R-Gene 10

WARNINGS

There have been reports of overdosage of R-Gene® 10 (arginine hydrochloride injection) in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE® 10 (arginine hydrochloride injection) INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE® 10 (arginine hydrochloride injection) 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 (arginine hydrochloride injection) administration. If anaphylaxis or other serious hypersensitivity reaction occurs, R-Gene 10 (arginine hydrochloride injection) should be discontinued and appropriate medical treatment initiated.

R-Gene® 10 (arginine hydrochloride injection) should always be administered by intravenous infusion because of its hypertonicity.

R-Gene® 10 (arginine hydrochloride injection) is a diagnostic aid and is not intended for therapeutic use.

PRECAUTIONS

General

R-Gene® 10 (arginine hydrochloride injection) 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 (arginine hydrochloride injection) 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 (arginine hydrochloride injection) 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 (arginine hydrochloride injection) is to be administered.

The chloride content of R-Gene® 10 (arginine hydrochloride injection) 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.

Carcinogenesis, mutagenesis, and impairment of fertility

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 (arginine hydrochloride injection) .

Pregnancy Category B

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 (arginine hydrochloride injection) in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.

Nursing Mothers

It is not known whether intravenous administration of R-Gene® 10 (arginine hydrochloride injection) 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 (arginine hydrochloride injection) is to be administered to nursing women.

Geriatric Use

Clinical studies of arginine did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Last reviewed on RxList: 2/11/2010
This monograph has been modified to include the generic and brand name in many instances.

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