Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
Novolin® R
(Regular, Human Insulin [rDNA origin] USP) Solution for Subcutaneous or Intravenous Use
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 (Regular, Human Insulin [rDNA origin]) Structural formula Illustration](https://images.rxlist.com/images/rxlist/novolin-r1.gif) |
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 is indicated to improve glycemic control in adults and children with diabetes mellitus.
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.
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]. Â
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.
Novolin R can be administered intravenously under medical supervision for glycemic control, Â 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 of Novolin R in insulin pumps is not recommended because of the risk of precipitation.
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.
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
Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
The incidence of adverse reactions during clinical trials comparing Novolin R and insulin aspart in adults with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.
Table 1: Adverse Reactions in a 24-Week Trial
Comparing Novolin R and Insulin Aspart in Adults with Type 1 Diabetes Mellitus
Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5%
in the Novolin R treatment group are listed)
| Novolin R + NPH N= 286 % |
Insulin aspart + NPH N=596 % |
|
| Hypoglycemia* | 72 | 75 |
| * Hypoglycemia was defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms. | ||
Table 2: Adverse Reactions
in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 2
Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an
incidence ≥ 5% in the Novolin R treatment group are listed)
| Novolin R + NPH N= 91 (%) |
Insulin aspart + NPH N= 91 (%) |
|
| Hypoglycemia* | 36 | 27 |
| *Hypoglycemia was defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms. | ||
The incidence of adverse reactions during a 24-week clinical trial comparing Novolin R and insulin aspart in children and adolescents with type 1 diabetes mellitus are listed in the table below.
Table 3: Adverse Reactions
in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Children and
Adolescents with Type 1 Diabetes Mellitus Also Treated with NPH Insulin
(adverse reactions with an incidence ≥ 5% in the Novolin R treatment group
are listed)
| Novolin R + NPH N= 96 (%) |
Insulin aspart + NPH N= 187 (%) |
|
| Hypoglycemia* | 85 | 79 |
| Injection site hypertrophy | 8 | 8 |
| *Hypoglycemia was defined as an episode of blood glucose concentration < 50 mg/dL, with or without symptoms. | ||
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R [See WARNINGS AND PRECAUTIONS]. Tables 4 and 5 summarize the incidence of severe hypoglycemia in the Novolin R clinical trials. Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring intervention of another person or hospitalization. The rates of severe hypoglycemia in the Novolin R clinical trials (see Clinical Studies for a description of the study designs) were comparable for all treatment regimens (see Tables 4 and 5).
Table 4: Severe Hypoglycemia
in Patients with Type 1 Diabetes
| Type 1 Diabetes Adults 24 weeks in combination with NPH insulin | Type 1 Diabetes Children and Adolescents (age 6-18) 24 weeks in combination with NPH insulin | Type 1 Diabetes Children (age 2-6) 24 weeks in combination with NPH insulin | ||||
| Novolin R | Insulin aspart | Novolin R | Insulin aspart | Novolin R | Insulin aspart | |
| Percent of patients (n/total N) | 19 (55/286) | 18 (105/596) | 9 (9/96) | 6 (11/187) | 12 (3/25) | 8 (2/26) |
| Event/patient/ year | 1.1 | 0.9 | 0.3 | 0.2 | 0.5 | 0.3 |
Table 5: Severe Hypoglycemia
in Patients with Type 2 Diabetes
| Type 2 Diabetes Adults 24 weeks in combination with NPH insulin | ||
| Novolin R | Insulin aspart | |
| Percent of patients (n/total N) | 5 (5/91) | 10 (9/91) |
| Event/patient/ year | 0.2 | 0.3 |
A number of medications affect glucose metabolism that may require insulin dose adjustment and particularly close monitoring for hypoglycemia or worsening glycemic control.
Included as part of the PRECAUTIONS section.
Subcutaneous injection of Novolin R should be followed by a meal. Patients should wait approximately 30 minutes after injection before starting the meal [see DOSAGE AND ADMINISTRATION]. Â
Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of Novolin R action may vary in different individuals or at different times in the same individual and is dependent on many conditions, including dosage, the site of injection, local blood supply, temperature, and physical activity. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages. Insulin requirements may be altered during illness, emotional disturbances, or other stresses.
