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Novolin R is a fast acting insulin called insulin regular, and is a humane derived hormone. It lowers blood glucose (sugar) levels in the treatment of diabetes. Novolin R is designed to start taking effect quicker than some other insulin's and lasts approximately 8 hours. Some veterinarians may prescribe Novolin R If your pet has been diagnosed with diabetes.
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.
Insulin Human
glycerol, metacresol, zinc, water for injection, hydrochloric acid and sodium hydroxide.
View Novolin R Drug Facts Sheet.
Always check insulin labels before administration [see Warnings and Precautions]
NOVOLIN R is contraindicated:
NOVOLIN R FlexPen must never be shared between patients, even if the needle is changed. Patients using NOVOLIN R vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].
Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia is the most common adverse reaction of all insulins, including NOVOLIN R. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)], or in patients who experience recurrent hypoglycemia.
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulin preparations, the glucose lowering effect time course of NOVOLIN R may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [see Clinical Pharmacology (12.2)]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication [see Drug Interactions (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
Accidental mix-ups between NOVOLIN R and other insulin products have been reported. To avoid medication errors between NOVOLIN R and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with NOVOLIN R. Generalized allergy to insulin may manifest as a whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis. If hypersensi-tivity reactions occur, discontinue NOVOLIN R; treat per standard of care and monitor until symptoms and signs resolve. NOVOLIN R is contraindicated in patients who have had hypersensitivity reactions to insulin human injection or its excipients [see Contraindications (4)].
All insulins, including NOVOLIN R, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including NOVOLIN R, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
The following adverse reactions are also discussed elsewhere in the labeling:
The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLIN R. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Adverse reactions associated with insulin initiation and glucose control intensification
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Hypersensitivity reactions
Severe, life-threatening, generalized allergy, including anaphylaxis.
Hypoglycemia
Hypoglycemia is the most commonlyobserved adverse reaction in NOVOLIN R.
Hypokalemia
NOVOLIN R can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions
NOVOLIN R can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in NOVOLIN R.
Lipodystrophy
Administration of insulin subcutaneously, including NOVOLIN R, has resulted in lipoatrophy (depression in the skin) or lipohyper-trophy (enlargement or thickening of tissue) [see Dosage and Administration (2.2)] in some patients.
Localized Cutaneous Amyloidosis
Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Medication Errors
Medication errors in which other insulins have been accidentally substituted for NOVOLIN R have been identified during postapproval use.
Peripheral edema
Insulins, including NOVOLIN R, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Weight gain
Weight gain can occur with insulin therapies, including NOVOLIN R, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Immunogenicity
As with all therapeutic peptides, insulin administration may cause anti-insulin antibodies to form. Increases in titers of anti-insulin antibodies that react with human insulin have been observed in patients treated with NOVOLIN R.
Please read the following Instructions for Use carefully before using your Novolin R 10 mL vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin 10 mL vial before. There may be new information.
Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.
Never re-use syringes and needles.
Different insulins should be mixed only under instruction from a healthcare provider. Do not mix Novolin R with any other type of insulin except NPH insulin. Novolin R should be mixed with NPH insulin right before use. When you are mixing Novolin R insulin with NPH insulin, always draw the Novolin R (clear) insulin into the syringe first.
This Patient Instructions for Use has been approved by the Food and Drug Administration.
Do not use Novolin R if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Before you start using Novolin R, talk to your healthcare provider about low blood sugar and how to manage it.
Keep Novolin R and all medicines out of the reach of children.
While using Novolin R do not:
Treatment with TZDs and NovolinŽ R may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
These are not all of the possible side effects of Novolin R. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.