Clinosol Gold IV Infusion

Amino Acids 7 % + Glucose + Electrolytes 10 %

7% + 10%

Opsonin Pharma Limited

Pack size	500ml bot
Dispensing mode
Source
Agent
Retail Price	500.00 AED

Indications

Clinosol Gold IV Infusion is used for: Prevent nitrogen loss, Negative nitrogen balance, Nutritional therapy

Adult Dose

For peripheral intravenous infusion, 1 to 1.5 g/kg/day of total amino acids will reduce protein catabolism.

Child Dose

As reported the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Renal Dose

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.

Administration

As with all intravenous fluid therapy, the primary aim is to provide sufficient water to compensate for insensible, urinary, and other fluid losses (nasogastric suction, fistula drainage, and diarrhea). Infused at a rate of 45 mL/kg/day, will meet the fluid and amino acid requirements of the stable adult patient. As reported the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Contra Indications

This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.

Precautions

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. nitrogen intake should be carefully monitored in patients with impaired renal function.

Pregnancy-Lactation

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.

Interactions

Adverse Effects

Side effects of Amino Acids 7 % + Glucose + Electrolytes 10 % : 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

Mechanism of Action

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, constitutes total parenteral nutrition (TPN). Amino Acids can also be administered by peripheral vein with dextrose and maintenance electrolytes.

Note

Clinosol Gold 7% + 10% IV Infusion manufactured by Opsonin Pharma Limited. Its generic name is Amino Acids 7 % + Glucose + Electrolytes 10 %. Clinosol Gold is availble in Bangladesh. Farmaco BD drug index information on Clinosol Gold IV Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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