DailyMed Label: Nandrolone Decanoate

DailyMed Label: Nandrolone Decanoate

2007

DailyMed Prescription

Nandrolone Decanoate

Nandrolone Decanoate

Watson Laboratories, Inc.

NDC: 0591-6717

NDC: 0591-2186

A sterile oleaginous solution containing per mL: Nandrolone Decanoate 100 mg with Benzyl Alcohol 10% as solubilizer/preservative, in Sesame Oil q.s., and Nandrolone Decanoate 200 mg with Benzyl Alcohol 5% as solubilizer/preservative, in Sesame Oil q.s. Nandrolone decanoate (C 28 H 44 O 3 ) 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.

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.

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. For example, when it is used in the treatment of refractory anemia, adequate iron intake is required for a maximal response. 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.

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.

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. 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. Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of anabolic therapy (see WARNINGS section). If children are treated, periodic (every six months) X-ray examinations of bone age should be made during treatment to determine the rate of bone maturation and the effects of anabolic therapy on the epiphyseal centers. Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids. Serum lipids and high-density lipoprotein cholesterol should be determined periodically. Because of the hepatotoxicity associated with the use of 17-alpha-alkylated anabolic steroids, liver function tests should be obtained periodically. 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. Anabolic steroid therapy may decrease thyroxine-binding globulin resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . Free thyroid hormone levels remain unchanged. Anabolic steroids may cause an increase in prothrombin time. Nandrolone decanoate has not been tested in laboratory animals for carcinogenic or mutagenic effects. Liver cell tumors have been reported in patients receiving androgenic anabolic steroid therapy (see WARNINGS section). Geriatric patients treated with anabolics may be at an increased risk for prostatic hypertrophy and prostatic carcinoma. Pregnancy Category X. See CONTRAINDICATIONS section. It is not known whether anabolic steroids are excreted in human milk. Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from anabolic steroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and efficacy of nandrolone decanoate in children with metastatic breast cancer (rarely found) has not been established. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for six months after the drug has been stopped. Therefore, therapy should be monitored by X-ray studies at six month intervals in order to avoid the risk of compromising the adult height.

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.

Nandrolone Decanoate Injection USP, 100 mg per mL is available in multiple dose vials of 2 mL, in cartons of 10. Nandrolone Decanoate Injection USP, 200 mg per mL is available in single dose vials of 1 mL, in cartons of 25. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Store in carton until contents are used. Literature revised: March 2006 Product Nos.: 0432-02, 0710-01 Watson Laboratories, Inc. Corona, CA 92880 USA

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.