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Novolin (Insulin Human) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Novolin R is indicated for subcutaneous administration for the treatment of patients with diabetes mellitus, for the control of hyperglycemia. Treatment with Novolin R is as an adjunct to diet and exercise for lowering blood glucose in patients with Type 1 diabetes or in patients with Type 2 diabetes for whom oral antidiabetic therapy is inadequate.

Novolin R may be administered intravenously under proper medical supervision in a clinical setting for glycemic control. (See DOSAGE AND ADMINISTRATION and RECOMMENDED STORAGE)

DOSAGE AND ADMINISTRATION

Novolin R, when used alone subcutaneously, is usually given three or more times daily before meals. The dosage and timing of Novolin R should be individualized and determined, based on the physician's advice, in accordance with the needs of the patient. Novolin R may also be used in combination with oral antidiabetic agents or longer-acting insulin products to suit the needs of the individual patients. The injection of Novolin R should be followed by a meal within approximately 30 minutes of administration.

The average range of total daily insulin requirement for maintenance therapy in insulin-treated patients lies between 0.5 and 1.0 IU/kg. However, in pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, but can be much lower during the period of partial remission. In severe insulin resistance, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for Type 2 diabetes patients are often lower, e.g. 0.2 to 0.4 IU/kg/day.

Novolin R should be administered by subcutaneous injection in the abdominal wall, the thigh, the gluteal region or in the upper arm. Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites. Injection into a lifted skin fold minimizes the risk of intramuscular injection. Injection sites should be rotated within the same region. As withá all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

Intramuscular and intravenous administrations of Novolin R are possible under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.

For intravenous use, Novolin R should be used at concentrations from 0.05 U/mL to 1.0 U/mL in infusion systems with the infusion fluids 0.9% sodium chloride, 5% dextrose, or 10% dextrose with 40 mmol/l potassium chloride using polypropylene infusion bags.

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 (thickened) or cloudy; use it only if it is clear and colorless. Novolin R should not be used after the printed expirationá date.

RECOMMENDED STORAGE

Novolin R vials, Novolin® R PenFill® cartridges, and Novolin® R InnoLet® prefilled insulin syringes should be stored in a cold (36░ - 46░F [2░ - 8░C]) place, preferably in a refrigerator, but not in the freezer. Do not freeze. Keep Novolin R vials, Novolin R PenFill cartridges and Novolin R InnoLet in their cartons so that they will stay clean and protected from light. They should not be exposed to heat or sunlight. A Novolin R vial in use can be kept unrefrigerated as long as it is kept as cool as possible and away from heat or sunlight. A Novolin R PenFill cartridge and Novolin R InnoLet in use should not be refrigerated but should be kept as cool as possible (below 86░F [30░C]) and away from direct heat and light. Unrefrigerated Novolin R PenFill cartridges and Novolin R InnoLet must be discarded 28 days after the first use, even if they still contain Novolin R insulin.

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

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

HOW SUPPLIED

Novolin R, Regular, Human Insulin Injection (rDNA origin) USP, 100 units/mL, is supplied as follows:

10 mL vial NDC 0169-1833-11

3 mL PenFill cartridges* NDC 0169-3473-18

3 mL Novolin R InnoLetá NDC 0169-2313-21

*Novolin R PenFill 3 mL cartridges are designed for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices, the NovoPen® 3 PenMate® and with NovoFine® disposable needles.

Date of issue: October 21, 2005

ReliOn®

For information contact: Novo Nordisk Inc., Princeton, NJ 08540

1-800-727-6500

www.novonordisk-us.com

Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark

Novo Nordisk®, Novolin®, PenFill®, InnoLet®, NovoPen®, PenMate® and NovoFine® are trademarks owned by Novo Nordisk A/S.

ReliOn® trademark owned by Access LLC

ReliOn® is licensed by Novo Nordisk Inc.

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