NDC 66887-004 Testopel

Testosterone

NDC Product Code 66887-004

NDC CODE: 66887-004

Proprietary Name: Testopel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Testosterone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.

NDC Code Structure

NDC 66887-004-10

Package Description: 10 AMPULE in 1 BOX > 1 PELLET in 1 AMPULE (66887-004-01)

NDC 66887-004-20

Package Description: 100 AMPULE in 1 BOX > 1 PELLET in 1 AMPULE (66887-004-01)

NDC Product Information

Testopel with NDC 66887-004 is a a human prescription drug product labeled by Endo Pharmaceuticals Inc.. The generic name of Testopel is testosterone. The product's dosage form is pellet and is administered via subcutaneous form.

Labeler Name: Endo Pharmaceuticals Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.

Testopel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TESTOSTERONE 75 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androstanes - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Endo Pharmaceuticals Inc.
Labeler Code: 66887
FDA Application Number: ANDA080911 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-31-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Testosterone Injection

Testosterone Injection is pronounced as (tes tos' ter one)

Why is testosterone injection medication prescribed?
Testosterone cypionate (Depo-Testosterone), testosterone enanthate (Delatestryl), testosterone undecanoate (Aveed), and testosterone pellet (Testopel) are forms of testos...
[Read More]

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Testopel Product Label Images

Testopel Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

TESTOPEL® (testosterone pellets) are cylindrically shaped pellets 3.2mm (1/8 inch) in
diameter and approximately 9mm in length. Each sterile pellet weighs
approximately 78mg (75mg testosterone) and is ready for implantation.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:INGREDIENTSEach TESTOPEL®
(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® (testosterone pellets) consist of crystalline testosterone. When implanted
subcutaneously, the pellets slowly release the hormone for a long acting
androgenic effect.

Clinical 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.PHARMACOKINETICSTestosterone 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.

Indications And Usage

  • MALESAndrogens are indicated for replacement therapy in conditions
  • Associated with a deficiency or absence of endogenous testosterone. a.Primary hypogonadism (congenital or acquired)
  • - testicular failure due to cryptorchidism, bilateral torsion,
  • Orchitis, vanishing testes syndrome; or orchiectomy.b.Hypogonadotropic hypogonadism (congenital or
  • Acquired) - gonadotropic LHRH deficiency, or pituitary
  • - hypothalamic injury from tumors, trauma or radiation.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.c.Androgens may be used to stimulate puberty in
  • Carefully selected males with clearly delayed puberty. These
  • Patients usually have a familial pattern of delayed puberty that is
  • Not secondary to a pathological disorder; puberty is expected to
  • Occur spontaneously at a relatively late date. Brief treatment with
  • Conservative doses may occasionally be justified in these patients
  • If they do not respond to psychological support. The potential
  • Adverse effect on bone maturation should be discussed with the
  • Patient and parents prior to androgen administration. An x-ray of
  • The hand and wrist to determine bone age should be taken every 6
  • Months to assess the effect of treatment on epiphyseal centers (see
  • WARNINGS).

Contraindications

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.

Warnings

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 PRECAUTIONS - 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 ADVERSE REACTIONS.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 DRUG ABUSE AND DEPENDENCE).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.

Precautions

  • GENERALPellet 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 PATIENTThe 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 TESTSBecause of the hepatotoxicity associated with
  • The use of 17-alpha-alkylated androgens, liver function tests should
  • Be obtained periodically.Periodic (every 6 months) x-ray examinations
  • Of the bone age should be made during treatment of prepubertal males
  • To determine the rate of bone maturation and the effects of androgen
  • Therapy on the epiphyseal centers.Hemoglobin and hematocrit should be checked
  • Periodically for polycythemia in patients who are receiving high
  • Doses of androgens.DRUG INTERACTIONSAnticoagulants. C-17 substituted derivatives
  • Of testosterone, such as methandrostenolone have been reported to
  • Decrease the anticoagulant requirements of patients receiving oral
  • Anticoagulants. Patients receiving oral anticoagulant therapy
  • Require close monitoring, especially when androgens are started or
  • Stopped.Oxyphenbutazone. Concurrent administration of
  • Oxyphenbutazone and androgens may result in elevated serum levels of
  • Oxyphenbutazone.Insulin. In diabetic patients the metabolic
  • Effects of androgens may decrease blood glucose and insulin
  • Requirements.DRUG/LABORATORY TEST
  • INTERFERENCESAndrogens may decrease levels of thyroxine-binding globulin,
  • Resulting in decreased total T4 serum levels and increased
  • Resin uptake of T3 and T4. Free thyroid hormone
  • Levels remain unchanged, however, and there is no clinical evidence of
  • Thyroid dysfunction.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF
  • FERTILITYAnimal 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.PREGNANCYTeratogenic Effects. Pregnancy Category X (see CONTRAINDICATIONS).NURSING MOTHERSIt 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 USEAndrogen 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 INDICATIONS
  • AND USAGE and WARNINGS).

Adverse Reactions

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 CLINICAL
PHARMACOLOGY).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 WARNINGS).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 WARNINGS)Miscellaneous. Rarely anaphylactoid reactions.

Drug Abuse And Dependence

  • Controlled SubstanceTESTOPEL® contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.AbuseDrug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.Abuse-Related Adverse ReactionsSerious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.DependenceBehaviors Associated with AddictionContinued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:Taking greater dosages than prescribedContinued drug use despite medical and social problems due to drug useSpending significant time to obtain the drug when supplies of the drug are interruptedGiving a higher priority to drug use than other obligationsHaving difficulty in discontinuing the drug despite desires and attempts to do soExperiencing withdrawal symptoms upon abrupt discontinuation of usePhysical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Overdosage

There have been no reports of acute overdosage with the
androgens.

Dosage And Administration

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.

How Supplied

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 OnlyDistributed by:Endo Pharmaceuticals Inc.Malvern, PA 19355
Revised 10/20168500049RG

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