NANDROLONE DECANOATE 250 MG INJECTION B.P / 1 ML

Nandrolone – 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 for Nandrolone

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.

Precautions

General

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.

Laboratory Tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of anabolic therapy.  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.

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.

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