NEODOSE

INDICATIONS

• Hyperglycemic infants with persistent glucose intolerance.(Very Low Birth Weight.
• Hyperglycemia in critically ill: Tight glycemic control (72 to 126 mg/dL) compared with conventional glycemic control(less than 216 mg/dL) did not provide improved number of days alive or mechanical ventilation rate at day 30 in critically ill patients(n = 1369, newborns(36 weeks gestation or more) to 16 years of age non – diabetic children) on mechanical ventilation and vasoactive drugs.Furthermore, severe hypoglycemic episodes were more common in the tight glycemic control group(7.3 % vs 1.5 % , p less than 0.001).
• Hyperkalemia: In combination with dextrose.

FDA APPROVED INDICATION

Regular human insulin is indicated for diabetes mellitus; type 1 and type 2 in pediatric patients (HumuLIN® R) and type 1 in pediatric patients 2 to 18 years of age. HumuLIN® R U-500 is indicated to improve glycemic control in patients with diabetes mellitus requiring more than 200 units of insulin daily.

CONTRAINDICATIONS

• During episode of hypoglycemia.
• Hypersensitivity to human regular insulin or any of its components.

PRECAUTIONS

• administration:
  • Do not administer 500 units/mL concentration IV, IM, or via insulin pump; do not dilute or mix with any other insulin products or solutions.
  • Pen devices and syringes are for single patient use only and never to be shared, even if the needle is changed, due to increased risk for transmission of bloodborne pathogens.
• Concomitant Use:
  • Concomitant peroxisome proliferator-activated receptor (PPAR)-gamma agonist therapy may cause dose-related fluid retention, potentially leading to new or worsening heart failure; monitoring recommended and dose reduction or discontinuation of PPAR-gamma agonist therapy may be required if heart failure develops.
• Endocrine and metabolic:
  • Severe hypoglycemia may occur 18 to 24 hours after administration with 500 units/mL.
  • Symptomatic hypoglycemia may be difficult to recognize in patients with longstanding diabetes, patients with nerve disease, patients using medications that block the sympathetic nervous system (eg, beta blocker) or patients who experience recurrent hypoglycemia; increased glucose monitoring recommended.
  • Increased risk for hypoglycemia with injection site changes, changes in meal patters, changes in level of physical activity, changes to coadministered medication, and patients with renal or hepatic impairment; increased glucose monitoring recommended.
  • Increased risk of hyperglycemia with repeated injections into areas of lipodystrophy or localized cutaneous amyloidosis.
  • Hypokalemia may occur; monitoring recommended in patients at risk for hypokalemia (eg, patients using potassium-lowering medications, patients taking medications sensitive to serum potassium).
• Hepatic:
  • Patients with hepatic impairment may require more frequent dose adjustments.
• Immunologic:
  • Severe, life-threatening, generalized allergy, including anaphylaxis, have been reported; discontinue if reactions occur.
• Medication Errors:
  • Hyperglycemia, hypoglycemia, and death have been reported due to medication error with 500 units/mL; ensure correct insulin is being used.
• Renal:
  • Patients with renal impairment may require more frequent dose adjustments.

ADVERSE EFFECTS

May rapidly induce hypoglycemia. Insulin resistance may develop, causing a larger dose requirement. Euglycemic hyperinsulinemia due to exogenous insulin administration may cause metabolic acidosis. The most recent randomized controlled trial (Beardsall) and systematic review (Raney) concluded that routine use of insulin in VLBW infants to promote growth is not warranted.

ADMINISTRATION

• Intravenous: Only regular insulin for injection may be administered intravenously. For continuous infusion, dilute regular insulin in compatible solution to a concentration of 0.05 to 1 unit/mL in polypropylene infusion bags (NovoLIN R) and 0.1 to 1 unit/mL in polyvinyl chloride bags (HumuLIN R). The recommended standard neonate concentrations are 0.1 unit/mL and 0.5 unit/mL.
• Tubing: To saturate plastic tubing binding sites, fill IV tubing with insulin solution and wait for at least 20 minutes before infusing (preconditioning). The use of higher insulin concentrations and longer wait times will shorten the time to steady-state. Other studies have examined preconditioning and/or priming volumes; running a certain volume of insulin infusion through the tubing prior to initiation. One study demonstrated that 20 mL of priming volume was sufficient to minimize adsorption losses for a 1 unit/mL insulin infusion. Results show that pre-flushing IV administration sets leads to greater and more predictable insulin delivery over time and that the combination of preconditioning and flushing offers the best combination to reduce insulin adsorption

MONITORING

Follow blood glucose concentration frequently (every 15 to 30 minutes) after starting insulin infusion and after changes in infusion rate. Monitor potassium concentrations closely when treating hyperkalemia.