Question

Drug card for Anti-Diabetic Drugs

Rapid acting:

• lispro (Humalog)

Answer 1

DRUG : Insulin lispro CLASSES: Rapid-acting Human Insulins and Analogs COMMON BRAND NAMES: Admelog, Admelog SoloStar, Humalog, Humalog Junior KwikPen, Humalog KwikPen.

INDICATIONS: HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

DOSAGE: For the treatment of type 1 diabetes mellitus. Intermittent subcutaneous dosage Adults Insulin lispro is equipotent to regular insulin, but with more rapid activity and a shorter duration of action when given via intermittent subcutaneous injection. The total daily dose is given as 2 to 4 subcutaneous injections, within 15 minutes before or immediately after a meal to avoid hypoglycemia. Total daily insulin requirements vary between patients and depend on the patient's clinical condition and diet; however, a common dosage range is 0.5 to 1 unit/kg/day. In general, 50 to 70% of total daily insulin requirements may be provided by insulin lispro; the remainder should be provided by an intermediate- or long-acting insulin. A common regimen is to administer insulin lispro just prior to the beginning of each meal with a dose of basal insulin (i.e., insulin glargine or insulin detemir) once daily. Insulin lispro can be given in combination with NPH or Lente insulin as 2 daily injections; about two-thirds of the daily insulin dose is given before breakfast and about one-third is given before the evening meal. An intermediate-to-insulin lispro ratio of 2:1 can be given within 5 to 10 minutes of breakfast and an intermediate-to-insulin lispro ratio of 1:1 can be given 5 to 10 minutes before dinner. Alternatively, the evening dose of intermediate insulin can be given at bedtime rather than at dinner. Children and Adolescents 3 years and older Insulin requirements are highly variable and must be individualized based on patient-specific factors and type of insulin regimen. During partial remission phase, total combined daily insulin requirement is often less than 0.5 units/kg/day. Prepubertal children (outside the partial remission phase) usually require 0.7 to 1 unit/kg/day. During puberty, insulin requirements are much greater, often between 1 to 2 units/kg/day. Administer pre-meal doses of insulin lispro immediately before a meal (i.e., meal starts within 15 minutes after injection). Alternatively, insulin lispro can be given immediately after eating. Use insulin lispro in combination with intermediate- or long-acting insulin as part of twice-daily regimens or basal-bolus regimens. Twice daily insulin regimens consist of 2 subcutaneous insulin injections given per day; approximately two-thirds of the total daily insulin dose is given in the morning and one-third in the evening. Initially, for each insulin dose, approximately one-third is given as a rapid-acting insulin and the other two-thirds is an intermediate-acting insulin. These ratios may change based on individual response. Basal-bolus regimens typically consist of 4 to 5 subcutaneous insulin injections given per day; 1 to 2 as an intermediate- or long-acting insulin plus 3 to 4 pre-meal rapid-acting insulin doses. Depending on the type of insulin used as the basal insulin, the proportion supplied as the rapid-acting insulin usually ranges from 40 to 60% of the total daily dose. Continuous subcutaneous infusion dosage (insulin lispro 100 units/mL only) Adults When insulin lispro 100 units/mL is used in an external insulin pump via continuous subcutaneous insulin infusion (CSII), the total daily dose should be based on the insulin dose from the previous regimen. Initially, 50% of the total dose can be given as meal-related boluses and the remainder as a basal infusion; therapy is provided by a professional team trained in CSII therapy and capable of supporting patient care continuously (i.e., 24-hours/7 days-a-week). NOTE: Use Admelog or Humalog 100 units/mL only. Do NOT administer Humalog 200 units/mL using a continuous subcutaneous infusion pump. Children and Adolescents 3 years and older When used in an external insulin pump via continuous subcutaneous insulin infusion (CSII), base the total daily subcutaneous dose on the insulin dose from the previous regimen. Initially, 50% of the total dose can be given as meal-related boluses and the remainder as a basal subcutaneous infusion. Infuse pre-meal boluses immediately before meals. NOTE: Use Admelog or Humalog 100 units/mL only. Do NOT administer Humalog 200 units/mL using a continuous subcutaneous infusion pump. Intravenous dosage (infusions prepared with insulin lispro 100 units/mL only) Adults Insulin lispro 100 units/mL can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Insulin lispro should be diluted and used intravenously at concentrations ranging from 0.1 unit/mL to 1 unit/mL in infusion systems containing 0.9% Sodium Chloride Injection. One study in 21 patients with type 1 diabetes (n = 21, starting blood glucose of 200 to 260 mg/dL) used an initial human lispro rate of 0.5 units/hour intravenously as a continuous infusion. The infusion rate was individualized and adjusted at regular timed intervals to achieve and maintain blood glucose concentrations between 100 and 160 mg/dL. All patients achieved the targeted glucose range at some point during the 6-hour assessment phase. NOTE: Use Admelog or Humalog 100 units/mL only to prepare infusions. Do NOT administer Humalog 200 units/mL intravenously.

