Recombinant DNA Origin (Novolin R)
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Recombinant DNA Origin (Novolin R)

Novolin® R
(Regular, Human Insulin [rDNA origin] USP) Solution for Subcutaneous or Intravenous Use

DRUG DESCRIPTION

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 of Novolin R Illustration

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 vials are latex-free.

What are the possible side effects of insulin regular (Humulin R, Novolin R, Novolin R Innolet, Novolin R PenFill, ReliOn/Novolin R)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose...

Read All Potential Side Effects and See Pictures of Novolin R »

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Novolin R (recombinant dna origin) is indicated for subcutaneous administration for the treatment of patients with diabetes mellitus, for the control of hyperglycemia. Treatment with Novolin R (recombinant dna origin) 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 (recombinant dna origin) 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 (recombinant dna origin) , when used alone subcutaneously, is usually given three or more times daily before meals. The dosage and timing of Novolin R (recombinant dna origin) should be individualized and determined, based on the physician's advice, in accordance with the needs of the patient. Novolin R (recombinant dna origin) 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 (recombinant dna origin) 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 (recombinant dna origin) 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 with 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 (recombinant dna origin) are possible under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. For intravenous use, Novolin R (recombinant dna origin) 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 (recombinant dna origin) if it has become viscous (thickened) or cloudy; use it only if it is clear and colorless. Novolin R (recombinant dna origin) should not be used after the printed expiration date.

Recommended Storage

Novolin R vials, Novolin® R (recombinant dna origin) PenFill® cartridges, and Novolin® R (recombinant dna origin) 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 (recombinant dna origin) vials, Novolin R (recombinant dna origin) PenFill cartridges and Novolin R (recombinant dna origin) 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 (recombinant dna origin) 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 (recombinant dna origin) PenFill cartridge and Novolin R (recombinant dna origin) 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 (recombinant dna origin) PenFill cartridges and Novolin R (recombinant dna origin) InnoLet must be discarded 28 days after the first use, even if they still contain Novolin R (recombinant dna origin) 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 (recombinant dna origin) , 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 (recombinant dna origin) InnoLet.................NDC 0169-2313-21

*Novolin R (recombinant dna origin) 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

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. Date of issue: October 21, 2005

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse events commonly associated with human insulin therapy include the following:

Body as Whole - Allergic reactions (see PRECAUTIONS, Allergy).

Skin and Appendages - Injection site reaction, lipodystrophy, pruritus, rash (see PRECAUTIONS, Allergy).

Other - Hypoglycemia, Hyperglycemia and ketosis (see PRECAUTIONS)

Read the Novolin R (recombinant dna origin) Side Effects Center for a complete guide to possible side effects »

DRUG 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 reduce insulin requirement: oral hypoglycemic agents (OHA), octreotide, monoamine oxidase inhibitors (MAOI), non-selective beta-blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, sulphonamide antibiotics, anabolic steroids, quinine, quinidine and alpha-adrenergic blocking agents.
  • The following are examples of substances that may increase insulin requirement: oral contraceptives thiazides, glucocorticoids, thryroid hormones and sympathomimetics, growth hormone, diazoxide, asparaginase and nicotinic acid.
  • Beta-blocking agents may mask the symptoms of hypoglycemia and delay recovery from hypoglycemia.
  • Alcohol may intensify and prolong the hypoglycemic effect of insulin

Mixing of Insulins

  • Novolin R (recombinant dna origin) should only be mixed as directed by the physician.
  • Novolin R (recombinant dna origin) is a short-acting insulin and is often used in combination with intermediate- or long-acting insulins.
  • The order of mixing and brand or model of syringe should be specified by the physician. A U-100 insulin syringe should always be used. Failure to use the correct syringe can lead to dosage errors.
  • In general, when a longer-acting insulin (e.g. NPH insulin isophane suspensions) is mixed with short-acting soluble insulin (e.g., regular), the short-acting insulin should be drawn into the syringe first

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Any change of insulin dose should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g. regular, NPH, analog, etc.), species (animal, human), or method of manufacture (rDNA versus animal-source insulin) may result in the need for a change in dosage.

