Drugs Details

Drugs Info of Humalog 75-25
Drugs Details
  • Drugs Type  : FDA
  • Date : 2nd Feb 2015 03:44 am
  • Brand Name : Humalog 75-25
  • Generic Name : 75% insulin lispro protamine) Suspension and (25% insulin lispro) Injection,
Descriptions

Humalog® Mix75/25™ [75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermediate-acting blood glucose-lowering agent. Chemically, insulin lispro is Lys(B28), Pro(B29) human insulin analog, created when the amino acids at positions 28 and 29 on the insulin B-chain are reversed. Insulin lispro is synthesized in a special non-pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered to produce insulin lispro. Insulin lispro protamine suspension (NPL component) is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation.

Insulin lispro has the following primary structure:

 

Humalog® Mix75/25™ [insulin lispro protamine] Structural Formula Illustration

Insulin lispro has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin.

Humalog Mix75/25 vials and Pens contain a sterile suspension of insulin lispro protamine suspension mixed with soluble insulin lispro for use as an injection.

Each milliliter of Humalog Mix75/25 injection contains insulin lispro 100 units, 0.28 mg protamine sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 1.76 mg Metacresol, zinc oxide content adjusted to provide 0.025 mg zinc ion, 0.715 mg phenol, and Water for Injection. Humalog Mix75/25 has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may have been added to adjust pH.

What are the precautions when taking 75-25 insulin lispro suspension and 25 insulin lispro injection (Humalog 75-25)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell...

Read All Potential Precautions of Humalog 75-25 »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog Mix75/25 has a more rapid onset of glucose-lowering activity compared with Humulin 70/30 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.

Dosage Administration

Table 1*: Summary of Pharmacodynamic Properties of Insulin Products (Pooled Cross-Study Comparison)

Insulin Products Dose, U/kg Time of Peak Activity, Hours After Dosing Percent of Total Activity Occurring inthe First 4 Hours
Humalog 0.3 2.4 (0.8 - 4.3) 70% (49 - 89%)
Humulin R 0.32 (0.26 - 0.37) 4.4 (4.0 - 5.5) 54% (38 - 65%)
Humalog Mix75/25 0.3 2.6 (1.0 - 6.5) 35% (21 - 56%)
Humulin 70/30 0.3 4.4 (1.5 - 16) 32% (14 - 60%)
Humalog Mix50/50 0.3 2.3 (0.8 - 4.8) 45% (27 - 69%)
Humulin 50/50 0.3 3.3 (2.0 - 5.5) 44% (21 - 60%)
NPH 0.32 (0.27 - 0.40) 5.5 (3.5 - 9.5) 14% (3.0 - 48%)
NPL component 0.3 5.8 (1.3 - 18.3) 22% (6.3 - 40%)
* The information supplied in Table 1 indicates when peak insulin activity can be expected and the percent of the total insulin activity occurring during the first 4 hours. The information was derived from 3 separate glucose clamp studies in nondiabetic subjects. Values represent means, with ranges provided in parentheses.

Humalog Mix75/25 is intended only for subcutaneous administration. Humalog Mix75/25 should not be administered intravenously. Dosage regimens of Humalog Mix75/25 will vary among patients and should be determined by the healthcare provider familiar with the patient's metabolic needs, eating habits, and other lifestyle variables. Humalog has been shown to be equipotent to Regular human insulin on a molar basis. One unit of Humalog has the same glucose-lowering effect as one unit of Regular human insulin, but its effect is more rapid and of shorter duration. Humalog Mix75/25 has a similar glucose-lowering effect as compared with Humulin 70/30 on a unit for unit basis. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate of insulin lispro from subcutaneous tissue.

Humalog Mix75/25 starts lowering blood glucose more quickly than Regular human insulin, allowing for convenient dosing immediately before a meal (within 15 minutes). In contrast, mixtures containing Regular human insulin should be given 30 to 60 minutes before a meal.

The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables. As with all insulin preparations, the time course of action of Humalog Mix75/25 may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques.

Humalog Mix75/25 should be inspected visually before use. Humalog Mix75/25 should be used only if it appears uniformly cloudy after mixing. Humalog Mix75/25 should not be used after its expiration date.

How Supplied

Humalog Mix75/25 [75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin)] is available in the following package sizes: each presentation containing 100 units insulin lispro per mL (U-100).

