Medication Guide App

Arginine Hydrochloride

Pronunciation: AR-ji-neen HYE-droe-KLOR-ide
Class: Diagnostic aid

Trade Names

R-Gene 10
- Injection, solution 1 g per 10 mL

Pharmacology

Induces a pronounced rise in plasma level of human growth hormone (HGH) in patients with intact pituitary function. This rise will be diminished or absent in patients with impaired pituitary function.

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Pharmacokinetics

Metabolism

Can be metabolized, resulting in nitrogen-containing products for excretion.

Special Populations

Renal Function Impairment

No data available.

Hepatic Function Impairment

No data available.

Indications and Usage

As an IV stimulant to the pituitary for the release of HGH in patients in whom the measurement of pituitary reserve for HGH can be of diagnostic usefulness.

Unlabeled Uses

Hyperammonemia, pulmonary hypertension, and severe metabolic acidosis in children.

Contraindications

Hypersensitivity to any component of the product.

Dosage and Administration

Adults and Children 60 kg or more

IV 30 g (300 mL) over 30 min (max, 30 g/dose).

Children less than 60 kg

IV 0.5 g (5 mL) per kg over 30 min (max, 30 g).

General Advice

  • Arginine is provided as a ready-to-use solution for patients weighing 60 kg or more and should not be further diluted. For patients weighing less than 60 kg, the weight-based dose should be placed in a separate container for IV infusion to avoid inadvertent delivery and administration of the total volume from the commercially available container. Appropriate containers include evacuated sterile glass containers, polypropylene syringes, and plastic containers made of polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA).
  • Arginine 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. Blood samples should be taken by venipuncture from the contralateral arm.
  • Prior to administration, inspect visually for particulate matter and discoloration.
  • If using the commercially available glass containers, a standard air-inletting, air-filtering IV infusion set with a bacterial air filter is required.
  • The test for measurement of pituitary reserve of HGH should be scheduled in the morning following a normal night's sleep, and an overnight fast should continue through the test period. Place patients at bed rest for at least 30 min before the arginine infusion begins. Care should be taken to minimize apprehension and distress. A desirable schedule for drawing blood samples is at −30, 0, 30, 60, 90, 120, and 150 min. Arginine should be infused beginning at zero time.

Storage/Stability

Store at 77°F; however, brief exposure up to 104°F does not adversely affect the product. Avoid excessive heat. Solution that has been frozen must not be used. The post-penetration storage period is not more than 4 h at room temperature or 24 h at refrigerated temperature (2° to 8°C).

Drug Interactions

None well documented.

Adverse Reactions

CNS

Headache, numbness (3%).

GI

Nausea, vomiting (3%).

Genitourinary

Hematuria (postmarketing).

Hypersensitivity

Allergic reaction; hypersensitivity reaction, including anaphylaxis (postmarketing).

Lab Tests

Decreased platelets.

Local

Local vein irritation (3%); extravasation leading to burn-like reaction and/or skin necrosis requiring surgical intervention (postmarketing).

Miscellaneous

Flushing (3%).

Precautions

Pregnancy

Category B.

Lactation

Undetermined.

Children

Overdosage in children leading to death has been reported. Exercise extreme caution when infusing arginine into children.

Hypersensitivity

Reactions including anaphylaxis have been reported. If anaphylaxis occurs, discontinue the infusion and initiate appropriate medical treatment.

Renal Function

Arginine can be metabolized, resulting in nitrogen-containing compounds for excretion. Consider the effect of an acute amino acid or nitrogen burden upon patients with impaired renal function.

Laboratory Test Abnormalities

Basal and poststimulation levels of growth hormone are elevated in patients who are pregnant or taking oral contraceptives.

Administration

Always administer IV; hypertonicity (950 mOsmol/L) and pH (5.6) of the solution can cause irritation and damage to tissues. Administer over 30 min; excessive infusion rates may result in local irritation and flushing, nausea, or vomiting. Inadequate dosing or prolongation of the infusion period may diminish the stimulus to the pituitary and nullify the test.

Deficiency of pituitary reserve

If an insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with arginine is advisable to confirm the negative response. Patients unresponsive to arginine in the first test should be retested to confirm the negative result. Allow a waiting period of 1 day between all tests.

Electrolyte imbalance

Contains chloride ion 47.5 mEq per 100 mL of solution. Evaluate the effect of infusing this amount of chloride into patients with electrolyte imbalance before the test is undertaken.

Extravasation

May occur. Refer to your institution-specific protocol.

Overdosage

Symptoms

Transient metabolic acidosis with hyperventilation, possibly leading to death.

Patient Information

  • Inform patients that medication will be prepared and administered by a health care provider.
  • Advise patients that hypersensitivity reactions, including anaphylaxis, may occur. Patients should immediately report any hives, rash, or difficulty swallowing or breathing to their health care provider.

Copyright © 2009 Wolters Kluwer Health.

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