Repotyn IV IV nfusion

Protein supply for parenteral nutrition. Prophylaxis & therapy of protein deficiency resulting from increased protein losses &/or increased protein requirements.

Adults: 10-20 mL/kg body wt (equiv to 1-2 g amino acids/kg body wt). Max infusion rate: 1 mL/kg body wt/hr (equiv to 0.1 g amino acid/kg body wt & hr). Max daily dose: 20 mL/kg body wt (equiv to 2 g amino acid/kg body wt).

Infants and Children: In children and infants, the rate of infusion is 28-35 ml/kg body wt/day is recommended, with a stepwise increment in the rate of administration during the first week of treatment.

Patients with renal impairment not needing dialysis require 0.6 to 0.8 g of protein/kg/day. Patients on hemodialysis or continuous renal replacement therapy should receive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses.

Clinical studies with amino acids have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

In patients with impaired liver function, parenteral nutrition solutions containing amino acids should be administered starting at the low end of the dosing range. Frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted

Depending upon patients requirements, 1000-2000 ml amino acid may be infused intravenously per 24 hours. It should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

Contraindicated in patients with inborn errors of amino acids metabolism. Moreover, amino acid should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.

Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. Hypersensitivity Reactions. Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State Vein Damage and Thrombosis: solutions with osmolarity of 900 mOsm/L or more must be infused through a central catheter. Hepatobiliary Disorders. Aluminum Toxicity: increased risk in patients with renal impairment, including preterm infants. Parenteral Nutrition Associated Liver Disease: increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. Electrolyte Imbalance and Fluid Overload: patients with cardiac insufficiency or renal impairment may require adjustment of fluid, protein and electrolyte content. increased risk of hypoglycemia/hyperglycemia Monitoring Parameters Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. monitor for signs and symptoms and discontinue infusion if reactions occur. monitor for signs and symptoms; monitor laboratory parameters. monitor liver function parameters and ammonia levels. monitor serum glucose concentrations. serum electrolyte levels should be closely monitored.

Not Classi Risk Summary Limited published data with injectable amino acids solutions, in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes. Animal reproduction studies have not been conducted with injectable amino acids solutions. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and ofmiscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. Lactation Risk Summary There are no data available to assess the presence of injectable amino acids, in human milk, the effects of amino acids on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of amino acids to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for amino acids and any potential adverse effects on the breastfed child from amino acids or from the underlying maternal condition.

Hypersensitivity reactions Risk of Infections Refeeding syndrome Hyperglycemia or hyperosmolar hyperglycemic state Vein damage and thrombosis Hepatobiliary disorders Aluminum toxicity Parenteral Nutrition Associated Liver Disease Electrolyte imbalance and fluid overload

A crystalline amino acid solution provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Amino Acids, given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitute total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.

Repotyn IV 5% IV nfusion manufactured by ACI Limited. Its generic name is Amino Acids (5 % & 10%) + D-sorbitol + Electrolytes.