 

10 mL vials NDC 0002-7511-01 (VL-7511)
5 x 3 mL prefilled insulin delivery devices (Pen) NDC 0002-8794-59 (HP-8794)
5 x 3 mL prefilled insulin delivery devices (KwikPen™) NDC 0002-8797-59 (HP-8797)

Storage

Humalog Mix75/25 should be stored in a refrigerator [2° to 8°C (36° to 46°F)], but not in the freezer. Do not use Humalog Mix75/25 if it has been frozen. Unrefrigerated [below 30°C (86°F)] vials must be used within 28 days or be discarded, even if they still contain Humalog Mix75/25. Unrefrigerated [below 30°C (86°F)] Pens, and KwikPens must be used within 10 days or be discarded, even if they still contain Humalog Mix75/25. Protect from direct heat and light. See table below:

 

  Not In-Use (Unopened) Room Temperature [Below 30°C (86°F)] Not In-Use (Unopened) Refrigerated In-Use (Opened) Room Temperature [Below30°C (86°F)]
10 mL Vial 28 days Until expiration date 28 days,refrigerated/room temperature.
3 mL Pen and KwikPen (prefilled) 10 days Until expiration date 10 days. Do not refrigerate.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. www.humalog.com.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not demonstrate a difference in frequency of adverse events between the two treatments.

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

Body as a Whole — allergic reactions (see PRECAUTIONS).

Skin and Appendages — injection site reaction, lipodystrophy, pruritus, rash.

Other — hypoglycemia (see WARNINGS AND PRECAUTIONS).

Read the Humalog 75-25 (75-25 insulin lispro suspension and 25 insulin lispro injection) Side Effects Center for a complete guide to possible side effects

Interactions

Insulin requirements may be increased by medications with hyperglycemic activity such as corticosteroids, isoniazid, certain lipid-lowering drugs (e.g., niacin), estrogens, oral contraceptives, phenothiazines, and thyroid replacement therapy.

Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzymeinhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Humalog differs from Regular human insulin by its rapid onset of action as well as a shorter duration of activity. Therefore, the dose of Humalog Mix75/25 should be given within 15 minutes before a meal.

Hypoglycemia is the most common adverse effect associated with the use of insulins, including Humalog Mix75/25. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., Regular, NPH, analog), species, or method of manufacture may result in the need for a change in dosage.

Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: 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 Humalog Mix75/25, 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 currentstandards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Precautions

General

Hypoglycemia and hypokalemia are among the potential clinical adverse effects associated with the use of all insulins. Because of differences in the action of Humalog Mix75/25 and other insulins, care should be taken in patients in whom such potential side effects might be clinically relevant (e.g., patients who are fasting, have autonomic neuropathy, or are using potassium- lowering drugs or patients taking drugs sensitive to serum potassium level). Lipodystrophy and hypersensitivity are among other potential clinical adverse effects associated with the use of all insulins.

As with all insulin preparations, the time course of Humalog Mix75/25 action may vary in different individuals or at different times in the same individual and is dependent on 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 stress.

Hypoglycemia

As with all insulin preparations, hypoglycemic reactions may be associated with the administration of Humalog Mix75/25. Rapid changes in serum glucose concentrations 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.

Renal Impairment

As with other insulins, the requirements for Humalog Mix75/25 may be reduced in patients with renal impairment.

Hepatic Impairment

Although impaired hepatic function does not affect the absorption or disposition of Humalog, careful glucose monitoring and dose adjustments of insulin, including Humalog Mix75/25, may be necessary.

Allergy

Local Allergy As with any 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. In some instances, these reactions may be related to factors other than insulin, such as irritants in the 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.

Antibody Production In clinical trials, antibodies that cross-react with human insulin and insulin lispro were observed in both human insulin mixtures and insulin lispro mixtures treatment groups.

Information for Patients

Patients should be informed of the potential risks and advantages of Humalog Mix75/25 and alternative therapies. Patients should not mix Humalog Mix75/25 with any other insulin. They should also be informed about the importance of proper insulin storage, injection technique, timing of dosage, adherence to meal planning, regular physical activity, regular blood glucose monitoring, periodic hemoglobin A1c testing, recognition and management of hypo- and hyperglycemia, and periodic assessment for diabetes complications.

Patients should be advised to inform their physician if they are pregnant or intend to become pregnant.

Refer patients to the PATIENT INFORMATION leaflet for information on normal appearance, timing of dosing (within 15 minutes before a meal), storing, and common adverse effects.

For Patients Using Insulin Pen Delivery Devices: Before starting therapy, patients should readthe Patient Information leaflet that accompanies the drug product and the User Manual thataccompanies the delivery device and re-read them each time the prescription is renewed. Patients should be instructed on how to properly use the delivery device, prime the Pen to a stream of insulin, and properly dispose of needles. Patients should be advised not to share their Pens with others.