DOSING CONSIDERATIONS Hepatic Impairment Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available. Some studies have noted increased circulating levels of insulin in patients with hepatic failure. Individualize dosage based on blood glucose and other clinical parameters. Renal Impairment The pharmacokinetics of insulin are generally unchanged with renal impairment, however, pharmacodynamic differences occur in insulin sensitivity as renal function declines, resulting in increased responses to a given dosage. Individualize dosage based on blood glucose and other clinical parameters.

SIDE EFFECTS: Get emergency medical help if you have signs of insulin allergy to Humalog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat. Call your doctor at once if you have: weight gain, swelling in your hands or feet, feeling short of breath; or low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling. Common Humalog side effects may include: low blood sugar; itching, mild skin rash; or thickening or hollowing of the skin where you injected the medicine.

ADMINISTRATION Injectable Administration Administer insulin lispro 100 mg/mL by subcutaneous injection or intravenous infusion only. Do not administer by intramuscular injection. Humalog U-200 insulin is for subcutaneous injection only; do NOT give Humalog U-200 insulin intravenously or by intramuscular injection. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use injections which are unusually viscous, cloudy, or discolored. Patients using insulin vials should never share needles or syringes with another person. Insulin Pens: The insulin pens should never be shared among patients. Even if the disposable needle is changed, sharing may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Do not share pens among multiple patients in an inpatient setting; use multidose vials instead, if available, or, reserve the use of any pen to 1 patient only. Ensure that the patient knows how to use the type of pen needles being dispensed. For standard pen needles with an outer cover and an inner needle cover, remove both covers before use. For the safety pen needle, remove only the outer cover; the fixed inner needle shield remains in place. Intravenous Administration Insulin lispro can be administered intravenously under medical supervision; use insulin lispro 100 units/mL only to prepare intravenous infusions. Do NOT administer Humalog U-200 intravenously. Close monitoring of blood glucose and potassium levels are required to avoid hypoglycemia and hypokalemia. Infusion systems containing 0.9% NaCl injection should be used to prepare the infusion. Appropriate infusion concentrations range from 0.1 Unit/mL to 1 Unit/mL. Storage of Humalog infusion: Infusion bags prepared with insulin lispro U-100 are stable when stored in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F) for 48 hours and then may be used at room temperature for up to an additional 48 hours. Storage of Admelog infusion: Infusion bags prepared with insulin lispro U-100 are stable when stored in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F) for 24 hours and then may be used at room temperature for up to 4 hours. Subcutaneous Administration When using insulin lispro 100 units/mL, ONLY use insulin syringes marked in insulin units. There may be differences in the way units are indicated, depending on the size of the syringe and the manufacturer. Insulin syringes are manufactured with 0.25-mL, 0.3-mL, 0.5-mL, and 1-mL capacity. Various lengths of needles are available: short (5, 6 mm) and long (8, 12.7 mm), studies have confirmed equal efficacy and safety/tolerability with short-length needles as compared to longer ones, even in obese patients. Do NOT use insulin syringes for Humalog U-200, as the markings on an insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia. Preferable administration for insulin lispro is within 15 minutes before or immediately after a meal. Subcutaneous injections are usually made into the anterior and lateral aspects of the thigh, the upper arms, the buttocks, or the abdomen. Double-check dosage in syringe or pen prior to administration. Lightly pinch a fold of skin; insert the needle; release the skin; inject at a 90 degree angle. Children or thin individuals can use a short needle and a 45 degree angle to avoid intramuscular injection. Aspiration is not necessary. Inject over 2 to 4 seconds. The needle should be remain in the skin for 5 seconds after injection to ensure complete delivery of the dose. Rotate administration sites with each injection to prevent lipodystrophy. However, staying within the same area (e.g., abdomen) is generally recommended to decrease the variability in insulin absorption from dose to dose. This is especially important with insulin lispro as it is has a slightly shorter duration of action following abdominal injection when compared to other injection sites.

