NANDROLONE DECANOATE - nandrolone decanoate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NANDROLONE DECANOATE (UNII: H45187T098) (NANDROLONE - UNII:6PG9VR430D)

Available from:

American Regent, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nandrolone decanoate is indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Surgically induced anephric patients have been reported to be less responsive. - Male patients with carcinoma of the breast or with known or suspected carcinoma of the prostate. - Carcinoma of the breast in females with hypercalcemia: androgenic anabolic steroids may stimulate osteolytic resorption of bones. - Pregnancy, because of masculinization of the fetus. - Nephrosis or the nephrotic phase of nephritis. Nandrolone decanoate injection is classified as a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990.

Product summary:

Nandrolone Decanoate Injection USP, 200 mg per mL is available in vials of 1 mL, in cartons of 20. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Store in carton until contents are used. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Revised: September 2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NANDROLONE DECANOATE - NANDROLONE DECANOATE INJECTION, SOLUTION
AMERICAN REGENT, INC.
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NANDROLONE DECANOATE INJECTION, USP
Rx Only
DESCRIPTION
A sterile oleaginous solution containing per mL: Nandrolone Decanoate
200 mg with Benzyl Alcohol
5% as solubilizer/preservative, in Sesame Oil q.s. Nandrolone
decanoate (C
H O ) occurs as a fine,
white to creamy white, crystalline powder. It is odorless, or may have
a slight odor. Nandrolone
decanoate is soluble in chloroform, in alcohol, in acetone, and in
vegetable oils. It is practically
insoluble in water.
CLINICAL PHARMACOLOGY
Anabolic steroids are synthetic derivatives of testosterone. Certain
clinical effects and adverse
reactions demonstrate the androgenic properties of this class of
drugs. Complete dissociation of
anabolic and androgenic effects has not been achieved. The actions of
anabolic steroids are therefore
similar to those of male sex hormones with the possibility of causing
serious disturbances of growth
and sexual development if given to young children. Anabolic steroids
suppress the gonadotropic
functions of the pituitary and may exert a direct effect upon the
testis. Anabolic steroids have been
reported to increase low-density lipoproteins and decrease
high-density lipoproteins. These changes
revert to normal on discontinuation of treatment.
INDICATIONS AND USAGE
Nandrolone decanoate is indicated for the management of the anemia of
renal insufficiency and has been
shown to increase hemoglobin and red cell mass. Surgically induced
anephric patients have been
reported to be less responsive.
CONTRAINDICATIONS
1. Male patients with carcinoma of the breast or with known or
suspected carcinoma of the prostate.
2. Carcinoma of the breast in females with hypercalcemia: androgenic
anabolic steroids may stimulate
osteolytic resorption of bones.
3. Pregnancy, because of masculinization of the fetus.
4. Nephrosis or the nephrotic phase of nephritis.
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3
WARNINGS
PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC
TISSUE IS REPLACED WIT