Hypoglycemia is the most common adverse reaction of all insulin therapies, including Novolin R. Severe hypoglycemia may lead to unconsciousness, convulsions, temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person, parenteral glucose infusion, and glucagon administration has been observed in clinical trials with insulin, including trials with Novolin R.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations [see CLINICAL PHARMACOLOGY]. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia [see DRUG INTERACTIONS]. As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., patients who are fasting or have erratic food intake, pediatric patients, and the elderly). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Rapid changes in serum glucose concentrations may induce symptoms of hypoglycemia in patients with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic neuropathy, use of medications such as beta-blockers, or intensified glycemic control [see DRUG INTERACTIONS]. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia. Intravenously administered insulin has a more rapid onset of action than subcutaneously administered insulin, requiring more close monitoring for hypoglycemia.
All insulins, including Novolin R, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia that, if left untreated, may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications and patients taking medications sensitive to serum potassium concentrations). Monitor glucose and potassium frequently when Novolin R is administered intravenously.
Hyperglycemia, diabetic ketoacidosis, or hyperosmolar hyperglycemic non-ketotic syndrome may develop in patients who take less insulin than needed to control blood glucose. These conditions can be precipitated by illness, infection, dietary indiscretion, or omission or improper administration of the prescribed insulin dose.
As with other insulins, the dose requirements for Novolin R may be reduced in patients with renal or hepatic impairment.
As with other insulins, patients may experience redness, swelling, or itching at the site of injection of Novolin R. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of Novolin R. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in Novolin R.
Severe, life-threatening, generalized allergy, including anaphylaxis may occur with any insulin, including Novolin R. Generalized allergy to insulin may manifest as a whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.
If Novolin R is mixed with NPH human insulin, Novolin R should be drawn into the syringe first and the mixture should be injected immediately after mixing. Insulin mixtures should not be administered intravenously.
Increases in titers of anti-insulin antibodies that react with human insulin have been observed in patients treated with Novolin R. Data from a 12-month controlled trial in patients with type 1 diabetes suggest that the increase in these antibodies is transient. The clinical significance of these antibodies is not known but does not appear to cause deterioration in glycemic control or necessitate increases in insulin dose.
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.
See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)
Maintenance of normal or near-normal glucose control is a treatment goal in diabetes mellitus and has been associated with a reduction in some diabetic complications. Patients should be informed about potential risks and benefits of Novolin R therapy including possible adverse reactions. Patients should also be offered continued education and advice on insulin therapies, injection technique, lifestyle 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 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.
The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or operating machinery. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant.
Patients should be instructed to always carefully check that they are administering the correct insulin to avoid medication errors between Novolin R and other insulins. Patients should check the label for the drug name Novolin R, the enlarged R letter, and the blue horizontal bar. If a prescription for Novolin R is needed, it should be written clearly to avoid confusion with other insulin products.
Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of Novolin R.
Novolin R is not mutagenic in the following in vitro tests: The chromosomal aberration assay in human lymphocytes, the micronucleus assay in mouse polychromatic erythrocytes, and the mutation frequency assay in Chinese hamster cells.
Standard reproduction and teratology studies in animals, including fertility assessments have not been conducted with Novolin R.
Pregnancy Category B: All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good glycemic control. It is essential for patients with diabetes or a history of gestational diabetes to maintain good glycemic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is important during pregnancy in patients with diabetes. Therefore, women should be advised to tell their healthcare provider if they intend to become, or if they become, pregnant while taking Novolin R.
No reproductive toxicity studies have been performed with Novolin R.
It is unknown whether Novolin R is excreted in breast milk. Small amounts of human insulin are secreted into breast milk, the significance of which is not known. Use of Novolin R is compatible with breastfeeding, but insulin doses may need to be adjusted because lactation can reduce insulin requirements.
The safety and effectiveness of subcutaneous injections of Novolin R have been established in pediatric patients (ages 2 to18 years) with type 1 diabetes [see Clinical Studies]. Novolin R has not been studied in pediatric patients younger than 2 years of age. Novolin R has not been studied in pediatric patients with type 2 diabetes.