PRECAUTIONS Never Share A HUMALOG KwikPen, Cartridge, Reusable Pen Compatible With Lilly 3 mL Cartridges1, Or Syringe Between Patients HUMALOG KwikPens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using HUMALOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens. Hyper-Or Hypoglycemia With Changes In Insulin Regimen: Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and under close medical supervision and the frequency of blood glucose monitoring should be increased. Hypoglycemia: Hypoglycemia is the most common adverse reaction associated with insulins, including HUMALOG. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia.

CONTRAINDICATION: Humalog is contraindicated: during episodes of hypoglycemia in patients who are hypersensitive to Humalog or to any of its excipients.

MECHANISM OF ACTION: Endogenous insulin regulates carbohydrate, fat, and protein metabolism by several mechanisms; in general, insulin promotes the storage and inhibits the breakdown of glucose, fat, and amino acids. Insulin lowers glucose concentrations by facilitating the uptake of glucose in muscle and adipose tissue and by inhibiting hepatic glucose production (glycogenolysis and gluconeogenesis). Insulin also regulates fat metabolism by enhancing the storage of fat (lipogenesis) and inhibiting the mobilization of fat for energy in adipose tissues (lipolysis and free fatty acid oxidation). Finally, insulin is involved in the regulation of protein metabolism by increasing protein synthesis and inhibiting proteolysis in muscle tissue. Diabetes mellitus type 1 is caused by insulin deficiency while diabetes mellitus type 2 is caused by a combination of insulin deficiency and resistance. Biosynthetic insulin is used as replacement therapy in patients with diabetes mellitus to temporarily restore their ability to use fats, carbohydrates, and proteins, and to convert glycogen to fat. Insulin administration also enables these patients to replete their liver glycogen stores.

PHARMACOKINETICS: Absorption: Rapidly absorbed from IM and SC injection sites. Onset: <15 min. Peak: 0.5–1 h. Duration: 3–4 h. Distribution: Throughout extracellular fluids. Metabolism: Metabolized in liver with some metabolism in kidneys. Elimination: <2% excreted in urine. Half-Life: Biological, up to 13 h.

NURSING IMPLICATIONS: Assessment & Drug Effects Monitor patient response to therapy (stabilization of blood glucose levels). Monitor for adverse effects (hypoglycemia, ketoacidosis, injection-site irritation). Assess for hypoglycemia from 1 to 3 h after injection. Evaluate patient understanding on drug therapy by asking the patient to name the drug, its indication, and adverse effects to watch for. Monitor patient compliance to drug therapy. Assess highly insulin-dependent patients for need for increases in intermediate/long-acting insulins. Advise patient not to breast feed while taking this drug without consulting physician.