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testosterone
Overview
What is Testopel?
TESTOPEL
Androgens are steroids that develop and maintain primary and
secondary male sex characteristics. Testosterone is a member of this
class.
Structural formula for testosterone follows:
INGREDIENTS
Each
(testosterone pellets) for subcutaneous implantation contains 75mg
testosterone. In addition each pellet contains the following inactive
ingredients: stearic acid NF 0.97mg and polyvinylpyrrolidone USP 2mg.
TESTOPEL
What does Testopel look like?
What are the available doses of Testopel?
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What should I talk to my health care provider before I take Testopel?
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How should I use Testopel?
MALES
Androgens are indicated for replacement therapy in conditions
associated with a deficiency or absence of endogenous testosterone.
If the above conditions occur prior to puberty, androgen
replacement therapy will be needed during the adolescent years for
development of secondary sex characteristics. Prolonged androgen
treatment will be required to maintain sexual characteristics in these
and other males who develop testosterone deficiency after puberty.
Safety and efficacy of Testopel (testosterone pellets) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Prior to initiating, Testopel (testosterone pellets) confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
The suggested dosage for androgens varies depending on the age,
and diagnosis of the individual patient. Dosage is adjusted according to
the patient’s response and the appearance of adverse reactions. The
dosage guideline for the testosterone pellets for replacement therapy in
androgen-deficient males is 150mg to 450mg subcutaneously every 3 to 6
months. Various dosage regimens have been used to induce pubertal
changes in hypogonadal males; some experts have advocated lower doses
initially, gradually increasing the dose as puberty progresses, with or
without a decrease in maintenance levels. Other experts emphasize that
higher dosages are needed to induce pubertal changes and lower dosages
can be used for maintenance after puberty. The chronological and
skeletal ages must be taken into consideration, both in determining the
initial dose and in adjusting the dose.
Dosages in delayed puberty generally are in the lower range of
that listed above and, for a limited duration, for example 4 to 6
months.
The number of pellets to be implanted depends upon the minimal
daily requirements of testosterone propionate determined by a gradual
reduction of the amount administered parenterally. The usual dosage is
as follows: implant two 75mg pellets for each 25mg testosterone
propionate required weekly. Thus when a patient requires injections of
75mg per week, it is usually necessary to implant 450mg (6 pellets).
With injections of 50mg per week, implantation of 300mg (4 pellets) may
suffice for approximately three months. With lower requirements by
injection, correspondingly lower amounts may be implanted. It has been
found that approximately one-third of the material is absorbed in the
first month, one-fourth in the second month and one-sixth in the third
month. Adequate effect of the pellets ordinarily continues for three to
four months, sometimes as long as six months.
What interacts with Testopel?
Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. The virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus, and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking these drugs she should be apprised of the potential hazard to the fetus.
What are the warnings of Testopel?
Desipramine hydrochloride use in the elderly has been associated with a proneness to falling as well as confusional states. (See
.)
In patients with breast cancer, androgen therapy may cause
hypercalcemia by stimulating osteolysis. In this case, the drug should
be discontinued.
Prolonged use of high doses of androgens has been associated with
the development of peliosis hepatis and hepatic neoplasms including
hepatocellular carcinoma (see - Carcinogenesis, Mutagenesis, Impairment of Fertility).
Peliosis hepatis can be a life-threatening or fatal complication.
Men treated with androgens may be at an increased risk for the
development of prostatic hypertrophy and prostatic carcinoma.
There have been postmarketing reports of venous thromboembolic events,
including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients
using testosterone products, such as Testopel (testosterone pellets).
Evaluate patients who report symptoms of pain, edema, warmth and erythema
in the lower extremity for DVT and those who present with acute shortness of breath for PE.
If a venous thromboembolic event is suspected, discontinue treatment with Testopel (testosterone pellets)
and initiate appropriate workup and management [see .
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testopel® (testosterone pellets).
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see )
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Edema with or without congestive heart failure may be a serious
complication in patients with preexisting cardiac, renal, or hepatic
disease. In addition to discontinuation of the drug, diuretic therapy
may be required.
Gynecomastia frequently develops in patients and occasionally
persists in patients being treated for hypogonadism.
Androgen therapy should be used cautiously in healthy males with
delayed puberty. The effect on bone maturation should be monitored by
assessing bone age of the wrist and hand every 6 months. In children,
androgen treatment may accelerate bone maturation without producing
compensatory gain in linear growth. This adverse effect may result in
compromised adult stature. The younger the child the greater the risk of
compromising final mature height.
