METHITEST- methyltestosterone tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

METHYLTESTOSTERONE (UNII: V9EFU16ZIF) (METHYLTESTOSTERONE - UNII:V9EFU16ZIF)

Dostopno od:

Amneal Pharmaceuticals of New York LLC

INN (mednarodno ime):

METHYLTESTOSTERONE

Sestava:

METHYLTESTOSTERONE 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: - Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. - Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual 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 methyltestosterone in men

Povzetek izdelek:

METHITEST™ (methyltestosterone) Tablets USP, 10 mg : Each compressed, single-scored, round, white tablet contains 10 mg of methyltestosterone USP, for oral use. Each tablet is debossed with “7037” on one side, and scored on the other side. They are available as: Bottles of 100:                                                NDC 0115-7037-01 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from Light, Moisture and Heat. This package is not for household dispensing. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2018-00

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METHITEST- METHYLTESTOSTERONE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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METHITEST™
(METHYLTESTOSTERONE) TABLETS, USP, CIII
DESCRIPTION
METHITEST™ (methyltestosterone) tablets, USP contain
methyltestosterone USP, a synthetic
androgen. Androgens are steroids that develop and maintain primary and
secondary male sex
characteristics. METHITEST™ (methyltestosterone) tablets, USP are to
be taken orally.
Androgens are derivatives of cyclopentanoperhydrophenanthrena.
Endogenous androgens are C-19
steroids with a side chain at C-17, and with two angular methyl
groups. Testosterone is the primary
endogenous androgen. In their active form, all drugs in the class have
a 17-beta-hydroxy group. 17-
alpha alkylation (methyltestosterone) increases the pharmacologic
activity per unit weight compared to
testosterone when given orally.
Methyltestosterone is the 17α-methyl derivative of testosterone, the
true testicular hormone.
Chemically, methyltestosterone is
17b-hydroxy-17-methylandrost-4-en-3-one, with the empirical
formula C
H O , a molecular weight of 302.5, and the following structural
formula:
C
H O M.W. 302.46 (CAS-58-18-4)
17 β-Hydroxy-17-methylandrost-4-en-3-one
Methyltestosterone, USP is a white to creamy-white, odorless, slightly
hydroscopic powder. It is
practically insoluble in water, and is soluble in alcohol and other
organic solvents.
METHITEST™ (methyltestosterone) tablets, USP contain
methyltestosterone, USP and acacia, lactose
monohydrate, confectioner’s sugar, corn starch, powdered cellulose,
sodium lauryl sulfate, magnesium
stearate, pregelatinized starch, and guar gum.
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 enlargement, vocal
cord thickening; alterations