In general, pediatric patients with type 1 diabetes are more susceptible to hypoglycemia than adult patients with type 1 diabetes. As in adults, the dosage of Novolin R must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
In 3 controlled clinical trials 18 of 1285 patients (1.4%) with type 1 diabetes treated with Novolin R and insulin aspart were ≥ 65 years of age. In 4 controlled clinical trials 151 of 635 patients (24%) with type 2 diabetes were ≥ 65 years of age. Therefore, conclusions are limited regarding the efficacy and safety of Novolin R in patients ≥ 65 years of age, particularly in patients with type 1 diabetes. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on Novolin R have not been performed.
Use caution in patients with advanced age, due to the potential for decreased renal function in this population [see WARNINGS AND PRECAUTIONS].
Excess insulin administration may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment can be treated with intramuscular or subcutaneous glucagon or intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately. [see WARNINGS AND PRECAUTIONS]
Novolin R is contraindicated:
The primary activity of Novolin R is the regulation of glucose metabolism. Insulins, including Novolin R, bind to insulin receptors on muscle and adipocytes and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
Novolin R is a short-acting insulin. When injected subcutaneously, the glucose-lowering effect of Novolin R begins approximately 30 minutes post-dose, is maximal between 1.5 and 3.5 hours post-dose and terminates approximately 8 hours post-dose. The onset of action of Novolin R, when administered intravenously, is more rapid in comparison to the subcutaneous administration. When injected subcutaneously, Novolin R has a slower onset of action and longer duration of action compared to the rapid-acting insulin analogs.
After single subcutaneous administration of 0.1 unit/kg of Novolin R to healthy subjects, peak insulin concentrations occurred between 1.5 to 2.5 hours post-dose. On average, insulin concentrations returned to baseline at around 5 hours post-dose.
The effects of sex, age, obesity, ethnic origin, renal and hepatic impairment, pregnancy, and smoking, on the pharmacodynamics and pharmacokinetics of Novolin R have not been studied.
Please see CLINICAL PHARMACOLOGY for information on the pharmacokinetics and pharmacodynamics of Novolin R.
Two six-month, open-label, active-controlled studies were conducted to compare the safety and efficacy of Novolin R and insulin aspart in adults with type 1 diabetes. Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin in either single or divided daily doses. Because the two study designs and results were similar, data are shown for only one study (see Table 6)
Table 6: Subcutaneous Novolin R Administration in Type
1 Diabetes (24 weeks; N=882)
| Novolin R + NPH N=286 |
Insulin aspart + NPH N=596 |
|
| Baseline HbA1c (%)* | 8.0 ± 1.2 | 7.9 ±1.1 |
| Change from Baseline HbA1c (%)* | 0.0 ± 0.8 | -0.1 ± 0.8 |
| Treatment Difference in HbA1c, Mean (95% confidence interval) Novolin R - insulin aspart group | 0.2 [0.1; 0.3] | |
| Baseline, total insulin dose (units/kg/day)* | 0.7 ± 0.2 | 0.7 ± 0.2 |
| End-of-Study, total insulin dose (units/kg/day)* | 0.7 ± 0.2 | 0.7 ± 0.2 |
| Baseline body weight (kg)* | 75.9 ± 13.1 | 75.3 ± 14.5 |
| Weight Change from baseline (kg)* | 0.9 ± 2.9 | 0.5 ± 3.3 |
| *Values are Mean ± SD | ||
A six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of Novolin R and insulin aspart in adults with type 2 diabetes (Table 7). Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin in either single or divided daily doses.
Table 7: Subcutaneous
Novolin R Administration in Type 2 Diabetes (24 weeks; N=182)
| Novolin R + NPH N = 91 |
Insulin aspart + NPH N = 91 |
|
| Baseline HbA1c (%)* | 7.8 ± 1.1 | 8.1 ± 1.2 |
| Change from Baseline HbAic (%)* | -0.1 ± 0.8 | -0.3 ± 1.0 |
| Treatment Difference in HbAic, Mean (95% confidence interval) Novolin R - insulin aspart group | 0.1 [-0.1; 0.4] | |
| Baseline, total insulin dose (units/kg/day)* | 0.6 ± 0.3 | 0.6 ± 0.3 |
| End-of-Study, total insulin dose (units/kg/day)* | 0.7 ± 0.3 | 0.7 ± 0.3 |
| Baseline body weight (kg)* | 85.8 ± 14.8 | 88.4 ± 13.3 |
| Weight Change from baseline (kg)* | 0.4 ± 3.1 | 1.2 ± 3.0 |
| *Values are Mean ± SD | ||
A six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of Novolin R and insulin aspart in children and adolescents aged 6-18 years with type 1 diabetes (Table 8). Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin.
