Medication info

Topramin Injection

Prescription medication
Ingredient · strength
L-Isoleucine›9.2gL-Leucine›9.45gL-Lysine Acetate›3.95gL-Methionine›0.44gL-Phenylalanine›0.3gL-Threonine›2.14gL-Tryptophan›0.7gL-Valine›8.9gL-Arginine›15.37gL-Histidine›3.1gL-Aspartic Acid›0.2gL-Alanine›8.4gGlycine›5.4gL-Proline›5.3gL-Serine›2.6gL-Tyrosine›0.4g
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
A colorless and transparent injection solution in a colorless, transparent glass bottle with a rubber stopper for infusions.
Packaging
250 mL/bottle
Approval status
Active

MFDS item code 199800955 · Notified 1998.10.02

Summary

Main use
Improvement of hepatic encephalopathy due to chronic liver disease.
Who uses it
Adults
Adult dosage
Generally, administer 500 mL as an intravenous infusion. The infusion rate is typically over 180 minutes per 500 mL. For central venous administration, mix 500 mL of this drug with a dextrose solution and continuously infuse it into the central vein over 24 hours. Adjust dosage appropriately based on age, symptoms, and weight.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of hepatic encephalopathy due to chronic liver disease.

View approved original text

This medicine helps to improve the symptoms of hepatic encephalopathy caused by chronic liver disease. It aids in the recovery of brain function, induces alleviation of symptoms, and is used to enhance overall health status.

Dosage and Administration

Adult dosage

Generally, administer 500 mL as an intravenous infusion. The infusion rate is typically over 180 minutes per 500 mL. For central venous administration, mix 500 mL of this drug with a dextrose solution and continuously infuse it into the central vein over 24 hours. Adjust dosage appropriately based on age, symptoms, and weight.

Precautions

This medication should be used strictly according to a doctor's instructions. It should not be administered to patients with severe kidney impairment, hypernitrogenemia, metabolic disorders not related to liver disease, metabolic disorders with nitrogen utilization issues, congestive heart failure, pulmonary edema, anuria, patients with hypernatremia, hyperchloremia, or alkalosis. Additionally, it should not be given to patients with atrioventricular block, myasthenia gravis, fluid overload, or myocardial infarction. Patients with severe acidosis, congestive heart failure, edema due to sodium retention, hyperkalemia, and patients with kidney impairment should use this drug with caution. Considering it contains sodium bisulfite, patients allergic to sulfites or with asthma should take precautions. Rarely, hypersensitivity reactions such as rashes may occur while using this drug; if such symptoms appear, usage should be immediately discontinued. Symptoms such as nausea, vomiting, chest discomfort, palpitations, rapid heartbeat, and elevated blood pressure may occur; caution is advised. Rapid administration of large volumes may lead to metabolic acidosis. Severe side effects such as chills, fever, headache, shortness of breath, shock, bronchoconstriction, and urinary tract constriction have also been reported. Peripheral vascular dilatation symptoms may occur if magnesium is included. Metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia, diabetes, dehydration, increased liver enzymes, vitamin imbalances, and electrolyte disturbances may occur. Patients with impaired liver or kidney function may experience increased blood urea nitrogen (BUN) levels. Patients with liver failure are at risk for serum amino acid imbalances, metabolic alkalosis, and coma. When administering this drug, maintain careful electrolyte balance, especially during large volume administration. Overdosage may result in metabolic alkalosis, thus dosage adjustment is necessary depending on the components included. Patients with renal disease, pulmonary disease, and heart disease should be cautious to avoid fluid overload. Diabetic patients should regularly monitor their blood sugar levels while using this drug. Patients with hyponatremia and impaired liver or kidney function should adjust dosage individually and manage fluid and electrolyte status meticulously. There may be interactions when used in conjunction with other medications, so inform healthcare providers. Women who are pregnant should only use this medication if the therapeutic benefits outweigh the risks, as its safety has not been established. Due to potential immature liver function in children, maintain a lower administration concentration and frequently check blood ammonia levels. Elderly patients may have diminished physical function, necessitating slower administration speeds and reduced dosages. This drug contains electrolytes, so special attention should be given to electrolyte balance during large volume administration; administering quickly can cause side effects, so it should be given slowly. Before use, confirm that the solution is clear and transparent; do not use if it is cloudy or discolored. The solution should be used promptly after preparation and utilized within 24 hours if stored in a refrigerator. During storage, do not open the package, and do not use if the package is damaged or if there is leakage of the solution. To use this drug safely, always maintain aseptic conditions and ensure that injection equipment is thoroughly sterilized.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, asthma attacks, respiratory distress, respiratory arrest, shock, bronchoconstriction, urinary tract constriction, severe edema accompanied by increased blood pressure, liver failure, kidney failure, liver abnormalities (including jaundice-related symptoms), severe allergic reactions, serious neurological symptoms, severe skin reactions.

Mild side effects

  • Rash
  • nausea
  • vomiting
  • chest discomfort
  • palpitations
  • rapid heart rate (tachycardia)
  • increased blood pressure
  • chills
  • fever
  • headache
Show 17 more
  • peripheral vascular dilation
  • metabolic acidosis
  • hypophosphatemia
  • alkalosis
  • hyperglycemia
  • diabetes
  • osmotic diuresis and dehydration
  • rebound hypoglycemia
  • increased liver enzymes
  • vitamin deficiencies and excesses
  • electrolyte imbalance
  • childhood hyperammonemia
  • serum amino acid imbalance
  • metabolic alkalosis
  • systemic nitrogenemia
  • hyperammonemia
  • dysesthesia.

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

Storage

This medication should be stored in a sealed container to avoid contact with air, kept away from direct sunlight, and stored at room temperature in order to maintain its effectiveness over time.

Appearance and packaging

Appearance

A colorless and transparent injection solution in a colorless, transparent glass bottle with a rubber stopper for infusions.

Package unit

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.

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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.