If an androgen-associated adverse reaction occurs, treatment should be interrupted and, after disappearance of the symptoms, be resumed at a lower dosage. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be monitored, since androgens may occasionally induce salt and fluid retention. Androgens should be used cautiously in pre-pubertal boys to avoid premature epiphyseal closure or precocious sexual development. A decrease in protein bound iodine (PBI) may occur,but this has no clinical significance. Treatment of male patients over the age of approximately 50 years with androgens should be preceded by a thorough examination of prostate and baseline measurement of prostate-specific antigen serum concentration.
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Carbamazepine has been shown to have adverse effects in reproduction studies in rats when given orally in dosages 10 to 25 times the maximum human daily dosage (MHDD) of 1200 mg on a mg/kg basis or to 4 times the MHDD on a mg/m 2 basis. In rat tera tology studies, 2 of 135 offspring showed kinked ribs at 250 mg/kg and 4 of 119 offspring at 650 mg/kg showed other anomalies (cleft palate, 1; talipes, 1; anophthal mos, 2). In reproduction studies in rats, nursing offspring demonstrated a lack of weight gain and an unkempt appearance at a maternal dosage level of 200 mg/kg.