Medication info

Power Arginine Injection (L-Arginine Hydrochloride)

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

MFDS item code 202402962 · Approved 2024.12.16

Summary

Main use
Treatment for hyperammonemia (congenital urea cycle disorders, lysinuric protein intolerance) and reduction of blood ammonia levels.
Who receives it
Adults
Adult administration
Administer 0.2–1g of L-arginine hydrochloride per kg of the patient's weight via slow intravenous infusion for more than 1 hour.

Ingredients

Manufacturer
제이더블유생명과학(주)

Efficacy & effects

Treatment for hyperammonemia (congenital urea cycle disorders, lysinuric protein intolerance) and reduction of blood ammonia levels.

  • Hyperammonemia
  • congenital urea cycle disorder
  • lysinuric protein intolerance
View approved original text

This medication is used to lower blood ammonia levels during acute exacerbations of hyperammonemia due to congenital urea cycle disorders, particularly when oral administration is insufficient for control. This includes deficiencies of carbamyl phosphate synthetase, ornithine transcarbamylase, argininosuccinate synthetase, and argininosuccinate lyase. It can also be administered to patients with lysinuric protein intolerance who are receiving adjunctive therapy with arginine preparations. During administration, blood ammonia levels and the patient's symptoms should be monitored closely. This drug is effectively used to manage hyperammonemia caused by the aforementioned conditions.

How it is given

Adult administration

Administer 0.2–1g of L-arginine hydrochloride per kg of the patient's weight via slow intravenous infusion for more than 1 hour.

Precautions

This drug should not be used in patients who are prone to allergic reactions. Furthermore, individuals with a history of hypersensitivity or allergic reactions to this medication or its components should not be administered this drug. Patients with severe acidosis or those with very low blood pressure should also avoid using this medication. It is contraindicated in patients with diseases related to nitric oxide production or those who have experienced myocardial infarction, as well as in patients with arginase deficiency. Use in patients with severe liver dysfunction or moderate renal impairment, kidney diseases, or anuria (almost no urination) should be approached with caution. Caution is also advised in uremic patients who may have elevated potassium levels and in those with electrolyte imbalances. For patients with bronchial asthma, symptoms may temporarily worsen, requiring attention. Rapid administration may cause nausea, vomiting, skin erythema, headache, numbness, or venous irritation. Very rarely, serious side effects such as hypotension, severe allergic reactions, and hyperkalemia can occur. Additionally, cases of hyperammonemia, skin ulcers, and increased blood urea have been reported. If an allergic reaction occurs 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, concurrent treatments such as peritoneal dialysis, hemodialysis, or exchange transfusion should be considered. Excessive administration of the hydrochloride component may lead to hyperchloremic acidosis, so pH levels of the blood should be periodically monitored during administration. Caution is needed for women who are pregnant or may become pregnant, and the drug should be administered cautiously only when the therapeutic benefits outweigh the risks; breastfeeding women should avoid administration or stop breastfeeding during treatment if necessary. Overdosage may cause temporary metabolic acidosis and hyperventilation, which may require correction with alkalinizing agents. If there is redness, swelling, skin necrosis, or ulceration suspected at the intravenous injection site, administration should be discontinued immediately and appropriate care provided. During storage, the solution should not be used if it becomes discolored, cloudy, or precipitated, and products beyond their expiration dates or with damaged packaging should not be used. Keep it out of reach of children, and do not reuse leftover injection solution.

Side effects and when to seek care immediately

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
Show 3 more
  • rash
  • hives
  • transient nausea

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

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering, and it is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will ensure the safety and effectiveness of the medication.

Appearance and packaging

Appearance

A colorless, transparent solution filled in a polypropylene, multilayer film plastic container for injection.

Package unit

100mL/pack

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.