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%.

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Panhypopituitarism --

Pituitary dwarfism -- A form of dwarfism caused by complete or partial GROWTH HORMONE deficiency, resulting from either the lack of GROWTH HORMONE-RELEASING FACTOR from the HYPOTHALAMUS or from the mutations in the growth hormone gene (GH1) in the PITUITARY GLAND. It is also known as Type I pituitary dwarfism. Human hypophysial dwarf is caused by a deficiency of HUMAN GROWTH HORMONE during development.

pituitary chromophobe adenoma -- A benign tumor of the anterior pituitary in which the cells do not stain with acidic or basic dyes.

Craniopharyngioma -- A benign pituitary-region neoplasm that originates from Rathke's pouch. The two major histologic and clinical subtypes are adamantinous (or classical) craniopharyngioma and papillary craniopharyngioma. The adamantinous form presents in children and adolescents as an expanding cystic lesion in the pituitary region. The cystic cavity is filled with a black viscous substance and histologically the tumor is composed of adamantinomatous epithelium and areas of calcification and necrosis. Papillary craniopharyngiomas occur in adults, and histologically feature a squamous epithelium with papillations. (From Joynt, Clinical Neurology, 1998, Ch14, p50)

Acromegaly -- WHAT: Acromegaly: Hypersecretion of growth hormone from a pituitary tumor resulting in insidious increase in the skeleton, soft tissues and organs. WHY: Acromegaly can result in an arthropathy with initial cartilage hypertrophy resulting in widening of the cartilage space on radiographs. The cartilage then undergoes premature osteoarthritis change with productive bony change characterized by broad distal tufts in the phalanges.

Gigantism -- The condition of accelerated and excessive GROWTH in children or adolescents who are exposed to excess HUMAN GROWTH HORMONE before the closure of EPIPHYSES. It is usually caused by somatotroph hyperplasia or a GROWTH HORMONE-SECRETING PITUITARY ADENOMA. These patients are of abnormally tall stature, more than 3 standard deviations above normal mean height for age.

Malnutrition -- disorder of nutrition due to unbalanced or insufficient diet or to defective assimilation or utilization of nutrients.

The administration of R-Gene 10 is contraindicated in persons having highly allergic tendencies.

There have been two reports of possible overdosage of R-Gene 10 in children.

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.R-Gene 10 should always be administered by intravenous injection because of its hypertonicity.A suitable antihistaminic drug should be available in the event that an allergic reaction occurs.R-Gene 10 is a diagnostic aid and is not intended for therapeutic use.