Special care should be taken when the transfer is from a standard beef or mixed species insulin to a purified pork or human insulin. If a dosage adjustment is needed, it will usually become apparent either in the first few days or over a period of several weeks. Any change in treatment should be carefully monitored.

PRECAUTIONS

General

Hypoglycemia, hypokalemia, lipodystrophy and hypersensitivity are among the potential clinical adverse effects associated with the use of all insulins.

As with all insulin preparations, the time course of Novolin R (recombinant dna origin) action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply temperature, and physical activity.

Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during illness, emotional disturbances, or other stresses.

Novolin R (recombinant dna origin) should only be used if it is clear and colorless. Due to the risk of precipitation in some pump catheters, Novolin R (recombinant dna origin) is not recommended for use in insulin pumps.

Hypoglycemia and hypokalemia - As with all insulin preparations, hypoglycemic and hypokalemic reactions may be associated with the administration of Novolin R (recombinant dna origin) , particularly via the IV route. Rapid changes in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control (see PRECAUTIONS: DRUG INTERACTIONS). Such situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to patients' awareness of hypoglycemia. Severe hypoglycemia can result in temporary or permanent impairment of brain function and death. Insulin stimulates potassium movement into the cells, possibly leading to hypokalemia that left untreated may cause respiratory paralysis, ventricular arrhythmia, and death. Since intravenously administered insulin has a rapid onset of action, increased attention to hypoglycemia and hypokalemia is necessary. Therefore, glucose and potassium levels must be monitored closely when Novolin R (recombinant dna origin) or any other insulin is administered intravenously.

In certain cases, the nature and intensity of the warning symptoms of hypoglycemia may change A few patients have reported that after being transferred to human insulin, the early warning symptoms for hypoglycemia had been less pronounced than they were with animal-source insulin.

Hyperglycemia and ketosis - Hyperglycemia, diabetic ketoacidosis, or diabetic coma may develop if the patient takes less Novolin R (recombinant dna origin) than needed to control blood glucose levels. This could be due to insulin demand during illness or infection, neglect of diet, omission or improper administration of prescribed insulin doses. A developing ketoacidosis will be revealed by urine tests which show large amounts of sugar and acetone. The symptoms of polydipsia, polyurea, loss of appetite, fatigue, dry skin and deep and rapid breathing come on gradually, usually over a period of some hours or days. Severe sustained hyperglycemia may result in diabetic coma or death.

Renal Impairment- As with other insulins, the dose requirements for Novolin R (recombinant dna origin) may be reduced in patients with renal impairment.

Hepatic Impairment - As with other insulins, the dose requirements for Novolin R (recombinant dna origin) may be reduced in patients with hepatic impairment.

Allergy - Local Allergy - As with other insulin therapy, patients may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of Novolin R (recombinant dna origin) . 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.

Systemic Allergy - Less common, but potentially more serious, is generalized allergy to insulin which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening.

Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.

Usage in Pregnancy

It is particularly important for patients to maintain good control of diabetes during pregnancy and special attention must be paid to diet, exercise and insulin regimens. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant

Laboratory Tests

As with all insulin therapy, the therapeutic response to Novolin R (recombinant dna origin) should be monitored by periodic blood glucose tests. Periodic measurement of glycosylated hemoglobin is recommended for the monitoring of long-term glycemic control. Urine ketones should be monitored frequently.

When Novolin R (recombinant dna origin) is administered intravenously, glucose and potassium levels must be closely monitored to avoid potentially fatal hypoglycemia and hypokalemia.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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]

CONTRAINDICATIONS

Novolin R is contraindicated:

  • During episodes of hypoglycemia
  • In patients with hypersensitivity to Novolin R or one of its excipients

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

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.

Pharmacodynamics

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.

Pharmacokinetics

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.

Clinical Studies

Please see Section 12 CLINICAL PHARMACOLOGY for information on the pharmacokinetics and pharmacodynamics of Novolin R.

