Medication info

Kwangdong L-Arginine Hydrochloride Injection

Prescription medicationInjections정맥
Ingredient · strength
L-Arginine Hydrochloride›10g / 100mL
Manufacturer / importer
광동제약(주)
Appearance
A colorless, transparent solution filled in a polypropylene, multi-layer film plastic container for injection.
Packaging
100 milliliters/pack
Approval status
Active

MFDS item code 202402996 · Approved 2024.12.18

Summary

Main use
Treatment of acute exacerbation of hyperammonemia (due to congenital urea cycle disorders, lysinuric protein intolerance) to lower blood ammonia concentration.
Who receives it
Adults
Adult administration
Administer L-Arginine Hydrochloride at a dosage of 0.2 to 1g per kg of body weight through slow intravenous drip over at least one hour.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Treatment of acute exacerbation of hyperammonemia (due to congenital urea cycle disorders, lysinuric protein intolerance) to lower blood ammonia concentration.

  • Hyperammonemia
  • congenital urea cycle disorders
  • carbamyl phosphate synthetase deficiency
  • ornithine transcarbamylase deficiency
  • argininosuccinate synthetase deficiency
  • argininosuccinate lyase deficiency
  • lysinuric protein intolerance.
View approved original text

This medication is used to lower blood ammonia levels during acute exacerbation of hyperammonemia caused by congenital urea cycle disorders. It is particularly applicable to patients with urea cycle disorders such as carbamyl phosphate synthetase (CPS) deficiency, ornithine transcarbamylase (OTC) deficiency, argininosuccinate synthetase (ASS) deficiency, argininosuccinate lyase (ASL) deficiency, and patients with lysinuric protein intolerance. It is primarily administered when oral administration is difficult to manage, and during treatment, blood ammonia levels and patient symptoms are continuously monitored. It is used in conjunction with adjunctive therapies such as arginine formulations to enhance the therapeutic effect. This medication helps stabilize acute symptoms in patients and effectively lowers blood ammonia levels.

How it is given

Adult administration

Administer L-Arginine Hydrochloride at a dosage of 0.2 to 1g per kg of body weight through slow intravenous drip over at least one hour.

Precautions

This drug should not be used in patients who frequently experience allergic reactions or have a history of hypersensitivity to any component of this medication. Moreover, it should not be administered to patients in severe acidosis, patients with low blood pressure, patients with diseases related to nitric oxide production, those with a history of myocardial infarction, and patients with arginine-degrading enzyme deficiencies. Caution is required when using this drug in patients with severe liver impairment, severely impaired kidney function, uremia, electrolyte imbalances, or those with bronchial asthma. Rapid administration of this drug may result in symptoms such as nausea, vomiting, skin redness, headache, numbness, and vein irritation. Rarely, hypotension, anaphylactic reactions, severe allergic reactions, or hyperkalemia may occur, so attention is necessary. If allergic symptoms occur during administration, antihistamines should be used, and blood pressure should be continuously monitored for 24 hours during and after administration. If hyperammonemia does not improve, additional treatments such as dialysis or exchange transfusions may be necessary. Excessive dosing of hydrochloride components may lead to increased chloride concentration in the blood, resulting in acidosis, thus monitoring the acid-base status of the blood should be done regularly. This drug may interact with spironolactone, so caution should be taken when used together. Women who are pregnant or may become pregnant should use this medication cautiously only when necessary, and breastfeeding mothers should ideally avoid administration or stop breastfeeding while using it. In case of overdose, metabolic acidosis and hyperventilation may occur, and persistent acidosis needs to be corrected with alkalizing agents. If signs of redness, swelling, skin necrosis or ulcers are suspected around the injection site when administering intravenously, administration should be stopped immediately, and appropriate treatment should be sought. Do not use if the solution is discolored, cloudy, has precipitates, exceeds its expiration date, or if the packaging is damaged. Store this medication out of the reach of children, and unused portions of the solution should not be reused.

Side effects and when to seek care immediately

Serious side effects

  • Possible hypotension
  • anaphylactic reactions
  • severe allergic reactions
  • severe hyperkalemia
  • skin necrosis
  • ulcers
  • urticaria
  • and severe swelling (edema).

Mild side effects

  • Nausea
  • vomiting
  • erythema
  • headache
  • numbness
  • partial vein irritation
  • hyperammonemia
  • skin ulcers
  • increased blood urea
  • hypersensitivity
Show 2 more
  • rash
  • urticaria (frequency unknown).

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent contact with air, and it should be kept at a temperature between 1 degree and 30 degrees Celsius at room temperature. Storing it in this manner helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A colorless, transparent solution filled in a polypropylene, multi-layer film plastic container for injection.

Package unit

100 milliliters/pack

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.