Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and the blood glucose values obtained while monitoring your blood glucose. Your dose of insulin should be injected subcutaneously under the skin or used in an insulin pump exactly as instructed by your doctor or diabetes educator.
The dose of insulin is measured in international units IU. Each mL of insulin contains IU. When insulin glulisine is injected under the skin, it should be given within 15 minutes before or within 20 minutes after starting a meal.
Longer-acting insulins are often used along with insulin glulisine to cover the periods of time between doses of insulin glulisine. There are many variations of insulin dosing.
To reduce irritation at the place of injection, allow insulin glulisine to reach room temperature before injecting. Insulin glulisine should be clear and colourless. Do not use the insulin if you notice anything unusual in the appearance of the solution, such as cloudiness, discoloration, or clumping.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor. It is important that this medication be used exactly as prescribed by your doctor.
The timing of insulin with respect to your meals is crucial to keeping blood glucose under control. Keep unopened insulin glulisine in the refrigerator until needed and use it before the expiry date on the label. Never allow insulin to freeze. Open vials can be refrigerated for up to 28 days. Insulin must not be exposed to extremely hot temperatures or to sunlight. Keep insulin out of the reach of children. Do not dispose of medications in wastewater e.
Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Do not use this medication if you are allergic to insulin glulisine or any ingredients of the medication. Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention. Stop taking the medication and seek immediate medical attention if any of the following occur:.
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.
These factors may affect how you should use this medication. Allergic reactions: If you notice signs of a serious allergic reaction swelling of the face or throat, difficulty breathing, wheezing, fast heart rate, sweating, low blood pressure, or itchy skin rash , stop using the medication and seek immediate medical attention.
Appearance of insulin: The contents of the vial of insulin glulisine should be clear and colourless. Do not use this medication if your notice anything unusual about its appearance, such as cloudiness, discoloration, or clumping. Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator.
It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.
Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:. It is important that your doctor know your current health situation and any changes that may affect the amount of insulin you need.
Blood glucose should be monitored regularly, as recommended by your doctor or diabetes educator. Diabetes identification: It is important to either wear a bracelet or necklace or carry a card indicating you have diabetes and are taking insulin. Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia low blood glucose. Keep a glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.
Insulin pumps: When used in an insulin pump, insulin glulisine should not be mixed with any other insulins or solutions. Low blood glucose hypoglycemia : Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. Symptoms of mild to moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, anxiety, irritability, trouble concentrating, fatigue, and numbness or tingling tongue, lips, or fingers.
Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. People taking insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks not diet soft drinks. Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures.
People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous into the vein glucose. Low blood sugar can impair your ability to drive or operate machinery. People who have frequent episodes of low blood sugar and people who are less aware of the warning symptoms of low blood sugar, should consider whether is it safe to drive or operate machinery.
Insulins inhibit lipolysis and proteolysis and enhance protein synthesis. Studies in healthy volunteers and patients with diabetes demonstrated that APIDRA has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously. On the x-axis, zero 0 is the start of a minute meal.
In a randomized, open-label, two-way crossover study, 16 healthy male subjects received an intravenous infusion of APIDRA or regular human insulin with saline diluent at a rate of 0. Pharmacokinetic profiles in healthy volunteers and patients with diabetes type 1 or type 2 demonstrated that absorption of insulin glulisine was faster than that of regular human insulin.
Insulin glulisine and regular human insulin were administered subcutaneously at a dose of 0. When APIDRA was injected subcutaneously into different areas of the body, the time-concentration profiles were similar. The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration are similar with volumes of distribution of 13 and 21 L and half-lives of 13 and 17 minutes, respectively.
After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes. The relative differences in pharmacokinetics and pharmacodynamics between APIDRA and regular human insulin in these patients with type 1 diabetes were similar to those in healthy adult subjects and adults with type 1 diabetes. A study in 24 healthy Caucasians and Japanese subjects compared the pharmacokinetics and pharmacodynamics after subcutaneous injection of insulin glulisine, insulin lispro, and regular human insulin.
There were similar findings with insulin lispro and regular human insulin. Studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure [see Use in Specific Populations 8.
Long-term carcinogenicity studies in animals have not been performed. In Sprague Dawley rats, a month study was conducted with insulin glulisine at subcutaneous doses of 2. There was a non-dose dependent higher incidence of mammary gland tumors in female rats administered insulin glulisine compared to untreated controls. The incidence of mammary tumors for insulin glulisine and regular human insulin was similar.
Insulin glulisine was not mutagenic in the following tests: Ames test, in vitro mammalian chromosome aberration test in V79 Chinese hamster cells, and in vivo mammalian erythrocyte micronucleus test in rats. The primary efficacy parameter in these trials was glycemic control, assessed using glycated hemoglobin GHb reported as HbA 1c equivalent.
