TESTIM- testosterone gel

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Stat Rx USA

INN (국제 이름):

TESTOSTERONE

구성:

TESTOSTERONE 50 mg in 5 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Testim® is indicated for testosterone 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 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 levels and gonadotropins (FSH, LH) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. Testim® has not been clinically evaluated in males under 18 years of age. Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testim® is

제품 요약:

Testim® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act. Testim® is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows: Storage Store at room temperature 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Disposal Used Testim® tubes should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets; contents flammable. RX Only Manufactured for: Auxilium Pharmaceuticals, Inc. Norristown, PA, 19401 USA By: Contract Pharmaceuticals Limited Mississauga, Ontario, Canada L5N 6L6 Labeling Code: AA2500.09 Issued: January 2005 0105-001.a 127997

승인 상태:

New Drug Application

제품 특성 요약

TESTIM - TESTOSTERONE GEL
STAT RX USA
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TESTIM (TESTOSTERONE) GEL
Structure Image
INDICATIONS AND USAGE
Testim is indicated for testosterone replacement therapy in adult
males for conditions associated with
a deficiency or absence of endogenous testosterone:
1. Primary hypogonadism (congenital or acquired): testicular failure
due to 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 levels
and gonadotropins (FSH, LH) above the normal range.
2. Hypogonadotropic hypogonadism (congenital or acquired): idiopathic
gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic
injury from tumors,
trauma, or radiation. These men have low testosterone serum levels but
have gonadotropins in the
normal or low range.
Testim has not been clinically evaluated in males under 18 years of
age.
CONTRAINDICATIONS
Androgens are contraindicated in men with carcinoma of the breast or
known or suspected carcinoma of
the prostate. Testim is not indicated for use in women, has not been
evaluated for use in women, and
must not be used in women.
Pregnant and nursing women should avoid skin contact with Testim
application sites on men.
Testosterone may cause fetal harm. Testosterone exposure during
pregnancy has been reported to be
associated with fetal abnormalities. In the event that unwashed or
unclothed skin to which Testim has
been applied comes in direct contact with the skin of a pregnant or
nursing woman, the general area of
contact on the woman should be immediately washed with soap and water.
Testim should not be used in patients with known hypersensitivity to
any of its ingredients, including
testosterone USP that is chemically synthesized from soy.
WARNINGS
1. Testim should not be applied to the abdomen.
2. Prolonged use of high doses of orally active 17-alpha-alkyl
androgens (e.g., methyltestosterone)
has been associated w