TESTOSTERONE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. - Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: - Safety and efficacy of testosterone topical solution in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - Safety and efficacy of testosterone topical solution in males <18 years old have not been established [see Use in Specific Populations (8.4)]. - Testosterone topical solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions(5.1)]. - Testosterone topical solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. Testosterone topical solution may cause fetal harm when administered to a pregnant woman. Testosterone topical solution may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to testosterone topical solution, she should be apprised of the potential hazard to the fetus. [See Use in Specific Populations (8.1, 8.3)]. Pregnancy Category X [see Contraindications (4)] — Testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Although it is not known how much testosterone transfers into human milk, testosterone topical solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affect lactation. [see Contraindications (4)] . Safety and efficacy of testosterone topical solution has not been established in males <18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. Of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. Additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer. No formal studies were conducted involving patients with renal impairment. No formal studies were conducted involving patients with hepatic impairment. Safety and efficacy of testosterone topical solution in males with BMI >35 kg/m2 has not been established. Testosterone topical solution contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Drug 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 by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious 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. Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: -   Taking greater dosages than prescribed -   Continued drug use despite medical and social problems due to drug use -   Spending significant time to obtain the drug when supplies of the drug are interrupted -   Giving a higher priority to drug use than other obligations -   Having difficulty in discontinuing the drug despite desires and attempts to do so -   Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical 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.

Product summary:

Testosterone topical solution USP is available as a metered-dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. One actuation delivers 30 mg of testosterone in 1.5 mL of solution. Each metered-dose pump is supplied with an applicator. The bottle and the applicator cup are not made with natural rubber latex. Keep testosterone topical solution out of reach of children. Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TESTOSTERONE- TESTOSTERONE SOLUTION
Alembic Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Testosterone (tes-TOS-te-rone)
topical solution USP, for topical use CIII
What is the most important information I should know about
testosterone topical solution?
1. Testosterone topical solution can transfer from your body to others
including, children and
women. Children and women should avoid contact with the unwashed or
not covered (unclothed)
areas where testosterone topical solution has been applied to your
skin.
Early signs and symptoms of puberty have occurred in young children
who have come in direct
contact with testosterone by touching areas where men have used
testosterone topical solution.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with testosterone
topical solution may include:
Abnormal sexual changes:
•
enlarged penis or clitoris.
•
early growth of hair near the vagina or around the penis (pubic hair).
•
erections or acting out sexual urges (sex drive).
Behavior problems:
•
acting aggressively, behaving in an angry or violent way.
Women
Signs and symptoms in women when they come in direct contact with
testosterone topical solution
may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone topical solution and call your healthcare
provider right away if you see any
signs and symptoms in a child or a woman that may have happened
through accidental touching of
the area where you have applied testosterone topical solution:
2. To lower the risk of transfer of testosterone topical solution from
your body to others, follow
these important instructions:
•
Apply testosterone topical solution only to your armpits.
•
Wash your hands right away with soap and water after applying
testosterone topical
solution.
•
After the solution has dried, cover the application area with
clothing. Keep the area
covered until you have washed the application area well or have
showered.
•
If you expect to have skin-to-skin conta

Summary of Product characteristics

TESTOSTERONE- TESTOSTERONE SOLUTION
ALEMBIC PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE TOPICAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TESTOSTERONE
TOPICAL SOLUTION.
TESTOSTERONE TOPICAL SOLUTION, FOR TOPICAL USE CIII
INITIAL U.S. APPROVAL:1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
VIRILIZATION HAS BEEN REPORTED IN CHILDREN WHO WERE SECONDARILY
EXPOSED TO TOPICAL
TESTOSTERONE PRODUCTS (5.2)
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN
USING TESTOSTERONE TOPICAL SOLUTION (2.2, 5.2)
HEALTHCARE PROVIDERS SHOULD ADVISE PATIENTS TO STRICTLY ADHERE TO
RECOMMENDED
INSTRUCTIONS FOR USE (2.2, 5.2, 17)
INDICATIONS AND USAGE
Testosterone topical solution is indicated for replacement therapy in
males for conditions associated with a
deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Limitations of use:
Safety and efficacy of testosterone topical solution in men with
"age-related hypogonadism" have not
been established. (1)
Safety and efficacy of testosterone topical solution in males <18
years old have not been established.
(8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating testosterone topical solution, confirm the
diagnosis of hypogonadism by ensuring that
serum testosterone has been measured in the morning on at least two
separate days and that these
concentrations are below the normal range (2).
Starting testosterone topical solution dose is 60 mg of testosterone
(1 pump actuation of 30 mg of
testosterone to each axilla), applied once daily, at the same time
each morning. (2.1)
Apply to clean, dry intact skin of the axilla, not to any other parts
of the body including the abdomen or
genitals (2.2)
Dose adjustment: The dose of testosterone may be decreased from 60 mg
(2 pump ac