Type 1 diabetes mellitus (adults)

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 HbAlc (%)* 8.0 ±1.2 7.9 ±1.1
Change from Baseline HbAlc (%)* 0.0 ± 0.8 -0.1 ±0.8
Treatment Difference in HbAlc, 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)* Weight Change from baseline (kg)* 75.9 ±13.1 0.9 ± 2.9 75.3 ± 14.5 0.5 ± 3.3
*Values are Mean ± SD

Type 2 diabetes mellitus (adults)

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 HbAlc (%)* 7.8 ±1.1 8.1 ±1.2
Change from Baseline HbAlc (%)* -0.1 ±0.8 -0.3 ±1.0
Treatment Difference in HbAlc 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)*
Weight Change from baseline (kg)*
85.8 ± 14.8
0.4 ±3.1
88.4 ±13.3
1.2 ±3.0
*Values are Mean ± SD

Type 1 diabetes mellitus (children and adolescents)

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 HbAlc (%)* 8.3+1.3 8.3+1.2
Change from Baseline HbAlc (%)* 0.1 + 1.1 0.1+1.0
Treatment Difference in HbAlc; 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)*
Weight Change from baseline (kg)*
48.7+15.8
2.4 + 2.6
50.6+19.6
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 HbAic was 7.8%. The estimated HbAic at end of treatment was 7.6% with Novolin R and 7.7% with insulin aspart.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

NOVOLIN® R
(NO-voe-lin) (Regular, Human Insulin Injection [recombinant DNA origin] DSP) 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:

  • Your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of Novolin R.
  • You are allergic to any of the ingredients in Novolin R. See the end of this leaflet for a complete list of ingredients in Novolin R. Check with your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking Novolin R?

Before you take Novolin R, tell your healthcare providers if you:

  • have liver or kidney problems.
  • have any other medical conditions. Medical conditions can affect your insulin needs and your dose of Novolin R.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if Novolin R passes into breast milk. You and your healthcare provider should decide if you will take Novolin R while you breast-feed.

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?

  • Novolin R comes in 10 mL vials for use with a syringe.
  • Take Novolin R exactly as prescribed.
  • Your healthcare provider will tell you how much Novolin R to take and when to take it.
  • Do not make any changes to your dose or type of insulin unless you are told to do so by your healthcare provider.
  • The effects of Novolin R usually start working within about 30 minutes after your injection and usually lasts for up to 8 hours.
  • While using Novolin R your healthcare provider may change your total dose of insulin, your dose of Novolin R, your dose of longer-acting insulin, or the number of injections of insulin you use.
  • Do not mix Novolin R with any insulins other than NPH in the same syringe.
  • Inject Novolin R under your skin (subcutaneously) of your abdomen (stomach area), upper arms, buttocks or upper legs. Novolin R may affect your blood sugar levels faster if you inject it into the skin of your abdomen (stomach area). Never inject Novolin R into a vein or into a muscle.
  • Do not use Novolin R in an insulin pump.
  • Change (rotate) your injection site within the chosen area (for example, stomach or upper arm) with each dose. Do not inject into the same spot for each injection.
  • Read the instructions for use that comes with your Novolin R. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject Novolin R before you start taking it.
  • If you take too much Novolin R, your blood sugar may fall too low (hypoglycemia). You can treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar (hypoglycemia) right away because it could get worse and could lead to passing out (loss of consciousness), seizures and death.
  • If you forget to take your dose of Novolin R, your blood sugar may go too high (hyperglycemia). If high blood sugar (hyperglycemia) is not treated it can lead to serious problems, like loss of consciousness (passing out), coma or even death. Follow your healthcare provider's instructions for treating high blood sugar. Know your symptoms of high blood sugar which may include:

  • increased thirst
  • frequent urination and dehydration
  • confusion or drowsiness
  • loss of appetite
  • fruity smell on breath
  • high amounts of sugar and ketones in your urine
  • nausea, vomiting (throwing up) or stomach pain
  • a hard time breathing

  • Do not share needles or syringes with others. You may give an infection to them or get an infection from them.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and how often you should check your blood sugar levels for hypoglycemia (too low blood sugar) and hyperglycemia (too high blood sugar).