Post-marketing cases associate TESTOPEL pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near the implantation site. Infection and extrusion may occur concurrently or separately. Reported signs and symptoms of infection and/or extrusion at the implant site included induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. Although cases of infection and/or extrusion may occur at any time, most reported cases occurred within the first month after TESTOPEL implantation. Infection and/or extrusion may require further treatment (see ADVERSE REACTIONS).
This drug has not been shown to be safe and effective for the
enhancement of athletic performance. Because of the potential risk for
serious adverse health effects, this drug should not be used for such
purpose.
What are the precautions of Testopel?
GENERAL
Pellet implantation is much less flexible for dosage adjustment
than is oral administration of or intramuscular injections of oil
solutions or aqueous suspensions. Therefore, great care should be used
when estimating the amount of testosterone needed.
In the face
of complications where the effects of testosterone should be
discontinued, the pellets would have to be removed.
INFORMATION FOR THE PATIENT
The physician should instruct patients to report any of the
following side effects of androgens:
Adult or adolescent males: Too frequent or persistent erections
of the penis. Any nausea, vomiting, changes in skin color, ankle
swelling.
Implantation site infection and/or pellet extrusion can occur and may be associated with implant site induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. (see WARNINGS and ADVERSE REACTIONS).
Any male adolescent patient receiving androgens for delayed
puberty should have bone development checked every 6 months.
LABORATORY TESTS
DRUG INTERACTIONS
DRUG/LABORATORY TEST
INTERFERENCES
Androgens may decrease levels of thyroxine-binding globulin,
resulting in decreased total T serum levels and increased
resin uptake of Tand T. Free thyroid hormone
levels remain unchanged, however, and there is no clinical evidence of
thyroid dysfunction.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF
FERTILITY
Animal Data. Testosterone has been tested by subcutaneous
injection and implantation in mice and rats. The implant induced
cervical-uterine tumors in mice, which metastasized in some cases. There
is suggestive evidence that injection of testosterone into some strains
of female mice increases their susceptibility to hepatoma. Testosterone
is also known to increase the number of tumors and decrease the degree
of differentiation of chemically induced carcinomas of liver in rats.
Human Data. There are rare reports of hepatocellular carcinoma in
patients receiving long-term therapy with androgens in high doses.
Withdrawal of the drugs did not lead to regression of the tumors in all
cases.
Geriatric patients treated with androgens may be at an increased
risk for the development of prostatic hypertrophy and prostatic
carcinoma.
PREGNANCY
Teratogenic Effects. Pregnancy Category X (see CONTRAINDICATIONS).
NURSING MOTHERS
It is not known whether androgens are excreted in human milk.
Because many drugs are excreted in human milk and because of the
potential for serious adverse reactions in nursing infants from
androgens, a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the drug
to the mother.
PEDIATRIC USE
Androgen therapy should be used very cautiously in children and
only by specialists who are aware of the adverse effects on bone
maturation. Skeletal maturation must be monitored every 6 months by an
x-ray of the hand and wrist (see and ).
What are the side effects of Testopel?
The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including TESTOPEL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Implantation Site Infection and Pellet Extrusion: (see WARNINGS)
Endocrine and Urogenital, Male. Gynecomastia and excessive
frequency and duration of penile erections. Oligospermia may occur at
high dosages (see ).
Skin and Appendages. Hirsutism, male
pattern of baldness, and acne.
Cardiovascular Disorders. Myocardial infarction, stroke.
Fluid and Electrolyte
Disturbances. Retention of sodium, chloride, water, potassium, calcium
and inorganic phosphates.
Gastrointestinal. Nausea, cholestatic
jaundice, alterations in liver function tests, rarely hepatocellular
neoplasms and peliosis hepatis (see ).
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.
Vascular Disorders: Venous thromboembolism (see )
Miscellaneous. Rarely anaphylactoid reactions.
What should I look out for while using Testopel?
Androgens are contraindicated in men with carcinomas of the
breast or with known or suspected carcinomas of the prostate. If
administered to pregnant women, androgens cause virilization of the
external genitalia of the female fetus. The virilization includes
clitoromegaly, abnormal vaginal development, and fusion of genital folds
to form a scrotal-like structure. The degree of masculinization is
related to the amount of drug given and the age of the fetus, and is
most likely to occur in the female fetus when the drugs are given in the
first trimester. If the patient becomes pregnant while taking these
drugs she should be apprised of the potential hazard to the
fetus.