Table 8: Subcutaneous
Novolin R Administration in Children and Adolescents with Type 1 Diabetes (24
weeks; N=283)
| Novolin R + NPH N=96 |
Insulin aspart + NPH N=187 |
|
| Baseline HbAic (%)* | 8.3 ± 1.3 | 8.3 ± 1.2 |
| Change from Baseline HbAic (%)* | 0.1 ± 1.1 | 0.1 ± 1.0 |
| Treatment Difference in HbAic, Mean (95% confidence interval) Novolin R - insulin aspart group # | 0.2 [-0.1; 0.5] | |
| Baseline, total insulin dose (units/kg/day)* | 1.0 ± 0.4 | 1.0 ± 0.3 |
| End-of-Study, total insulin dose (units/kg/day)* | 1.2 ± 0.4 | 1.2 ± 0.4 |
| Diabetic ketoacidosis n (%) | 2 (2%) | 10 (5%) |
| Baseline body weight (kg)* | 48.7 ± 15.8 | 50.6 ± 19.6 |
| Weight Change from baseline (kg)* | 2.4 ± 2.6 | 2.7 ± 3.5 |
| * Values are Mean ± SD # The treatment difference and corresponding 95% confidence interval is based on the Analysis of Covariance Model |
||
Novolin R and insulin aspart have also been compared in an open-label, randomized, crossover trial in 26 children with type 1 diabetes aged 2-6 years. Patients received each treatment for 12 weeks. Insulin aspart was administered by subcutaneous injection immediately prior to meals and Novolin R was administered by subcutaneous injection 30 minutes before meals. Both treatment groups also received subcutaneous injections of NPH insulin. In this study, the mean baseline HbA1c was 7.8%. The estimated HbA1c at end of treatment was 7.6% with Novolin R and 7.7% with insulin aspart.
NOVOLIN®R
(NO-voe-lin)
(Regular, Human Insulin Injection [recombinant DNA origin] USP)
Solution for Subcutaneous Injection
Read the Patient Information leaflet that comes with Novolin® R before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes.
What is Novolin® R?
Novolin® R is a man-made insulin (recombinant DNA origin) that is used to control high blood sugar in adults and children with diabetes mellitus.
Who should not use Novolin® R?
Do not take Novolin® R if:
What should I tell my healthcare provider before taking Novolin® R?
Before you take Novolin® R, tell your healthcare providers if you:
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Novolin® R may affect the way other medicines work, and other medicines may affect how Novolin® R works.
Know the medicines you take. Keep a list of your medicines with you to show all your healthcare providers and pharmacist when you get a new medicine.
How should I take Novolin® R?
Your insulin dosage may need to change because of:
See the end of this patient information for instructions about preparing and giving the injection.
What should I avoid while taking Novolin® R?
What are the possible side effects of Novolin® R?
Novolin® R may cause serious side effects, including:
Very low blood sugar (hypoglycemia) can cause loss of consciousness (passing out), seizures, temporary or permanent brain problems or death.
Talk to your healthcare provider about how to tell if you have low blood sugar and what to do if this happens while taking Novolin® R. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar.
Talk to your healthcare provider if low blood sugar is a problem for you. Your dose of Novolin® R may need to be changed.
Treatment with TZDs and Novolin® R may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Other side effects of Novolin® R may include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects from Novolin® R. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Novolin® R?
Unopened Novolin® R:
Novolin® R in use:
Never use insulin after the expiration date which is printed on the label and carton.
General information about Novolin® R
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Novolin® R for a condition for which it was not prescribed. Do not give Novolin® R to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Novolin® R. If you would like more information about Novolin® R or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Novolin® R that is written for healthcare professionals.
For more information about Novolin® R, call 1-800-727-6500 or go to www.novonordisk-us.com.
What are the ingredients in Novolin® R?
Active ingredient: Regular Human Insulin Injection (recombinant DNA origin) USP.
Inactive ingredients: glycerol, metacresol, zinc chloride, water for injection, hydrochloric acid and sodium hydroxide may be added.
