Medication info

Daehan New Pharm Arginine Premix Injection (L-Arginine Hydrochloride)

Prescription medicationInjections정맥
Ingredient · strength
L-Arginine Hydrochloride›10g / 100mL
Manufacturer / importer
대한뉴팜(주)
Appearance
An injection in a colorless, transparent liquid filled in a polypropylene, multilayer film plastic container.
Packaging
100 milliliters/box
Approval status
Active

MFDS item code 202403001 · Approved 2024.12.18

Summary

Main use
Treatment of hyperammonemia (congenital urea cycle defects, lysinuric protein intolerance) by reducing blood ammonia concentration.
Who receives it
Adults
Adult administration
Administer L-Arginine Hydrochloride at a rate of 0.2 to 1g per kg of body weight intravenously via slow drip infusion for over 1 hour.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Treatment of hyperammonemia (congenital urea cycle defects, lysinuric protein intolerance) by reducing blood ammonia concentration.

  • Hyperammonemia
  • congenital urea cycle defects
  • 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 in acute exacerbations of hyperammonemia due to congenital urea cycle defects when oral administration is insufficient. Major target diseases include carbamyl phosphate synthetase deficiency, ornithine transcarbamylase deficiency, argininosuccinate synthetase deficiency, and argininosuccinate lyase deficiency. It is also applicable to patients with lysinuric protein intolerance. Blood ammonia concentrations and patient symptoms should be closely monitored during administration, and it is used in conjunction with adjunctive therapies such as arginine preparations. This medicine helps effectively control acute conditions in patients with specific congenital metabolic disorders.

How it is given

Adult administration

Administer L-Arginine Hydrochloride at a rate of 0.2 to 1g per kg of body weight intravenously via slow drip infusion for over 1 hour.

Precautions

This medication should not be used in patients who are prone to allergic reactions or have a history of hypersensitivity to the ingredients of this drug. Additionally, it should not be administered to patients who have severe acidosis or very low blood pressure, those with diseases related to nitric oxide production, patients with myocardial infarction and their history, and patients with arginine-degrading enzyme deficiency. It should be used cautiously in patients with severe liver dysfunction, moderate renal impairment, kidney disease, and anuria, and caution is also required for patients with uremia, as blood potassium levels may increase. Care should be taken when administering to patients with electrolyte imbalances, particularly those at risk of progressing to hyperchloremic acidosis and bronchial asthma, as symptoms may worsen. Rapid administration of this drug may cause side effects such as nausea, vomiting, skin rash, headache, numbness, and venous irritation; therefore, it is recommended to administer slowly. Rarely, hypotension, anaphylaxis, serious allergic reactions, and hyperkalemia have been reported, so any unusual symptoms should be immediately reported to healthcare professionals. During use of this medication, if allergic symptoms occur, antihistamines should be administered, and blood pressure should be periodically monitored for 24 hours during and after administration. If hyperammonemia does not improve, additional treatments such as peritoneal dialysis, hemodialysis, or exchange transfusion should be initiated, and care should be taken to observe the blood's pH levels due to potential acidosis. This medicine has not established safety in pregnant women or those who may become pregnant, so it should be used cautiously only when the benefits of treatment outweigh the risks. Safety has not been confirmed in nursing women, and it should ideally not be administered; if it must be used, breastfeeding should be discontinued. In the case of overdose, metabolic acidosis and hyperventilation may occur, so if acidosis persists, corrective treatment with alkalizing agents may be necessary. If this drug leaks outside the blood vessels, skin necrosis or ulceration may occur, so if redness, swelling, or pain appears at the injection site, administration should be stopped immediately and appropriate treatment should be sought. If the solution is discolored, cloudy, or has precipitates, or if the expiration date has passed or the packaging is damaged, it should not be used, and it should be kept out of the reach of children. Any remaining injection solution should not be reused, and when administered with other injectable drugs, a Y-type infusion set should be used.

Side effects and when to seek care immediately

Serious side effects

  • Severe allergic reactions
  • hypotension
  • anaphylactic reactions
  • severe hyperkalemia
  • skin necrosis
  • ulcer formation.

Mild side effects

  • Nausea
  • vomiting
  • erythema
  • headache
  • numbness
  • partial venous irritation
  • hypersensitivity
  • rash
  • urticaria
  • transient gastrointestinal nausea
Show 3 more
  • hyperammonemia
  • skin ulceration
  • increased blood urea.

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress and should be safely stored at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

An injection in a colorless, transparent liquid filled in a polypropylene, multilayer film plastic container.

Package unit

100 milliliters/box

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.