In patients with breast cancer, androgen therapy may cause
hypercalcemia by stimulating osteolysis. In this case, the drug should
be discontinued.
Prolonged use of high doses of androgens has been associated with
the development of peliosis hepatis and hepatic neoplasms including
hepatocellular carcinoma (see - Carcinogenesis, Mutagenesis, Impairment of Fertility).
Peliosis hepatis can be a life-threatening or fatal complication.
Men treated with androgens may be at an increased risk for the
development of prostatic hypertrophy and prostatic carcinoma.
There have been postmarketing reports of venous thromboembolic events,
including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients
using testosterone products, such as Testopel (testosterone pellets).
Evaluate patients who report symptoms of pain, edema, warmth and erythema
in the lower extremity for DVT and those who present with acute shortness of breath for PE.
If a venous thromboembolic event is suspected, discontinue treatment with Testopel (testosterone pellets)
and initiate appropriate workup and management [see .
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testopel® (testosterone pellets).
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see )
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Edema with or without congestive heart failure may be a serious
complication in patients with preexisting cardiac, renal, or hepatic
disease. In addition to discontinuation of the drug, diuretic therapy
may be required.
Gynecomastia frequently develops in patients and occasionally
persists in patients being treated for hypogonadism.
Androgen therapy should be used cautiously in healthy males with
delayed puberty. The effect on bone maturation should be monitored by
assessing bone age of the wrist and hand every 6 months. In children,
androgen treatment may accelerate bone maturation without producing
compensatory gain in linear growth. This adverse effect may result in
compromised adult stature. The younger the child the greater the risk of
compromising final mature height.
Post-marketing cases associate TESTOPEL pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near the implantation site. Infection and extrusion may occur concurrently or separately. Reported signs and symptoms of infection and/or extrusion at the implant site included induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. Although cases of infection and/or extrusion may occur at any time, most reported cases occurred within the first month after TESTOPEL implantation. Infection and/or extrusion may require further treatment (see ADVERSE REACTIONS).
This drug has not been shown to be safe and effective for the
enhancement of athletic performance. Because of the potential risk for
serious adverse health effects, this drug should not be used for such
purpose.
What might happen if I take too much Testopel?
There have been no reports of acute overdosage with the
androgens.
How should I store and handle Testopel?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F).Dispense accompanying Medication Guide to each patient.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F).Dispense accompanying Medication Guide to each patient.Testosterone pellets each containing 75mg testosterone. One pellet per vial in boxes of 10 (NDC: 66887-004-10) and 100 (NDC: 66887-004-20). Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Rx Only8500049RGTestosterone pellets each containing 75mg testosterone. One pellet per vial in boxes of 10 (NDC: 66887-004-10) and 100 (NDC: 66887-004-20). Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Rx Only8500049RGTestosterone pellets each containing 75mg testosterone. One pellet per vial in boxes of 10 (NDC: 66887-004-10) and 100 (NDC: 66887-004-20). Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Rx Only8500049RG
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous androgens 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 beard, pubic, chest and axillary hair,
laryngeal enlargements, vocal cord thickening, alterations in body
musculature and fat distribution. Drugs in this class can also cause
retention of nitrogen, sodium, potassium, phosphorus, and decreased
urinary excretion of calcium.
Androgens have been reported to increase protein anabolism and
decrease protein catabolism.
Nitrogen balance is improved only when there is sufficient intake
of calories and protein.
Androgens are responsible for the growth spurt of adolescence and
for the eventual termination of linear growth which is brought about by
the fusion of the epiphyseal growth centers. In children, exogenous
androgens accelerate linear growth rates, but may cause a
disproportionate advancement in bone maturation. Use over long periods
may result in fusion of the epiphyseal growth centers and termination of
growth process. Androgens have been reported to stimulate the production
of red blood cells by enhancing the production of erythropoietic
stimulating factor.
During exogenous administration of androgens, endogenous
testosterone release is inhibited through feedback inhibition of
pituitary luteinizing hormone (LH). At large doses of exogenous
androgens, spermatogenesis may also be suppressed through feedback
inhibition of pituitary follicle stimulating hormone (FSH).
There is a lack of substantial evidence that androgens are
effective in fractures, surgery, convalescence, and functional uterine
bleeding.
PHARMACOKINETICS
Testosterone in plasma is 98 percent bound to a specific
testosterone-estradiol binding globulin, and about 2 percent is free.
