Drug Label Information Updated November 16, If you are a consumer or patient please visit this version. Approval: Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness.
Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.
Risk Mitigation Strategies for Hypoglycemia Patients and caregivers must be educated to recognize and manage hypoglycemia. The following adverse reactions are discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions 5. Hypokalemia [see Warnings and Precautions 5.
Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred. Data Human Data While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Protect from heat and light. Do not freeze. Do not use after the expiration date. Refrigerated Do NOT store in a refrigerator. Do not refrigerate. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. Change rotate your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy pits in skin or thickened skin and localized cutaneous amyloidosis skin with lumps at the injection sites.
Do not use the exact same spot for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Know the type and strength of insulin you use. Do not change the type of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin.
Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger.
Get medical help right away, if you have any of these symptoms of an allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, or sweating. This can happen even if you have never had heart failure or heart problems before. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, swelling of your ankles or feet, sudden weight gain.
Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion. Call your doctor for medical advice about side effects. Active Ingredient: insulin human Inactive Ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, phenol, zinc oxide, water for injection, hydrochloric acid or sodium hydroxide For more information, call or go to www.
Vial Syringe. Step 1: Gently roll the vial between the palms of your hands at least 10 times. Step 2: Carefully invert the vial at least 10 times. Mixing is important to make sure you get the right dose. Do not use it if it looks clear or contains any lumps or particles. Step 3: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper. Step 4: Wipe the Rubber Stopper with an alcohol swab. Step 5: Hold the syringe with the needle pointing up.
Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose. Step 7: Push the plunger all the way in. This puts air into the vial. Step 8: Turn the vial and syringe upside down and slowly pull the Plunger down until the tip is a few units past the line for your prescribed dose.
If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top. Example Dose: 20 units Plunger is shown at 24 units Step 9: Slowly push the Plunger up until the tip reaches the line for your prescribed dose. Check the syringe to make sure that you have the right dose. Step Choose your injection site. Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.
Step Insert the needle into your skin. Step Push down on the Plunger to inject your dose. In addition insulin has several anabolic and anti-catabolic actions on a variety of different tissues. Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.
The typical activity profile glucose utilisation curve following subcutaneous injection is illustrated as follows by the heavy line. Individual variability will depend on factors such as size of dose, site of injection temperature and physical activity of the patient.
See Figure 2. Therefore, it is more appropriate to examine glucose utilization curves as discussed previously when considering the activity of insulin. Toxicology: Preclinical safety data: Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays. For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
Cartridge and KwikPen: The dosage should be determined by the physician, according to the requirement of the patient. Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen.
Use of injection sites should be rotated so that the same site is not used more than approximately once a month. Care should be taken when injecting any Insulin Human Humulin insulin preparations to ensure that a blood vessel has not been entered. After any insulin injection, the injection site should not be massaged.
Patients must be educated to use proper injection techniques. This formulation should not be administered intravenously. A patient's treatment regimen should be based on their individual metabolic requirements. Vial: Dosage schedule has been individualized for each patient, because each case of diabetes is different.
Consult a physician on the type of insulin, dosage strength and when to inject the insulin. The usual insulin dose may be affected by changes in food intake, activity or work schedule. The patient should carefully follow the physician's instructions to allow for these changes.
Other things that may affect the insulin dose are: Illness: Illness, especially with nausea and vomiting, may cause insulin requirements to change. Even if the patient is not eating, insulin will still be required. The patient and the physician should establish a sick-day plan to use in case of illness.
Pregnancy: Good control of diabetes is especially important for the patient and the unborn baby. Pregnancy may make managing diabetes more difficult. If planning to be pregnant, already pregnant, or nursing a baby, consult a doctor. Medication: Insulin requirements may be increased if the patient is taking other drugs with hyperglycemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral hypoglycemics, salicylates for example, aspirin , sulfa antibiotics, and certain antidepressants.
Exercise: Exercise may lower the body's need for insulin during and for some time after the activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site eg, the leg should not be used for injection just prior to running.
Discuss with the physician how to adjust dosage regimen to accommodate exercise. Travel: Persons traveling across more than 2 time zones should consult their doctor concerning adjustments in their insulin schedule.
Humulin Mixture formulation is a ready-made defined mixture of soluble and isophane insulin designed to avoid the need for the patient to mix insulin preparations.
Each pack contains a patient information leaflet with instructions on how to inject insulin. Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.
Hypoglycemia may occur as a result of an excess of insulin relative to food intake and energy expenditure. Hypoglycemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting. Mild hypoglycemic episodes will respond to oral administration of glucose or sugar products. Correction of moderately severe hypoglycemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently.
Patients who fail to respond to glucagon must be given glucose solution intravenously. If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously, if glucagon is not available or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.
It starts to work as quickly as regular insulin but lasts longer. This insulin product works by helping blood sugar glucose get into cells so your body can use it for energy.
This product may be used alone or with other oral diabetes drugs such as metformin. If you have any questions, ask your doctor, diabetes educator, or pharmacist. Learn all preparation and usage instructions from your health care professional and the product package. Before using, gently roll the vial or cartridge, turning it upside down and back 10 times to mix the medication. Do not shake the container. Check this product visually for particles or discoloration.
Sometimes interactions are harmful and can change how a drug works. Humulin N and Novolin N have similar interactions with other substances. Humulin N and Novolin N may cause your blood sugar level to get too low if you take either of them with the following drugs:. Note: Beta-blockers and other drugs used to treat high blood pressure, such as clonidine, may also make it difficult to recognize symptoms of low blood sugar. Humulin N and Novolin N could cause a buildup of fluid in your body and make your heart failure worse if you take either drug with:.
People with kidney disease or liver disease may be at increased risk of low blood sugar while using Humulin N or Novolin N. If you decide to take either of these drugs, you may need to monitor your blood sugar more often if you have these diseases. Both Humulin N and Novolin N are considered safer drugs to control high blood sugar during pregnancy. It is especially important for you to keep your blood sugar level under control while you are pregnant. High blood sugar levels during pregnancy can lead to complications such as high blood pressure and birth defects.
Talk to your doctor if you wish to breastfeed while taking Humulin N or Novolin N. Your doctor will likely adjust your dosage. Some insulin passes through breast milk to the child. However, breastfeeding while taking either of these types of insulin is generally considered safe. Both Humulin N and Novolin N are effective at helping to reduce your blood sugar level. Results from one study of Humulin N reported an average maximum effect at 6. Novolin N reaches its maximum effect somewhere between four hours and 12 hours after you inject it.
Read more: How to give a subcutaneous injection ». Humulin N and Novolin N are two different brands of the same type of insulin. Because of this, they are similar in many ways. The risk factors for type 2 diabetes are complex and range from genetic to environmental to lifestyle choices.
Learn more. My diagnosis was a wake-up call. It was time to take care of my health.
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