Levemir Flexpen100 IU/ml

Levemir Flexpen 100 IU/ml is a long-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.Important Limitations of Use: Not recommended for treating diabetic ketoacidosis. Use intravenous, rapid acting or short-acting insulin instead.

Long Acting Insulin

The primary activity of Levemir Flexpen 100 IU/ml is the regulation of glucose metabolism. Insulins, including Levemir Flexpen 100 IU/ml, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Adult: In insulin-naive patients with type 2 DM who are not well controlled on oral antidiabetic drugs: Initial: 0.1 -0.2 unit/kg once daily in the evening or 10 unit 1-2 times/day, adjust subsequently based on glycaemic control.In patients on basal insulin only: May substitute with Levemir Flexpen 100 IU/ml on a unit-for-unit basis based on the current basal insulin dosage, adjust subsequently to achieve glycaemic targets.

Adult: In insulin-naive patients with type 2 DM who are not well controlled on oral antidiabetic drugs: Initial: 0.1 -0.2 unit/kg once daily in the evening or 10 unit 1-2 times/day, adjust subsequently based on glycaemic control.In patients on basal insulin only: May substitute with Levemir Flexpen 100 IU/ml on a unit-for-unit basis based on the current basal insulin dosage, adjust subsequently to achieve glycaemic targets.

Possible absence of hypoglycaemic warning symptoms with beta-blockers. Increased blood sugar with thiazide diuretics, corticosteriods, chlorpromazine, tibolone, isoniazid, niacin, some calcium-channel blockers such as diltiazem or nifedipine, diazoxide, lithium and thyroid hormones. Increased risk of hypoglycemia with disopyramide, larges doses of aspirin, gatifloxacin, MAOIs, mebanazine, nandrolone, pegvisomant, testosterone. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.

Levemir Flexpen 100 IU/ml is contraindicated in patients with hypersensitivity to Levemir Flexpen 100 IU/ml or any of its excipients. Reactions have included anaphylaxis

Hypoglycaemia, lipodystrophy, pruritus, rash, wt gain, sodium retention and oedema. Inj site reactions e.g. pain, itching, hives, swelling and inflammation. Influenza-like symptoms, Pallor, Palpitation, Tachycardia, Mental confusion, Weakness, Blurred vision, Itching, Hunger, Nausea.

Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.Nursing Mothers: It is unknown whether Insulin detemir is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, use caution when administering Insulin detemir to a nursing woman. Women with diabetes who are lactating may require adjustments of their insulin doses.

Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Continuous rotation of the inj site within a given area to reduce inj site reactions. Pregnancy, lactation

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. 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. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia

Unused (unopened) Levemir Flexpen 100 IU/ml should be stored in the refrigerator between 2° and 8°C. Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Levemir Flexpen 100 IU/ml if it has been frozen. Unused (unopened) Levemir Flexpen 100 IU/ml can be kept until the expiration date printed on the label if it is stored in a refrigerator. Keep unused Levemir Flexpen 100 IU/ml in the carton so that it stays clean and protected from light.If refrigeration is not possible, unused (unopened) Levemir Flexpen 100 IU/ml can be kept unrefrigerated at room temperature, below 30°C as long as it is kept as cool as possible and away from direct heat and light. Unrefrigerated Levemir Flexpen 100 IU/ml should be discarded 42 days after it is first kept out of the refrigerator, even if the FlexPen or vial still contains insulin.

Pediatric Use: The pharmacokinetics, safety and effectiveness of subcutaneous injections of Levemir Flexpen 100 IU/ml have been established in pediatric patients (age 6 to 17 years) with type 1 diabetes. Levemir Flexpen 100 IU/ml has not been studied in pediatric patients younger than 6 years of age with type 1 diabetes. Levemir Flexpen 100 IU/ml has not been studied in pediatric patients with type 2 diabetes. The dose recommendation when converting to Levemir Flexpen 100 IU/ml is the same as that described for adults. As in adults, the dosage of Levemir Flexpen 100 IU/ml must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.Geriatric Use: In controlled clinical trials comparing Levemir Flexpen 100 IU/ml to NPH insulin or insulin glargine, 64 of 1624 patients (3.9%) in the type 1 diabetes trials and 309 of 1082 patients (28.6%) in the type 2 diabetes trials were≥65 years of age. A total of 52 (7 type 1 and 45 type 2) patients (1.9%) were ≥75 years of age. Nooverall differences in safety or effectiveness were observed between these patients and younger patients, but small sample sizes, particularly for patients ≥65 years of age in the type 1 diabetes trials and for patients ≥75 years of age in all trials limits conclusions. Greater sensitivity of some older individuals cannot be ruled out. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be difficult to recognize in the elderly.

Long Acting Insulin

The primary activity of Levemir Flexpen 100 IU/ml is the regulation of glucose metabolism. Insulins, including Levemir Flexpen 100 IU/ml, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.Nursing Mothers: It is unknown whether Insulin detemir is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, use caution when administering Insulin detemir to a nursing woman. Women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric Use: The pharmacokinetics, safety and effectiveness of subcutaneous injections of Levemir Flexpen 100 IU/ml have been established in pediatric patients (age 6 to 17 years) with type 1 diabetes. Levemir Flexpen 100 IU/ml has not been studied in pediatric patients younger than 6 years of age with type 1 diabetes. Levemir Flexpen 100 IU/ml has not been studied in pediatric patients with type 2 diabetes. The dose recommendation when converting to Levemir Flexpen 100 IU/ml is the same as that described for adults. As in adults, the dosage of Levemir Flexpen 100 IU/ml must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.Geriatric Use: In controlled clinical trials comparing Levemir Flexpen 100 IU/ml to NPH insulin or insulin glargine, 64 of 1624 patients (3.9%) in the type 1 diabetes trials and 309 of 1082 patients (28.6%) in the type 2 diabetes trials were≥65 years of age. A total of 52 (7 type 1 and 45 type 2) patients (1.9%) were ≥75 years of age. Nooverall differences in safety or effectiveness were observed between these patients and younger patients, but small sample sizes, particularly for patients ≥65 years of age in the type 1 diabetes trials and for patients ≥75 years of age in all trials limits conclusions. Greater sensitivity of some older individuals cannot be ruled out. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be difficult to recognize in the elderly.