Laboratory Tests

As with all insulins, the therapeutic response to Humalog Mix75/25 should be monitored by periodic blood glucose tests. Periodic measurement of hemoglobin A1c is recommended for the monitoring of long-term glycemic control.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Humalog, Humalog Mix75/25, or Humalog Mix50/50. Insulin lispro was not mutagenic in a battery of in vitro and in vivo genetic toxicity assays (bacterial mutation tests, unscheduled DNA synthesis, mouse lymphoma assay, chromosomal aberration tests, and a micronucleus test). There is no evidence from animal studies of impairment of fertility induced by insulin lispro.

Pregnancy

Teratogenic Effects - Pregnancy Category B

Reproduction studies with insulin lispro have been performed in pregnant rats and rabbits at parenteral doses up to 4 and 0.3 times, respectively, the average human dose (40 units/day) based on body surface area. The results have revealed no evidence of impaired fertility or harm to the fetus due to insulin lispro. There are, however, no adequate and well-controlled studies with Humalog, Humalog Mix75/25, or Humalog Mix50/50 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is unknown whether insulin lispro is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when Humalog Mix75/25 is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in Humalog Mix75/25 dose, meal plan, or both.

Pediatric Use

Safety and effectiveness of Humalog Mix75/25 in patients less than 18 years of age have not been established.

Geriatric Use

Clinical studies of Humalog Mix75/25 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should take into consideration the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this population.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. 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 may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.

 

ContrainDications

Humalog Mix75/25 is contraindicated during episodes of hypoglycemia and in patients sensitive to insulin lispro or any of the excipients contained in the formulation.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Antidiabetic Activity

The primary activity of insulin, including Humalog Mix75/25, is the regulation of glucose metabolism. In addition, all insulins have several anabolic and anti-catabolic actions on many tissues in the body. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly, promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat.

Insulin lispro, the rapid-acting component of Humalog Mix75/25, has been shown to be equipotent to Regular human insulin on a molar basis. One unit of Humalog® has the same glucose-lowering effect as one unit of Regular human insulin, but its effect is more rapid and of shorter duration. Humalog Mix75/25 has a similar glucose-lowering effect as compared with Humulin® 70/30 on a unit for unit basis.

Pharmacokinetics

Absorption

Studies in nondiabetic subjects and patients with type 1 (insulin-dependent) diabetes demonstrated that Humalog, the rapid-acting component of Humalog Mix75/25, is absorbed faster than Regular human insulin (U-100). In nondiabetic subjects given subcutaneous doses of Humalog ranging from 0.1 to 0.4 U/kg, peak serum concentrations were observed 30 to 90 minutes after dosing. When nondiabetic subjects received equivalent doses of Regular human insulin, peak insulin concentrations occurred between 50 to 120 minutes after dosing. Similar results were seen in patients with type 1 diabetes.

Figure 1: Serum Immunoreactive Insulin (IRI) Concentrations, After Subcutaneous Injection of Humalog Mix75/25 or Humulin 70/30 in Healthy Nondiabetic Subjects.

Serum Immunoreactive Insulin (IRI) Concentrations - Illustration

Humalog Mix75/25 has two phases of absorption. The early phase represents insulin lispro and its distinct characteristics of rapid onset. The late phase represents the prolonged action of insulin lispro protamine suspension. In 30 healthy nondiabetic subjects given subcutaneous doses (0.3 U/kg) of Humalog Mix75/25, peak serum concentrations were observed 30 to 240 minutes (median, 60 minutes) after dosing (see Figure 1). Identical results were found in patients with type 1 diabetes. The rapid absorption characteristics of Humalog are maintained with Humalog Mix75/25 (see Figure 1).

Figure 1 represents serum insulin concentration versus time curves of Humalog Mix75/25 and Humulin 70/30. Humalog Mix75/25 has a more rapid absorption than Humulin 70/30, which has been confirmed in patients with type 1 diabetes.

Distribution

Radiolabeled distribution studies of Humalog Mix75/25 have not been conducted. However, the volume of distribution following injection of Humalog is identical to that of Regular human insulin, with a range of 0.26 to 0.36 L/kg.

Metabolism

Human metabolism studies of Humalog Mix75/25 have not been conducted. Studies in animals indicate that the metabolism of Humalog, the rapid-acting component of Humalog Mix75/25, is identical to that of Regular human insulin.

