Amino Acid + D-Sorbitol + Electrolytes
Composition
Each 100 ml solution (5%) contains:
Essential Amino Acids-
Total Energy Content: 1551 kj/L (371.14 Kcal/L)
Essential Amino Acids-
- L-Isoleucine 0.352 gm
- L-Leucine 0.490 gm
- L-Lysine Hydrochloride 0.430 gm
- L-Methionine 0.225 gm
- L-Phenylalanine 0.533 gm
- L-Threonine 0.250 gm
- L-Tryptophan 0.090 gm
- L-Valine 0.360 gm
- L-Histidine 0.250 gm
- L-Tyrosine 0.025 gm
- L-Arginine 0.500 gm
- L-Aspartic Acid 0.250 gm
- L-Glutamic Acid 0.075 gm
- L-Alanine 0.200 gm
- L-Cystine 0.010 gm
- Glycine (Aminoacetic Acid) 0.760 gm
- L-Proline 0.100 gm
- L-Serine 0.100 gm
- D-Sorbitol 5.000 gm
- Sodium (Na+) 57 mmol/L
- Potassium (K+) 25 mmol/L
- Magnesium (Mg++) 1.2 mmol/L
- Chloride (Cl-) 87 mmol/L
- Acetate (CH3COO-) 25 mmol/L
Total Energy Content: 1551 kj/L (371.14 Kcal/L)
Indications
Amino acid is indicated as a source of
amino acids for protein synthesis in patients needing intravenous
nutrition. Amino acid is particularly suitable for patients with basal
amino acid requirements. Amino acid is also indicated in faster recovery
in surgery, burns, renal insufficiency, hepatic insufficiency and
effective management of cancer.
Pharmacology
This IV solution is a sterile aqueous
solution of crystalline Amino Acid and D-Sorbitol with electrolytes,
which are necessary as the nitrogen source for parenteral nutrition.
Nitrogen provided in the form of essential and non-essential amino
acids. This IV solution contains all 18 essential and non-essential
amino acids needed for protein synthesis. The amino acid composition is
such that positive nitrogen balance can be achieved in the postoperative
period and during extended periods of intravenous nutrition. The
solution is clear, colorless to pale yellow colored, having a p H lying
in the range of 5.0 to 7.0.
Dosage & Administration
The nitrogen requirement for maintenance of
body protein mass depends on the patient's condition (nutritional state
and degree of metabolic stress).
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.
- No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
- Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
- Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
In children and infants: The rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step-wise increase in the rate of administration during the frst week.
Interaction
At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
Contraindications
This is contraindicated in patients with
inborn errors of amino acids metabolism, severe liver dysfunction and in
severe uremia when dialysis facilities are not available. Due to the
content of glucose, Amino Acids IV infusion and 10% Glucose with
Electrolytes is contraindicated in patients with hyperosmolar nonketotic
diabetic coma.
Side Effects
This preparation is usually well tolerated.
Nausea occurs rarely. Vomiting, flushing and sweating have been
observed during infusion of Amino acid at rates exceeding the
recommended maximal rate. Transient increases liver test during
intravenous nutrition have been reported. The reasons are at present
unclear. Hypersensitivity reactions have been reported. As with all
hypertonic infusion solutions, thrombophlebitis may occur when
peripheral veins are used. The incidence may be reduced by the
simultaneous infusion of 10% fat emulsion. If given to severely ill,
premature infants, hyperphenylalaninemia may occur.
Pregnancy & Lactation
Successful and safe administration of amino
acid solutions during pregnancy in the human has been reported. Animal
reproduction studies have not been carried out with Amino acid.
Precautions & Warnings
IV infusion of amino acids is accompanied
by increased urinary excretion of the trace elements copper and in
particular zinc, which should be taken into account in the dosing of
trace elements, particularly during long-term IV nutrition.
Hyperphenylalaninemia may occur in severely ill, premature infants. In
these patients, monitoring of the phenylalanine level is recommended and
the infusion rate adjusted as needed. Amino Acids IV infusion and 10%
Glucose with Electrolytes should be used with caution in patients with
diabetes mellitus, severe heart failure or with renal function in
combination with fluid restrictions or oliguria/anuria of another
origin. In patients with hyperglycemia, administration of exogenous
insulin might be necessary. In severely malnourished patients refeeding
carbohydrates can trigger thiamine (vitamin B1 ) deficiency syndrome.
Those at high risk are patients with a history of alcohol abuse,
anorexia nervosa, prolonged fasting or starvation and pregnant women
with hyperemesis gravidarum. In this kind of patients, parenteral
nutrition containing glucose should be given with caution and parenteral
administration of thiamine should be considered before and during the
administration of glucose. Monitoring of serum potassium and blood
glucose is recommended if Amino Acids IV infusion and 10% Glucose with
electrolytes is infused rapidly or in a large quantity. For patients
with hypophosphatemia, an additional supply of phosphate is recommended.
Overdose Effects
If Amino Acids IV infusion and 10% Glucose
with Electrolytes is administered at a higher rate than recommended,
there is an augmented risk for nausea, vomiting and sweating. When
peripheral veins are used thrombophlebitis may occur. Osmotic diuresis
with dehydration may occur if the dosage recommendations are exceeded.
There is also a risk of symptoms related to hyperglycemia with Amino
Acids IV infusion and 10% Glucose with Electrolytes. In case of symptoms
due to overdose, the infusion should be slowed down or discontinued.
Therapeutic Class
Parenteral nutritional preparations
Storage Conditions
Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of reach of children.
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