Medication info

Aminosterilen-Hepa 8% Injection

Prescription medicationInjections
Ingredient · strength
L-Isoleucine›1.04g / 100mLL-Leucine›1.309g / 100mLL-Lysine Acetate›0.971g / 100mLL-Methionine›0.11g / 100mLAcetylcysteine›0.07g / 100mLL-Phenylalanine›0.088g / 100mLL-Threonine›0.44g / 100mLL-Tryptophan›0.07g / 100mLL-Valine›1.008g / 100mLL-Arginine›1.072g / 100mLL-Histidine›0.28g / 100mLGlycine›0.582g / 100mLL-Alanine›0.464g / 100mLL-Proline›0.573g / 100mLL-Serine›0.224g / 100mL
Manufacturer / importer
프레지니우스카비코리아(주)
Appearance
A colorless, transparent liquid contained in a colorless, transparent vial for injection
Packaging
250 milliliters/vial [× 10], 500 milliliters/vial [× 10]
Approval status
Active

MFDS item code 200711983 · Notified 2007.10.31

Summary

Main use
Treatment of severe liver dysfunction and hepatic coma
Who uses it
Adults
Adult dosage
Generally, the maximum intravenous infusion is 1.5 g of total amino acids per kg of body weight per day (equivalent to 1300 mL per day for a 70 kg person). The infusion rate should not exceed 1.25 mL per kg of body weight over 60 minutes.

Ingredients

Importer
프레지니우스카비코리아(주)

Efficacy & effects

Treatment of severe liver dysfunction and hepatic coma

  • Impaired brain function
  • severe liver dysfunction
  • hepatic coma
View approved original text

This medication is used in cases of severe liver dysfunction, whether or not accompanied by liver failure. It is also effectively used in cases of impaired brain function and treatment of hepatic coma. It helps to improve patients' conditions by supplying necessary amino acids when liver function is severely diminished. It supports patients' recovery in cases of complications such as hepatic coma. This medication is particularly effective in improving symptoms associated with liver dysfunction.

Dosage and Administration

Adult dosage

Generally, the maximum intravenous infusion is 1.5 g of total amino acids per kg of body weight per day (equivalent to 1300 mL per day for a 70 kg person). The infusion rate should not exceed 1.25 mL per kg of body weight over 60 minutes.

Precautions

This medication must be used strictly according to a physician's instructions and should not be administered or consumed arbitrarily. This medication should not be used in patients with poor kidney function or high nitrogen levels in the blood, patients with issues in amino acid metabolism unrelated to liver dysfunction, patients with nitrogen utilization disorders, patients with weak heart function, patients with pulmonary edema, patients with very low or absent urine output, patients with acidified blood, patients with excessive body water, patients with a history of myocardial infarction or current myocardial infarction, patients with low sodium levels in the blood, patients in shock, and patients with oxygen deficiency. Patients with sodium retention causing edema or history of kidney, lung, or heart disease, as well as diabetic patients, should use this medication with extreme caution. Rarely, allergic reactions like skin rashes may occur when using this medication, and if such symptoms appear, administration should be stopped immediately. Gastrointestinal symptoms such as nausea or vomiting, discomfort in the chest, palpitations, rapid pulse, and elevated blood pressure may also occur. If this medication is administered quickly or in large volumes, acidosis due to blood acidification may occur, so caution is needed. Symptoms such as chills, fever, headache, respiratory distress, respiratory arrest, shock, bronchospasm, and urinary tract spasms may also occasionally appear. Metabolic complications such as metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, dehydration, hypoglycemia, elevated liver enzymes, vitamin deficiencies or excesses, electrolyte imbalances, and in children, hyperammonemia may occur. Patients with poor kidney function may experience increased blood BUN levels, and serum ammonia levels may vary depending on the treatment response. When administering in large volumes or with electrolyte-containing solutions, careful monitoring of electrolyte balance is required, and caution should be exercised when using medications with high electrolyte concentrations in conjunction with amino acid solutions. Patients with history of kidney, lung, or heart disease should take care to avoid excessive fluid supply in the body, and diabetic patients should frequently monitor their blood sugar levels. Regular testing of blood electrolytes, fluid balance, acid-base balance, blood sugar, proteins, creatinine, and liver function levels is necessary. When this medication is administered peripherally, it is advisable to frequently check the infusion site to reduce the risk of thrombophlebitis. This medication may lose efficacy when used in conjunction with some antibiotics; therefore, it is essential to consult with a professional before using it with other medications. Pregnant or nursing women should only use this medication when the benefits of treatment are deemed greater than the risks due to the uncertainty of its safety. Due to potential immature liver function in children, it is necessary to maintain lower concentrations for administration and frequently check blood ammonia levels. Elderly patients require caution in administering as their body function may be decreased; the administration speed may need to be slowed, and doses may need to be reduced. This medication contains electrolytes, requiring attention to electrolyte balance during large volume administration, and should be slowly infused to avoid chills or vomiting. Before use, ensure that the solution is completely clear; do not use if the solution is cloudy or discolored. Preparation and management of the infusion must be conducted in an aseptic manner; it should be stored unopened, and if opened, used within 24 hours. If crystals form in the solution, it should be warmed and then cooled to body temperature before use. During storage, care must be taken to prevent the solution from leaking or discoloring, and if the packaging is damaged, it should not be used.

Side effects and when to seek care immediately

Serious side effects

  • Rash
  • difficulty breathing
  • shock
  • bronchospasm
  • chest discomfort
  • elevated blood pressure.

Mild side effects

  • Nausea
  • vomiting
  • rash
  • chest discomfort
  • palpitations
  • rapid pulse (tachycardia)
  • elevated blood pressure
  • acidosis
  • chills
  • fever
Show 15 more
  • headache
  • urinary spasms
  • metabolic acidosis
  • hypophosphatemia
  • alkalosis
  • hyperglycemia
  • diabetes
  • osmotic diuresis and dehydration
  • rebound hypoglycemia
  • elevated liver enzymes
  • vitamin deficiencies and excesses
  • electrolyte imbalances
  • pediatric hyperammonemia
  • elevated BUN
  • changes in serum ammonia levels.

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 from entering and is best kept at room temperature between 1 to 30 degrees Celsius. Storing in this manner will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

A colorless, transparent liquid contained in a colorless, transparent vial for injection

Package unit

250 milliliters/vial [× 10], 500 milliliters/vial [× 10]

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.