GC Arginine Injection (L-Arginine Hydrochloride)

Adult dosage

1. In acute exacerbation of hyperammonemia, when oral administration is ineffective, it should only be administered as an intravenous drip of L-arginine hydrochloride at a dosage of 0.2 to 1g per kg of body weight over more than 1 hour. 2. As an acidifying agent in severe metabolic alkalosis, the intravenous dosage is calculated as hydrochloride L-arginine = decrease in the concentration of bicarbonate in plasma (mM/L) × [patient's weight (kg)] / 9.6.

This drug should not be used in patients with allergic reactions or hypersensitivity to this drug's components. Also, it should not be administered to patients with severe acidosis, hypotension, diseases related to nitric oxide production, patients with a history of myocardial infarction, and patients with arginine-degrading enzyme deficiency. Caution should be exercised in patients with severe liver dysfunction or moderate renal impairment, renal disease, or anuria, and patients with uremia or electrolyte imbalances also require careful monitoring. In patients with bronchial asthma, this drug may exacerbate symptoms, so caution is advised. Rapid administration of this drug may result in side effects such as nausea, vomiting, skin rash, headache, numbness, and venous irritation. Serious side effects such as hypotension, anaphylaxis, severe allergic reactions, and hyperkalemia have also been reported rarely. If an allergic reaction occurs during administration of this drug, antihistamines should be used, and blood pressure should be closely monitored during and for 24 hours after administration. Administration should be limited to patients with a confirmed diagnosis, and in suspected cases of congenital urea cycle disorders, careful use should be based on blood ammonia levels and symptoms. If hyperammonemia does not improve with this drug, additional treatments such as peritoneal dialysis, hemodialysis, or exchange transfusion may be required. Excessive administration of hydrochloride can lead to hyperchloremic acidosis, so acidity (pH) of the blood should be monitored during administration, and if acidosis is suspected, administration should be stopped and alkalinizing treatment should be provided. This drug may interact with spironolactone, so caution is advised when used together. It is advisable not to administer this drug to pregnant women or those who may become pregnant, and breastfeeding women should use it with caution. Overdosage may cause transient metabolic acidosis and hyperventilation, and treatment may be necessary to correct acidosis. No sufficient studies have been conducted regarding carcinogenicity, mutagenicity, or effects on reproductive ability with long-term use of this drug. During administration, there may be necrosis or ulceration of the skin at the injection site, so if redness, swelling, or pain occurs at the injection site, administration should be stopped immediately and appropriate treatment should be received. When stored, ensure that the solution does not discolor, cloud, or form precipitates, and do not use expired products or those with damaged packaging. Also, keep out of reach of children, and unused injection solution should not be reused.

Serious side effects

Hives, severe allergic reactions (anaphylactic reactions), hypotension.

Mild side effects

• Nausea
• vomiting
• erythema
• headache
• numbness
• partial venous irritation
• hypersensitivity
• rash
• transient vomiting
• skin necrosis

This drug should be stored in a sealed container to prevent exposure to air, and the storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's effectiveness and prevent degradation.

Appearance

A colorless and transparent clear liquid filled in a colorless and transparent vial injection.

Package unit

10 milliliters/vial[x 10], 20 milliliters/vial[x 10], 25 milliliters/vial[x 10]