Oxandrolone Tablets USP

COMPOSITION: 
Each tablet contains: 
Oxandrolone USP 10 mg 
 

INDICATIONS: 
Certain cases of disseminated breast cancer in women. 
Osteoporosis due to androgen deficiency in hypogonadal males. 

CONTRA-INDICATIONS: 
Not intended for use in children. 
Known or suspected prostatic carcinoma and mammary carcinoma in the male. 
Not intended for use in female patients other than those with disseminated breast cancer. 
Contraindicated in nephrosis or the nephrotic phase of nephritis, cardiac and renal failure, hypercalcaemia, oedema, jaundice, liver disease with impaired bilirubin excretion, testicular and hepatic carcinoma. 
 

DOSAGE AND DIRECTIONS FOR USE: 
Dynavar should be taken orally per day in divided doses. 
Adult dose: 5-10 mg every day. 
 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS: 
Vrrilisation which appears in sensitive women as hoarseness, acne, hirsutism, and increased libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in a long-lasting, sometimes irreversible deepening of the voice. 
 

OTHER ADVERSE REACTIONS MAY INCLUDE: 
Oligospermia and decreased ejaculatory volume; 
Suppression of ovarian activity, atrophy of the breasts and endometrial tissue. 
Amenorrhoea and inhibition of spermatogenesis. 
Water and salt retention. 
Premature epiphyseal closure. 
If signs of virilisation develop, treatment should be discontinued. 
Increase in nitrogen retention and skeletal weight; 
Oedema; 
Increased vascularity of the skin; 
Increased growth of the bone; 
Elderly males may become over-stimulated.