(arginine HCl)
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.
R-Gene® 10 is a hypertonic (950 mOsmol/liter) and acidic (average pH of 5.6) solution that can cause irritation and damage to tissues. Care should be used to ensure administration of R-Gene® 10 through a patent catheter within a patent vein. Excessive rates of infusion may result in local irritation and in flushing, nausea, or vomiting. Inadequate dosing or prolongation of the infusion period may diminish the stimulus to the pituitary and nullify the test.
The arginine in R-Gene® 10 can be metabolized resulting in nitrogen-containing products for excretion. The effect of an acute amino acid or nitrogen burden upon patients with impairment of renal function should be considered when R-Gene® 10 is to be administered.
The chloride content of R-Gene® 10 is 47.5 mEq per 100 mL of solution, and the effect of infusing this amount of chloride into patients with electrolyte imbalance should be evaluated before the test is undertaken.
It should be noted that the basal and post stimulation levels of growth hormone are elevated in patients who are pregnant or are taking oral contraceptives.
Long term animal studies have not been performed to evaluate the carcinogenic potential, the mutagenic potential or the effect on fertility of intravenously administered R-Gene® 10.
Reproduction studies have been performed in rabbits and mice at doses 12 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to R-Gene® 10 (10% Arginine Hydrochloride Injection, USP). There have been no adequate or well controlled studies for the use of R-Gene® 10 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.
It is not known whether intravenous administration of R-Gene® 10 could result in significant quantities of arginine in breast milk. Systemically administered amino acids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when R-Gene® 10 is to be administered to nursing women.
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