HUMALOG 200 U/ml KwikPen Injection

HUMALOG 200 U/ml KwikPen Injection is used for: Diabetes mellitus

Subcutaneous Type 1 diabetes mellitus Approximately one third of the total daily insulin requirements SC; rapid-acting or short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements Usual daily maintenance range is 0.5-1 unit/kg/day in divided doses; nonobese may require 0.4-0.6 unit/kg/day; obese may require 0.8-1.2 units/kg/day Type 2 diabetes mellitus Type 2 diabetes mellitus inadequately controlled with oral medication Adult: SC Usual range: 0.5-1 u/kg/day. Rapid-acting formulations, such as insulin lispro, given before meals with an intermediate- or long-acting insulin as a dose of 10 units/day SC (or 0.1-0.2 unit/kg/day) given at bedtime generally recommended Continuous SC injection (insulin pump) May be administered by continuous SC infusion in the abdominal wall Do not use diluted or mixed insulins in external insulin pumps Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy Continuous subcutaneous infusion pump (i.e., insulin pump) not for Insulin Lispro U-200 administration;Insulin Lispro U-100 only Initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen Intravenous Administration Dilute Insulin Lispro U-100 to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% sodium chloride. Administer Insulin Lispro U-100 intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia Dosing Considerations When given subcutaneously, insulin lispro has a more rapid onset of action and a shorter duration of action than regular human insulin Dosage must be individualized; blood glucose monitoring is essential in all patients receiving insulin therapy Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs

Type I Diabetes Mellitus Rapid-acting human insulin analogue indicated to improve glycemic control in adults and children with diabetes mellitus <3 years: Safety and efficacy not established >3 years: May require 0.8-1.2 units/kg/day SC during growth spurts; otherwise, use adult dosing (0.5-1 unit/kg/day)

Renal impairment: Dose reduction may be needed.

Administer within 15 minutes before a meal or immediately after a meal by injection into the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy, rotate the injection site within the same region from one injection to the next.

Hypoglycaemia.Hypersensitivity to any of the components.

Renal or hepatic impairment; pregnancy, lactation; transferring from other insulin. Monitor serum glucose, potassium, electrolytes, HbA1c and lipid profile. Concomitant illness esp infections. Lactation: Considered safe for use during breastfeeding

Pregnancy Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy Diabetes or gestational diabetes patients’ insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery Female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking insulin lispro Published studies with human insulins suggest optimizing overall glycemic control (eg, postprandial control, before conception, during pregnancy) improves fetal outcome Limited available data with Admelog in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity Animal data In a combined fertility and embryo-fetal development study, female rats were given SC insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human SC dose of 1 unit/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through gestation day 19; fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter Lactation There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; one small published study reported that exogenous insulin was present in human milk; however, there is insufficient information to determine effects of drug on breastfed infant and no available information on effects on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for insulin, any potential adverse effects on breastfed child from drug or from underlying maternal condition

Effects may be increased by: oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics. Effects may be decreased by: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, oral contraceptives, lithium. Signs of hypoglycaemia may be masked by beta-blockers, clonidine.

Side effects of Insulin Lispro : Hypoglycaemia; hypokalemia, oedema; pruritus; pulpitation, nausea, rash; hypersensitivity reactions; lipoatropy or lipohypertrophy with SC Inj.

Insulin lispro, a rapid-acting analog of human insulin, lowers blood glucose levels. It regulates carbohydrate, protein and fat metabolism by inhibiting hepatic glucose production and lipolysis, and enhancing peripheral glucose disposal.

HUMALOG 200 U/ml KwikPen 200 U/ml Injection manufactured by ELI LILLY AND COMPANY. Its generic name is Insulin Lispro. HUMALOG 200 U/ml KwikPen is availble in United Arab Emirates. Farmaco UAE drug index information on HUMALOG 200 U/ml KwikPen Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.