Your insulin dosage may need to change because of:

  • illness
  • stress
  • other medicines you take
  • change in diet
  • change in physical activity or exercise
  • surgery

See the end of this patient information for instructions about preparing and giving the injection.

What should I avoid while taking Novolin R?

  • Drinking alcohol. Alcohol may affect your blood sugar when you take Novolin R. This could lead to blood sugar that is too low (hypoglycemia).
  • Driving and operating machinery. You may have trouble paying attention or reacting if you have low blood sugar (hypoglycemia). Be careful when you drive a car or operate machinery. Ask your healthcare provider if it is alright for you to drive if you often have:
    • low blood sugar
    • decreased or no warning signs of low blood sugar

What are the possible side effects of Novolin R?

Novolin R may cause serious side effects, including:

  • Low blood sugar (hypoglycemia).

The general symptoms of low blood sugar (hypoglycemia) may be one or more of the following:

  • sweating
  • dizziness or lightheadedness
  • shakiness
  • hunger
  • fast heart beat
  • anxiety, irritability or mood changes
  • tingling in your hands, feet, lips or tongue
  • trouble concentrating or confusion
  • blurred vision
  • slurred speech
  • headache

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.

  • Low blood potassium (hypokalemia). A decrease of potassium in your blood can cause breathing problems, a change in your heartbeat and death.
  • Serious allergic reaction (whole body reaction). You can have a serious allergic reaction that may be life-threatening. Get medical help right away if you have any of these symptoms of an allergic reaction:
    • a rash over your body
    • have trouble breathing
    • a fast heartbeat
    • sweating
    • feel faint

Other side effects of Novolin R may include:

  • Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions, or they are serious, talk to your healthcare provider. You may need to stop using Novolin R and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy.
  • Changes at the injection site (lipodystrophy). The fatty tissue under the skin may shrink (lipoatrophy) or thicken (lipohypertrophy) at the injection site. Change (rotate) the site where you inject your insulin to help reduce the chance of developing these skin changes. Do not inject insulin into this type of skin.
  • Weight gain.
  • Swelling of your arms and legs.

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:

  • Unopened Novolin R should be kept in the refrigerator between 36°F to 46°F (2° to 8°C). Unopened vials can be used until the expiration date on the Novolin R label, if the medicine has been stored in a refrigerator.
  • If refrigeration is not possible or if you want to carry a spare Novolin R vial you can keep the unopened vial at room temperature for up to 42 days, as long as it is kept at or below 77°F (25°C). Throw away the vial 42 days after it is first kept out of the refrigerator, even if the vial is unopened.
  • Do not freeze. Do not use Novolin R if it has been frozen.
  • Keep unopened Novolin R in the carton to protect it from light.

Novolin R in use:

  • Keep at room temperature below 77°F (25°C).
  • Keep vials away from heat or light.
  • Do not refrigerate an opened vial.
  • Throw away the vial 42 days after it is first kept out of the refrigerator, even if there is insulin left in the vial.

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.

All Novolin R vials are latex-free.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Patient Instructions for Use

Novolin® R 10 mL vial (100 Units/mL, U-100)

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.

How should I use the Novolin R vial?

1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.

2. Look at the vial and the insulin. The insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap had been removed before your first use of the vial, or if the insulin is cloudy, colored, or contains any particles, do not use it and call Novo Nordisk at 1-800-727-6500.

3. Wash your hands with soap and water. Clean your injection site with an alcohol swab and let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.

4. If you are using a new vial, pull off the tamper-resistant

Look at the vial and the insulin - Illustration

Wipe the rubber stopper with an alcohol swab.

Wipe the rubber stopper with an alcohol swab - Illustration

5. Do not roll or shake the vial. Shaking right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.

6. Pull back the plunger on the syringe until the black tip reaches the marking for the number of units you will inject.

Pull back the plunger - Illustration

7. Push the needle through the rubber stopper of the vial.

Push the needle through the rubber stopper - Illustration

8. Push the plunger all the way in to force air into the vial.

Push the plunger all the way in - Illustration

9. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose.

