Genotropin (Somatropin) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Concomitant glucocorticoid treatment may inhibit the growth-promoting effect of growth hormone. Pediatric GHD patients with coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth (see also PRECAUTIONS - General). Limited published data indicate that growth hormone treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in man. These data suggest that growth hormone administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g. corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when growth hormone is administered in combination with other drugs known to be metabolized by CP450 liver enzymes.

OVERDOSAGE

There is little information on acute or chronic overdosage with GENOTROPIN Lyophilized Powder. Intravenously administered growth hormone has been shown to result in an acute decrease in plasma glucose. Subsequently, hyperglycemia was seen. It is thought that the same effect might occur on rare occasions with a high dosage of GENOTROPIN administered SC. Long-term overdosage may result in signs and symptoms of acromegaly consistent with overproduction of growth hormone.

CONTRAINDICATIONS

GENOTROPIN Lyophilized Powder should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumor therapy complete prior to the institution of therapy. GENOTROPIN should be discontinued if there is evidence of tumor growth. Growth hormone should not be used for growth promotion in pediatric patients with fused epiphyses.

Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs 19.3%) among somatropin treated patients (doses 5.3 to 8 mg/day) compared to those receiving placebo (see WARNINGS).

Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (see WARNINGS).