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Uses
Novolin R is indicated to improve glycemic control in adults and children with diabetes mellitus.
History
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Other Information
Novolin R (Regular Human Insulin Injection [Recombinant DNA origin] United States Pharmacopeia) is a polypeptide hormone structurally identical to native human insulin and is produced by recombinant DNA technology, utilizing Saccharomyces cerevisiae (baker’s yeast) as the production organism. Novolin R has the empirical formula C257H383N65O77S6 and a molecular weight of 5808.
Figure 1: Structural formula of Novolin R
Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH is adjusted to 7.4. Hydrochloric acid 2N or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free.
Sources
Novolin R Manufacturers
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Novo Nordisk
Novolin R | Novo Nordisk
2.1 DosingThe dosage and timing of Novolin R must be individualized. Blood glucose monitoring is essential for all patients receiving insulin therapy.
Total daily insulin requirements vary and are usually between 0.5 and 1.0 units/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered medications.
2.2 Subcutaneous InjectionNovolin R should generally be injected approximately 30 minutes prior to the start of a meal.
Novolin R given by subcutaneous injection should generally be used in regimens that include an intermediate or long-acting insulin [see How Supplied/Storage and Handling (16.1, 16.2)].
Novolin R should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or the upper arm. Subcutaneous injection into the abdominal wall is generally associated with faster absorption than other injection sites. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. Injection into a lifted skin fold minimizes the risk of intramuscular injection.
2.3 Intravenous UseNovolin R can be administered intravenously under medical supervision for glycemic control, with close monitoring of blood glucose and potassium concentrations to avoid hypoglycemia and hypokalemia [see Warnings and Precautions (5.2, 5.3), How Supplied/Storage and Handling (16.1, 16.2)].
Intravenous administration of insulin is commonly used in the treatment of diabetic ketoacidosis, peri-operative management of diabetes, and maintenance of glycemic control during labor in pregnant diabetic women. For intravenous use, Novolin R should be used at concentrations from 0.05 units/mL to 1.0 unit/mL in infusion systems using polypropylene infusion bags. Novolin R can be used with the following infusion fluids: 0.9% sodium chloride, 5% dextrose, or 10% dextrose with 40 mmol/L potassium chloride.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Never use Novolin R if it has become viscous or cloudy; use Novolin R only if it is clear and colorless. Vials should not be used if leakage is observed. Novolin R should not be used after the printed expiration date.
The onset of action of Novolin R, when administered intravenously, is more rapid in comparison to subcutaneous administration.
2.4 Use in Insulin PumpsUse of Novolin R in insulin pumps is not recommended because of the risk of precipitation.
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