Humulin R U-500 (concen) Vl 20ml
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin, typically in the upper arm, thigh, buttocks, or stomach area. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before use, wash your hands thoroughly. It is recommended to take this medication 30 minutes before meals. To minimize the risk of injection site reactions, rotate the injection site with each dose.
Important Administration Guidelines
Do not shake the medication before use.
Avoid injecting into skin that is thickened, has pits or lumps, or is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
If the solution changes color, do not use it.
Safe Disposal of Needles and Syringes
After use, dispose of needles and syringes in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Special Instructions for U-500 Vials
If you are using U-500 vials, you will need to use a specialized insulin syringe. It is crucial to only use this specific syringe to measure and inject your dose, as using the wrong syringe can result in incorrect dosing, leading to low or high blood sugar levels. Consult your doctor if you have any questions.
Additional Important Information
Do not mix this insulin with other types of insulin in the same syringe.
Do not draw the medication into a syringe and store it for future use.
Do not mix the medication with other liquids.
Adhere to the diet and exercise plan recommended by your doctor.
* Be aware of the steps to take if you do not eat as much as usual or skip a meal.
Storage and Disposal
Store unopened containers in the refrigerator. If necessary, unopened containers can also be stored at room temperature. Do not freeze the medication, and do not use it if it has been frozen.
Missed Dose
If you forget to take a dose, be aware of the steps to take. If you are unsure, contact your doctor for guidance.
Lifestyle & Tips
- Follow a consistent meal plan and exercise regimen as advised by your healthcare provider.
- Do not skip meals after taking insulin.
- Always carry a source of fast-acting sugar (e.g., glucose tablets, juice) to treat mild to moderate hypoglycemia.
- Inform all healthcare providers that you are taking U-500 insulin.
- Wear a medical alert bracelet or carry identification stating you have diabetes and use insulin.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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, so prompt medical attention is crucial.
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Swelling in the arms or legs
Thick skin, pits, or lumps at the injection site
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. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Weight gain
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Symptoms of severe hypoglycemia: disorientation, seizures, unconsciousness. Seek immediate medical attention.
- Symptoms of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing. Seek immediate medical attention.
- Symptoms of hypokalemia: muscle weakness, cramps, irregular heartbeat.
Before Using This Medicine
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 allergic reaction you experienced, including any symptoms that occurred.
If you have low blood sugar (hypoglycemia), as this may affect your treatment plan.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent any potential interactions or adverse effects.
Precautions & Cautions
To avoid errors, verify that you have the correct insulin product, as insulin products are available in various containers, such as vials, cartridges, and pens. Make sure you are familiar with how to measure and prepare your dose. If you have any questions or concerns, do not hesitate to contact your doctor or pharmacist.
Hypoglycemia (low blood sugar) is a potential side effect of this medication. Severe hypoglycemia can lead to seizures, loss of consciousness, permanent brain damage, and even death. Discuss the risks and symptoms of hypoglycemia with your doctor.
Additionally, this medication may cause hypokalemia (low blood potassium), which, if left untreated, can result in abnormal heart rhythms, severe respiratory problems, and even death. Consult your doctor if you experience any symptoms.
Until you are familiar with how this medication affects you, avoid driving and other activities that require your full attention. Certain diabetes medications, such as pioglitazone or rosiglitazone, may increase the risk of heart failure when used in combination with insulin. If you are taking one of these medications, discuss the potential risks with your doctor.
During periods of stress, such as illness, infection, injury, or surgery, your blood sugar levels may be more challenging to control. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.
It is recommended that you wear a medical alert identification (ID) to inform others of your condition in case of an emergency. Do not drive if you have recently experienced hypoglycemia, as this can increase your risk of being involved in an accident.
Monitor your blood sugar levels as directed by your doctor, and have regular blood tests to ensure your safety while taking this medication. Consult your doctor before consuming alcohol or using products that contain alcohol.
Do not share your insulin product, including pens, cartridge devices, needles, or syringes, with anyone else, even if the needle has been changed, as this can transmit infections. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (low blood sugar): confusion, blurred vision, slurred speech, seizures, unconsciousness, coma.
