Overview
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) (0.1 g/mL). 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.
Mechanism of Action
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. Expected Plasma Levels of HGH in ng/mL Patient Control Range Range of Peak Response to Arginine Normal 0–6 10–30 Pituitary deficient 0–4 0–10 These ranges are based on the mean values of plasma HGH levels calculated from the data of several clinical investigators and reflect their experiences with various methods of radioimmunoassay. Upon gaining experience with this diagnostic test, each clinician will establish his/her own ranges for control and peak levels of HGH.
Indications
- 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.
Common Doses
- 30 g
- 300 mL
- 0.5 g
- 5 mL
Dosage
DOSAGE AND ADMINISTRATION Adult Dosage The recommended adult dose is 30 g arginine hydrochloride (300 mL of R-Gene ® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride. See Directions for Use for preparation instructions. Pediatric Dosage The recommended pediatric dose is 0.5 g/kg arginine hydrochloride (5 mL/kg of R-Gene ® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride.
Contraindications
- CONTRAINDICATIONS The administration of R-Gene ® 10 is contraindicated in persons having known hypersensitivity to any ingredient in this product.
Side Effects
- ADVERSE REACTIONS Adverse reactions associated with 1670 infusions in premarketing studies were as follows: Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients. One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered. One patient had an apparent decrease in platelet count from 150,000 to 60,000.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.