Humalog Mix 50/50 Inj, 10ml

Insulin Lispro Protamine and Insulin Lispro is a biphasic insulin analog suspension. Insulin Lispro is a rapid-acting insulin that lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin Lispro Protamine is an intermediate-acting insulin, formed by combining insulin lispro with protamine, which delays its absorption and prolongs its action. Both components bind to insulin receptors on target cells, facilitating the cellular uptake of glucose and inhibiting gluconeogenesis and glycogenolysis.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some allergic reactions can be life-threatening.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Thick skin, pits, or lumps at the injection site
Swelling in the arms or legs
Shortness of breath
Low blood sugar, which may cause:
+ Dizziness or fainting
+ Blurred vision
+ Mood changes
+ Slurred speech
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
+ Seizures

If you experience any of these symptoms, call your doctor right away. If you have low blood sugar, follow the instructions you have been given, which may include taking glucose tablets, liquid glucose, or some fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Irritation at the injection site
* Weight gain

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have low blood sugar (hypoglycemia), as this may affect your treatment.

This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Be aware that this medication can cause low blood sugar, which may lead to seizures, loss of consciousness, permanent brain damage, and even death if not properly managed. Consult your doctor to discuss the risks and prevention strategies.

Additionally, this medication can cause low blood potassium levels, which, if left untreated, may result in abnormal heart rhythms, severe breathing difficulties, and potentially death. It is crucial to discuss this risk with your doctor.

If you are taking diabetes medications like pioglitazone or rosiglitazone, be aware that they may increase the risk of heart failure or worsen existing heart failure. Using insulin with these medications may further increase this risk. If you are taking one of these medications, consult your doctor to discuss the potential risks and benefits.

To ensure safe use, verify that you have the correct insulin product and understand how to measure and prepare your dose. Insulin products are available in various containers, including vials, cartridges, and pens. If you have any questions or concerns, contact your doctor or pharmacist.

During times of stress, such as illness, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.

For your safety, wear a medical alert identification (ID) that indicates your condition. Avoid driving if you have experienced low blood sugar, as it can increase your risk of being involved in an accident.

Follow your doctor's instructions for monitoring your blood sugar levels and scheduling blood work. Consult your doctor before consuming alcohol or using products that contain alcohol.

Do not share your insulin product or any related devices, including pens, cartridge devices, needles, or syringes, with others, even if the needle has been changed. Sharing can transmit infections, including those you may not be aware of having.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.

• Beta-blockers (may mask symptoms of hypoglycemia)
• Thiazolidinediones (TZDs) (increased risk of fluid retention and heart failure when used with insulin)
• Corticosteroids (may increase blood glucose, requiring higher insulin doses)
• Diuretics (especially thiazide and loop diuretics, may increase blood glucose)
• Sympathomimetics (e.g., albuterol, epinephrine, may increase blood glucose)
• Atypical antipsychotics (may cause hyperglycemia)
• Protease inhibitors (may cause hyperglycemia)

• Alcohol (may potentiate hypoglycemic effect)
• Salicylates (e.g., aspirin, may enhance insulin's glucose-lowering effect)
• Sulfonamide antibiotics (may enhance insulin's glucose-lowering effect)
• Monoamine Oxidase Inhibitors (MAOIs) (may enhance insulin's glucose-lowering effect)
• Angiotensin-converting enzyme (ACE) inhibitors (may enhance insulin's glucose-lowering effect)
• Somatostatin analogs (e.g., octreotide, may decrease insulin requirements)
• Danazol (may increase insulin requirements)

• Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness.
• Symptoms of hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss, nausea, vomiting, fruity breath odor (ketoacidosis).
• Symptoms of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing.

Insulin is the preferred treatment for diabetes in pregnancy. Humalog Mix 50/50 can be used, but careful monitoring and dose adjustment are crucial to maintain strict glycemic control and minimize risks to both mother and fetus. The FDA's new pregnancy labeling (PLLR) for insulin lispro states that available data from published studies on insulin lispro use in pregnant women have not reported an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Insulin is compatible with breastfeeding. Insulin is a normal component of human milk and is not orally absorbed by the infant. No adverse effects on the breastfed infant are expected. Insulin requirements may decrease during lactation, especially in the immediate postpartum period.

Humalog Mix 50/50 is approved for use in pediatric patients with diabetes. Dosing must be highly individualized and carefully monitored due to varying insulin sensitivity and growth patterns. Risk of hypoglycemia may be higher in younger children.

Use with caution in elderly patients due to increased risk of hypoglycemia, particularly in those with renal or hepatic impairment. Start with lower doses and titrate slowly. Monitor blood glucose levels more frequently and educate on hypoglycemia symptoms.

• Always inspect the vial for particulate matter or discoloration before use. Humalog Mix 50/50 should appear uniformly cloudy after resuspension.
• Gently roll the vial between the palms 10 times and invert 10 times immediately before each injection to ensure the insulin is thoroughly mixed.
• Administer Humalog Mix 50/50 subcutaneously into the abdomen, thigh, upper arm, or buttocks. Rotate injection sites within the same region to reduce the risk of lipodystrophy.
• This product is a fixed combination; it cannot be adjusted for individual rapid-acting or intermediate-acting needs separately. If a patient's needs for rapid-acting and intermediate-acting insulin differ significantly, separate insulin products may be more appropriate.
• Never share insulin pens or syringes between patients, even if the needle is changed, due to the risk of blood-borne pathogen transmission.
• Store unopened vials in the refrigerator (2°C to 8°C [36°F to 46°F]). Once opened, store at room temperature (below 30°C [86°F]) and discard after 28 days.

• Basal-bolus insulin regimens (e.g., long-acting insulin + rapid-acting insulin)
• Basal insulin only (e.g., Insulin Glargine, Insulin Detemir, Insulin Degludec)
• Rapid-acting insulin only (e.g., Insulin Lispro, Insulin Aspart, Insulin Glulisine)
• Oral antidiabetic agents (e.g., Metformin, Sulfonylureas, SGLT2 inhibitors, GLP-1 receptor agonists)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.