Insulin lispro protamine and insulin lispro (subcutaneous route)


    Brand Name

    US Brand Name

    Humalog Mix 50/50

    Humalog Mix 75/25


    Description

    Insulin lispro protamine and insulin lispro is a combination of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. When you have diabetes mellitus, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.

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

    This product is available in the following dosage forms:

    • Suspension

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin lispro protamine and insulin lispro combination injection in the elderly. However, elderly patients are more likely to have age-related heart, liver, kidney problems, or hypoglycemia, which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Acarbose
    • Alogliptin
    • Bexagliflozin
    • Bromocriptine
    • Canagliflozin
    • Chloroquine
    • Chlorpropamide
    • Ciprofloxacin
    • Dapagliflozin
    • Delafloxacin
    • Empagliflozin
    • Enoxacin
    • Ertugliflozin
    • Gatifloxacin
    • Gemifloxacin
    • Glimepiride
    • Glipizide
    • Glyburide
    • Grepafloxacin
    • Hydroxychloroquine
    • Lanreotide Acetate
    • Levofloxacin
    • Linagliptin
    • Liraglutide
    • Lomefloxacin
    • Macimorelin
    • Metformin
    • Metoclopramide
    • Metreleptin
    • Miglitol
    • Moxifloxacin
    • Nateglinide
    • Norfloxacin
    • Octreotide Acetate
    • Ofloxacin
    • Pasireotide Diaspartate
    • Pioglitazone
    • Pramlintide

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    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 change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Heart failure or
    • Hypokalemia (low potassium in the blood)—Use with caution. May make this condition worse and increase your chance of having serious side effects.
    • Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.
    • Infection or
    • Illness or
    • Stress (eg, physical or emotional)—These conditions increase blood sugar and may increase the amount of insulin you need.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

    Proper Use

    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.


    Precautions

    It is very important that your doctor check your progress at regular visits, especially during the first few weeks you use this medicine. Blood tests may be needed to check for unwanted effects.

    Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

    It is very important to follow carefully 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 during the time you are using this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
    • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
    • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

    In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

    • Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
    • Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs.
    • Keep some kind of quick-acting sugar handy to treat low blood sugar.
    • Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

    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 have a rash, itching, shortness of breath, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.

    Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

    You may have some skin 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 a skin area that is red, swollen, or itchy.

    Too much insulin lispro protamine and insulin lispro combination can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin aspart with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

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

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

    Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, 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, fruit-like breath odor, increased urination, ketones in urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.

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

    This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately 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 need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 occur in some patients. If you notice any other effects, check with 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.






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