MethylTESTOSTERone (Page 3 of 3)

OVERDOSAGE

There have been no reports of acute overdosage with the androgens.

DOSAGE AND ADMINISTRATION

Prior to initiating methyltestosterone, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Methyltestosterone capsules are administered orally. The suggested dosage for androgens varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions.

Replacement therapy in androgen-deficient males is 10 mg to 50 mg of methyltestosterone daily. Various dosage regimens have been used to induce pubertal changes in hypogonadal males, some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration both in determining the initial dose and in adjusting the dose.

Doses used in delayed puberty generally are in the lower range of that given above, and for a limited duration, for example 4 to 6 months.

Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease. Thus, many experts prefer to use the shorter acting androgen preparations rather than those with prolonged activity for treating breast carcinoma, particularly during the early stages of androgen therapy. The dosage of methyltestosterone for androgen therapy in breast carcinoma in females is from 50 mg to 200 mg daily.

HOW SUPPLIED

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

PRINCIPAL DISPLAY PANEL — 10 mg Bottle Label

1
(click image for full-size original)
METHYLTESTOSTERONE
methyltestosterone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1408
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLTESTOSTERONE (METHYLTESTOSTERONE) METHYLTESTOSTERONE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
GELATIN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color RED (translucent) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AA1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1408-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0115-1408-03 1000 CAPSULE in 1 BOTTLE None
3 NDC:0115-1408-08 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204851 09/21/2015
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS (0115-1408), LABEL (0115-1408), MANUFACTURE (0115-1408), PACK (0115-1408)

Revised: 05/2019 Amneal Pharmaceuticals of New York LLC

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