Humalog Mix 50 / 50

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting form of insulin. Insulin lispro protamine is an intermediate-acting form of insulin.

Insulin lispro and insulin lispro protamine is used to treat type 1 diabetes in adults. It is usually given together with another long-acting insulin.

Insulin lispro and insulin lispro protamine may also be used for purposes not listed in this medication guide.

Although appropriate studies on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of this medicine in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution and an adjustment in the dose for patients receiving this medicine.

Since this medicine is used before meals, you may not be on a timed dosing schedule. Whenever you use the medicine, be sure to eat a meal within 15 minutes. Do not use extra medicine to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

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

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 in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of this medicine in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

• Balofloxacin
• Besifloxacin
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Lanreotide
• Levofloxacin
• Liraglutide
• Lomefloxacin
• Metreleptin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Pioglitazone
• Pramlintide
• Prulifloxacin
• Rosiglitazone
• Rufloxacin
• Sparfloxacin
• Thioctic Acid
• Tosufloxacin

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
• Furazolidone
• Glucomannan
• Guar Gum
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

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:

• 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.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

• Infection or any 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—Effects of insulin lispro protamine and insulin lispro combination may be increased because of the slower removal of the medicine from the body.

Individualize dose based on glucose treatment goals, metabolic needs, eating habits, and other lifestyle variables.

Available as:
-Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro)
-Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro)

Usual dose: Administer prescribed units subcutaneously within 15 minutes before or after meal initiation

Comments:
-Duration of action may vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

Use: To improve glycemic control in patients with diabetes mellitus.

Use with caution; insulin requirements may be reduced in patients with renal impairment.

Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. When compared to human insulin, insulin lispro has not shown any adverse effect on pregnancy or on the health of the fetus. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. There are no adequate and well-controlled studies of insulin lispro or this combination insulin in pregnant women. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is considered acceptable AU TGA pregnancy category: A US FDA pregnancy category: B Comments: -Good glycemic control is essential for patients with diabetes or a history of gestational diabetes before conception and throughout pregnancy. -Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery