Oxandrolone (Oxandrin, Anavir) is a synthetic anabolic steroid that is used in the for weight gain and muscle mass in emaciated patients. It also promotes wound healing in patients with severe burns.

Oxandrolone Uses:

• Weight gain (adjunctive therapy):

  • To promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who, without definite pathophysiologic reasons, fail to gain or to maintain a normal weight, start Adjunctive therapy.

• Other indications included in manufacturer labeling:

  • Adjunctive therapy to offset protein catabolism with prolonged corticosteroid administration.
  • Relief of bone pain associated with osteoporosis (current guidelines do not make recommendations regarding use of oxandrolone for osteoporosis-related bone pain)

• Off Label Use of Oxandrolone in Adults:

  • Severe Burns (adjunctive therapy)

Oxandrolone Dose in Adults

Oxandrolone Dose in the treatment of severe burns (off-label):

• P/O, Enteral feeding tube:

• 10 mg every 12 hours starting ~5 days after injury.

Weight gain (adjunctive therapy ):

• P/O:
• Based on individual response, 2.5-20 milligram in divided doses 2-4 times a day.
• A course of therapy of 2-4 weeks is usually adequate.
• May repeat intermittently as required.

Oxandrolone Dose in Childrens

Oxandrolone dose in the treatment of severe burn management; to increase lean muscle mass and promote wound healing: 

• Children and Adolescents:

  • P/O:
  • 0.1 mg/kg/dose twice a day for up to 12 months has been shown to increase lean body mass, bone mineral density, and muscle strength.
  • Shortened length of ICU stay and improved donor site wound healing was also observed.
  • Benefits have been shown to persist for up to 5 years post-burn.

Oxandrolone dose in the treatment of Constitutional delay of growth and puberty (CDGP) in males:

• Children and Adolescents 9 to 16 years:

  • P/O:
  • 1.25-2.5 mg once a day in the evening.
  • Normal duration: 3-12 months although longer (~5 years) has been reported.

Oxandrolone Dose in the treatment of Turner Syndrome:

• Children and Adolescents less than 8 years:

  • P/O:
  • Reported range:
  • 0.03-0.06 mg/kg/day at bedtime in combination with growth hormone & estrogen.
  • Max single dose:
  • 2.5 milligram per dose.
  • Due to risks of dose-related virilization, doses ≥0.05 mg/kg/day should generally be avoided.
  • Typically, therapy initiated at 8-9 years of age and continued until goal height attained or further growth is unlikely (eg, bone age ≥14 years and growth velocity <2 cm/year).

Oxandrolone for Weight gain (an adjunct to diet and other therapies):

• Children and Adolescents:

  • P/O:
  • Total daily dose:
  • ≤0.1 mg/kg.
  • May be repeated intermittently as required.
  • The daily dose is divided 2 to 4 times daily in adult patients.
  • Typical therapy duration: 2-4 weeks.

Pregnancy Risk Factor X

• Pregnant women should not use this product.
• Reports have been made about the maculinization and mutilation of the fetus.

Oxandrolone use during breastfeeding:

• It is unknown if oxandrolone secretes in breast milk.
• Due to the possibility of serious adverse reactions in nursing infants, breastfeeding is not recommended.

Oxandrolone Dose in Kidney Disease:

• In the manufacturer’s labeling, there are no dosage adjustments provided.
• Due to the propensity to cause edema, use cautiously.

Oxandrolone Dose in Liver Disease:

• Preexisting impairment:

  • In the manufacturer’s labeling, there are no dosage adjustments provided.
  • use cautiously.

• Hepatotoxicity during therapy:

  •  If abnormal liver function tests or cholestatic hepatitis with jaundice occurs, discontinue use.

Side effects of Oxandrolone:

• Cardiovascular:

  • Edema

• Central Nervous System:

  • Deepening Of The Voice (Females)
  • Depression
  • Excitement
  • Habituation
  • Insomnia

• Dermatologic:

  • Acne Vulgaris (Females And Prepubertal Males)
  • Androgenetic Alopecia (Females)

• Endocrine & Metabolic:

  • Changes In Libido
  • Decreased Glucose Tolerance
  • Decreased HDL Cholesterol
  • Electrolyte Disturbance
  • Gynecomastia
  • Hirsutism (Females)
  • Increased LDL Cholesterol
  • Inhibition Of Gonadotropin Secretion
  • Menstrual Disease (Females)

• Genitourinary:

  • Clitoromegaly (Females)
  • Epididymitis (Postpubertal Males)
  • Erectile Dysfunction (Prepubertal Males; Increased Or Persistent Erections)
  • Impotence (Postpubertal Males)
  • Inhibition Of Testicular Function (Postpubertal Males)
  • Irritable Bladder (Postpubertal Males)
  • Oligospermia (Postpubertal Males)
  • Phallic Enlargement (Prepubertal Males)
  • Priapism (Chronic; Postpubertal Males)
  • Testicular Atrophy (Postpubertal Males)

• Hematologic & Oncologic:

  • Clotting Factors Suppression
  • Prolonged Prothrombin Time

• Hepatic:

  • Cholestatic Jaundice
  • Hepatocellular Neoplasm
  • Increased Serum Alkaline Phosphatase
  • Increased Serum ALT
  • Increased Serum AST
  • Increased Serum Bilirubin
  • Peliosis Hepatitis (Longterm Therapy)

• Neuromuscular & Skeletal:

  • Increased Creatine Phosphokinase
  • Premature Epiphyseal Closure (Children)

• Renal:

  • Increased Creatinine Clearance

Contraindications to Oxandrolone:

• Nephrosis.
• Females with hypercalcemia are at greater risk of developing breast cancer.
• Men with suspected or confirmed prostate cancer or breast cancer.
• Hypercalcemia.
• Pregnancy

Warnings and precautions

• Blood lipid changes: [US Boxed Warning]

  • Could cause blood lipid changes and increase the risk of developing arteriosclerosis.
  • Patients at high risk of, or who have a history of, cardiovascular disease should be cautious.
  • As directed, review your lipid profile and adjust your therapy.
  • Lipid changes can usually be reversed after discontinuation of therapy.

• Gynecomastia

  • May cause gynecomastia.

• Hepatic effects: [US Boxed Warning]

  • Anabolic steroids can cause liver cell tumors, peliosis liveritis or liver failure.
  • This may not become apparent until intra-abdominal hemorhage or liver failure occurs.
  • Stop taking medication if you have cholestatic liver disease with jaundice, abnormal liver function tests or cholestatic hepatitis.
  • Drug-induced jaundice can be reversed after discontinuation.
  • Use caution in patients with hepatic impairment.

• Oligospermia:

  • May inhibit spermatogenesis.
  • Oligospermia may occur.

• Polycythemia

  • High doses anabolic steroids can cause increased hemoglobin or hematocrit.

• Priapism

  • Excessive sexual stimulation or priapism may be a possibility.

• Breast cancer

  • Use caution when treating breast cancer patients.
  • Hypercalcemia can be caused by stimulating osteolysis
  • Contraindicated in females with hypercalcemia and breast cancer.
  • If hypercalcemia occurs, discontinue use.
  • Men with breast cancer are not advised to use this medication.

• Carbohydrate intolerance:

  • Could have negative effects on glucose tolerance
  • Patients with diabetes should be cautious.

• COPD:

  • Patients with COPD should be cautious.

• Conditions that are edematous:

  • Patients with edema (eg., cardiovascular disease, migraines, seizure disorder) should be cautious.
  • May cause fluid retention.

Oxandrolone: Drug Interaction

Monitoring Parameters:

• Liver function tests
• cholesterol profile
• hemoglobin/hematocrit.
• INR/PT in patients on anticoagulant therapy

Children:

• Radiographs of left wrist and hand every 6 months (to assess bone maturation)

Adult females:

• Signs of virilization (deepening voice, hirsutism, acne, clitoromegaly).
• Urine & serum calcium in women with breast cancer

How to administer Oxandrolone?

Enteral feeding tube (off-label):

• In severe burn patients unable to tolerate oral administration, may dissolve oxandrolone tablets in ethanol and administer through an enteral feeding tube.

Mechanism of action of Oxandrolone:

• Synthetic testosterone derivative with similar androgenic and anabolic actions

Absorption:

• Well absorbed when taken orally

Protein binding:

• 95 percent

Half-life elimination:

• 10-13 hours

Time to peak serum concentration:

• ~1 hour

Excretion:

• Urine (28 percent as unchanged drug).

International Brands of Oxandrolone:

• Oxandrin
• Kicker
• Xtendrol

Oxandrolone Brand Names in Pakistan:

No Brands Available in Pakistan.