Arcis Injection (L-Arginine Hydrochloride)

Adult administration

Administer as an intravenous drip of L-arginine hydrochloride at 0.2 to 1g per kg of body weight slowly over more than 1 hour.

This medication should not be used in patients who frequently have allergic reactions. Patients with a history of allergy or hypersensitivity to this medication or its components should also avoid use. It should not be administered to patients in a state of severe acidosis. It is safest not to use this drug in patients with very low blood pressure. Patients with diseases related to nitrogen oxide production may be affected by this drug, hence it should not be administered. It should be avoided in patients with myocardial infarction or those who have a history of myocardial infarction. This drug is not suitable for patients with arginine-degrading enzyme deficiencies. Patients with severely impaired liver function should use this drug with caution. Patients with moderate to severe impaired kidney function, kidney diseases, or anuria should also be cautious. Uremic patients may have elevated blood potassium levels and should proceed cautiously. Patients with electrolyte imbalances should be careful as this medication may worsen hyperchloremic acidosis. It should be administered cautiously in patients with bronchial asthma, as it may temporarily exacerbate symptoms. Rapid injection of this drug may cause symptoms such as nausea, vomiting, skin redness, headache, numbness, and venous irritation. Very rarely, serious adverse effects such as hypotension, anaphylaxis (severe allergic reaction), and severe hyperkalemia have been reported. Investigations after overseas use have also reported adverse reactions such as elevated blood ammonia levels, skin ulcers, and increased blood urea. Adverse effects such as hypersensitivity, rash, urticaria, and nausea may occur with similar injection drugs used in pituitary function tests. If allergic symptoms appear during this drug treatment, antihistamines should be used for treatment. There may be a risk of hypotension for 24 hours after using this drug, so it is essential to monitor the patient’s blood pressure consistently. If hyperammonemia does not improve, appropriate treatments such as peritoneal dialysis, hemodialysis, or exchange transfusion should be carried out concurrently. Excessive doses of the hydrochloride component may lead to hyperchloremic acidosis, so blood acidity (pH) must be monitored during administration. If acidosis symptoms appear, the administration of this drug should be stopped and appropriate actions such as administering alkalizing agents like sodium bicarbonate should be taken. This drug may interact with the medication spironolactone, and caution is required when they are used together. The safety of this drug has not been established in pregnant women or women who may become pregnant, so it should be administered with caution only when the potential benefit outweighs the risks. When administering this drug to nursing mothers, safety has not been established, and it is advisable to avoid usage; if necessary, breastfeeding should be discontinued. In cases of overdose, transient metabolic acidosis and hyperventilation may occur. If acidosis persists, the deficit of alkali should be calculated and corrected with alkalizing substances. Due to stimulation of nitric oxide production, hypotension may occur, so caution is necessary. If this drug leaks out of the blood vessels, skin necrosis or ulceration may occur; hence, if redness, swelling, or pain at the injection site appears, administration should be stopped immediately, and appropriate treatment should be initiated. The solution of this drug should not be used if it is discolored, cloudy, or contains precipitates. Products that have passed their expiration date or are in damaged packaging should not be used. It should be stored out of reach of children. The solution should not be used if it leaks or droplets are found on the package. Any remaining injection solution should not be reused. The markings on the container are for reference only, and care should be taken to confirm the exact dosage. When administering with other injections, a Y-type infusion set should be used for safe administration.

Serious side effects

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

Mild side effects

• Nausea
• vomiting
• erythema
• headache
• numbness
• partial venous irritation
• hyperammonemia
• skin ulcers
• increased blood urea
• hypersensitivity

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

Appearance

Injection solution filled in a polypropylene, multi-layer film plastic container, clear and colorless

Package unit

100 milliliters/box