Daehan L-Arginine Hydrochloride Injection 10% (L-Arginine Hydrochloride)

Adult administration

Administer 0.2 to 1 g of L-arginine hydrochloride per kg of body weight as a slow intravenous infusion over at least 1 hour.

This medication should not be used in patients with a history of allergic reactions to it or its ingredients, as well as in patients prone to allergic reactions. It should not be administered to patients with severe acidosis, hypotension, diseases related to nitric oxide production, or a history of myocardial infarction. Administration should also be avoided in patients with arginine-degrading enzyme deficiency. Use with caution in patients with severe liver impairment, moderate renal impairment, kidney disease, or anuria, and pay attention in patients with nitrogen retention where plasma potassium levels may increase. Electrolyte imbalance patients are at risk of progressing to hyperchloremic acidosis, so blood condition should be carefully monitored during administration. Patients with bronchial asthma should be cautious as symptoms may temporarily worsen. When administered rapidly, symptoms such as nausea, vomiting, flushing, headache, numbness, and venous irritation may occur, and rarely, hypotension, severe allergic reactions, and hyperkalemia have been reported. If an allergic reaction occurs during use, antihistamines should be administered, and blood pressure should be monitored periodically during and for 24 hours after administration. If hyperammonemia does not improve, additional treatments such as peritoneal dialysis or hemodialysis may be necessary. This medication contains hydrochloride, which can induce hyperchloremic acidosis, so it is essential to carefully monitor the acid-base status of the blood, and if acidosis is suspected, administration should be halted and alkalizing agents given. Caution is advised when used together with spironolactone due to potential interactions. In pregnant women or those who may become pregnant, it should only be administered when the benefits of treatment outweigh the risks, and in nursing mothers, administration should be avoided if possible or breastfeeding should be suspended if administered. In cases of overdose, transient metabolic acidosis and hyperventilation may occur; therefore, appropriate alkalizing treatment may be required if acidosis persists. When injecting this medication, extravasation of the drug may cause skin necrosis or ulceration; thus, if erythema, swelling, or pain occurs at the injection site, administration should be immediately stopped, and proper treatment should be provided. When storing, the solution should not be used if it has turned discolored, become cloudy, or if precipitates are formed, if the expiration date has passed, or if the packaging is damaged, and should be kept out of reach of children. Unused injection solutions after use should not be reused, and it is safer to use a Y-type infusion set when administering with other injectables.

Serious side effects

• Hypotension
• anaphylactic reaction
• severe allergic reactions
• severe hyperkalemia
• skin necrosis
• ulcer formation

Mild side effects

• Nausea
• vomiting
• flushing
• headache
• numbness
• partial venous irritation
• rash
• urticaria
• hyperammonemia
• skin ulceration

This medication should be stored in a sealed container to prevent air or moisture from entering. It is important to maintain a storage temperature at room temperature between 1 and 30 degrees Celsius.

Appearance

A transparent and colorless solution in a colorless and transparent plastic container for injection

Package unit

100mL/bottle, 150mL/bottle, 100mL/bag, 150mL/bag