Turn the vial and syringe upside down - Illustration

10. If there are any air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles present in the syringe back into the vial.

Tap the syringe gently - Illustration

11. Check to make sure you have the right dose of Novolin R in the syringe.

12. Pull the syringe out of the vial's rubber stopper.

13. Your healthcare provider should tell you if you need to pinch the skin before and while inserting the needle. This can vary from patient to patient so it is important to ask your healthcare provider if you did not receive instructions on pinching the skin. Insert the needle into the skin. Press the plunger of the syringe to inject the insulin. When you are finished injecting the insulin, pull the needle out of your skin. You may see a drop of Novolin R at the needle tip. This is normal and has no effect on the dose you just received. If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol wipe. Do not rub the area.

Insert the needle into the skin - Illustration

14. After your injection, do not recap the needle. Place used syringes, needles and used insulin vials in a disposable puncture-resistant sharps container, or some type of hard plastic or metal container with a screw on cap such as a detergent bottle or coffee can.

15. Ask your healthcare provider about the right way to throw away used syringes and needles. There may be state or local laws about the right way to throw away used syringes and needles. Do not throw away used needles and syringes in household trash or recycle.

How should I mix Novolin R with NPH insulin?

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.

1. Add together the total number of units of NPH and Novolin R that you need to inject. Your total dose of medicine to inject will be the amount of NPH and Novolin R in the syringe after drawing up both insulins. For example, if you need 5 units of NPH and 2 units of Novolin R, the total dose of insulin in the syringe would be 7 units.

Preparing your NPH and Novolin R insulins for injection:

2. Roll the NPH vial between your hands until all of the liquid in the vial is cloudy.

3. Pull the plunger of the syringe down so that the dark end is lined up to the number of units needed for your NPH insulin. This will draw into the syringe the same amount of air as the NPH dose needed.

4. Put the needle through the rubber stopper of the cloudy NPH insulin bottle. After you inject the air into the NPH vial, remove the needle from the vial but do not withdraw any of the NPH insulin. Putting air in the bottle makes it easier to draw the insulin out of the bottle.

5. Pull the plunger of the syringe down to the number of units needed for your Novolin R insulin. After you draw the air into the syringe, inject the air into the Novolin R vial.

Drawing up and mixing your NPH and Novolin R insulins for injection:

6. With the needle in place, turn the clear insulin vial of Novolin R upside down and slowly pull the plunger back to a few units beyond the right dose of Novolin R. The tip of the needle must be in the Novolin R liquid to get the full dose and not an air dose.

7. Check the syringe for air bubbles. If you see air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles in the syringe back into the vial.

8. After withdrawing the needle from the Novolin R vial, insert the needle into the NPH vial.

9. Turn the NPH vial upside down with the syringe and needle still in the vial. Slowly pull the plunger back to withdraw your NPH dose.

Remember the total dose of medicine in the syringe should be your total dose of NPH and Novolin R insulins. (See Step 1 under "How should I mix Novolin R with NPH insulin?")

10. Inject your insulin right away otherwise it might not work properly.

This Patient Instructions for Use has been approved by the Food and Drug Administration.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

NOVOLIN® R
(NO-voe-lin) (Regular, Human Insulin Injection [recombinant DNA origin] DSP) 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:

  • Your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of Novolin R.
  • You are allergic to any of the ingredients in Novolin R. See the end of this leaflet for a complete list of ingredients in Novolin R. Check with your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking Novolin R?

Before you take Novolin R, tell your healthcare providers if you:

  • have liver or kidney problems.
  • have any other medical conditions. Medical conditions can affect your insulin needs and your dose of Novolin R.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if Novolin R passes into breast milk. You and your healthcare provider should decide if you will take Novolin R while you breast-feed.

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?

