Arginine Injection (Arginine Hydrochloride Injection) - Indications and Dosage

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 (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%.

DIRECTIONS FOR USE OF I.V. CONTAINER

The important feature of this container is that it is a closed system. That is, no unfiltered air comes in contact with the solution. The spike is thrust through a solid stopper, the air enters through a bacterial air filter, and only filtered air enters the bottle then or during the infusion. The rubber stopper surface beneath the metal seal is sterile.

A special air-inletting, air-filtering set with a bacterial air filter is required. No airway needle is needed.

1. Use only if solution is clear and seal is intact. Carefully examine bottle for evidence of damage, e.g., dents or other evidence of damage to metal cap, small cracks, dents in seal, or areas of dried powder on exterior. Do not administer contents if such damage is found.
2. Remove tamperproof metal seal and metal disc from bottle to expose rubber stopper, taking care that you do not contaminate the target site of the stopper with fingers, hair, clothing, etc. Immediately perform step #3.
3. With shut-off clamp closed, remove sterility protector from spike of administration set and immediately insert set with a quick thrust into center of stopper with bottle upright on table. (Push straight in -- don't twist -- twisting may cause stopper coring.)
4. Promptly invert bottle to automatically establish fluid level in drip chamber and to check for vacuum by observing rising filtered air bubbles. Discard bottle if there is no vacuum or if the solution is not clear.
5. Clear tubing of air. Proceed with infusion.

CAUTION: While the top of the rubber stopper is sterile, as soon as the seal and disc are removed the stopper is exposed. The longer the time between removal of the seal and disc and the piercing of the stopper, the greater the chance of contamination of the stopper.

NOTE: When medication is to be added to the bottle:

1. See #1 and #2 above.
2. Add medications before attaching administration set. Vacuum should be observed at this point, by sucking in of additive container content, since vacuum may be lost during this procedure and not observable during administration set insertion.
3. If medications have been placed in bottle through stopper, it is recommended that the face of the stopper be swabbed immediately before piercing with administration set.

CONTINUED USE OF SOLUTIONS AND SETS

Procedure differs with every hospital for the length of time solutions and administration sets may be used continuously. Some recommend change of both every 8 hours, others recommend change of both every 24 hours, and others recommend change of solutions every 8 hours and change of sets every 24 hours. The shorter the period of use the less the possibility of multiplication of organisms inadvertently introduced.

74-3624-16

(Revised August 2003)

DOSAGE AND ADMINISTRATION

The intravenous dose for adults is 300 mL (30 g arginine hydrochloride) of R-Gene^® 10. The intravenous dose for children is 5 mL (0.5 g arginine hydrochloride) per kilogram of body weight of R-Gene^® 10.

The intravenous infusion of R-Gene^® 10 is a part of the test for measurement of pituitary reserve of human growth hormone and, for successful administration of the test, clinical conditions and procedures should be as follows:

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 (10% Arginine Hydrochloride Injection, USP) should be infused through an indwelling needle or soft catheter placed in an antecubital vein or other suitable vein. 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 should be infused beginning at zero time at a uniform rate which will permit the recommended dose to be administered in 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, or one may elect to confirm with the insulin hypoglycemia test. A waiting period of one day is advised between tests.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

R-Gene^® 10 is supplied as a 300 mL fill in 500 mL containers.

NDC 0009-0436-24

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Solution that has been frozen must not be used.

Manufactured for

Pharmacia & Upjohn Company

A subsidiary of Pharmacia Corporation

Kalamazoo, Michigan 49001, USA

By

Fresenius Kabi Clayton, L.P.

Clayton, NC 27520 USA

R-Gene^® is a registered trademark of Pharmacia AB.