Insulin aspart protamine

Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is not recommended for the treatment of diabetic ketoacidosis. • The proportions of rapid-acting and long-acting insulins in Insulin Aspart Protamine and Insulin Aspart Mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments. …

• Inspect visually before use
• Appearance should be uniformly white and cloudy
• Do not use it if it looks clear or if it contains solid particles . • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 must be resuspended immediately before use
• Resuspension is easier when the insulin has reached room temperature . • Inject Insulin Aspart Protamine and Insulin Aspart Mix 70/30 subcutaneously in the abdominal region, buttocks, thigh, or upper arm . • Administer the dose within 15 minutes before meal initiation
• For patients with type 2 diabetes, the dose may also be given after meal initiation . • Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis . • Do not administer intravenously or use in insulin infusion pumps . • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack) . • Individualize dosage based on metabolic needs, blood glucose monitoring results, glycemic control goal . • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness . • When switching from another insulin to Insulin Aspart Protamine and Insulin Aspart Mix 70/30, a different dosage of Insulin Aspart Protamine and Insulin Aspart Mix 70/30 may be needed . …

Injectable suspension: 100 units/mL (U-100) of Insulin Aspart Protamine and Insulin Aspart Mix 70/30, 70% insulin aspart protamine and 30% insulin aspart, is a white and cloudy suspension available as: • 10 mL multiple-dose vial • 3 mL single-patient-use FlexPen prefilled pen Injectable suspension: 100 units/mL (U-100) of Insulin Aspart Protamine and Insulin Aspart Mix 70/30, 70% insulin aspart pr …

• Safety and effectiveness of Insulin Aspart Protamine and Insulin Aspart have not been established
• In pediatric patients with diabetes mellitus

Clinical studies of Insulin Aspart Protamine and Insulin Aspart did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger adult patients. In geriatric patients with diabetes, the initial dosing, dose increments should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in geriatric patients.

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Never Share an Insulin Aspart Protamine and Insulin Aspart Mix 70/30 FlexPen between Patients Advise patients that they must never share Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart ) FlexPen device with another person even if the needle is changed
• Advise patients using Insulin Aspart Protamine and Insulin Aspart vials not to share needles or syringes with another person
• Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ] . …

Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] • In patients with hypersensitivity to Insulin Aspart Protamine and Insulin Aspart Mix 70/30 or one of its excipients [see Warnings and Precautions ( 5.5 )] • Do not use during episodes of hypoglycemia (4) . • Do not use in patients with hypersensitivity to Insulin Aspart Protamine and Insulin Aspart Mix 70/30 or one of its excipients (4) .

The table below presents clinically significant drug interactions with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 Table 3: Clinically Significant Drug Interactions with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 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 Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Aspart Protamine and Insulin Aspart is concomitantl …

• Never share a Insulin Aspart Protamine and Insulin Aspart Mix 70/30 FlexPen 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 also discussed elsewhere: • 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 therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash and pruritus (6) . To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Pharma, Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary There are no available data with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart ) in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. …

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6)] . 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 intramuscular/subcutaneous glucagon 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.

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.