterone conjugates.
Indications:
Testosterone replacement therapy for primary or secondary hypogonadal disorders in men;
* primary hypogonadism (hypergonadotropic hypogonadism)
secondary hypogonadism (hypergonadotropic hypogonadism)
* to stimulate puberty in appropriately selected delayed pubertal individuals
* masculinization in female transsexuals
Contraindications:
* Male known or suspected prostatic hyperplasia, prostate cancer or breast cancer
* Hypersensitivity to the active substance or to any of the thickening agents
Warnings / Precautions:
* In general, androgens and Virigen Testocaps can accelerate epiphyseal closure and sexual maturation without prolonged lengthening if used in high-dose by men in pre-pubertal period for the treatment of delayed puberty. Therefore, skeletal development should be monitored regularly with hand and wrist radiographs every 6 months.
* Secret or overt heart failure, renal impairment, hypertension, epilepsy or migraine (or a history of these disorders) in patients with, in some cases may cause agitation or recurrence should be used under close medical supervision.
* In general, androgens and Virigen Testocaps can increase glucose tolerance and the effect of anticoagulants.
Androgens should be used with caution in men with benign prostatic hypertrophy.
* It should be used with caution in patients with demographic characteristics that may be associated with elderly patients or prostate cancer and should be followed regularly.
* Data on the safety of testosterone esters in men with sleep apnea are insufficient. Nevertheless, people with chronic lung disease or obesity should be treated with caution and shouldbe followed clinically.
* In the case of adverse reactions associated with androgens, treatment with Virigen Testocaps should be discontinued and restarted with a lower dose after the symptoms disappear.
* Virigen Testocaps should be taken with meals to ensure better absorption.
Use during pregnancy and lactation
Pregnancy Category: X
Virigen Testocaps is contraindicated in pregnancy and lactation. (See contraindications)
Impact on vehicle and machine use
As far as is known, Virigen Testocaps has no adverse effect on the alertness and concentration.
Side effects / Advers effects:
The following adverse reactions are generally associated with androgen therapy.
Cardiovascular: Flushing, edema, hypertension
Central nervous system: Excitation, aggressive behaviors, insomnia, anxiety, depression, headache
Dermatology: Hirsutism (increased pubic hair growth), acne
Endocrine and metabolic: Menstrual problems (amenorrhea), virilism, breast sensitivity, gynecomastia, hypercalcemia, hypoglycemia, fluid retention
Gastrointestinal: Nausea, vomiting, gastrointestinal irritation
Urogenital: Bladder irritability, epididymitis, erectile dysfunction, priapism, prostate cancer, prostatic hyperplasia, PSA increase, testicular atrophy
Hepatic: Hepatic dysfunction, cholestatic hepatitis, hepatic necrosis Hematologic: Leukopenia, polycythemia, suppression of coagulation factors
Other: Hypersensitivity reactions
CONSULT YOUR DOCTOR WHEN AN UNEXPECTED EFFECT IS SEEN.
Usage and dosage:
The dosage should generally be adjusted according to the individual patient response.
In general, an initial dose of 120-160 mg testosterone undecanoate daily for 2-3 weeks is followed by a maintenance dose of 40-120 mg testosterone undecanoate daily.
Virigen Testocaps should be taken with some liquid and should be swallowed without chewing.
It is recommended that half of the daily dose be taken in the morning and the other half in the evening.
Overdose
The acute oral toxicity of testosterone undecanoate is very low. High doses of Virigen Testocaps can cause gastrointestinal complaints due to the oily solvent in the capsule. Treatment should be performed in the form of emptying the stomach and supporting measures.
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