METHYLTESTOSTERONE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novitium Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1. Males 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

Product summary:

Methyltestosterone Capsules USP, 10 mg are hard gelatin capsules with red translucent body and cap imprinted “novitium 10 mg” on the body and “255” on the cap in black ink; containing white to off-white powder. They are available as follows: Bottles of 100:             NDC 70954-255-10 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. Manufactured By: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 06/2021 LB4274-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLTESTOSTERONE - METHYLTESTOSTERONE CAPSULE
NOVITIUM PHARMA 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 Molecular Weight: 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:
pregelatinized starch,
lactose anhydrous, D&C Yellow #10, gelatin, FD&C Blue #1, FD&C Red
#40. Additionally,
the capsule imprinting ink contains strong ammonia solution, potassium
hydroxide, iron
oxide black, propylene glycol and shellac.
FDA approved dissolution test specifications differ from USP.
20
30
2
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 in body
musculature, and fat
distribution. Drugs in this class also cause retentio