Aminoleban 8% Amino Acid: For Intravenous Administration

AMINOLEBAN®

8% Amino Acid
For Intravenous Administration

Etiologically the onset of hepatic encephalopathy has been related to excess ammonia, short-
chain fatty acids and mercaptans. Recent studies have emphasized the importance of other
contributory factors involved in severe hepatic impairment: disturbance of the free amino acid
pattern in plasma characterized by an increase of L-Phenylalanine, L-Tryptophan, L-Tyrosine
and L-Methionine and a decrease of branched-chain amino acids such as L-Leucine, L-
Isoleucine and L-Valine.

The disturbance of the free plasma amino acid pattern causes disturbances in the transport of
amino acid across the blood-brain barrier, blocks synthesis of false neurotransmitters in the
brain, resulting in the disturbance of the overall cerebral amine metabolism. This disturbance
of cerebral amine metabolism is suspected to be the major cause of hepatic encephalopathy.
With these findings as background information, Fischer et al developed a special formula of

amino acids, containing high concentrations of branched-chain amino acids and low
concentrations of L-Phenylalanine, L-Tryptophan and L-Methionine, without L-Tyrosine, to
correct the disturbance of the plasma free amino acid pattern. They have conducted
experimental and clinical studies of the special formula for the treatment of hepatic
encephalopathy and demonstrated that the normalization of the plasma free amino acid pattern
is effective in improving hepatic encephalopathy.
AMINOLEBAN® is prepared with an amino acid composition identical to that of Fischer's

formula. Clinical studies have shown that the injection is effective in correcting plasma amino
acid concentrations and the clinical symptoms of hepatic encephalopathy.
COMPOSITION
Each 500 mL of AMINOLEBAN® contains the following ingredients:
L-Threonine 2.25 g L-Leucine 5.50 g
L-Serine 2.50 g L-Phenylalanine 0.50 g
L-Proline 4.00 g L-Tryptophan 0.35 g
L-Cysteine HCl.H2O 0.20 g L-Histidine HCl.H2O 1.60 g
(L-Cysteine equivalent 0.15 g) (L-Histidine equivalent 1.20 g)
Aminoacetic acid 4.50 g Lysine HCl 3.80 g
L-Alanine 3.75 g (L-Lysine equivalent 3.05 g)
L-Valine 4.20 g L-Arginine HCl 3.65 g
L-Methionine 0.50 g (L-Arginine equivalent 3.00 g)
L-Isoleucine 4.50 g Water for Injection ad 500 mL
Amino acids 7.99% (w/v) Total nitrogen 12.2 g/L
-
Branched-chain amino acid 35.5% (w/w) Cl Approx. 94 mEq/L
Fischer’s ratio* 37.05 Na+ Approx. 12 mEq/L
E/N ratio 1.09 Osmolarity Approx. 768 mOsm/L
* Molar ratio of (L-Valine+L-Leucine+L-Isoleucine)/(L-Tyrosine+L-Phenylalanine)
Sodium bisulfite 0.3 g/L is used as a stabilizer.
INDICATIONS
Treatment of hepatic encephalopathy in patients with chronic liver disease.
DOSAGE AND ADMINISTRATION

The usual adult dose of AMINOLEBAN® is 500-1000 mL per dose by intravenous drip
infusion. The usual peripheral infusion rate is 500 mL over 180-300 minutes in adults (approx.
25-40 drops per minute). For total parenteral nutrition, 500-1000 mL of the injection should be
suitable combined with dextrose or other solutions and administered over 24 hours via the
central vein. The dosage may be adjusted depending on the patient's age, symptoms and body
weight.
PRECAUTIONS
CONTRAINDICATIONS (AMINOLEBAN Infusion is contraindicated in the
following patients.)
(1) Patients with serious renal disorder (patients on dialysis or hemofiltration are
excluded) [Urea and other amino acid metabolites may be retained, which may
worsen the patient’s clinical condition.]
(2) Patients with abnormal amino acid metabolism (Since the infused amino acids are
not adequately metabolized, the patient’s clinical condition may be worsened.)
1. Careful Administration (AMINOLEBAN Infusion should be administered with

caution in the following patients.)
(1)Patients with severe acidosis (The patient’s clinical condition may be worsened.)
(2)Patients with congestive cardiac failure (An increase in the circulating blood volume
may worsen the patient’s clinical condition.)
(3)Patients on dialysis or hemofiltration with serious renal disorder
2. Important Precautions
The volume of urea, etc. removed and accumulated in patients on dialysis or hemofiltration
with serious renal disorder varies depending on the dialysis method and patients’
conditions. Initiation and continuation of administration should be determined after the
patient’s conditions are carefully checked based on assessment of blood biochemistry,
acid-base equilibrium, and body-fluid balance, etc
3. Adverse Reactions (rarely: < 0.1%, infrequently: 0.1% - < 5% no specific designation:
5% or frequency unknown)
1) Clinically significant adverse reactions:

