Medication info

Amifostine 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
광동제약(주)
Appearance
An injection filled in a colorless transparent glass container, consisting of a colorless transparent solution.
Packaging
100 mL/bottle, 250 mL/bottle
Approval status
Active

MFDS item code 201708086 · Notified 2017.11.27

Summary

Main use
Treatment of severe liver dysfunction and hepatic coma
Who uses it
Adults
Adult dosage
Generally, as a total amino acid, intravenous drip of up to 1.5 g per day per kg of body weight (for a weight of 70 kg, this corresponds to 1300 mL per day) should be administered. The administration rate should be a maximum of 1.25 mL per kg body weight over a period of 60 minutes.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Treatment of severe liver dysfunction and hepatic coma

  • Brain function impairment
  • severe liver dysfunction
  • hepatic coma
View approved original text

This medication is used for non-oral amino acid supplementation in cases of severe liver dysfunction or when treatment for hepatic coma is required, particularly in situations where there is accompanying impairment of brain function or not.

Dosage and Administration

Adult dosage

Generally, as a total amino acid, intravenous drip of up to 1.5 g per day per kg of body weight (for a weight of 70 kg, this corresponds to 1300 mL per day) should be administered. The administration rate should be a maximum of 1.25 mL per kg body weight over a period of 60 minutes.

Precautions

This medication should only be used under the direction of a physician, and should not be taken or discontinued arbitrarily. It should not be administered to patients with poor kidney function or hyperazotemia, patients with amino acid metabolism issues other than liver dysfunction, or patients with impaired nitrogen utilization. It should also not be used in patients with heart failure, pulmonary edema, oliguria or anuria, acidosis, or conditions of excessive fluid supply. This medication is unsuitable for patients with a history of myocardial infarction, hyponatremia, shock, or hypoxia. Care should be taken when administering it to patients with edema due to sodium retention, a history of kidney, lung, or heart diseases, or diabetes. Due to the presence of sodium pyruvate, which can cause allergic reactions or asthma attacks, particularly asthmatic patients should be cautious. During administration, rare hypersensitivity reactions such as skin rashes may occur, and if such symptoms occur, use should be immediately discontinued. Digestive symptoms such as nausea or vomiting, chest discomfort, palpitations, rapid heartbeat, and increased blood pressure may occur. Rapid large dose administration of this medication may lead to acidosis, so care must be taken regarding the administration speed. Occasionally, symptoms such as chills, fever, headache, dyspnea, shock, bronchospasm, and urinary tract spasm may occur, so if any abnormal symptoms arise, they should be reported immediately. Metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, dehydration, rebound hypoglycemia, elevated liver enzymes, vitamin imbalances, and electrolyte imbalances may occur, so regular monitoring is necessary. In patients with renal failure, blood urea nitrogen levels may rise, so kidney function should be periodically checked. When large doses are administered or used alongside fluids containing electrolytes, electrolyte balance should be closely monitored, as excessive administration can lead to metabolic alkalosis. In patients with a history of kidney, lung, or heart diseases, fluid overload should be avoided by administering it slowly. Diabetic patients should frequently monitor and manage their blood glucose levels. Serum electrolytes, fluid balance, acid-base balance, blood glucose, protein, creatinine, and liver function tests should be monitored regularly. It is advisable to check the injection site frequently to prevent thrombophlebitis. There may be interactions with other medications, so caution should be exercised, especially when used with tetracycline-class drugs. This medication poses a risk of microbial contamination and should not be mixed with other treatments except for non-oral nutritional products, using only those that are permitted to be mixed. The safety of this medication has not been established in pregnant women or breastfeeding mothers, so it should be administered cautiously only when the benefits of treatment outweigh the risks. In children, liver function may be immature, so lower concentrations should be maintained, and particularly in infants, frequent checks of blood ammonia levels should be conducted as there is a risk of hyperammonemia. Elderly patients may have decreased bodily functions, so the administration speed should be slow, and dosages should be reduced as needed. This medication contains electrolytes, and care should be taken with electrolyte balance during large doses, using a slow administration speed to prevent side effects such as chills or vomiting. During administration, the temperature of the solution should be adjusted, and it should be prepared and managed in a sterile state to minimize infection risk. If any abnormalities such as discoloration or leakage are found in the solution, it should not be used, and during storage, packaging should be maintained until opened, and once opened, it should be used promptly. The administration container should be used accurately according to the markings, where soft bag products do not require venting, and vial products should be punctured immediately before administration.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • rash
  • blisters
  • skin peeling
  • pain in the oral/eye mucosa
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  • respiratory distress
  • respiratory arrest
  • shock
  • bronchial spasm
  • asthma attack
  • increased blood pressure
  • severe edema
  • or abnormal urination

Mild side effects

  • Rash
  • nausea
  • vomiting
  • chest discomfort
  • palpitations
  • rapid heartbeat (tachycardia)
  • increased blood pressure
  • metabolic acidosis
  • hypophosphatemia
  • alkalosis
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  • hyperglycemia
  • diabetes
  • osmotic diuresis and dehydration
  • rebound hypoglycemia
  • elevated liver enzymes
  • vitamin deficiency and excess
  • electrolyte imbalances
  • pediatric hyperammonemia
  • elevated BUN
  • chills
  • fever
  • headache
  • urinary tract spasm

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 and moisture ingress, and the storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. This storage condition preserves the medication's efficacy and safety.

Appearance and packaging

Appearance

An injection filled in a colorless transparent glass container, consisting of a colorless transparent solution.

Package unit

100 mL/bottle, 250 mL/bottle

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.