METHYLTESTOSTERONE capsule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

METHYLTESTOSTERONE

রচনা:

METHYLTESTOSTERONE 10 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: - Primary hypogonadism (congenital or acquired) — testicular failure due to cryptorchidism, bilateral torsions, 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 with “ag

পণ্য সারাংশ:

Methyltestosterone Capsules USP, 10 mg are capsules with red translucent body and cap imprinted with “AA1” in black ink; containing white to off-white powder. They are available as follows: Bottles of 30:                                      NDC 0115-1408-08 Bottles of 100:                                    NDC 0115-1408-01 Bottles of 1000:                                  NDC 0115-1408-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2018-00

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

METHYLTESTOSTERONE- METHYLTESTOSTERONE CAPSULE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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METHYLTESTOSTERONE CAPSULES, USP, CIII
(10 MG)
RX ONLY
DESCRIPTION
The androgens are steroids that develop and maintain primary and
secondary male sex characteristics.
Androgens are derivatives of cyclopentanoper-hydrophenanthrene.
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, a synthetic derivative of testosterone, is an
androgenic preparation given by the
oral route in a capsule form. It has the following structural formula:
C
H O M.W. 302.46
17-β-hydroxy-17-methylandrost-4-en-3-one
Methyltestosterone, USP occurs as white or creamy white crystals or
powder, which is soluble in
various organic solvents but is practically insoluble in water.
Each capsule, for oral administration, contains 10 mg of
methyltestosterone, USP. In addition, each
capsule contains the following inactive ingredients: corn starch, D&C
Yellow #10, gelatin, FD&C Blue
#1, FD&C Red #40, and magnesium stearate. Additionally, the capsule
printing inks contain D&C
Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide
black, propylene glycol, and
shellac.
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
chord thickening, alterations in body
musculature, and fat distribution. Drugs in this class also cause
retention of nitrogen, sodium, potassium,
phosphorus, and decrease