Aminoleban Infusion Soln

Aminoleban Infusion Soln

Manufacturer:

Otsuka (Philippines)

Distributor:

Zuellig
Full Prescribing Info
Contents
Amino acids.
Description
This product contains the following ingredients: See Table 1.

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Sodium Bisulfite 0.3 g/L is used as a stabilizer.
Sodium Hydroxide is used as a pH adjuster.
AMINOLEBAN Injection is a clear and colorless solution for injection.
pH: Approx. 5.9 (mean value obtained immediately after manufacture) and 5.5-6.5 (specification value).
Osmotic pressure ratio (relative to physiological saline): Approx. 3.
Action
Pharmacology: AMINOLEBAN Injection normalized the Fischer's ratio in the plasma and brain, improved monoamine metabolism in the brain, and corrected a sleep-wakefulness pattern in portacaval-shunted rats (chronic hepatic insufficiency model).
When infused to portacaval-shunted rats loaded with ammonia, AMINOLEBAN Injection normalized the Fischer's ratio in the plasma and brain, decreased blood ammonia levels, and improved EEG and monoamine metabolism in the brain.
Clinical Studies: AMINOLEBAN Injection was administered to patients with hepatic encephalopathy associated with chronic liver disease, and the clinical effect of AMINOLEBAN Injection was evaluated. A prompt improvement in the coma scale (an index of disturbance of consciousness) and a prompt decrease in blood ammonia concentrations were observed. In addition, patients showed improvement in neuropsychological function as assessed by writing, drawing, flapping tremor, number connection test, and orientation and calculation tests as well as by EEG tracings.
The efficacy of AMINOLEBAN Injection in hepatic encephalopathy in clinical studies was summarized as follows: See Table 2.

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Pharmacokinetics: Reference data in rats: 14C-labeled amino acids formulated in AMINOLEBAN Injection were readily distributed to almost the entire body after intravenous infusion in rats. In 6 hours, 50 to 70% of the administered amino acids was taken up into protein fractions. The ratio of branched-chain amino acids to the total amino acids in the protein fractions was highest in the brain. Up to 72 hr, 41.7% of the administered dose was excreted in the expired air, 5.9% in the urine, and 2.6% in the feces.
Indications/Uses
Treatment of hepatic encephalopathy in patients with chronic liver disease.
Dosage/Direction for Use
The usual adult dose of AMINOLEBAN Injection is 500-1000 mL per dose, infused via a peripheral vein. The usual peripheral infusion rate is 500 mL over 180-300 min in adults. For total parenteral nutrition, 500-1000 mL of AMINOLEBAN Injection should be combined with glucose or other solutions and administered over 24 hours via a central vein. The dosage should be adjusted according to the patient's age, symptoms, and body weight.
Precautions: AMINOLEBAN Injection contains about 14 mEq/L of sodium and 94 mEq/L of chloride. Concomitant use with an electrolyte solution or administration of a large dose requires careful monitoring of electrolyte balance.
Overdosage
Hyperammonemia has been reported when an amino acid solution, including AMINOLEBAN Injection, was administered in combination with oral intake of nitrogen (total nitrogen: 160 g). (See Clinically significant adverse reactions under Adverse Reactions.)
Contraindications
AMINOLEBAN Injection is contraindicated in the following patients: Patients with serious renal disorders: The amount of water tends to be excessive and the patient's clinical condition may be worsened. Urea and other amino acid metabolites may be retained, which may worsen the patient's clinical condition.
Patients with abnormal amino acid metabolism: Because the infused amino acids are not adequately metabolized, the patient's clinical condition may be worsened.
Special Precautions
Careful Administration: AMINOLEBAN Injection should be administered with care in the following patients: Patients with severe acidosis: The patient's clinical condition may be worsened.
Patients with congestive cardiac failure: An increase in the circulating blood volume may worsen the patient's clinical condition.
Use in Children: The safety in children has not been established (no clinical experience).
Use in Elderly: Because elderly patients often have reduced physiological function, it is advisable to consider reducing the dose by decreasing the infusion rate.
Adverse Reactions
Reported incidence rates are based on data from 3324 patients with chronic liver disease, and a total of 35 patients (1.1%) experienced 52 adverse reactions (Drug Efficacy Reevaluation, March 1998, Japan).
Clinically significant adverse reactions: Hypoglycemia (frequency unknown): Hypoglycemia may occur. If the patient develops hypoglycemia, glucose should be administered promptly by intravenous infusion. In addition, appropriate nutrition management is recommended in such patients.
Hyperammonemia (frequency unknown): Hyperammonemia has been reported. If the patient develops persistent hyperammonemia during the administration of AMINOLEBAN Injection, discontinue administration of nitrogen sources including AMINOLEBAN Injection and institute appropriate measures.
Other adverse reactions: If adverse reactions are observed, discontinue the administration, and institute appropriate treatment. (See Table 3.)

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Caution For Usage
Precautions Concerning Use: Before administration: To minimize the risk of infection, carry out all procedures under aseptic conditions.
In cold environmental conditions, the solution should be warmed to near body temperature before use.
Use the solution immediately after opening the container. After use, discard all unused solution.
During administration: Administer the solution slowly via a vein.
When vascular pain occurs, use an alternate site or discontinue administration.
Precautions for Handling: Crystals may precipitate in a cool place. Warm the container at 50-60°C to dissolve the precipitates and use the solution after cooling to about 37°C.
Do not remove the inner wrap until immediately before use.
Do not use the solution if the inner wrap covering the product has been damaged, or droplets of water or leakage of the content is noted, the solution is discolored or cloudy, or a precipitate that cannot be dissolved.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Infusion 500 mL.
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