Elimination

Humalog Mix75/25 has two absorption phases, a rapid and a prolonged phase, representative of the insulin lispro and insulin lispro protamine suspension components of the mixture. As with other intermediate-acting insulins, a meaningful terminal phase half-life cannot be calculated after administration of Humalog Mix75/25 because of the prolonged insulin lispro protamine suspension absorption.

Pharmacodynamics

Studies in nondiabetic subjects and patients with diabetes demonstrated that Humalog has a more rapid onset of glucose-lowering activity, an earlier peak for glucose-lowering, and a shorter duration of glucose-lowering activity than Regular human insulin. The early onset of activity of Humalog Mix75/25 is directly related to the rapid absorption of Humalog. The time course of action of insulin and insulin analogs, such as Humalog (and hence Humalog Mix75/25), may vary considerably in different individuals or within the same individual. The parameters of Humalog Mix75/25 activity (time of onset, peak time, and duration) as presented in Figures 2 and 3 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, exercise, and other variables (see General under PRECAUTIONS).

In a glucose clamp study performed in 30 nondiabetic subjects, the onset of action and glucose-lowering activity of Humalog, Humalog® Mix50/50™, Humalog Mix75/25, and insulin lispro protamine suspension (NPL component) were compared (see Figure 2). Graphs of mean glucoseinfusion rate versus time showed a distinct insulin activity profile for each formulation. The rapid onset of glucose-lowering activity characteristic of Humalog was maintained in Humalog Mix75/25.

In separate glucose clamp studies performed in nondiabetic subjects, pharmacodynamics of Humalog Mix75/25 and Humulin 70/30 were assessed and are presented in Figure 3. Humalog Mix75/25 has a duration of activity similar to that of Humulin 70/30.

Figure 2: Insulin Activity After Injection of Humalog, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine Suspension (NPL Component) in 30 Nondiabetic Subjects.

Insulin Activity After Injection of Humalog - Illustration

Figure 3: Insulin Activity After Injection of Humalog Mix75/25 and Humulin 70/30 in Nondiabetic Subjects.

View Enlarged Table

Figures 2 and 3 represent insulin activity profiles as measured by glucose clamp studies in healthy nondiabetic subjects.

Figure 2 shows the time activity profiles of Humalog, Humalog Mix50/50, Humalog Mix75/25, and insulin lispro protamine suspension (NPL component).

Figure 3 is a comparison of the time activity profiles of Humalog Mix75/25 (see Figure 3a) andof Humulin 70/30 (see Figure 3b) from two different studies.

Special Populations

Age and Gender Information on the effect of age on the pharmacokinetics of Humalog Mix75/25 is unavailable. Pharmacokinetic and pharmacodynamic comparisons between men and women administered Humalog Mix75/25 showed no gender differences. In large Humalog clinical trials, sub-group analysis based on age and gender demonstrated that differences between Humalog and Regular human insulin in postprandial glucose parameters are maintained across sub-groups.

Smoking The effect of smoking on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied.

Pregnancy The effect of pregnancy on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied.

Obesity The effect of obesity and/or subcutaneous fat thickness on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied. In large clinical trials, which included patients with Body Mass Index up to and including 35 kg/m2, no consistent differences were observed between Humalog and Humulin® R with respect to postprandialglucose parameters.

Renal Impairment The effect of renal impairment on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied. In a study of 25 patients with type 2 diabetes and a wide range of renal function, the pharmacokinetic differences between Humalog and Regular human insulin were generally maintained. However, the sensitivity of the patients to insulin did change, with an increased response to insulin as the renal function declined. Careful glucose monitoring and dose reductions of insulin, including Humalog Mix75/25, may be necessary in patients with renal dysfunction.

Hepatic Impairment Some studies with human insulin have shown increased circulating levels of insulin in patients with hepatic failure. The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied. However, in a study of 22 patients with type 2 diabetes, impaired hepatic function did not affect the subcutaneous absorption or general disposition of Humalog when compared with patients with no history of hepatic dysfunction. In that study, Humalog maintained its more rapid absorption and elimination when compared with Regular human insulin. Careful glucose monitoring and dose adjustments of insulin, including Humalog Mix75/25, may be necessary in patients with hepatic dysfunction.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Humalog®
(HU-ma-log) Mix75/25™ 75% insulin ispro protamine suspension and 25% insulin lispro injection (rDNA origin)

Important:

Know your insulin. Do not change the type of insulin you use unless told to do so by your healthcare provider. Your insulin dose and the time you take your dose can change with different types of insulin.

Make sure you have the right type and strength of insulin prescribed for you.