(1) Hypoglycemia: Hypoglycemia may occur. If the patient develops hypoglycemia,
glucose should be administered promptly by intravenous infusion. In addition,
appropriate nutrition management is required in such patients.
(2) Hyperammonemia: Hyperammonemia has been reported. If the patient develops
persistent hyperammonemia during the administration of AMINOLEBAN®,
discontinue administration and take measures to eliminate other nitrogen sources.
2) Other adverse reactions
(1) Hypersensitivity
Symptoms such as skin rash may occur rarely. In the event of skin rash,
discontinue the administration and institute appropriate treatment.
(2) Gastrointestinal
Symptoms such as nausea and vomiting may occur infrequently.
(3) Cardiovascular
Symptoms such as chest discomfort and palpitation may occur infrequently.
(4) Metabolic
The nitrogen content of this preparation may induce a transient increase in blood
ammonia concentrations.
(5) Large dose and rapid administration
Acidosis may occur when large doses are administered rapidly.
(6) Others
Chills, fever, headache and vascular pain may infrequently occur.
4. Use in the Elderly

Since elderly patients often have a reduced physiological function, it is advisable to
take such measures as reducing the dose by decreasing the infusion rate.
5. Pediatric Use
Safety in children has not been established.
6. Cautions in Use
(1) Before administration
1. To prevent associated infection, carry out all procedures under aseptic
conditions.
2. Use the solution after warming to near body temperature during cold
environmental conditions.
3. Use the solution immediately after opening the package. After use, discard all
unused solution.
(2) During administration

1. The solution contains about 12 mEq/L of sodium and 94 mEq/L chloride.
Concomitant use with an electrolyte solution or a large dose requires careful
monitoring of electrolyte balance.
2. Administer slowly via a peripheral vein.
3. When vascular pain occurs, use an alternate site or discontinue the
administration.
7. Overdosage
Hyperammonemia has been reported after the administration of amino acid preparations,
including this solution, in combination with oral intake of nitrogen (total nitrogen dose:
160 g).
(See "Clinically significant adverse reactions" above).
PHARMACOLOGY
1. AMINOLEBAN® normalized the pattern of free amino acids in the plasma and brain,
improved serotonin metabolism in the brain and corrected a sleep-wakefulness pattern in
a rat model of chronic hepatic insufficiency which underwent a portacaval shunt operation.
2. When infused to portacaval-shunted rats loaded with ammonia, AMINOLEBAN®
improved EEG pattern and corrected amine metabolism in the brain as evidenced by
correction of the free amino acid pattern in the plasma and brain and by suppression of an
increase of the false neurotransmitter octopamine.
DESCRIPTION
AMINOLEBAN® is a sterile and pyrogen free, colorless solution for injection.
pH: Approx. 5.9 (mean obtained immediately after manufacture) and 5.5 – 6.5 (specification).
Specific gravity (20oC): 1.025
Osmolarity: Approx. 768 mOsm/L
PRECAUTION AND HANDLING

1. A crystalline precipitate may form due to temperature changes during storage. Shake
the solution at temperature 15-25oC to dissolve precipitate before use and after cooling
to near body temperature.
2. Do not use the product if the solution is discolored or a precipitate that cannot be
dissolved by shaking has formed.
3. Open the outer wrap just before use.
4. Do not use if bag is leaking, solution cloudy or contains foreign matters.
STORAGE
Store below 30oC, protected from light.
PACKAGE
Soft bag of 500 mL
REG. No.: DKL8718701649A1
Manufactured by:
PT. Otsuka Indonesia
Jl Sumber Waras No 25,
Lawang, Malang 65216, Indonesia

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Aminoleban 8% Amino Acid: For Intravenous Administration

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AMINOLEBAN®

With these findings as background information, Fischer et al developed a special formula of

AMINOLEBAN® is prepared with an amino acid composition identical to that of Fischer's

DOSAGE AND ADMINISTRATION

1. Careful Administration (AMINOLEBAN Infusion should be administered with

1) Clinically significant adverse reactions:

4. Use in the Elderly

(2) During administration

PRECAUTION AND HANDLING

REG. No.: DKL8718701649A1

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