Novolin R (Novo Nordisk)

Novolin R (Novo Nordisk) - General Information

51 residue peptide hormone, covalently linked by disulfide bonds. The protein is synthesized in a special non-disease-producing special laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production.

Pharmacology of Novolin R (Novo Nordisk)

Used in the treatment of type I and type II diabetes. The primary activity of insulin is the regulation of glucose metabolism. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly. It also promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat.

Novolin R (Novo Nordisk) for patients

For all patients:

Patients should be informed about potential risks and advantages of NovoLog therapy including the possible side effects. Patients should also be offered continued education and advice on insulin therapies, injection technique, life-style management, regular glucose monitoring, periodic glycosylated hemoglobin testing, recognition and management of hypo-and hyperglycemia, adherence to meal planning, complications of insulin therapy, timing of dose, instruction in the use of injection or subcutaneous infusion devices, and proper storage of insulin. Patients should be informed that frequent, patient-performed blood glucose measurements are needed to achieve optimal glycemic control and avoid both hyper- and hypoglycemia.

Female patients should be advised to tell their physician if they intend to become, or if they become pregnant. Information is not available on the use of NovoLog during pregnancy or lactation.

For patients using pumps:

Patients using external pump infusion therapy should be trained in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.

Pumps:

NovoLog is recommended for use in Disetronic H-TRON series, MiniMed 500 series and other equivalent pumps

Reservoirs and infusion sets:

NovoLog is recommended for use in any reservoir and infusion sets that are compatible with insulin and the specific pump. Please see recommended reservoir and infusion sets in the pump manual.

To avoid insulin degradation, infusion set occlusion, and loss of the preservative (metacresol), reservoirs, infusion sets, and injection site should be changed at least every 48 hours.

Insulin exposed to temperatures higher than 37°C (98.6°F) should be discarded. The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing, or sport case is exposed to sunlight or radiant heat. Infusion sites that are erythematous, pruritic, or thickened should be reported to medical personnel, and a new site selected because continued infusion may increase the skin reaction and/or alter the absorption of NovoLog. Pump or infusion set malfunctions or insulin degradation can lead to hyperglycemia and ketosis in a short time because of the small subcutaneous depot of insulin. This is especially pertinent for rapid-acting insulin analogs that are more rapidly absorbed through skin and have shorter duration of action. These differences are particularly relevant when patients are switched from infused buffered regular insulin or multiple injection therapy. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Problems include pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Less commonly, hypoglycemia from pump malfunction may occur. If these problems cannot be promptly corrected, patients should resume therapy with subcutaneous insulin injection and contact their physician.

Novolin R (Novo Nordisk) Interactions

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

� The following are examples of substances that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetic products, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics.

� The following are examples of substances that may reduce the blood-glucose-lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives).

� Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

� In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of hypoglycemia may be reduced or absent.

Mixing of Insulins

� A clinical study in healthy male volunteers (n=24) demonstrated that mixing NovoLog with NPH human insulin immediately before injection produced some attenuation in the peak concentration of NovoLog, but that the time to peak and the total bioavailability of NovoLog were not significantly affected. If NovoLog is mixed with NPH human insulin, NovoLog should be drawn into the syringe first. The injection should be made immediately after mixing. Because there are no data on the compatibility of NovoLog and crystalline zinc insulin preparations, NovoLog should not be mixed with these preparations.

� The effects of mixing NovoLog with insulins of animal source or insulin preparations produced by other manufacturers have not been studied .

� Mixtures should not be administered intravenously.

� When used in external subcutaneous infusion pumps for insulin, NovoLog should not be mixed with any other insulins or diluent.

Novolin R (Novo Nordisk) Contraindications

NovoLog is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog or one of its excipients.

Additional information about Novolin R (Novo Nordisk)

Novolin R (Novo Nordisk) Indication: For treatment of diabetes (type I and II)
Mechanism Of Action: Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism and catabolism.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Insulin recombinant
Synonyms: Insulin precursor
Drug Category: Hypoglycemic Agents
Drug Type: Biotech; Approved

Other Brand Names containing Insulin recombinant: Novolin R (Novo Nordisk);
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Insulin is predominantly cleared by metabolic degradation via a receptor-mediated process.
Half Life: Not Available
Dosage Forms of Novolin R (Novo Nordisk): Liquid Intramuscular
Suspension Intramuscular
Liquid Oral
Liquid Subcutaneous
Suspension Subcutaneous
Liquid Intravenous
Solution Subcutaneous
Solution Intravenous
Chemical IUPAC Name: Human insulin
Chemical Formula: C257H387N65O76S6
Insulin recombinant on Wikipedia: Not Available
Organisms Affected: Humans and other mammals