Aminoleban

Aminoleban Injection Indication: Aminoleban® is indicated for the treatment of Hepatic Encephalopathy in patients with acute and chronic liver disease. Aminoleban® is beneficial in patients under hypercatabolic state such as, surgery, trauma, sepsis and burns with evidence of negative nitrogen balance, which largely owing to an increase net rate of skeletal muscle breakdown. Contraindication: Use is contraindicated in patients with severe renal impairment and abnormal amino acid metabolism other than hepatic disorders.

Precautions:
The solution should be use with care in the following instances:
severe acidosis, congestive heart failure. Sodium and chloride are formulated in volumes of about 14 and 94 mEq/L, concomitant use with electrolyte solutions and administration of solution in large doses require careful monitoring of electrolyte values. Slow intravenous infusion is recommended.

Adverse Reactions : Hypersensitivity: rare skin eruptions. If hypersensitivity reactions occur, the solution should be discontinued. Gastrointestinal: occasional nausea and vomiting. Cardiovascular: occasional chest discomfort and palpitation. Large and acute administration: acidosis was reported. Others: occasional chills, fever, headache and vascular pain.

Dosage Forms : DOSAGE FORMS: The usual adult dose is 500-1000mL per dose by drip intravenous infusion. The usual peripheral infusion rate is 500mL over 180-300 minutes (about 25-40 drops per minute). Typically, 500-1000mL of AMINOLEBAN® is appropriately mixed with dextrose solution and administered over 24 hours via the central vein. The dosage may be increased or decreased according to the patient's age, symptoms and body weight.

Aminoleban Oral Indication : Aminoleban® ORAL is a balanced and tolerable food supplement developed to nutritionally support patients with chronic liver disease. Aminoleban® ORAL is an enteral formula containing amino acids, carbohydrates, fats, vitamins and minerals as a dietary supplement especially for patients with liver impairment.

Precautions :
Aminoleban® ORAL is reconstituted before use. When storage is required after mixing, the reconstituted Aminoleban® ORAL should be stored in a cool place not exceeding 10 hours. Boiling water should not be used for reconstitution in order to avoid denaturation of the protein. When a mixer is used for reconstitution, mix at low speed for not longer than 1 minute.

Dosage and Administration :
The usual dosage is 50 g (1 sachet) of Aminoleban® ORAL three times a day. The regular usage of 150 g per day provides 40.5 g of protein and a total of 630 kcal. The dosage should be determined by the patient's age and condition. If the patient needs more protein and calories, the balance should be supplemented in the patient's diet.

Adverse Reactions :
Occasional diarrhea and nausea may occur. Close supervision of the patient is necessary. When the symptom is observed, please consult your physician.

Diluting :
50 g (1 sachet) of Aminoleban® ORAL can be reconstituted with 180 ml of lukewarm water so that the patients can drink the reconstituted Aminoleban® ORAL in a diluted state.

Cooling:
Reconstitute with lukewarm water in a slightly concentrated state (reduce the amount of water to 100mL), then cool with ice.

Note: Dilution may cause ascitis, so check periodically.

What is known?
• Protein- Energy Malnutrition (PEM) is a common manifestation in cirrhotic patients with reported incidence as high as 65-90%.

• Protein Malnutrition is represented by reduced serum albumin level (visceral protein) and decreased skeletal muscle volume (muscular protein) in cirrhosis.

Survival rate clearly deteriorates among the group with serum albumin concentration
lower than 3.5 mg/dL.2

Parameters which determine prognosis in liver cirrhosis (A multivariate analysis)

REE*, npRQ** and serum albumin are significant parameters to determine survival of patients with liver cirrhosis.

AMINOLEBAN® prolongs the life span of patients with decompensated liver cirrhosis3
(A Multicenter Study, Historical Controlled Trial)

92.7% of those who received Amino Acid + Vitamins + Minerals (Aminoleban®)
were still alive at the end of 6 months study period.

Incidences of total events and aggravation of hepatic failure were significantly lower in the BCAA group than in the diet group.