  • Novolin R comes in 10 mL vials for use with a syringe.
  • Take Novolin R exactly as prescribed.
  • Your healthcare provider will tell you how much Novolin R to take and when to take it.
  • Do not make any changes to your dose or type of insulin unless you are told to do so by your healthcare provider.
  • The effects of Novolin R usually start working within about 30 minutes after your injection and usually lasts for up to 8 hours.
  • While using Novolin R your healthcare provider may change your total dose of insulin, your dose of Novolin R, your dose of longer-acting insulin, or the number of injections of insulin you use.
  • Do not mix Novolin R with any insulins other than NPH in the same syringe.
  • Inject Novolin R under your skin (subcutaneously) of your abdomen (stomach area), upper arms, buttocks or upper legs. Novolin R may affect your blood sugar levels faster if you inject it into the skin of your abdomen (stomach area). Never inject Novolin R into a vein or into a muscle.
  • Do not use Novolin R in an insulin pump.
  • Change (rotate) your injection site within the chosen area (for example, stomach or upper arm) with each dose. Do not inject into the same spot for each injection.
  • Read the instructions for use that comes with your Novolin R. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject Novolin R before you start taking it.
  • If you take too much Novolin R, your blood sugar may fall too low (hypoglycemia). You can treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar (hypoglycemia) right away because it could get worse and could lead to passing out (loss of consciousness), seizures and death.
  • If you forget to take your dose of Novolin R, your blood sugar may go too high (hyperglycemia). If high blood sugar (hyperglycemia) is not treated it can lead to serious problems, like loss of consciousness (passing out), coma or even death. Follow your healthcare provider's instructions for treating high blood sugar. Know your symptoms of high blood sugar which may include:

  • increased thirst
  • frequent urination and dehydration
  • confusion or drowsiness
  • loss of appetite
  • fruity smell on breath
  • high amounts of sugar and ketones in your urine
  • nausea, vomiting (throwing up) or stomach pain
  • a hard time breathing

  • Do not share needles or syringes with others. You may give an infection to them or get an infection from them.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and how often you should check your blood sugar levels for hypoglycemia (too low blood sugar) and hyperglycemia (too high blood sugar).

Your insulin dosage may need to change because of:

  • illness
  • stress
  • other medicines you take
  • change in diet
  • change in physical activity or exercise
  • surgery

See the end of this patient information for instructions about preparing and giving the injection.

What should I avoid while taking Novolin R?

  • Drinking alcohol. Alcohol may affect your blood sugar when you take Novolin R. This could lead to blood sugar that is too low (hypoglycemia).
  • Driving and operating machinery. You may have trouble paying attention or reacting if you have low blood sugar (hypoglycemia). Be careful when you drive a car or operate machinery. Ask your healthcare provider if it is alright for you to drive if you often have:
    • low blood sugar
    • decreased or no warning signs of low blood sugar

What are the possible side effects of Novolin R?

Novolin R may cause serious side effects, including:

  • Low blood sugar (hypoglycemia).

The general symptoms of low blood sugar (hypoglycemia) may be one or more of the following:

  • sweating
  • dizziness or lightheadedness
  • shakiness
  • hunger
  • fast heart beat
  • anxiety, irritability or mood changes
  • tingling in your hands, feet, lips or tongue
  • trouble concentrating or confusion
  • blurred vision
  • slurred speech
  • headache

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.

  • Low blood potassium (hypokalemia). A decrease of potassium in your blood can cause breathing problems, a change in your heartbeat and death.
  • Serious allergic reaction (whole body reaction). You can have a serious allergic reaction that may be life-threatening. Get medical help right away if you have any of these symptoms of an allergic reaction:
    • a rash over your body
    • have trouble breathing
    • a fast heartbeat
    • sweating
    • feel faint

Other side effects of Novolin R may include:

  • Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions, or they are serious, talk to your healthcare provider. You may need to stop using Novolin R and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy.
  • Changes at the injection site (lipodystrophy). The fatty tissue under the skin may shrink (lipoatrophy) or thicken (lipohypertrophy) at the injection site. Change (rotate) the site where you inject your insulin to help reduce the chance of developing these skin changes. Do not inject insulin into this type of skin.
  • Weight gain.
  • Swelling of your arms and legs.

