Insulin lispro protamine

Insulin Lispro Protamine and Insulin Lispro Mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. Insulin Lispro Protamine and Insulin Lispro Mix75/25™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. ( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. …

• See Full Prescribing Information for important preparation and administration instructions
• Inject Insulin Lispro Protamine and Insulin Lispro Mix75/25 subcutaneously within 15 minutes before a meal in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis
• Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal
• Do not administer Insulin Lispro Protamine and Insulin Lispro Mix75/25 intravenously or by a continuous subcutaneous insulin infusion pump
• Insulin Lispro Protamine and Insulin Lispro Mix75/25 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack)
• Important Preparation and Administration Instructions Preparation Instructions Always check insulin labels before administration
• This product is HUMALOG Mix75/25 [see Warnings and Precautions ]
• Insulin Lispro Protamine and Insulin Lispro Mix75/25 is a suspension that must be resuspended immediately before use
• Resuspension is easier when the insulin has reached room temperature
• To resuspend KwikPen, gently roll the KwikPen at least 10 times and then carefully invert the KwikPen at least 10 times until the suspension appears uniformly white and cloudy
• Inspect Insulin Lispro Protamine and Insulin Lispro Mix75/25 visually before use
• Do not use if discoloration or particulate matter is seen. …

Injectable Suspension: 100 units/mL (U-100) of Insulin Lispro Protamine and Insulin Lispro, 75% insulin lispro protamine and 25% insulin lispro is a white and cloudy suspension available as: 3 mL single-patient-use KwikPen prefilled pen Injectable suspension: 100 units/mL (U-100) of Insulin Lispro Protamine and Insulin Lispro Mix75/25, 75% insulin lispro protamine and 25% insulin lispro available …

• Safety and effectiveness of Insulin Lispro Protamine and Insulin Lispro Mix75/25
• In pediatric patients have not been established

Clinical studies of Insulin Lispro Protamine and Insulin Lispro Mix75/25 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In patients aged 65 and over with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.3 )].

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Never Share an Insulin Lispro Protamine and Insulin Lispro Mix75/25 KwikPen Between Patients Advise patients using Insulin Lispro Protamine and Insulin Lispro Mix75/25 KwikPens not to share needles or KwikPens with another person
• Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ]
• Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. …

• Insulin Lispro Protamine and Insulin Lispro Mix75/25 is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ] in patients who have had hypersensitivity reactions to Insulin Lispro Protamine and Insulin Lispro Mix75/25 or to any of its excipients. [see Warnings and Precautions ] Do not use during episodes of hypoglycemia
• Do not use in patients with hypersensitivity to Insulin Lispro Protamine and Insulin Lispro Mix75/25 or any of its excipients. …

Table 1 below presents clinically significant drug interactions with Insulin Lispro Protamine and Insulin Lispro Mix75/25. Table 1: Clinically Significant Drug Interactions with Insulin Lispro Protamine and Insulin Lispro Mix75/25 Drugs that May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. …

Never share an Insulin Lispro Protamine and Insulin Lispro Mix75/25 KwikPen between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening. …

The following adverse reactions are discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.3 )] Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with Insulin Lispro Protamine and Insulin Lispro Mix75/25 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, edema, pruritus, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). …

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately [see Warnings and Precautions ( 5.3 , 5.6 )].

Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from direct heat and light. Do not freeze and do not use if it has been frozen. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.