Read the Patient Information that comes with Humalog Mix75/25 before you start using 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 treatment. Make sure that you know how to manage your diabetes. Ask your healthcare provider if you have questions about managing your diabetes.

What is Humalog Mix75/25?

Humalog Mix75/25 is a mixture of fast-acting and longer-acting man-made insulins. Humalog Mix75/25 is used to control high blood sugar (glucose) in people with diabetes.

Humalog Mix75/25 comes in:

  • 10 mL vials (bottles) for use with a syringe
  • Prefilled pens

Who should not take Humalog Mix75/25?

Do not take Humalog Mix75/25 if:

  • your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of Humalog Mix75/25.
  • you are allergic to anything in Humalog Mix75/25. See the end of this leaflet for a complete list of ingredients in Humalog Mix75/25.

What should I tell my healthcare provider before taking Humalog Mix75/25?

Before you use Humalog Mix75/25, tell your healthcare provider if you:

  • have liver or kidney problems or any other medical conditions. Medical conditions can affect your insulin needs and your dose of Humalog Mix75/25.
  • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humalog Mix75/25.
  • are pregnant or breastfeeding. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant or breastfeeding. Humalog Mix75/25 has not been studied in pregnant or nursing women.
  • take other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements. Many medicines can affect your blood sugar levels and insulin needs. Your Humalog Mix75/25 dose may need to change if you take other medicines.

Know the medicines you take. Keep a list of your medicines with you to show to all of your healthcare providers.

How should I use Humalog Mix75/25?

Talk to your healthcare provider if you have any questions. Your healthcare provider will tell you the right syringes to use with Humalog Mix75/25 vials. Your healthcare provider should show you how to inject Humalog Mix75/25 before you start using it. Read the User Manual that comes with your Humalog Mix75/25 prefilled pen.

  • Use Humalog Mix75/25 exactly as prescribed by your healthcare provider.
  • Humalog Mix75/25 starts working faster than other insulins that contain regular human insulin. Inject Humalog Mix75/25 fifteen minutes or less before a meal. If you do not plan to eat within 15 minutes, delay the injection until the correct time (15 minutes before eating).
  • Check your blood sugar levels as told by your healthcare provider.
  • Mix Humalog Mix75/25 well before each use. For Humalog Mix75/25 in a vial, carefully shake or rotate the vial until completely mixed. For prefilled pens, carefully follow the User Manual for instructions on mixing the pen. Humalog Mix75/25 should be cloudy or milky after mixing well.
  • Look at your Humalog Mix75/25 before each injection. If it is not evenly mixed or has solid particles or clumps in it, do not use. Return it to your pharmacy for new Humalog Mix75/25.
  • Inject your dose of Humalog Mix75/25 under the skin of your stomach area, upper arm, upper leg, or buttocks. Never inject Humalog Mix75/25 into a muscle or vein.
  • Change (rotate) your injection site with each dose.
  • Your insulin needs may change because of:
    • illness
    • stress
    • other medicines you take
    • changes in eating
    • physical activity changes
      Follow your healthcare provider's instructions to make changes in your insulin dose.
  • Never mix Humalog Mix75/25 in the same syringe with other insulin products.
  • Never use Humalog Mix75/25 in an insulin pump.
  • Always carry a quick source of sugar to treat low blood sugar, such as glucose tablets, hard candy, or juice.

What are the possible side effects of Humalog Mix75/25?

Low Blood Sugar (Hypoglycemia). Symptoms of low blood sugar include:

  • hunger
  • dizziness
  • feeling shaky or shakiness
  • lightheadedness
  • sweating
  • irritability
  • headache
  • fast heartbeat
  • confusion

Low blood sugar symptoms can happen suddenly. Symptoms of low blood sugar may be different for each person and may change from time to time. Severe low blood sugar can cause seizures and death. Low blood sugar may affect your ability to drive a car or use mechanical equipment, risking injury to yourself or others. Know your symptoms of low blood sugar. Low blood sugar can be treated by drinking juice or regular soda or eating glucose tablets, sugar, or hard candy. 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.

  • Serious allergic reactions (whole body allergic reaction). Severe, life-threatening allergic reactions can happen with insulin. Get medical help right away if you develop a rash over your whole body, have trouble breathing, wheezing, a fast heartbeat, orsweating.
  • Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having injection site reactions or they are serious, you need to call your healthcare provider. Do not inject insulin into a skin area that is red, swollen, or itchy.
  • Skin thickens or pits at the injection site (lipodystrophy). This can happen if you don'tchange (rotate) your injection sites enough.