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:

  • Unopened Novolin R should be kept in the refrigerator between 36°F to 46°F (2° to 8°C). Unopened vials can be used until the expiration date on the Novolin R label, if the medicine has been stored in a refrigerator.
  • If refrigeration is not possible or if you want to carry a spare Novolin R vial you can keep the unopened vial at room temperature for up to 42 days, as long as it is kept at or below 77°F (25°C). Throw away the vial 42 days after it is first kept out of the refrigerator, even if the vial is unopened.
  • Do not freeze. Do not use Novolin R if it has been frozen.
  • Keep unopened Novolin R in the carton to protect it from light.

Novolin R in use:

  • Keep at room temperature below 77°F (25°C).
  • Keep vials away from heat or light.
  • Do not refrigerate an opened vial.
  • Throw away the vial 42 days after it is first kept out of the refrigerator, even if there is insulin left in the vial.

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.

All Novolin R vials are latex-free.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Patient Instructions for Use

Novolin® R 10 mL vial (100 Units/mL, U-100)

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.

How should I use the Novolin R vial?

1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.

2. Look at the vial and the insulin. The insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap had been removed before your first use of the vial, or if the insulin is cloudy, colored, or contains any particles, do not use it and call Novo Nordisk at 1-800-727-6500.

3. Wash your hands with soap and water. Clean your injection site with an alcohol swab and let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.

4. If you are using a new vial, pull off the tamper-resistant

Look at the vial and the insulin - Illustration

Wipe the rubber stopper with an alcohol swab.

Wipe the rubber stopper with an alcohol swab - Illustration

5. Do not roll or shake the vial. Shaking right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.

6. Pull back the plunger on the syringe until the black tip reaches the marking for the number of units you will inject.

Pull back the plunger - Illustration

7. Push the needle through the rubber stopper of the vial.

Push the needle through the rubber stopper - Illustration

8. Push the plunger all the way in to force air into the vial.

Push the plunger all the way in - Illustration

9. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose.

Turn the vial and syringe upside down - Illustration

10. If there are any air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles present in the syringe back into the vial.

Tap the syringe gently - Illustration

11. Check to make sure you have the right dose of Novolin R in the syringe.

12. Pull the syringe out of the vial's rubber stopper.

13. Your healthcare provider should tell you if you need to pinch the skin before and while inserting the needle. This can vary from patient to patient so it is important to ask your healthcare provider if you did not receive instructions on pinching the skin. Insert the needle into the skin. Press the plunger of the syringe to inject the insulin. When you are finished injecting the insulin, pull the needle out of your skin. You may see a drop of Novolin R at the needle tip. This is normal and has no effect on the dose you just received. If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol wipe. Do not rub the area.

Insert the needle into the skin - Illustration

14. After your injection, do not recap the needle. Place used syringes, needles and used insulin vials in a disposable puncture-resistant sharps container, or some type of hard plastic or metal container with a screw on cap such as a detergent bottle or coffee can.

15. Ask your healthcare provider about the right way to throw away used syringes and needles. There may be state or local laws about the right way to throw away used syringes and needles. Do not throw away used needles and syringes in household trash or recycle.

How should I mix Novolin R with NPH insulin?

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.

1. Add together the total number of units of NPH and Novolin R that you need to inject. Your total dose of medicine to inject will be the amount of NPH and Novolin R in the syringe after drawing up both insulins. For example, if you need 5 units of NPH and 2 units of Novolin R, the total dose of insulin in the syringe would be 7 units.

Preparing your NPH and Novolin R insulins for injection:

2. Roll the NPH vial between your hands until all of the liquid in the vial is cloudy.

3. Pull the plunger of the syringe down so that the dark end is lined up to the number of units needed for your NPH insulin. This will draw into the syringe the same amount of air as the NPH dose needed.

4. Put the needle through the rubber stopper of the cloudy NPH insulin bottle. After you inject the air into the NPH vial, remove the needle from the vial but do not withdraw any of the NPH insulin. Putting air in the bottle makes it easier to draw the insulin out of the bottle.

5. Pull the plunger of the syringe down to the number of units needed for your Novolin R insulin. After you draw the air into the syringe, inject the air into the Novolin R vial.

