Rx Item-R-Gene 10 Arginine HCl 10% Solution 300Ml By Pfizer Pharma

Clinical Information
Gen. Code and Des.
37018 arginine HCl INTRAVEN IV SOLN 10 %
GCN and Des.
57881 arginine HCl INTRAVEN IV SOLN 10 %
Strength
Dose Form
INTRAVENOUS SOLUTION
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
36660000 PITUITARY FUNCTION
Active Ingredients
5095 arginine HCl 1119342
Inactive Ingredients
18822 rubber, unspecified

R-GENE- arginine hydrochloride injection, solution
Pharmacia and Upjohn Company


For Intravenous Use

DESCRIPTION

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.

CLINICAL PHARMACOLOGY

Intravenous infusion of R-Gene 10 often induces a pronounced rise in the plasma level of human growth hormone (HGH) in subjects with intact pituitary function. This rise is usually diminished or absent in patients with impairment of this function.
R-Gene 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%.

RX ITEM-R-Gene 10 10% Solution 300Ml By
Item No.: RX213876 NDC No.9043601 0009-0436-01 0009043601 00009-0436-01 UPC No.:300090436018 NDC No.00009-0436-01 UPC/GTIN No.3-00090-43601-8 300090436018 300090-436018 MPN 43601

R-Gene 10 10% Solution 300Ml By Pfizer P
Item No.: RX213876 NDC No.9043601 0009-0436-01 0009043601 00009-0436-01 UPC No.:300090436018 NDC No.00009-0436-01 UPC/GTIN No.3-00090-43601-8 300090436018 300090-436018 MPN 43601

ARGININE HCL INTRAVEN IV
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