ND-250

DESCRIPTION

A sterile oleaginous solution containing per ml: Nandrolone Decanoate 250 mg with Benzyl Alcohol 5% as solubilizer/preservative, in Sesame Oil q.s. Nandrolone decanoate (C28H44O3) 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

ND-250 (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

– 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.

General Precautions

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitorimegaly and menstrual irregularities).  Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization.  Such virilization is usual following anabolic steroid use in high doses.  The insulin or oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids.

Information for Patients

The physician should instruct patients to report any of the following side effects of androgenic anabolic steroids: Hoarseness, acne, changes in menstrual periods, more hair on the face, nausea, vomiting, changes in skin color, or ankle swelling.

Drug Interactions

Anticoagulants. Anabolic steroids may increase sensitivity to oral anticoagulants.  Dosage of the anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level.  Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

Dosage and Administration

ND-250 (Nandrolone decanoate) injection is intended for deep intramuscular injection only, into the gluteal muscle preferably.  Dosage should be based on therapeutic response and consideration of the benefit to risk ratio.  Duration of therapy will depend on the response of the condition and the appearance of adverse reactions.  If possible, therapy should be intermittent.  Nandrolone decanoate should be regarded as adjunctive therapy and adequate quantities of nutrients should be consumed in order to obtain maximal therapeutic effects.

Anemia of Renal Disease

A dose of 50 to 100 mg per week is recommended for women and 100 to 200 mg per week for men. Drug therapy should be discontinued if no hematologic improvement is seen within the first six months. For children from 2 to 13 years of age, the average dose is 25 to 50 mg every 3 to 4 weeks.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

How is ND-250 Supplied

ND-250 (Nandrolone Decanoate), 250 mg per mL is available in vials of 1 mL, in cartons of 10.
Store at 20° to 25°C (68° to 77°F).
PROTECT FROM LIGHT. Store in carton until contents are used.