Insulin lispro protamine and insulin lispro (Subcutaneous)

Insulin lispro protamine and insulin lispro is a mix of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help manage blood sugar levels. If you have diabetes mellitus, your body either does not produce enough insulin or does not use it effectively. Therefore, you need to take extra insulin to control your blood sugar and maintain your health. This is crucial because high blood sugar levels can be harmful to your health.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits, especially in the first few weeks of using this medicine. You may need blood tests to check for any unwanted effects.

Never share insulin pens or cartridges with anyone. It is unsafe for one pen to be used by more than one person. Sharing needles or pens can lead to the transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

Follow any instructions from your health care team about:

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines while using this medicine unless your doctor has discussed them with you. This especially includes over-the-counter medicines like aspirin and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members should learn how to prevent or help with side effects if they occur. Patients with diabetes may need special counseling about changes in medicine dosing due to lifestyle changes, such as changes in exercise and diet. Counseling on contraception and pregnancy may also be needed because of the issues that can arise during pregnancy for patients with diabetes.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for emergencies as you normally would. Adjust for time zone changes and keep your meal times as close as possible to your usual schedule.

In case of emergency—You may need emergency help for a problem caused by your diabetes. Be prepared for these emergencies by:

• Wearing a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that indicates you have diabetes and lists all your medicines.
• Keeping an extra supply of insulin and syringes with needles or injection devices available in case of high blood sugar.
• Having some quick-acting sugar on hand to treat low blood sugar.
• Having a glucagon kit and a syringe and needle available in case of severe low blood sugar. Regularly check and replace any expired kits.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you experience a rash, itching, shortness of breath, swelling of the face, tongue, or throat, trouble breathing, or chest pain after receiving the injection.

Using this medicine with other diabetes medicines (for example, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may lead to serious heart problems or edema (fluid retention). Contact your doctor immediately if you rapidly gain weight, experience chest pain or discomfort, extreme tiredness or weakness, trouble breathing, an uneven heartbeat, or excessive swelling in your hands, wrists, ankles, or feet.

You may notice some redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject this medicine into any area of skin that is red, swollen, or itchy.

Taking too much insulin lispro protamine and insulin lispro can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin aspart with another antidiabetic medicine, make changes to your insulin regimen (for example, change in insulin strength, type of insulin, or injection site), delay or skip a meal or snack, exercise more than usual, drink alcohol, or cannot eat due to nausea, vomiting, or diarrhea. Symptoms of low blood sugar must be treated before they lead to unconsciousness. Different people may feel different symptoms of low blood sugar. It is important for you to learn which symptoms you typically experience so you can treat them quickly.

Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or unusual behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If you experience symptoms of low blood sugar, consume glucose tablets or gel, corn syrup, honey, sugar cubes, or drink fruit juice, non-diet soft drinks, or sugar dissolved in water to relieve the symptoms. Also, check your blood sugar level. Seek medical help immediately if the symptoms do not improve. Someone should call for emergency help right away if severe symptoms, such as convulsions (seizures) or unconsciousness, occur. Have a glucagon kit available, along with a syringe and needle, and ensure you know how to use it. Members of your household should also be familiar with how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough of your antidiabetic medicine or skip a dose, make changes to your insulin regimen (for example, change in insulin strength, type of insulin, or injection site), overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, a fruity breath odor, increased urination, ketones in urine, loss of appetite, stomachache, nausea, vomiting, tiredness, rapid and deep breathing, unconsciousness, or unusual thirst.

If you have symptoms of high blood sugar, check your blood sugar level and then call your doctor for instructions.

This medicine may make you feel dizzy or drowsy. Do not drive or engage in any activities that could be dangerous until you understand how this medicine affects you.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies, including to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how insulin lispro protamine and insulin lispro combination injection affects children. Safety and effectiveness have not been established for this age group.

Geriatric

So far, studies have not found any specific problems that would limit the use of insulin lispro protamine and insulin lispro combination injection in older adults. However, elderly patients are more likely to have heart, liver, or kidney issues, or low blood sugar, which may require careful monitoring and dose adjustments.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. If you are using this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are significant but not exhaustive.

