Oxandrin

Oxandrolone is usually given for only a few weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Oxandrolone will not enhance athletic performance and should not be used for that purpose.

Oxandrolone may be habit-forming. Never share oxandrolone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

If a child is taking this medicine, tell your doctor if the child has any changes in weight. Oxandrolone doses are based on weight in children.

While using oxandrolone, you will need frequent blood tests. Your kidney function may also need to be checked with urine tests.

Oxandrolone can cause bone overgrowth in children, especially young children. Bone development may need to be checked with x-rays every 6 months during treatment.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxandrolone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Oxandrin® (oxandrolone) oral tablets contain 2.5 mg or 10 mg of the anabolic steroid oxandrolone.

Oxandrolone is 17β-hydroxy-17α-methyl-2-oxa-5α-androstan-3-one with the following structural formula:

Inactive ingredients include cornstarch, lactose, magnesium stearate, and hydroxypropyl methylcellulose.

Patients with moderate to severe COPD or COPD patients who are unresponsive to bronchodilators should be monitored closely for COPD exacerbation and fluid retention.

The following adverse reactions have been associated with use of anabolic steroids:

Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy (See WARNINGS). Reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT)

In males

Prepubertal: Phallic enlargement and increased frequency or persistence of erections.

Postpuberal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability.

In females

Clitoral enlargement, menstrual irregularities.

CNS: Habituation, excitation, insomnia, depression, and changes in libido.

Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.

Breast: Gynecomastia.

Larynx: Deepening of the voice in females.

Hair:Hirsutism and male pattern baldness in females.

Skin:Acne (especially in females and prepubertal males).

Skeletal: Premature closure of epiphyses in children (See PRECAUTIONS: Pediatric use).

Fluid and electrolytes: Edema, retention of serum electrolytes (sodium chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance (See PRECAUTIONS: Laboratory tests), increased creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.

Drug Abuse And Dependence

Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic).

PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITH BLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVING ANDROGENIC ANABOLIC STEROID THERAPY. THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMAL HEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEEN ASSOCIATED WITH LIVER FAILURE. THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE DISAPPEARANCE OF LESIONS.

LIVER CELL TUMORS ARE ALSO REPORTED. MOST OFTEN THESE TUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED. WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR. HOWEVER, HEPATIC TUMORS ASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. BLOOD LIPID CHANGES THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITH ANDROGENS OR ANABOLIC STEROIDS. THESE CHANGES INCLUDE DECREASED HIGH-DENSITY LIPOPROTEINS AND SOMETIMES INCREASED LOW-DENSITY LIPOPROTEINS. THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE.

Cholestatic hepatitis and jaundice may occur with 17-alpha-alkylated androgens at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, oxandrolone should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued.

In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. Oxandrolone therapy should be discontinued if hypercalcemia occurs.

Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. Concomitant administration of adrenal cortical steroid or ACTH may increase the edema.

In children, androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect results in compromised adult height. The younger the child, the greater the risk of compromising final mature height. The effect on bone maturation should be monitored by assessing bone age of the left wrist and hand every 6 months (See PRECAUTIONS: Laboratory Tests).

Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.

ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO ENHANCE ATHLETIC ABILITY.

• Savient Pharmaceuticals, Inc..

Other drugs may interact with oxandrolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Catabolic and Wasting Disorders

Adjunct to conventional therapy to promote weight gain in individuals who experience weight loss following extensive surgery, chronic infections (e.g., HIV-associated wasting syndrome; designated an orphan drug by FDA for this use),3 or severe trauma (e.g., burns, spinal cord injury).1 5 17 19 22 32

Adjunct to conventional therapy for management of unexplained weight loss.1

Corticosteroid-induced Protein Catabolism

Adjunct to conventional therapy to offset protein catabolism (e.g., muscle wasting, muscle pain or weakness, delayed wound healing, atrophy of protein matrix of bone) associated with long-term corticosteroid therapy.1 4 20 21 33

Osteoporosis

Labeled for the symptomatic treatment of bone pain accompanying osteoporosis.1 4 23

Misuse and Abuse

Androgens have been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique†.6 7 8 9 10 32

Medical and sports experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae.9 Such misuse by athletes is contrary to rules and ethical principles of athletic competition.7 8 9 10

Manufacturer states that androgens have not been shown to enhance athletic performance.1

• Produces marked anabolic activity and relatively few androgenic effects.5 6 7 13 14 22

• Produces retention of nitrogen,5 7 13 17 22 increases protein anabolism and amino acid utilization, and decreases urinary calcium concentrations.2 5 13 16 18 23

• Increases lean body mass, body cell mass, and muscle strength.7 9 16 17 18 19 20 22

• Increases bone mineral density and content.5 13 16 22

• Inhibits protein catabolism induced by corticosteroids.5 6 8 17 22

• Androgens stimulate production of erythrocytes, apparently by enhancing production of erythropoietin.22 (See Hematologic Effects under Cautions.)

• Inhibits release of endogenous testosterone via feedback inhibition of pituitary luteinizing hormone (LH).1 4 7 8 10 19 22 32

• Large doses of androgens may suppress spermatogenesis.1 4 6 7 8 9 22

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Risk of virilization in females.1 2 4 6 Advise female patients to contact their clinician if they notice hoarseness, acne, menstrual changes, baldness, genital changes, or growth of facial hair.1 2 4

• Risk of priapism; importance of males informing clinicians if too frequent or persistent penile erections occur.1 4

• Advise male patients to contact their clinician if they notice new or worsening acne.1 4

• Importance of periodic assessments to determine rate of bone maturation in pediatric patients.1 4

• Importance of informing clinician if nausea, vomiting, changes in skin color, or ankle swelling occurs.1 4

• Risk of potential liver toxicity and/or lipid abnormalities (e.g., increased LDL-cholesterol concentrations and decreased HDL-cholesterol concentrations.1 4 Importance of regular laboratory monitoring of liver function and cholesterol concentrations.1 4

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 4

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription (e.g., warfarin, antidiabetic medications) and OTC drugs and herbal supplements, as well as any concomitant illnesses.1 4

• Importance of informing patients of other important precautionary information.1 4 (See Cautions.)

No symptoms or signs associated with overdosage have been reported. It is possible that sodium and water retention may occur.

The oral LD50 of oxandrolone in mice and dogs is greater than 5,000 mg/kg. No specific antidote is known, but gastric lavage may be used.

Oxandrolone has been assigned to pregnancy category X by the FDA. Anabolic steroid use, particularly during the first trimester of pregnancy, may cause virilization of the external genitalia of the female fetus. Reversible oligospermia may occur after prolonged administration or excessive dosage in male patients. There are no controlled data in human pregnancy. Oxandrolone use is considered contraindicated during pregnancy.

If reversible oligospermia occurs, the anabolic steroid can be discontinued and if restarted, a lower dosage should be utilized.