Humalog Mix75/25 may cause serious side effects, including:

  • swelling of your hands and feet
  • heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humalog Mix75/25 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Humalog Mix75/25. Your healthcare provider should monitor you closely while you are taking TZDs with Humalog Mix75/25. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain

Treatment with TZDs and Humalog Mix75/25 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

These are not all the side effects from Humalog Mix75/25. Ask your healthcare provider or pharmacist for more information.

How should I store Humalog Mix75/25?

  • Store all unopened (unused) Humalog Mix75/25 in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Do not use Humalog Mix75/25 that has been frozen.
  • Do not use after the expiration date printed on the carton and label.
  • Protect Humalog Mix75/25 from extreme heat, cold or light.

After starting use (open):

  • Vials: Keep in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days. Keep open vials away from direct heat or light. Throw away an opened vial 28 days after first use, even if there is insulin left in the vial.
  • Prefilled Pens: Do not store a prefilled pen that you are using in the refrigerator. Keep at room temperature below 86°F (30°C) for up to 10 days. Throw away a prefilled pen 10days after first use, even if there is insulin left in the pen.

General information about Humalog Mix75/25

Use Humalog Mix75/25 only to treat your diabetes. Do not share it with anyone else, even if they also have diabetes. It may harm them.

This leaflet summarized the most important information about Humalog Mix75/25. If you would like more information about Humalog Mix75/25 or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Humalog Mix75/25 that is written for healthcare providers.

For questions you may call 1-800-LillyRx (1-800-545-5979) or visit www.humalog.com.

What are the ingredients in Humalog Mix75/25?

Active ingredients: insulin lispro protamine suspension and insulin lispro.

Inactive ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), phenol and water for injection.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Instructions for Use

HUMALOG® Mix75/25™ KwikPen™
75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA origin)

 

View Enlarged Table

Read the Instructions for Use before you start taking HUMALOG Mix75/25 and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

HUMALOG® Mix75/25™ KwikPen™ (“Pen”) is a disposable pen containing 3 mL (300 units) of U-100 HUMALOG® Mix75/25™ [75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA origin)] insulin. You can inject from 1 to 60 units in a single injection.

Do not share your HUMALOG Mix75/25 KwikPen or needles with anyone else. You may give an infection to them or get an infection from them.

This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

 

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Supplies you will need to give your HUMALOG Mix75/25 injection:

  • HUMALOG Mix75/25 KwikPen
  • HUMALOG Mix75/25 KwikPen compatible needle (Becton, Dickinson and Company Pen Needles recommended)
  • Alcohol swab

Preparing HUMALOG Mix75/25 KwikPen:

  • Wash your hands with soap and water.
  • Check the HUMALOG Mix75/25 KwikPen Label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
  • Do not use HUMALOG Mix75/25 past the expiration date printed on the Label.
  • Always use a new needle for each injection to help ensure sterility and prevent blocked needles.

Step 1

Pull the Pen Cap straight off. Wipe the Rubber Seal with an alcohol swab.

  • Do not twist the cap.
  • Do not remove the KwikPen Label.

 

Pull the Pen Cap straight off - Illustration

Step 2

Gently roll the Pen ten times.

Invert the Pen ten times.

HUMALOG Mix75/25 should look white and cloudy after mixing. Do not use if it looks clear or contains any lumps or particles.

 

Gently roll the Pen - Illustration

Step 3

Pull off the Paper Tab from Outer Needle Shield.

 

Pull off the Paper Tab - Illustration

Step 4

Push the capped Needle straight onto the Pen and turn the Needle forward until it is tight.

 

Push the capped Needle straight onto the Pen - Illustration

Step 5

Pull off the Outer Needle Shield. Do not throw it away.

Pull off the Inner Needle Shield and throw it away.

 

Pull off the Outer Needle Shield - Illustration

Priming your HUMALOG Mix75/25 KwikPen:

Prime before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.

Step 6

Turn the Dose Knob to select 2 units.

 

Turn the Dose Knob to select 2 units - Illustration

Step 7

Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

 

Tap the Cartridge Holder gently - Illustration

Step 8

Hold your Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window. Hold the Dose Knob in and count to 5 slowly.

  • A stream of insulin should be seen from the needle.
    • If you do not see a stream of insulin, repeat steps 6 to 8, no more than 4 times.
    • If you still do not see a stream of insulin, change the needle and repeat steps 6 to 8.

 

Hold the Dose Knob in and count to 5 slowly - Illustration

 

Selecting your dose

Step 9

Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.

