R-gene

R-gene

R-gene Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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%.

History

There is currently no drug history available for this drug.

Other Information

Each 100 mL of R-Gene® 10 (Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP (equivalent to a 10% solution). L-arginine is a naturally occurring amino acid.

R-Gene 10 is hypertonic (950 mOsmol/liter) and contains 47.5 mEq of chloride ion per 100 mL of solution. The pH is adjusted to 5.6 (5.0–6.5) with arginine base or hydrochloric acid.

R-gene Manufacturers


  • Pharmacia And Upjohn Company
    R-gene (Arginine Hydrochloride) Injection, Solution [Pharmacia And Upjohn Company]

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