Aminosteril N-Hepa IV Infusion

Amino acids IV
8%
Radiant Pharmaceutical Ltd.
Pack size 500 ml bottle
Dispensing mode
Source
Agent
Retail Price 1166.00 AED

Indications

Aminosteril N-Hepa IV Infusion is used for: Parenteral nutrition

Adult Dose

Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). 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. The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml amino acid IV/kg/day. In obese patients, the dose should be based on the estimated ideal weight. A maximum fluid supply of 40 mL/kg/day of parenteral nutrition solution, based on protein, should not be exceeded in adult patients

Child Dose

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.

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

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.

Contra Indications

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.

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.

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 IV : 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

Provides nutritional requirements that support neurotransmitter synthesis and physiological activities involved in neuropathic pain; helps restore nutrient balance of arginine, choline, glutamine, histidine, tryptophan, and serine which support the balance of the neurotransmitters GABA, histamine, nitric oxide, serotonin, and acetylcholine Under usual physiological conditions, glutamine, arginine, serine, and choline are considered nonessential because endogenous synthesis is sufficient to satisfy metabolic demand; with neuropathic pain, the usual rate of synthesis is no longer sufficient and these nutrients become conditionally essential, requiring that supplemental amounts be consumed.

Note

Aminosteril N-Hepa 8% IV Infusion manufactured by Radiant Pharmaceutical Ltd.. Its generic name is Amino acids IV. Aminosteril N-Hepa is availble in Bangladesh. Farmaco BD drug index information on Aminosteril N-Hepa 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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