Description
Amisol™ Gold is a sterile aqueous solution of Amino Acids IV Infusion and 10% Glucose with electrolytes, which are necessary as the nitrogen sources for parenteral nutrition. Nitrogen is provided in the form of essential and non-essential amino acids.
 

Composition
Each 100 ml contains
 

Active ingredients                     Specification                         Quantity

Essential Amino Acids

L-Isoleucine                                         USP                             0.390 g

L-Leucine                                             USP                             0.530 g

L-Lysine Hydrochloride                        USP                             0.390 g

L-Methionine                                        USP                             0.190 g

L-Phenylalanine                                    USP                             0.550 g

L-Threonine                                         USP                             0.300 g

L-Tryptophan                                       USP                             0.100 g

L-Valine                                               USP                             0.430 g

L-Histidine                                           USP                             0.240 g

L-Tyrosine                                           USP                             0.050 g

Non-Essential Amino Acids

L-Arginine                                            USP                             0.330 g

L-Aspartic Acid                                   USP                             0.410 g

L-Glutamic Acid                                   BP                               0.900 g

L-Alanine                                             USP                             0.300 g

L-Cystine                                             BP                               0.140 g

Glycine (Aminoacetic Acid)                  USP                             0.210 g

L-Proline                                              USP                             0.810 g

L-Serine                                               USP                             0.750 g

Carbohydrate

Anhydrous Glucose                              BP                               10.00 g

Electrolytes (mmol/L)

Potassium Chloride                               BP                               0.0375 g

Calcium Chloride Dihydrate                  BP                               0.0368 g

Magnesium Chloride Hexahydrate         BP                               0.0305 g

Pharmacology
Pharmacodynamics: Amino Acid IV Infusion with 10% Glucose and Electrolytes contains amino acids and electrolytes, which are all present in ordinary food. Apart from the nutritive properties Amino Acid IV Infusion with 10% Glucose and Electrolytes should have no specific pharmacodynamic effects. To optimize the utilization of supplied amino acids, adequate energy should be supplied in the form of carbohydrates (preferably glucose) and fat. Pharmacokinetics: The principle pharmacokinetic properties for Amino Acid IV Infusion with 10% Glucose and Electrolytes are essentially the same as for amino acids supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the systemic circulation directly. Toxicology: Preclinical Safety Data: Preclinical safety studies with Amino Acid IV Infusion with 10% Glucose and Electrolytes demonstrated good tolerance.

Indications
As a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. Amino Acid IV Infusion with 10% Glucose and Electrolytes is particularly suitable for patients with basal amino acids requirements.

Dosage
Adults: The nitrogen requirement for maintenance of body protein mass depends on the condition of the patient (nutritional state and degree of metabolic stress). The requirements are 0.1-0.15 g nitrogen/kg body weight/day (no or minor metabolic stress and normal nutritional state), 0.15-0.2 g nitrogen/kg body weight/day (moderate metabolic stress with or without malnutrition) and up to 0.2-0.25 g nitrogen/kg body weight/day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.1-0.25 g nitrogen/kg body weight/day corresponds to 11-27 mL Amino Acid IV Infusion with 10% Glucose and Electrolytes /kg body weight/day, respectively.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patient requirements, up to 1000-2000 mL of Amino Acid IV Infusion with 10% Glucose and Electrolytes may be infused IV per 24 hrs. Amino Acid IV Infusion with 10% Glucose and Electrolytes should be infused slowly, at a rate not exceeding 1000 mL in 6 hrs corresponding to approximately 2.8 mL/min. In patients with basal amino acids requirements, the less concentrated Amino Acid IV Infusion with 10% Glucose and Electrolytes may be used. Infants and Children: In children and infants, a maximal rate of infusion of 30 mL Amino Acid IV Infusion with 10% Glucose and Electrolytes/kg body weight/day is recommended, with a stepwise increase in the rate of administration during the 1st week of treatment.

Contraindications
Patients with inborn errors of amino acid 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.


Precautions
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 has been noted 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 other origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary. In severely malnourished patients refeeding carbohydrates can trigger a 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.

Use in Pregnancy
Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Amino Acids IV Infusion and 10% Glucose with electrolytes. There are, however, published reports of successful and safe administration of amino acid solutions during pregnancy.

Adverse Drug Reactions
Nausea occurs rarely. Transient increases in liver tests during IV nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amounts in the IV feeding regimens have been suggested. Hypersensitivity reactions have been reported with amino acid solutions. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of Intralipid. Extravascular disposition may cause tissue necrosis. Hyperphenylalaninemia may occur in severely ill, premature infants.

Drug Interactions
Not to be expected.

Overdosage
If Amino Acid IV Infusion with 10% Glucose and 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 Acid IV Infusion with 10% Glucose and Electrolytes. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.

Pharmaceutical Precautions
Protect from light and store between 150C to 250C temperature. Avoid freezing. Keep medications out of reach of children.

Commercial Pack
Amisol™ Gold is available in 500 ml glass bottle.