Drawing up and mixing your NPH and Novolin R insulins for injection:

6. With the needle in place, turn the clear insulin vial of Novolin R upside down and slowly pull the plunger back to a few units beyond the right dose of Novolin R. The tip of the needle must be in the Novolin R liquid to get the full dose and not an air dose.

7. Check the syringe for air bubbles. If you see air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles in the syringe back into the vial.

8. After withdrawing the needle from the Novolin R vial, insert the needle into the NPH vial.

9. Turn the NPH vial upside down with the syringe and needle still in the vial. Slowly pull the plunger back to withdraw your NPH dose.

Remember the total dose of medicine in the syringe should be your total dose of NPH and Novolin R insulins. (See Step 1 under "How should I mix Novolin R with NPH insulin?")

10. Inject your insulin right away otherwise it might not work properly.

This Patient Instructions for Use has been approved by the Food and Drug Administration.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Novolin® R
(Regular, Human Insulin [rDNA origin] USP) Solution for Subcutaneous or Intravenous Use

DRUG DESCRIPTION

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 of Novolin R Illustration

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 vials are latex-free.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Novolin® R
(Regular, Human Insulin [rDNA origin] USP) Solution for Subcutaneous or Intravenous Use

DRUG DESCRIPTION

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 of Novolin R Illustration

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 vials are latex-free.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Novolin® R
(Regular, Human Insulin [rDNA origin] USP) Solution for Subcutaneous or Intravenous Use

DRUG DESCRIPTION

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 of Novolin R Illustration

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 vials are latex-free.

Last reviewed on RxList: 4/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Novolin R Patient Information Including Side Effects

Brand Names: Humulin R, Novolin R, Novolin R Innolet, Novolin R PenFill, ReliOn/Novolin R

Generic Name: insulin regular (Pronunciation: IN soo lin REG yoo lar)

What is insulin regular (Novolin R)?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin regular is a short-acting form of insulin.

Insulin regular is used to treat diabetes.

Insulin regular may also be used for other purposes not listed in this medication guide.

What are the possible side effects of insulin regular (Novolin R)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Novolin R (recombinant dna origin) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about insulin regular (Novolin R)?

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin dose.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Do not change the brand of insulin or syringe you are using without first talking to your doctor or pharmacist. Some brands of insulin regular and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Side Effects Centers

Novolin R Patient Information including How Should I Take

What should I discuss with my healthcare provider before using insulin regular (Novolin R)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure you can safely use insulin, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

FDA pregnancy category B. Insulin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether insulin regular passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use insulin regular (Novolin R)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Insulin regular is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Insulin regular should look as clear as water. Do not use the medication if has changed colors, looks cloudy, or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some types of insulin needles can be used more than once. But reusing needles increases your risk of infection. Used needles must be properly cleaned and inspected for bending or breakage. Ask your doctor or pharmacist whether you can reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking insulin for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your insulin dose if needed. Do not change your medication dose or schedule without your doctor's advice.

If your doctor changes your brand, strength, or type of insulin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of insulin you receive at the pharmacy.

Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Unopened vials may also be stored at room temperature, away from heat and bright light.

Storing after your first use: Keep the "in-use" vials or cartridges at room temperature.

Do not freeze insulin regular, and throw away the medication if it has become frozen.

Throw away any insulin not used before the expiration date on the medicine label.

Side Effects Centers

Novolin R Patient Information including If I Miss a Dose

What happens if I miss a dose (Novolin R)?

Since insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin regular, be sure to eat a meal or snack within 15 to 30 minutes. Do not use extra insulin to make up a missed dose.

It is important to keep insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose (Novolin R)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while using insulin regular (Novolin R)?

Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin regular.

What other drugs will affect insulin regular (Novolin R)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

  • albuterol (Proventil, Ventolin);
  • clonidine (Catapres);
  • reserpine; or
  • beta-blockers such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

Where can I get more information?

Your pharmacist can provide more information about insulin regular.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision date: 2/14/2011.

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Side Effects Centers

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