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If both are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Abiraterone Acetate
• Acarbose
• Alogliptin
• Bexagliflozin
• Bromocriptine
• Canagliflozin
• Chloroquine
• Chlorpropamide
• Ciprofloxacin
• Dapagliflozin
• Delafloxacin
• Empagliflozin
• Enoxacin
• Ertugliflozin
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydroxychloroquine
• Lanreotide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lomefloxacin
• Macimorelin
• Metformin
• Metoclopramide
• Metreleptin
• Miglitol
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Pramlintide
• Repaglinide
• Rosiglitazone
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Trovafloxacin
• Vildagliptin

Using this medicine with any of the following may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both are prescribed together, your doctor may modify the dose or frequency of use for one or both medicines.

• Acebutolol
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant but not exhaustive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may adjust the dose or how often you take this medicine, or give you specific instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Other medical conditions may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Heart failure or
• Hypokalemia (low potassium in the blood)—Use carefully. This may worsen your condition and increase the risk of serious side effects.

• Hypoglycemia (low blood sugar)—Should not be used if you have this condition. If you have low blood sugar and take Insulin, your blood sugar may drop to dangerously low levels.

• Infection or
• Illness or
• Stress (e.g., physical or emotional)—These conditions can increase blood sugar levels and may require more Insulin.

• Kidney disease or
• Liver disease—Use cautiously. The effects may be stronger due to slower removal of the medicine from your body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may happen, but if they do, they may require medical attention.

Contact your doctor right away if any of the following side effects occur:

Incidence not known

• Anxiety
• blurred vision
• chest tightness
• chills
• cold sweats
• confusion
• cool, pale skin
• cough
• decreased urine
• depression
• difficulty with swallowing
• dizziness
• dry mouth
• fast heartbeat
• flushing or redness of the skin
• headache
• hives, itching, skin rash
• increased hunger
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea
• nervousness
• nightmares
• numbness or tingling in the hands, feet, or lips
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• slurred speech
• sweating
• swelling of the arms or legs
• unusual tiredness or weakness
• unusually warm skin
• vomiting

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Contact your health care professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• redistribution or accumulation of body fat
• weight gain

Other side effects not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Humalog Mix 50/50
• Humalog Mix 75/25

Available Dosage Forms:

• Suspension

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Lispro, Recombinant

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. It is given as a shot under your skin of your stomach, buttocks, thigh, or upper arm.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

Each package of insulin lispro protamine and insulin lispro combination injection contains a patient information leaflet and patient instructions. Read and follow the instructions carefully before beginning your treatment and each time you get a refill for any new information. Make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to use disposable insulin delivery device.
• How to dispose of syringes, needles, and injection devices.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not use the exact same spot for each injection. This will help prevent skin problems from the injections.

Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.

This medicine should be white and cloudy after mixing. Do not use if it is clear, or has lumps or particles in it.

When used as a mealtime insulin, this insulin combination should be taken within 15 minutes before a meal (2 meals or a meal and a snack).

To use the vial:

• Wash your hands with soap and water.
• Gently roll the vial between the palm of your hands and move the vial up and down at least 10 times.
• Use only syringes that are made for insulin injections. Use a new syringe and needle each time you give yourself an injection.
• Do not mix this medicine with any other insulin.

To use the Kwik® Pen:

• Wash your hands with soap and water.
• Gently roll the pen between your hands at least 10 times. Move the pen up and down at least 10 times.
• Prime the pen by removing the air from the needle and cartridge. Select 2 units when turning the dose knob.
• Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
• Press the dose knob until it stops. You should see a "0" in the dose window.
• You should see insulin at the needle tip. If you do not see insulin, repeat the priming steps but not more than 4 times. If there is still no insulin, change the needle and repeat the priming steps.
• Turn the dose knob, be careful not to press it.
• Insert the needle into your skin and press the dose knob all the way in for at least 5 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
• Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is broken or damaged.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should never mix insulin lispro protamine and insulin lispro combination with other insulin injections without checking with your doctor first. These injections are usually done separately. Also, this medicine should not be used in an insulin infusion pump. If you have questions about this, ask your doctor or pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (suspension):For diabetes mellitus: Adults—The dose is based on your blood sugar and must be determined by your doctor. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Store unopened vials or pens in the refrigerator. Do not freeze. Do not use the insulin if it has been frozen. You may also store the pen for 10 days or vial for 28 days at room temperature. Throw the medicine away after the expiration date has passed.

Store opened pens at room temperature for up to 10 days. Do not refrigerate. Store opened vials in the refrigerator or at room temperature for up to 28 days. Do not freeze.