TESTOSTERONE gel, metered

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Par Pharmaceutical, Inc.

INN (Medzinárodný Name):

TESTOSTERONE

Zloženie:

TESTOSTERONE 10 mg in 0.5 g

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Testosterone gel 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, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH] and 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 serum testosterone concentrations but have gonadotropins in the normal or low range. Limitations of Use   - Safety and efficacy of testosterone gel in men with “age-related hypogonadism” (also referred to as “late-onset hypogona

Prehľad produktov:

Testosterone gel is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One (1) pump actuation dispenses 0.5 g of gel. Testosterone gel is available in a 60 g canister NDC 0603-7831-88. Store at controlled room temperature 20o C-25o C (68o F-77o F); excursions permitted to 15o C-30o C (59o F-86o F). [See USP]. Do Not Freeze. Used testosterone gel canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Stav Autorizácia:

New Drug Application Authorized Generic

Príbalový leták

Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Testosterone Gel CIII
for topical use
What is the most important information I should know about
testosterone gel?
1. Testosterone gel 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 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.
Children
Signs and symptoms of early puberty in a child when they come in
direct contact with testosterone gel 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 may include:
•
changes in body hair.
•
an abnormal increase in pimples (acne).
Stop using testosterone gel 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.
2. To lower the risk of transfer of testosterone gel from your body to
others, follow these important
instructions:
•
Apply testosterone gel only to the front and inside area of your
thighs that will be covered by
clothing.
•
Wash your hands right away with soap and water after applying
testosterone gel.
•
After the gel 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 contact with another person, first
wash the application area well
with soap and water.
•
If a child or woman touches the area where you have applied
testosterone gel,

Súhrn charakteristických

TESTOSTERONE- TESTOSTERONE GEL, METERED
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TESTOSTERONE GEL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TESTOSTERONE
GEL.
TESTOSTERONE GEL 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 is an androgen 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 in men with “age-related
hypogonadism” have not been
established (1).
Safety and efficacy of testosterone gel in males less than 18 years
old have not been established. (8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating testosterone gel, 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 is 40 mg of testosterone (4 pump
actuations) applied topically once
daily in the morning. (2.1)
Apply to clean, dry, intact skin of the thighs. Do not apply
testosterone gel to the genitals or other parts
of the body. (2.2)
Dose adjustment: testosterone gel can be dose adjusted between a
minimum of 10 mg of testosterone
(1 pump actuation) and a maximum of 70 mg of testosterone (7 pump
actuations) on the basis of total
serum testoster