Insulin glargine was administered once daily in the evening as the basal insulin. There was a 4-week run-in period with insulin lispro and insulin glargine prior to randomization. Fifty eight percent of the patients were men. The mean age was 39 years range 18 to 74 years. Glycemic control, the number of daily short-acting insulin injections and the total daily doses of APIDRA and insulin lispro were similar in the two treatment groups see Table 7. NPH human insulin was given twice a day as the basal insulin.
All patients participated in a 4-week run-in period with regular human insulin and NPH human insulin. The mean age was 58 years range 26 to 84 years. The average body mass index BMI was These patients were instructed to continue use of their oral antidiabetic agent at the same dose throughout the trial.
The reductions from baseline in GHb were similar between the 2 treatment groups see Table 8. No differences between APIDRA and regular human insulin groups were seen in the number of daily short-acting insulin injections or basal or short-acting insulin doses see Table 8. A week, randomized, open-label, active-controlled, non-inferiority study was conducted in patients with type 1 diabetes to assess the safety and efficacy of APIDRA administered at different times with respect to a meal.
Insulin glargine was administered once daily at bedtime as the basal insulin. There was a 4-week run-in period with regular human insulin and insulin glargine followed by randomization.
The mean age was 40 years range 18 to 73 years. Glycemic control see Table 9 was comparable for the 3 treatment regimens. No changes from baseline between the treatments were seen in the total daily number of short-acting insulin injections see Table 9.
Patients also received insulin glargine administered once daily in the evening or NPH insulin administered once in the morning and once in the evening. There was a 4-week run-in period with insulin lispro and insulin glargine or NPH prior to randomization. Fifty percent of the patients were male. The mean age was Mean BMI was Glycemic control see Table 10 was comparable for the two treatment regimens. All patients were Caucasian. The mean age was 46 years range 21 to 73 years.
The mean GHb increased from baseline to endpoint in both treatment groups from 6. Protect from light. Discard if it has been frozen. Opened vials, whether or not refrigerated, must be used within 28 days. The opened in-use SoloStar kept at room temperature must be discarded after 28 days.
Infusion sets reservoirs, tubing, and catheters and the APIDRA in the reservoir must be discarded after 48 hours of use or after exposure to temperatures that exceed Infusion bags in normal saline solution 0. Sharing carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions 5. Inform patients that hypoglycemia is the most common adverse reaction with insulin.
Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of APIDRA therapy.
Instruct patients on handling of special situations such as intercurrent conditions illness, stress, or emotional disturbances , an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions 5.
Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery. Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions 5.
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions 5. Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see Warnings and Precautions 5. Inform patients to replace the infusion sets reservoir, tubing, and catheter and the APIDRA in the reservoir at least every 48 hours and select a new infusion site.
The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing, or sport case is exposed to sunlight or radiant heat. Discard insulin exposed to temperatures higher than Instruct patients to report infusion sites that are erythematous, pruritic, or thickened to their healthcare professional and select a new site.
Inform patients that pump or infusion set malfunctions or handling errors or insulin degradation can lead to rapid hyperglycemia, and ketosis and diabetic ketoacidosis.
Instruct patients to resume therapy with subcutaneous insulin injection and contact their healthcare professional if pump problems cannot be promptly corrected [see Dosage and Administration 2.
Other brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U. Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Do the injection exactly as shown to you by your healthcare provider. Be sure to read, understand, and follow these instructions before using APIDRA with an external insulin infusion pump.
Always read the instruction manual for your pump. These instructions may differ from the instructions that accompany your insulin infusion pump. If you get reactions at the injections infusion site you may need to change infusion sites more often.
Keep this leaflet in case you need to look at it again later. You can select a dose from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose.
The plunger will only move to the end of the cartridge when units of insulin have been given. Do not reuse needles. Always use a new sterile needle for each injection to help prevent you from getting a serious infection contamination and potential needle blocks.
Please note: Pen needles may look different. The pen needles shown are for illustrative purposes only. The safety test:. You can select the insulin dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose larger than 80 units, you should give it as two or more injections.
This helps prevent:. Approval: Inspect visually for particulate matter and discoloration. APIDRA may be administered by subcutaneous injection, by continuous subcutaneous infusion insulin pump , or intravenously [see Dosage and Administration 2.
Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns i. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions 5.
During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions 5. APIDRA given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin.
Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not dilute or mix insulins in external insulin pumps. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Patients administering APIDRA by continuous subcutaneous infusion must have an alternative insulin delivery system in case of pump system failure [see Warnings and Precautions 5.
Intravenous Administration Administer APIDRA intravenously only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions 5. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.
Risk Mitigation Strategies for Hypoglycemia Patients and caregivers must be educated to recognize and manage hypoglycemia. Insulin Initiation and Intensification of Glucose Control Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy.
Lipodystrophy Long-term use of insulin, including APIDRA, can cause lipodystrophy at the site of repeated insulin injections or infusion. Peripheral Edema Insulin, including APIDRA, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Weight Gain Weight gain can occur with insulin therapy, including APIDRA, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when APIDRA is coadministered with these drugs. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Data Animal data Insulin glulisine was given to pregnant female rabbits during gestation at doses up to 1.
