IT IS ONE OF ESSENTIAL AMINO ACIDS & IS GIVEN AS NUTRITIONAL SUPPORT TO THE DEBILITATED PATIENTS.
ARGININE HYDROCHLORIDE INJECTION 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 ARGININE HYDROCHLORIDE INJECTION IS ADVISABLE TO CONFIRM THE NEGATIVE RESPONSE. THIS CAN BE DONE AFTER A WAITING PERIOD OF ONE DAY. AS PATIENTS MAY NOT RESPOND TO ARGININE HYDROCHLORIDE INJECTION, 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 ARGININE HYDROCHLORIDE INJECTION DO NOT RESPOND TO INSULIN AND VICE VERSA. THE RATE OF FALSE POSITIVE RESPONSES FOR ARGININE HYDROCHLORIDE INJECTION IS APPROXIMATELY 32%, AND THE RATE OF FALSE NEGATIVES IS APPROXIMATELY 27%.
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.
PEDIATRIC DOSAGE:
THE RECOMMENDED PEDIATRIC DOSE IS 0.5 G/KG ARGININE HYDROCHLORIDE (5 ML/KG OF R-GENE® 10 (ARGININE HYDROCHLORIDE INJECTION) ) ADMINISTERED BY INTRAVENOUS INFUSION OVER 30 MINUTES. THE TOTAL DOSE SHOULD NOT EXCEED 30 G ARGININE HYDROCHLORIDE.
FOR PATIENTS WEIGHING 59 KG OR LESS, WITHDRAW A WEIGHT BASED DOSE FROM A SEALED R-GENE® 10 (ARGININE HYDROCHLORIDE INJECTION) BOTTLE AND PLACE IN A SEPARATE CONTAINER FOR INTRAVENOUS INFUSION TO AVOID THE INADVERTENT DELIVERY AND ADMINISTRATION OF THE TOTAL VOLUME FROM THE COMMERCIALLY AVAILABLE CONTAINER.
FOR PATIENTS WEIGHING 60 KG OR MORE, THE RECOMMENDED DOSE IS 30 G ARGININE HYDROCHLORIDE (300 ML OF R-GENE® 10 (ARGININE HYDROCHLORIDE INJECTION).
TEST PROCEDURE
1.THE TEST SHOULD BE SCHEDULED IN THE MORNING FOLLOWING A NORMAL NIGHT'S SLEEP, AND AN OVERNIGHT FAST SHOULD CONTINUE THROUGH THE TEST PERIOD.
2.PATIENTS MUST BE PLACED AT BED REST FOR AT LEAST 30 MINUTES BEFORE THE INFUSION BEGINS. CARE SHOULD BE TAKEN TO MINIMIZE APPREHENSION AND DISTRESS. THIS IS PARTICULARLY IMPORTANT IN CHILDREN.
3.R-GENE® 10 (ARGININE HYDROCHLORIDE INJECTION, USP) IS A HYPERTONIC SOLUTION AND SHOULD ONLY BE INFUSED THROUGH AN INDWELLING NEEDLE OR SOFT CATHETER PLACED IN AN ANTECUBITAL VEIN OR OTHER SUITABLE VEIN (SEE PRECAUTIONS). BLOOD SAMPLES SHOULD BE TAKEN BY VENIPUNCTURE FROM THE CONTRA-LATERAL ARM.
4.A DESIRABLE SCHEDULE FOR DRAWING BLOOD SAMPLES IS AT -30, 0, 30, 60, 90, 120 AND 150 MINUTES.
5.R-GENE® 10 (ARGININE HYDROCHLORIDE INJECTION) SHOULD BE INFUSED BEGINNING AT ZERO TIME AT A UNIFORM RATE WHICH WILL PERMIT THE RECOMMENDED DOSE TO BE ADMINISTERED OVER 30 MINUTES.
6.BLOOD SAMPLES SHOULD BE PROMPTLY CENTRIFUGED AND THE PLASMA STORED AT -20°C UNTIL ASSAYED BY ONE OF THE PUBLISHED RADIOIMMUNOASSAY PROCEDURES.
7.DIAGNOSTIC TEST RESULTS SHOWING A DEFICIENCY OF PITUITARY RESERVE FOR HGH SHOULD BE CONFIRMED BY A SECOND TEST WITH R-GENE® 10 (ARGININE HYDROCHLORIDE INJECTION) , OR ONE MAY ELECT TO CONFIRM WITH THE INSULIN HYPOGLYCEMIA TEST. A WAITING PERIOD OF ONE DAY IS ADVISED BETWEEN TESTS.