  • The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.
  • The even numbers are printed on the dial. The odd numbers, after the number 1, are shown as full lines.

 

Select your dose - Illustration
  • The HUMALOG Mix75/25 KwikPen will not let you dial more than the number of units left in the Pen.
  • If your dose is more than the number of units left in the Pen, you may either:
    • inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or
    • get a new Pen and inject the full dose.
  • The Pen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that can't be delivered.

Giving your HUMALOG Mix75/25 injection:

  • Inject your HUMALOG Mix75/25 as your healthcare provider has shown you.
  • Change (rotate) your injection site for each injection.
  • Do not try to change your dose while injecting HUMALOG Mix75/25.

Step 10

Choose your injection site.

HUMALOG Mix75/25 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.

Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.

 

Choose your injection site - Illustration

Step 11

Insert the Needle into your skin.

 

Insert the Needle into your skin - Illustration

Step 12

Put your thumb on the Dose Knob and push the Dose Knob in until it stops. Hold the Dose Knob in and slowly count to 5.

 

Hold the Dose Knob in and slowly count to 5 - Illustration

Step 13

Pull the Needle out of your skin.

You should see “0” in the Dose Window. If you do not see “0” in the Dose Window, you did not receive your full dose.

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 swab. Do not rub the area.

A drop of insulin at the needle tip is normal. It will not affect your dose.

If you do not think you received your full dose, do not take another dose. Call Lilly or your healthcare provider for assistance.

 

Dose window - Illustration

Step 14

Carefully replace the Outer Needle Shield.

 

Carefully replace the Outer Needle Shield - Illustration

Step 15

Unscrew the capped Needle and throw it away.

Do not store the Pen with the Needle attached to prevent leaking, blocking of the Needle, and air from entering the Pen.

 

Unscrew the capped Needle - Illustration

Step 16

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

 

Replace the Pen Cap - Illustration

After your injection

  • Put your used needles and pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

How should I store my HUMALOG Mix75/25 KwikPen?

  • Store unused HUMALOG Mix75/25 Pens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using can be stored out of the refrigerator below 86°F (30°C).
  • Do not freeze HUMALOG Mix75/25. Do not use HUMALOG Mix75/25 if it has been frozen.
  • Unused HUMALOG Mix75/25 Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
  • The HUMALOG Mix75/25 Pen you are using should be thrown away after 10 days, even if it still has insulin left in it.
  • Keep HUMALOG Mix75/25 away from heat and out of the light.

General information about the safe and effective use of HUMALOG Mix75/25 KwikPen

  • Keep HUMALOG Mix75/25 KwikPen and needles out of the reach of children.
  • Do not use your Pen if any part looks broken or damaged.
  • Always carry an extra Pen in case yours is lost or damaged.
  • If you can not remove the Pen Cap, gently twist the Pen Cap back and forth, and then pull the Pen Cap straight off.
  • If it is hard to push the Dose Knob or the Pen is not working the right way:
    • Your Needle may be blocked. Put on a new Needle and prime the Pen.
    • You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new one.
    • It may help to push the Dose Knob more slowly during your injection.
  • Use the space below to keep track of how long you should use each HUMALOG Mix75/25 KwikPen.
    • Write down the date you start using your HUMALOG Mix75/25 KwikPen. Count forward 10 days.
    • Write down the date you should throw it away.

Example:

Pen 1 - First used on[Date] _______ + 10 days = Throw out on [Date]______

Pen 1 - First used on [Date]_______ Throw out on [Date]_______

Pen 2 - First used on [Date] _______ Throw out on [Date]_______

Pen 3 - First used on [Date] _______ Throw out on [Date]_______

Pen 4 - First used on [Date]_______ Throw out on[Date] _______

Pen 5 - First used on [Date] _______ Throw out on [Date]_______

If you have any questions or problems with your HUMALOG Mix75/25 KwikPen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMALOG Mix75/25 KwikPen and insulin, go to www.humalog.com.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

INSULIN LISPRO PROTAMINE (NPL)/INSULIN LISPRO - INJECTION

 

(IN-sue-lin LISS-pro PRO-tah-meen(NPL)/IN-sue-lin LISS-pro)

 

COMMON BRAND NAME(S): Humalog Mix

 

USES: Insulin lispro protamine/insulin lispro is used along with a proper diet and exercise program to control high blood sugar. It is used in people with type 1 (insulin-dependent) or type 2 diabetes. This product is a combination of two man-made insulins: intermediate-acting insulin lispro protamine and rapid-acting insulin lispro. This combination starts working faster and lasts for a longer time than regular insulin.

