Arginine Hydrochloride

INDICATIONS AND USAGE R-Gene ® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature. If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene ® 10 is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may not respond to R-Gene ® 10 (Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day. Some patients who respond to R-Gene ® 10 do not respond to insulin and vice versa. The rate of false positive responses for R-Gene ® 10 is approximately 32%, and the rate of false negatives is approximately 27%.

WARNINGS There have been reports of overdosage of R-Gene ® 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE ® 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE ® 10 IN PEDIATRIC PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS, CEREBRAL EDEMA, OR POSSIBLY DEATH. Hypersensitivity reactions, including anaphylaxis have been reported. Appropriate medical support should be available during R-Gene ® 10 administration. If anaphylaxis or other serious hypersensitivity reaction occurs, R-Gene ® 10 should be discontinued and appropriate medical treatment initiated. R-Gene ® 10 should always be administered by intravenous infusion because of its hypertonicity. R-Gene ® 10 is a diagnostic aid and is not intended for therapeutic use.