TESTOSTERONE GEL, 1% gel

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Encube Ethicals Private Limited

Stjórnsýsluleið:

TRANSDERMAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Testosterone gel, 1% is indicated for replacement therapy in adult 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 (follicle-stimulating hormone [FSH], luteinizing hormone [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 gel, 1% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - Safety and efficacy of testosterone gel, 1% in males less than 18 years old have not been established [see Use in Specific Populations (8.4) ]. - Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure (1, 12.3). - Testosterone gel, 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ), and Nonclinical Toxicology ( 13.1 )] . -  Testosterone gel, 1% is contraindicated in women who are pregnant. Testosterone gel, 1% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel, 1%. If a pregnant woman is exposed to testosterone gel, 1%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.2 ) and Use in Specific Populations (8.1 )] . Risk Summary   Testosterone gel, 1% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications (4) and Clinical Pharmacology (12.1)] . Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data   Animal Data   In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. Risk Summary   Testosterone gel, 1% is not indicated for use in women. Infertility   Testis disorder, testicular atrophy, and oligospermia have been identified during use of testosterone gel, 1% [see Adverse Reactions ( 6.1 , 6.2 )] . During treatment with large doses of exogenous androgens, including testosterone gel, 1%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.8 )] . Reduced fertility is observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence ( 9.2 )] . With either type of use, the impact on fertility may be irreversible. The safety and efficacy of testosterone gel, 1% in pediatric patients less than 18 years old has not been established. 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 gel, 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH. No studies were conducted in patients with renal impairment. No studies were conducted in patients with hepatic impairment. Testosterone gel, 1% 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. Testosterone gel, 1% (tes TOS ter one Jel) CIII    For topical use Read this Instructions for Use for testosterone gel, 1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Applying testosterone gel, 1%: Testosterone Gel, 1% comes in a pump or in packets. - Before applying testosterone gel, 1%, make sure that your shoulders, upper arms or stomach are clean, dry, and there is no broken skin. - The application sites for testosterone gel, 1% are the shoulders, upper arms or stomach area (abdomen) that will be covered by a short sleeve t-shirt (see Figure A). Do not apply testosterone gel, 1% to any other parts of your body such as your penis, scrotum, chest, armpits (axillae), knees, or back. If you are using the Testosterone Gel, 1% pump: - Before using a new bottle of Testosterone Gel, 1% for the first time, you will need to prime the pump. To prime the Testosterone Gel, 1% pump, slowly push the pump all the way down 3 times, over the sink drain. Do not use any Testosterone Gel, 1% that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your Testosterone Gel, 1% pump is ready to use. - Remove the cap from the pump. Then, position the nozzle over the palm of your hand and slowly push the pump all the way down. Apply Testosterone Gel, 1% to the application site. You may also apply Testosterone Gel, 1% from the pump directly to the application site. Your healthcare provider will tell you the number of times to press the pump for each dose. - Wash your hands with soap and water right away. If you are using Testosterone Gel, 1% packets: - Tear open the packet completely at the dotted line. Squeeze from the bottom of the packet to the top. - Squeeze all of the Testosterone Gel, 1% out of the packet into the palm of your hand. - Let the application areas dry completely before putting on a t-shirt. - Testosterone Gel, 1% is flammable until dry. Let testosterone gel, 1% dry before smoking or going near an open flame. - Wash your hands with soap and water right away after applying testosterone gel, 1%. - Avoid showering, swimming, or bathing for at least 5 hours after you apply testosterone gel, 1%. - Apply Testosterone Gel, 1% to the application site. You may also apply Testosterone Gel, 1% from the packet directly to the application site. How should I store testosterone gel, 1%?   - Store testosterone gel, 1% at room temperature between 68ºF to 77ºF (20ºC to 25ºC). - Safely throw away used testosterone gel, 1% in the household trash. Be careful to prevent accidental exposure of children or pets. - Keep testosterone gel, 1% away from fire. Keep testosterone gel, 1% and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive,Suite 202 Durham, NC 27713 USA Rev.02/2024

Vörulýsing:

Testosterone gel 1% is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered- dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations; each pump actuation dispenses 1.25 g of gel. NDC Number                                                                           Package Size 21922-019-47                                                                        2 x 75 g pumps per carton (each pump dispenses 60 metered pump actuations with each pump actuation containing 12.5 mg of testosterone in 1.25 g of gel) Testosterone Gel, 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 5 g gel contains 50 mg testosterone, USP, respectively.  NDC Number                                                                            Package Size 21922-019-02                                                           30 packets (a unit dose packet containing 50 mg of testosterone provided in 5 g of gel)                                                                          Keep testosterone gel out of the reach of children.   Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Disposal Used testosterone gel 1% pump or used testosterone gel 1% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Encube Ethicals Private Limited
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MEDICATION GUIDE
Testosterone Gel, 1% (tes TOS ter one Jel) CIII
For topical use
What
is
the
most
important
information
I
should
know
about
testosterone
gel,
1%?
1. Testosterone gel, 1% 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 gel 1%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 gel
1%.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with testosterone gel,1%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
gel,
1%may
include:
•
changes
in
body
hair.
•
an
abnormal
increase
in
pimples
(acne).
Stop using testosterone gel, 1%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
gel,
1%.
2. To lower the risk of transfer of testosterone gel, 1% from your
body to others, follow these important instructions:
•
Apply testosterone gel, 1% only to areas of your shoulders, upper
arms, or stomach area (abdomen) that will be covered by a short sleeve
t-shirt.
•
Wash your hands right away with soap and water after applying
testosterone gel, 1%.
•
After the gel has dried, cover the application area with clothing.
Keep the area covered until you have washed the gel off the
application
area well or have showered.
•
If you expect to have skin-to-skin contact with another person, first
wash the applica

Vara einkenni

TESTOSTERONE GEL, 1% - TESTOSTERONE GEL, 1% GEL
ENCUBE ETHICALS PRIVATE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE GEL, 1%
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE GEL, 1%.
TESTOSTERONE GEL 1%, 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
TESTOSTERONE GEL. (5.2, 6.2)
CHILDREN SHOULD AVOID CONTACT WITH UNWASHED OR UNCLOTHED APPLICATION
SITES IN MEN
USING TESTOSTERONE GEL. (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 gel, 1% 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 gel, 1% in men with “age-related
hypogonadism” have not been
established. (1)
Safety and efficacy of testosterone gel, 1% in males less than 18
years old have not been established.
(8.4)
Topical testosterone products may have different doses, strengths or
application instructions that may
result in different systemic exposure. (1, 12.3)
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION FOR TESTOSTERONE GEL, 1% DIFFERS FROM
TESTOSTERONE GEL,
1.62%. FOR DOSAGE AND ADMINISTRATION OF TESTOSTERONE GEL, 1.62% REFER
TO ITS FULL
PRESCRIBING INFORMATION. (2)
Prior to initiating testosterone gel, 1%., 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 dose of testosterone gel, 1% is 50 mg of testosterone (4 pump
actuations, or one 50