;Hypoglycemia is the most common adverse effect of insulin therapy; hypoglycemia is the major barrier to achieving optimal glycemic control long term. Insulin is contraindicated in patients during episodes of hypoglycemia. Patients at risk for hypoglycemia are those who have brittle diabetes, have received an overdose of insulin, have a delayed or decreased food intake, or undergo an excessive amount of exercise relative to their usual insulin dose. Furthermore, patients with a body mass index (BMI) > 32 may be at increased risk for hypoglycemia when using insulin aspart; insulin aspart clearance is reduced by 28% in patients with a BMI > 32 compared to patients with a BMI < 23 when a single dose of 0.1 units/kg was administered. The clinical significance of this is unknown as only 3 patients with a BMI of < 23 were studied. Patients at risk for severe, iatrogenic hypoglycemia include those with insulin deficiency (i.e., type 1 diabetes mellitus and advanced type 2 diabetes mellitus), those with a history of severe hypoglycemia or hypoglycemia unawareness, and those undergoing intensive insulin therapy. In addition, when insulin aspart is administered IV, patients should be monitored closely for hypoglycemia. Patient and family education regarding hypoglycemia management is crucial; the patient and patient's family should be instructed on how to recognize and manage the symptoms of hypoglycemia. Early warning signs of hypoglycemia may be less obvious in patients with hypoglycemia unawareness which can be due to a long history of diabetes (where deficiencies in the release or response to counterregulatory hormones exist), with autonomic neuropathy, or taking beta-blockers. Patients should be aware of the need to have a readily available source of glucose (dextrose, d-glucose) or other carbohydrate to treat hypoglycemic episodes. In patients who are currently taking an alpha-glucosidase inhibitor (i.e., acarbose or miglitol) along with their insulin, oral glucose (dextrose) should be used to treat hypoglycemia; sucrose (table sugar) is unsuitable. In severe hypoglycemia, intravenous dextrose or glucagon injections may be needed. Insulin injections should not be used by the family to treat those patients who are unconscious. In clinical trials of insulin aspart, 2.6% of patients were aged 65 years or older; approximately half of these patients had type 1 diabetes mellitus. When compared to regular human insulin, the HbA1c response to insulin aspart did not differ by age. In general, however, geriatric patients are especially at risk for hypoglycemic episodes when using insulin. The specific reasons identified include intensive insulin therapy, use of an excessive insulin dose, improper timing of insulin administration with regards to meals, injection of the wrong type of insulin, renal failure, severe liver disease, alcohol ingestion, defective counterregulatory hormone release, missing meals/fasting, and gastroparesis.[30444] Because hypoglycemic events may be difficult to recognize in some elderly patients, the initial dosing and dosing increments of any insulin product should be conservative. Severe or frequent hypoglycemia in any patient is an indication for the modification of treatment regimens, including setting higher glycemic goals.
In addition to hypoglycemia, hypokalemia may also occur as insulin facilitates the intracellular uptake of potassium. Patients at risk for hypokalemia (e.g., patients who are using potassium-lowering drugs or taking potassium concentration sensitive drugs) should be monitored closely for these effects. In addition, compared with subcutaneous administration, insulin aspart administered IV has a quicker onset of action. When insulin aspart is administered intravenously, patients should be monitored closely for hypokalemia.
Insulin aspart may be given via intravenous administration under proper medical supervision in a clinical setting for glycemic control. Because the onset of action is more rapid with IV administration, patients should be monitored closely for hypoglycemia and hypokalemia.
Insulin aspart is contraindicated for use in patients hypersensitive to the insulin or the excipients in the formulations. Minor, local sensitivity characterized by redness, swelling, or itching at the site of injection does not usually contraindicate therapy. Insulin aspart contains m-cresol and should be avoided in patients with m-cresol hypersensitivity; localized reactions and general myalgias have been reported with the use of cresol as an injectable excipient. Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash, pruritus, shortness of breath, wheezing, hypotension, tachycardia, and diaphoresis. Severe cases, including anaphylactoid reactions, may be life threatening.
Insulin aspart is classified as FDA pregnancy category B.[22299] In an open-label, randomized study of 322 women with type I diabetes mellitus (157 receiving insulin aspart and 165 receiving regular insulin), mean HbA1c (6% for both groups) and the incidence of maternal hypoglycemia were not different between the 2 groups. However, approximately two-thirds of the women were already pregnant when they were enrolled into the study, and the number of remaining participants was too small to evaluate congenital malformations. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 Units/kg/day and rabbits at a dose of 10 units/kg/day (approximately 32 times and 10 times the human subcutaneous dose of 1 unit/kg/day, respectively). The effects are probably secondary to maternal hypoglycemia at high doses as no significant effects were observed in rats at 8 times or rabbits at equivalent doses to the human subcutaneous dose of 1 unit/kg/day. Most experts recommend human insulin as the therapy of choice to maintain blood glucose as close to normal as possible during pregnancy in patients with Type 1 or 2 diabetes mellitus, and, if diet therapy alone is not successful, for those patients with gestational diabetes. In general, insulin requirements decline during the first trimester and increase during the second and third trimesters. Careful monitoring of the patient on insulin is required throughout pregnancy. Optimizing glycemic control before conception and during pregnancy appears to improve fetal outcome; this should include the avoidance of episodes of hypoglycemia as the toxic effects of maternal hypoglycemia on the fetus have been well-documented. During the perinatal period, careful monitoring of neonates born to mothers with diabetes is recommended. Post-partum, maternal insulin requirements may need adjustment.
