Nandrolone Decanoate

Pronouncation: (NAN-drole-ohn deh-KAN-oh-ate)
Class: Anabolic steroid

Trade Names:
Nandrolone Decanoate
- Injection 200 mg/mL (in oil)
- Injection 100 mg/mL (in oil)

Mechanism of Action

Pharmacology

Suppresses gonadotropic functions of the pituitary and may exert a direct effect upon the testes.

Indications and Usage

Management of anemia of renal insufficiency and has been shown to increase Hgb and RBC mass.

Contraindications

Men with carcinoma of the breast or known or suspected carcinoma of the prostate; carcinoma of the breast in women with hypercalcemia; pregnancy; nephrosis or nephrotic phase of nephritis.

Dosage and Administration

Adults

IM 50 to 100 mg/wk for women and 100 to 200 mg/wk for men. If no hematologic improvement is seen within the first 6 mo, discontinue therapy.

Children 2 to 13 yr of age

IM 25 to 50 mg q 3 to 4 wk.

General Advice

  • For deep IM administration only, preferably into gluteal muscle. Not for intradermal, subcutaneous, IV, or intra-arterial administration.
  • Rotate injection sites.
  • Do not administer if particulate matter, cloudiness, or discoloration noted.

Storage/Stability

Store vials at controlled room temperature (59° to 86°F). Protect from light. Store in carton until contents are used.

Drug Interactions

Anticoagulants (eg, warfarin)

Anticoagulant effects may be increased.

Insulin, oral hypoglycemic agents

May decrease glucose control; dosage adjustments may be necessary.

Laboratory Test Interactions

Thyroxine-binding globulin may be decreased, resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . Free thyroid hormone levels are not changed.

Adverse Reactions

CNS

Depression; excitation; habituation; insomnia; increased and decreased libido.

Dermatologic

Acne (women and prepubertal boys); hirsutism and male pattern baldness (women).

EENT

Deepening of voice (women).

GI

Diarrhea; nausea; vomiting.

Genitourinary

Gynecomastia; inhibition of testicular atrophy and oligospermia, testicular function, impotence, chronic priapism, epididymitis, bladder irritability (postpubertal men); increased frequency of erection, phallic enlargement (prepubertal men); clitoral enlargement, menstrual irregularities (women).

Hepatic

Hepatocellular neoplasms; peliosis hepatitis.

Metabolic-Nutritional

Decreased glucose tolerance and HDL; increased creatine, creatinine excretion, serum creatinine phosphokinase, and serum levels of LDL; serum electrolyte retention (including calcium, chloride, phosphate, potassium, sodium).

Musculoskeletal

Premature closure of epiphyses (children).

Miscellaneous

Edema.

Precautions

Warnings

Peliosis hepatitis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, occurred in patients receiving androgenic anabolic steroids. The condition may not be recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Lesions completely resolve upon discontinuation. Liver cell tumors, often benign and androgen-dependent but sometimes malignant, have occurred. Drug discontinuation often results in regression or cessation of tumor growth. Hepatic tumors associated with androgens or anabolic steroids may be silent until life-threatening, intra-abdominal hemorrhage develops. Blood lipid changes, including decreased HDL and increased LDL, associated with increased risk of atherosclerosis are seen in some patients treated with androgens and anabolic steroids.


Monitor

Assess Hgb and Hct, liver function (eg, transaminases, bilirubin), prostate specific antigen, total cholesterol, and HDL-C before starting therapy and periodically thereafter during prolonged treatment.

Monitor blood sugar in diabetic patient when drug is started or dose is changed.

Monitor serum and urine calcium closely in women with disseminated breast carcinoma.

Monitor serum and urine calcium is closely monitored in women with disseminated breast carcinoma.

Monitor bone maturation by assessing bone age in wrist and hand q 6 mo when medication is used to treat delayed puberty.


Pregnancy

Category X .

Lactation

Undetermined.

Children

Safety and efficacy not established in children with metastatic breast cancer. May accelerate epiphyseal maturation more rapidly than linear growth and the effect may continue for 6 mo after the drug is stopped.

Elderly

May be at an increased risk for prostatic hypertrophy and prostatic carcinoma.

Special Risk Patients

Use with caution in patients with cardiac, renal, or hepatic disease.

Athletic performance enhancement

Should not be used for this purpose.

Cholestatic jaundice

Associated with therapeutic use of anabolic and androgenic steroids.

Hypercalcemia

May occur in women with disseminated breast carcinoma.

Virilization

May occur in women; observe for signs of voice deepening, hirsutism, acne, clitorimegaly, and menstrual irregularities.

Patient Information

  • Explain name, action, and potential side effects of drug.
  • Advise patient that medication will be prepared and administered by a health care provider in a medical setting.
  • Advise patient that dose will be adjusted based upon response and tolerance to therapy.
  • Advise patient that iron supplementation will probably be needed and to take iron supplements as prescribed.
  • Caution patient that nandrolone has not been shown to be safe or effective for enhancing athletic performance and, because of potential for serious health risks, should not be used for this purpose.
  • Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
  • Instruct patient to inform health care provider if any of the following occur: hoarseness; acne; more hair on face; nausea; vomiting; changes in skin color; ankle swelling. Instruct women also to report the following: deepening of voice; enlargement of clitoris; menstrual irregularities; increased facial hair.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
  • Remind patient that office visits and laboratory tests will be required to monitor therapy and to keep appointments.
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