What to Do:
For mild hypoglycemia, consume fast-acting carbohydrates (e.g., glucose tablets, juice, candy). For severe hypoglycemia, administer glucagon injection if available and call emergency services. Call 911 or 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Major Interactions
- Drugs that may increase the risk of hypoglycemia (e.g., other antidiabetic agents, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, octreotide, pramlintide, salicylates, sulfonamide antibiotics).
- Beta-blockers (may mask symptoms of hypoglycemia).
Moderate Interactions
- Drugs that may decrease the blood glucose lowering effect (e.g., corticosteroids, diuretics, sympathomimetics, somatropin, danazol, isoniazid, phenothiazine derivatives, thyroid hormones, estrogens, progestins, atypical antipsychotics, protease inhibitors).
- Alcohol (can potentiate or diminish insulin's effect).
Confidence Interactions
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Rationale: To establish baseline glucose levels.
Timing: Prior to initiation
Rationale: To assess kidney function as insulin clearance can be affected.
Timing: Prior to initiation
Rationale: To assess liver function as insulin metabolism can be affected.
Timing: Prior to initiation
Routine Monitoring
Frequency: Multiple times daily (e.g., pre-meal, post-meal, bedtime, overnight as needed)
Target: Individualized, typically 80-130 mg/dL pre-meal, <180 mg/dL post-meal
Action Threshold: Hypoglycemia (<70 mg/dL) or Hyperglycemia (>180-250 mg/dL depending on target)
Frequency: Every 3-6 months
Target: Individualized, typically <7%
Action Threshold: Above target range indicates need for therapy adjustment
Frequency: Daily
Target: N/A
Action Threshold: Any occurrence requires immediate attention and potential dose adjustment
Symptom Monitoring
- Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety.
- Symptoms of hyperglycemia: increased thirst, increased urination, fatigue, blurred vision, unexplained weight loss, nausea, vomiting.
Special Patient Groups
Pregnancy
Insulin is the preferred treatment for diabetes in pregnancy (including gestational diabetes) due to its efficacy and safety profile. Insulin does not cross the placenta in significant amounts.
Trimester-Specific Risks:
Lactation
Insulin is compatible with breastfeeding. It is considered safe for the infant as it is a protein and is degraded in the infant's gastrointestinal tract. Insulin requirements may decrease postpartum.
Pediatric Use
U-500 insulin is generally not recommended for routine use in pediatric patients due to the high risk of dosing errors and severe hypoglycemia. It may be considered in adolescents with severe insulin resistance under strict medical supervision and with careful patient/caregiver education.
Geriatric Use
Increased risk of hypoglycemia due to potential for impaired renal/hepatic function, reduced counter-regulatory responses, and cognitive impairment. Dosing should be conservative, and glucose monitoring should be frequent. Education on hypoglycemia symptoms and management is critical.
Clinical Information
Clinical Pearls
- Humulin R U-500 is 5 times more concentrated than U-100 insulin. Extreme caution is required to prevent dosing errors.
- Always use a U-500 insulin syringe (marked in U-500 units) or the Humulin R U-500 KwikPen for accurate dosing. Never use a U-100 syringe for U-500 insulin from a vial, as this will lead to a 5-fold overdose.
- Patients requiring U-500 insulin often have severe insulin resistance and may need very large doses.
- Due to its prolonged action, U-500 insulin can act as both a basal and prandial insulin for some patients.
- Educate patients and caregivers thoroughly on proper administration, storage, recognition and management of hypoglycemia, and the critical difference between U-100 and U-500 insulin.
- Consider continuous glucose monitoring (CGM) for patients on U-500 to help manage glycemic control and detect hypoglycemia.
Alternative Therapies
- Other insulin formulations (e.g., U-100 regular insulin, rapid-acting insulins like insulin lispro, insulin aspart, insulin glulisine; intermediate-acting insulins like NPH; long-acting insulins like insulin glargine, insulin detemir, insulin degludec).
- Oral antidiabetic agents (e.g., metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists).
- Pramlintide (amylin analog).