Generally, the amount of this sex-hormone binding globulin in the plasma
will determine the distribution of testosterone between the free and
bound forms, and the free testosterone concentration will determine its
half-life.
About 90 percent of a dose of testosterone is excreted as
glucuronic and sulfuric acid conjugates of testosterone and its
metabolites; about 6 percent of a dose is excreted in feces, mostly in
the unconjugated form. Inactivation of testosterone occurs primarily in
the liver. Testosterone is metabolized to various 17-keto steroids
through two different pathways. There are considerable variations of the
half-life as reported in the literature, ranging from 10-100 minutes.
In many tissues the activity of testosterone appears to depend on
reduction to dihydrotestosterone, which binds to cytosol receptor
proteins. The steroid-receptor complex is transported to the nucleus
where it initiates transcription events and cellular changes related to
androgen action.
Non-Clinical Toxicology
Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. The virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus, and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking these drugs she should be apprised of the potential hazard to the fetus.In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued.
Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see - Carcinogenesis, Mutagenesis, Impairment of Fertility). Peliosis hepatis can be a life-threatening or fatal complication.
Men treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Testopel (testosterone pellets). Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Testopel (testosterone pellets) and initiate appropriate workup and management [see .
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testopel® (testosterone pellets).
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see )
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia frequently develops in patients and occasionally persists in patients being treated for hypogonadism.
Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.
Post-marketing cases associate TESTOPEL pellet(s) insertion with implant site infection (cellulitis and abscess), and/or pellet extrusion at or near the implantation site. Infection and extrusion may occur concurrently or separately. Reported signs and symptoms of infection and/or extrusion at the implant site included induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. Although cases of infection and/or extrusion may occur at any time, most reported cases occurred within the first month after TESTOPEL implantation. Infection and/or extrusion may require further treatment (see ADVERSE REACTIONS).
This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk for serious adverse health effects, this drug should not be used for such purpose.
Thiazides may add to or potentiate the action of other antihypertensive drugs.
The thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the responsiveness to tubocurarine.
Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Refer to the package insert on lithium before use of such concomitant therapy.
Acute renal failure has been reported in a few patients receiving indomethacin and formulations containing triamterene and hydrochlorothiazide. Caution is therefore advised when administering non-steroidal anti-inflammatory agents with triamterene and hydrochlorothiazide.
Potassium-sparing agents should be used very cautiously, if at all, in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to a greatly increased risk of hyperkalemia. Serum potassium should be monitored frequently.
GENERAL
Pellet implantation is much less flexible for dosage adjustment than is oral administration of or intramuscular injections of oil solutions or aqueous suspensions. Therefore, great care should be used when estimating the amount of testosterone needed.
In the face of complications where the effects of testosterone should be discontinued, the pellets would have to be removed.
INFORMATION FOR THE PATIENT
The physician should instruct patients to report any of the following side effects of androgens:
Adult or adolescent males: Too frequent or persistent erections of the penis. Any nausea, vomiting, changes in skin color, ankle swelling.
Implantation site infection and/or pellet extrusion can occur and may be associated with implant site induration, inflammation, fibrosis, bleeding, bruising, wound drainage, pain, itching, and pellet extrusion. (see WARNINGS and ADVERSE REACTIONS).
Any male adolescent patient receiving androgens for delayed puberty should have bone development checked every 6 months.
LABORATORY TESTS
DRUG INTERACTIONS
DRUG/LABORATORY TEST INTERFERENCES
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T serum levels and increased resin uptake of Tand T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Animal Data. Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of liver in rats.
Human Data. There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
PREGNANCY
Teratogenic Effects. Pregnancy Category X (see CONTRAINDICATIONS).
NURSING MOTHERS
It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
PEDIATRIC USE
Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every 6 months by an x-ray of the hand and wrist (see and ).
The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including TESTOPEL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Implantation Site Infection and Pellet Extrusion: (see WARNINGS)
Endocrine and Urogenital, Male. Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see ).
Skin and Appendages. Hirsutism, male pattern of baldness, and acne.
Cardiovascular Disorders. Myocardial infarction, stroke.
Fluid and Electrolyte Disturbances. Retention of sodium, chloride, water, potassium, calcium and inorganic phosphates.
Gastrointestinal. Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see ).
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.
Vascular Disorders: Venous thromboembolism (see )
Miscellaneous. Rarely anaphylactoid reactions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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