Insulin is a natural substance that allows the body to properly use sugar from the diet. It replaces the insulin that your body no longer produces, thereby lowering your blood sugar. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

 

HOW TO USE: Read the patient information leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Follow all package directions for proper use/injection/storage of the particular type of device/insulin you are using. Your health care professional will teach you how to properly inject this medication. If any of the information is unclear, consult your doctor or pharmacist.

Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature (see also Storage section). Wash your hands before measuring and injecting insulin. Check the product visually for particles, thickening, or clumps before rolling and turning the container. If any are present, discard that container.

To avoid damaging the insulin, do not shake the container. Gently roll and turn it between your palms at least 10 times. If using a cartridge or prefilled syringe, turn it upside down so that the glass ball moves from one end to the other. Gently mix the insulin until it appears evenly white and cloudy. If it does not appear this way, discard it.

The dosage is based on your medical condition and response to treatment. Measure each dose carefully, and use exactly as prescribed by your doctor. Even small changes in the amount of insulin may have a large effect on your blood sugar levels.

Before injecting each dose, make sure the injection site is clean and dry. Inject this medication under the skin of the abdomen, upper arms, or thighs, usually twice daily, 15 minutes or less before the morning and evening meal or as directed by your doctor. Do not inject into a vein or muscle. Eat promptly after taking this insulin to avoid low blood sugar (see also Side Effects section). Change the location of the injection site daily and do not reuse the same site for two weeks to avoid problem areas under the skin.

Do not mix this product with other insulins or use it in an insulin pump.

Use this medication regularly as directed by your doctor in order to get the most benefit from it. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended. Monitor your blood sugar on a regular basis. Keep track of the results, and share them with your doctor. This is very important in order to determine the correct insulin dose. Inform your doctor if your blood sugar measurements are too high or too low. Your dosage may need to be changed.

If you are measuring doses from vials, do not reuse needles and syringes. If you are using the cartridges or pens, use a new needle each time. Learn how to discard needles and medical supplies safely. Consult your pharmacist for more information.

Consumer Overview Side Effect

SIDE EFFECTS: See also the How to Use section.

Pain, redness, swelling or itching at the injection site may occur. These effects usually go away after a few days or weeks. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Too much insulin can cause low blood sugar (hypoglycemia). This effect may also occur if you do not consume enough calories. The symptoms include chills, cold sweats, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose (sugar) tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent low blood sugar, eat meals on a regular schedule and do not skip meals.

Too little insulin can cause high blood sugar (hyperglycemia). Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your treatment plan may need to be changed.

This medication may cause low potassium levels in the blood (hypokalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following signs of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Humalog 75-25 (75-25 insulin lispro suspension and 25 insulin lispro injection) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor immediately if you experience symptoms of high or low blood sugar.

Do not use this medication when you have low blood sugar.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your treatment plan may be required.

Changes in your lifestyle or activity level may affect the amount of insulin your body needs to control blood sugar levels. If you notice an unusual change in your insulin needs, tell your doctor.

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across more than two time zones, ask your doctor about how to adjust your insulin schedule.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: rosiglitazone.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet. Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (such as cough-and-cold products) carefully. Some products may contain sugar or alcohol and may affect your blood sugar levels. Ask your doctor or pharmacist about using these products safely.

Other medications can affect the results of urine tests for sugar or ketones. Consult your doctor or pharmacist for more information.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, vision changes, unexplained heavy sweating, agitation, fainting, seizures.

 

NOTES: Do not share this medication, needles, or syringes with others.

Attend a diabetes education program to learn more about diabetes and the important aspects of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar.

Check your blood sugar levels regularly as directed. Keep all medical appointments. Laboratory and/or medical tests (such as fasting blood glucose, hemoglobin A1c) should be performed periodically to check for side effects and monitor your response to treatment.

Wear or carry identification stating that you have diabetes and are using this drug.

 

MISSED DOSE: It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Keep extra supplies of insulin and an extra syringe and needle on hand. Discuss specific instructions with your doctor now in case you miss a dose of insulin or a meal in the future.

 

STORAGE: See also the How to Use section.

Store all unopened insulin containers in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze, and do not use insulin that has been frozen. If you are using the vials, store open vials in the refrigerator or at room temperature below 86 degrees F (30 degrees C) away from direct heat and light. Store in the carton to protect from light. Do not refrigerate cartridges or pens that are currently in use. Discard cartridges and vials in use after 28 days, and pens in use after 10 days, even if there is insulin left. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.

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