Chemically, insulin glulisine is 3 B -lysine B -glutamic acid-human insulin, has the empirical formula C 25 8 H 38 4 N 6 4 O 7 8 S 6 and a molecular weight of and has the following structural formula: APIDRA insulin glulisine injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use.
Distribution and Elimination The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration are similar with volumes of distribution of 13 and 21 L and half-lives of 13 and 17 minutes, respectively. Race A study in 24 healthy Caucasians and Japanese subjects compared the pharmacokinetics and pharmacodynamics after subcutaneous injection of insulin glulisine, insulin lispro, and regular human insulin.
Obesity Insulin glulisine and regular human insulin were administered subcutaneously at a dose of 0. Renal impairment Studies with human insulin have shown increased circulating levels of insulin in patients with renal failure.
Do not use after the expiration date see carton and container. Open In-Use Vial Opened vials, whether or not refrigerated, must be used within 28 days. Use in an External Insulin Pump Infusion sets reservoirs, tubing, and catheters and the APIDRA in the reservoir must be discarded after 48 hours of use or after exposure to temperatures that exceed Intravenous Use Infusion bags in normal saline solution 0.
Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Hypoglycemia due to Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions 5. LLC Other brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.
Food and Drug Administration. APIDRA is a fast rapid acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus. Before using APIDRA, tell your healthcare provider about all your medical conditions including if you: have liver or kidney problems. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the best time for you to take your insulin. This may change if you take a different type of insulin or if the way you give your insulin changes, for example, using an insulin pump instead of giving injections under the skin subcutaneous injections.
Check your insulin label each time you give your injection to make sure you have the correct insulin. This is especially important if you also take long-acting insulin. Always use a new needle for each injection.
Using a new needle for each injection lowers your risk of getting an infection. APIDRA is injected under the skin subcutaneously of your upper arms, thighs, buttocks, or stomach area abdomen , or by continuous infusion under the skin subcutaneously through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump. Change rotate injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy pits in skin or thickened skin and localized cutaneous amyloidosis skin with lumps at the injection sites: Do not use the exact same spot for each injection.
Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly, or hard, or into scars or damaged skin. Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
Your dose of APIDRA may need to change because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take. APIDRA may cause serious side effects that can lead to death, including: low blood sugar hypoglycemia.
Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, trouble concentrating or confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger severe allergic reaction whole body reaction. Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, shortness of breath, trouble breathing, fast pulse, sweating, or feeling faint low potassium in your blood hypokalemia.
This can happen even if you have never had heart failure or heart problems before. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, swelling of your ankles or feet, sudden weight gain. Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion. The most common side effects of APIDRA include: low blood sugar hypoglycemia , weight gain, itching, rash, swelling, allergic reactions including reactions at your injection site, skin thickening or pits at the injection site lipodystrophy.
Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about APIDRA that is written for health professionals. Active ingredient: insulin glulisine Inactive ingredients: metacresol, tromethamine, sodium chloride, polysorbate 20, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.
Choose an injection area upper arm, thigh, or stomach area. Change rotate your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy pits in the skin or thickened skin and localized cutaneous amyloidosis skin with lumps at the injection sites.
Do not inject into the exact same spot for each injection. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Inject the mixture right away.
Use the needles and syringes prescribed by your healthcare provider. Do not reuse or share your syringes with other people. Before every injection make sure you have the following items: Alcohol swabs Needle and syringe Insulin vial Puncture resistant container.
See " How do I dispose of used needles and syringes? Drawing the insulin into a syringe 1. Preparing for an injection 2. Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. It should look clear. If you are using a new vial, remove the protective cap.
Do not remove the stopper. Wipe the rubber stopper with an alcohol swab. Use a new needle and syringe for each injection. Use disposable syringes and needles only one time. Draw air into the syringe equal to the insulin dose prescribed by your healthcare provider.
Put the needle through the rubber stopper of the vial and push the plunger to inject the air into the vial. Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin solution. With your free hand, pull back on the plunger to draw the correct dose of insulin into the syringe. Before you take the needle out of the vial, check the syringe for air bubbles.
If you see bubbles in the syringe, hold the syringe straight up and tap the side of the syringe with your finger a few times to make any air bubbles float to the top. Gently push the air bubbles out with the plunger and draw insulin back into the syringe until you have the correct dose.
Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject. Giving the injection Do the injection exactly as shown to you by your healthcare provider. Choose an injection area for example upper arm, thigh or stomach area. Change injection sites within the area you choose. Do not inject in the same spot. Clean the area with an alcohol swab. Let the injection site dry before you inject. Pinch the skin.
Insert the needle into the skin. Release the skin. Inject the dose by slowly pushing in the plunger of the syringe all the way, making sure you have injected all the insulin. Keep the needle in the skin for at least 10 seconds. Pull the needle out of your skin, gently press the injection site with a finger for several seconds. Do not rub the area.
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