;Hypoglycemia is the most common adverse effect of insulin therapy; hypoglycemia is the major barrier to achieving optimal glycemic control long term. Insulin is contraindicated in patients during episodes of hypoglycemia. Patients at risk for hypoglycemia are those who have brittle diabetes, have received an overdose of insulin, have a delayed or decreased food intake, or undergo an excessive amount of exercise relative to their usual insulin dose. Furthermore, patients with a body mass index (BMI) > 32 may be at increased risk for hypoglycemia when using insulin aspart; insulin aspart clearance is reduced by 28% in patients with a BMI > 32 compared to patients with a BMI < 23 when a single dose of 0.1 units/kg was administered. The clinical significance of this is unknown as only 3 patients with a BMI of < 23 were studied. Patients at risk for severe, iatrogenic hypoglycemia include those with insulin deficiency (i.e., type 1 diabetes mellitus and advanced type 2 diabetes mellitus), those with a history of severe hypoglycemia or hypoglycemia unawareness, and those undergoing intensive insulin therapy. In addition, when insulin aspart is administered IV, patients should be monitored closely for hypoglycemia. Patient and family education regarding hypoglycemia management is crucial; the patient and patient's family should be instructed on how to recognize and manage the symptoms of hypoglycemia. Early warning signs of hypoglycemia may be less obvious in patients with hypoglycemia unawareness which can be due to a long history of diabetes (where deficiencies in the release or response to counterregulatory hormones exist), with autonomic neuropathy, or taking beta-blockers. Patients should be aware of the need to have a readily available source of glucose (dextrose, d-glucose) or other carbohydrate to treat hypoglycemic episodes. In patients who are currently taking an alpha-glucosidase inhibitor (i.e., acarbose or miglitol) along with their insulin, oral glucose (dextrose) should be used to treat hypoglycemia; sucrose (table sugar) is unsuitable. In severe hypoglycemia, intravenous dextrose or glucagon injections may be needed. Insulin injections should not be used by the family to treat those patients who are unconscious. In clinical trials of insulin aspart, 2.6% of patients were aged 65 years or older; approximately half of these patients had type 1 diabetes mellitus. When compared to regular human insulin, the HbA1c response to insulin aspart did not differ by age. In general, however, geriatric patients are especially at risk for hypoglycemic episodes when using insulin. The specific reasons identified include intensive insulin therapy, use of an excessive insulin dose, improper timing of insulin administration with regards to meals, injection of the wrong type of insulin, renal failure, severe liver disease, alcohol ingestion, defective counterregulatory hormone release, missing meals/fasting, and gastroparesis.[30444] Because hypoglycemic events may be difficult to recognize in some elderly patients, the initial dosing and dosing increments of any insulin product should be conservative. Severe or frequent hypoglycemia in any patient is an indication for the modification of treatment regimens, including setting higher glycemic goals.In addition to hypoglycemia, hypokalemia may also occur as insulin facilitates the intracellular uptake of potassium. Patients at risk for hypokalemia (e.g., patients who are using potassium-lowering drugs or taking potassium concentration sensitive drugs) should be monitored closely for these effects. In addition, compared with subcutaneous administration, insulin aspart administered IV has a quicker onset of action. When insulin aspart is administered intravenously, patients should be monitored closely for hypokalemia.Insulin aspart may be given via intravenous administration under proper medical supervision in a clinical setting for glycemic control. Because the onset of action is more rapid with IV administration, patients should be monitored closely for hypoglycemia and hypokalemia.Insulin aspart is contraindicated for use in patients hypersensitive to the insulin or the excipients in the formulations. Minor, local sensitivity characterized by redness, swelling, or itching at the site of injection does not usually contraindicate therapy. Insulin aspart contains m-cresol and should be avoided in patients with m-cresol hypersensitivity; localized reactions and general myalgias have been reported with the use of cresol as an injectable excipient. Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash, pruritus, shortness of breath, wheezing, hypotension, tachycardia, and diaphoresis. Severe cases, including anaphylactoid reactions, may be life threatening.
Insulin aspart is classified as FDA pregnancy category B.[22299] In an open-label, randomized study of 322 women with type I diabetes mellitus (157 receiving insulin aspart and 165 receiving regular insulin), mean HbA1c (6% for both groups) and the incidence of maternal hypoglycemia were not different between the 2 groups. However, approximately two-thirds of the women were already pregnant when they were enrolled into the study, and the number of remaining participants was too small to evaluate congenital malformations. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 Units/kg/day and rabbits at a dose of 10 units/kg/day (approximately 32 times and 10 times the human subcutaneous dose of 1 unit/kg/day, respectively). The effects are probably secondary to maternal hypoglycemia at high doses as no significant effects were observed in rats at 8 times or rabbits at equivalent doses to the human subcutaneous dose of 1 unit/kg/day. Most experts recommend human insulin as the therapy of choice to maintain blood glucose as close to normal as possible during pregnancy in patients with Type 1 or 2 diabetes mellitus, and, if diet therapy alone is not successful, for those patients with gestational diabetes. In general, insulin requirements decline during the first trimester and increase during the second and third trimesters. Careful monitoring of the patient on insulin is required throughout pregnancy. Optimizing glycemic control before conception and during pregnancy appears to improve fetal outcome; this should include the avoidance of episodes of hypoglycemia as the toxic effects of maternal hypoglycemia on the fetus have been well-documented. During the perinatal period, careful monitoring of neonates born to mothers with diabetes is recommended. Post-partum, maternal insulin requirements may need adjustment.
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