July 24, 2016
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Novolin R

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Novolin R




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Diabetes Mellitus

Novolin R is indicated to improve glycemic control in adults and children with diabetes mellitus.

DOSAGE AND ADMINISTRATION

Dosing

The 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.

Subcutaneous Injection

Novolin 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].

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.

Intravenous Use

Novolin 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, HOW SUPPLIED/Storage and Handling].

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.

Use In Insulin Pumps

Use of Novolin R in insulin pumps is not recommended because of the risk of precipitation.

HOW SUPPLIED

Dosage Forms And Strengths

  • Novolin R is available in 10 mL vials. The concentration of Novolin R is 100 USP units of human insulin (rDNA origin)/mL.

Storage And Handling

Novolin R is available in 10 mL vials (NDC 0169-1833-11 and ReliOn® brand NDC 0169-183302). The concentration of Novolin R is 100 USP units of human insulin (rDNA origin)/mL. One vial is provided in each sale pack.

Recommended Storage

Unopened Novolin R vials should be stored in the refrigerator (36° -46°F [2° -8°C]). If carried as a spare or if refrigeration is not possible, unopened Novolin R vials can be kept at room temperature provided they are kept as cool as possible (not above 77°F [25°C]). If kept at room temperature, Novolin R vials must be discarded after 42 days even if they are unopened.

Do not freeze and do not use Novolin R if it has been frozen. In addition, unopened Novolin R vials should be kept in their cartons so that they will stay clean and protected from light. They should not be exposed to heat or light.

An opened (In use) Novolin R vial can be kept at room temperature provided it is kept as cool as possible (below 77°F [25°C]) and away from heat or light. Do not refrigerate after first use.

Unopened and opened (In use) Novolin R vials must be discarded 42 days after they are first kept out of the refrigerator, even if they still contain Novolin R insulin.

Table 9: Storage Conditions for Novolin R vials

Unopened (Refrigerated) Unopened (Room Temperature up to 77°F [25°C]) Opened (In use) (Room Temperature below 77°F [25°C])
Until expiration date 42 days* 42 days*
* The total time allowed at room temperature (up to 25°C) is 42 days regardless of whether the product is unopened or opened (In use)

Infusion bags prepared as indicated under DOSAGE AND ADMINISTRATION (2.3) are stable at room temperature for 24 hours. A certain amount of insulin will be initially adsorbed to the material of the infusion bag.

Always remove the needle after each injection. Always use a new disposable syringe and needle for each injection to prevent contamination.

Never use insulin after the expiry date which is printed on the label and carton.

Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. For information about Novolin® R contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536. Revised: Jan 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/23/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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