Insulin aspart must be injected. Learn all preparation and usage instructions, including how to inject this medication properly and how to self-manage your diabetes (e.g., monitoring blood glucose, recognizing and treating high/low blood sugar). Your health care professional will teach you how to use this medication. Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor, diabetes educator, or pharmacist. Before using, inspect this product visually for particles or discoloration. If either is present, do not use the insulin. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid developing problem areas under the skin (lipodystrophy). To reduce discomfort at the injection site, do not inject cold insulin. The insulin container you are currently using can be kept at room temperature. Insulin aspart may be injected in the abdominal wall, the thigh, or the back of the upper arm. Inject this medication under the skin within 5-10 minutes before eating a meal or as directed by your doctor. Because this insulin is fast-acting, not eating immediately after a dose of this insulin may lead to low blood sugar (hypoglycemia). After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area. The dosage is based on your medical condition and response to therapy. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar levels. Check your urine/blood sugar as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Giving insulin aspart into a vein should only be done in a medical office, clinic, or hospital. Severe low blood sugar may result. Also, it should not be injected into a muscle. If you are directed to inject this insulin with an infusion pump, read the instruction manual and directions that come with the infusion pump. If you have any questions, consult your doctor, diabetes educator, or pharmacist. Avoid exposing the pump or its tubing to direct sunlight or other heat sources. This product may be mixed only with certain other insulin products such as NPH insulin. Always draw the insulin aspart into the syringe first, then follow with the longer-acting insulin. Consult your pharmacist about which products may be mixed and the proper method for mixing insulin. Never inject a mixture of different insulins into a vein. Do not mix or dilute insulins if you are using an insulin pump. Do not change brands or types of insulin without directions on how to do so from your doctor. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Before using insulin aspart, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients (such as cresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Do not use this medication when you have low blood sugar (hypoglycemia). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia. During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication or how often you test your blood sugar may be required. Check your blood sugar readings before and after exercise. You may need a snack beforehand. If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you. The elderly may be more sensitive to the effects of this drug, especially hypoglycemia. Children may be more sensitive to the effects of this drug, especially hypoglycemia. When used in children, diluting insulin aspart before injecting is recommended. Ask your pharmacist about the correct way to dilute insulin. Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details. This medication does not pass into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: rosiglitazone. Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs. Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.

Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if this unlikely but serious side effect occurs: muscle pain. This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.) or if you have taken too much insulin aspart. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar level by eating a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal. Too little insulin aspart can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, fast heartbeat, sweating, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Insulin aspart must be injected. Learn all preparation and usage instructions, including how to inject this medication properly and how to self-manage your diabetes (e.g., monitoring blood glucose, recognizing and treating high/low blood sugar). Your health care professional will teach you how to use this medication. Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor, diabetes educator, or pharmacist. Before using, inspect this product visually for particles or discoloration. If either is present, do not use the insulin. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid developing problem areas under the skin (lipodystrophy). To reduce discomfort at the injection site, do not inject cold insulin. The insulin container you are currently using can be kept at room temperature. Insulin aspart may be injected in the abdominal wall, the thigh, or the back of the upper arm. Inject this medication under the skin within 5-10 minutes before eating a meal or as directed by your doctor. Because this insulin is fast-acting, not eating immediately after a dose of this insulin may lead to low blood sugar (hypoglycemia). After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area. The dosage is based on your medical condition and response to therapy. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar levels. Check your urine/blood sugar as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Giving insulin aspart into a vein should only be done in a medical office, clinic, or hospital. Severe low blood sugar may result. Also, it should not be injected into a muscle. If you are directed to inject this insulin with an infusion pump, read the instruction manual and directions that come with the infusion pump. If you have any questions, consult your doctor, diabetes educator, or pharmacist. Avoid exposing the pump or its tubing to direct sunlight or other heat sources. This product may be mixed only with certain other insulin products such as NPH insulin. Always draw the insulin aspart into the syringe first, then follow with the longer-acting insulin. Consult your pharmacist about which products may be mixed and the proper method for mixing insulin. Never inject a mixture of different insulins into a vein. Do not mix or dilute insulins if you are using an insulin pump. Do not change brands or types of insulin without directions on how to do so from your doctor. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Before using insulin aspart, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients (such as cresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Do not use this medication when you have low blood sugar (hypoglycemia). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia. During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication or how often you test your blood sugar may be required. Check your blood sugar readings before and after exercise. You may need a snack beforehand. If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you. The elderly may be more sensitive to the effects of this drug, especially hypoglycemia. Children may be more sensitive to the effects of this drug, especially hypoglycemia. When used in children, diluting insulin aspart before injecting is recommended. Ask your pharmacist about the correct way to dilute insulin. Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details. This medication does not pass into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: rosiglitazone. Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs. Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.

Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if this unlikely but serious side effect occurs: muscle pain. This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.) or if you have taken too much insulin aspart. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar level by eating a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal. Too little insulin aspart can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, fast heartbeat, sweating, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the patient information leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Follow all package directions for proper use/injection/storage of the particular type of device/insulin you are using. Your health care professional will teach you how to properly inject this medication. If any of the information is unclear, consult your doctor or pharmacist. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature (see also Storage section). Wash your hands before measuring and injecting insulin. Check the product visually for particles, thickening, or clumps before rolling and turning the container. If any are present, discard that container. To avoid damaging the insulin, do not shake the container. Gently roll and turn it between your palms at least 10 times. If using a cartridge or pen, turn it upside down so that the glass ball moves from one end to the other. Gently mix the insulin until it appears evenly white and cloudy. If it does not appear this way, discard it. The dosage is based on your medical condition and response to treatment. Measure each dose carefully, and use exactly as prescribed by your doctor. Even small changes in the amount of insulin may have a large effect on your blood sugar levels. Before injecting each dose, make sure the injection site is clean and dry. Inject this medication under the skin of the abdomen, upper arms, or thighs, usually twice daily, 15 minutes or less before the morning and evening meal or as directed by your doctor. Do not inject into a vein or muscle. Eat promptly after taking this insulin to avoid low blood sugar (see also Side Effects section). Change the location of the injection site daily and do not reuse the same site for two weeks to avoid problem areas under the skin. Do not mix this product with other insulins or use it in an insulin pump. Use this medication regularly as directed by your doctor in order to get the most benefit from it. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended. Monitor your blood sugar on a regular basis. Keep track of the results, and share them with your doctor. This is very important in order to determine the correct insulin dose. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage may need to be changed. If you are measuring doses from vials, do not reuse needles and syringes. If you are using the cartridges or pens, use a new needle each time. Learn how to discard needles and medical supplies safely. Consult your pharmacist for more information.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: rosiglitazone. Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet. Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet. Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs. Check the labels on all your medicines (such as cough-and-cold products) carefully. Some products may contain sugar or alcohol and may affect your blood sugar levels. Ask your doctor or pharmacist about using these products safely. Other medications can affect the results of urine tests for sugar or ketones. Consult your doctor or pharmacist for more information.

Side Effects info...

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease. Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor immediately if you experience symptoms of high or low blood sugar. Do not use this medication when you have low blood sugar. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar. During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your treatment plan may be required. Changes in your lifestyle or activity level may affect the amount of insulin your body needs to control blood sugar levels. If you notice an unusual change in your insulin needs, tell your doctor. Check your blood sugar before and after exercise. You may need a snack before exercising. If traveling across more than two time zones, ask your doctor about how to adjust your insulin schedule. Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Before using TOPICORT, tell your doctor if you have, or have ever had:

• Diabetes
• Cushing's syndrome (an overproduction of cortisol by the adrenal gland)
• Circulation problems
• Any condition that affects your immune system, such as HIV/AIDS or severe combined immunodeficiency (SCID)
• Intracranial hypertension (increased pressure in the head)
• A skin infection
• Thinning of the skin or other skin conditions
• Liver disease
• A recent vaccination
• Measles
• Tuberculosis (TB)
• Chickenpox or shingles
• Glaucoma or cataracts (eye conditions)
• Allergies to medicines

If you have diabetes, TOPICORT may raise your blood sugar levels. Be sure to monitor your condition carefully.

Treatment with TOPICORT may lead to an increase or decrease in the level of steroid hormones in your body.

Don't use this medicine for longer than four consecutive weeks, unless your doctor tells you otherwise.

Using too much TOPICORT — or using this medicine for a long period of time — may raise your risk of developing adrenal gland problems.

Tell your doctor right away if you experience any of the following symptoms:

• Blurred vision
• Dizziness or fainting
• Fast or irregular heartbeat
• Irritability, depression, or anxiety
• Unusual tiredness or weakness
• Increased thirst or urination
• Unusual weight gain, especially in the face or abdomen
• New or worsening high blood pressure
• Loss of appetite or weight loss
• Muscle weakness

Steroids may affect growth in some children and teens. Talk to your doctor if this is a concern.

Don't use this medicine on a child under age 10 without consulting with a doctor.

Tell your healthcare provider you're using TOPICORT before having any type of medical or dental procedure.

Let your doctor know if your symptoms worsen or don't improve after a few days of treatment with TOPICORT.

If you use this medicine long-term, your healthcare provider will check your blood often to monitor your condition. Keep all appointments with your doctor and laboratory.

Pregnancy and TOPICORT

It's not known whether TOPICORT could harm an unborn baby if used during pregnancy.

Tell your doctor if you're pregnant, or might become pregnant, while using this medicine.

It's also unknown whether TOPICORT passes into breast milk. Talk to your doctor before breastfeeding a baby while using this drug.

Common Side Effects of TOPICORT

Tell your doctor if any of the following side effects become severe or don't go away:

• Mild skin itching, dryness, burning, or peeling
• Irritation around the mouth
• Swollen hair follicles
• Unwanted hair growth
• Blisters, pimples, or crusting of the skin
• Stretch marks
• Changes in color of the treated skin

Serious Side Effects of TOPICORT

Tell your doctor right away if you experience any of the symptoms listed in the TOPICORT Warnings section above, or the following serious side effects:

• Severe skin irritation or rash
• Insomnia
• Signs of an infection, which may include redness, swelling, or oozing of the skin
• Signs of anaphylaxis, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Medication that suppresses the immune system, such as Imuran or Azasan (azathioprine), Gengraf, Neoral, or Sandimmune (cyclosporine), Rheumatrex or Trexall (methotrexate), Rapamune (sirolimus), or Prograf (tacrolimus)
• Other medicines that contain corticosteroids
• Other topical medicines
• Vitamins

TOPICORT comes as an ointment, cream, spray, or gel to apply to the skin.

It's typically applied twice a day.

Follow the instructions on your package label carefully. Don't use more or less TOPICORT than is recommended.

Wash your hands before and after using this medicine, unless your hands are being treated.

Apply a small amount of TOPICORT to the affected area, and rub it in gently.

Don't apply this medicine over a large area of the skin.

Ask your doctor before using cosmetics or other skin products on areas of your body that are being treated with TOPICORT.

Don't wrap or bandage treated areas of your skin unless your doctor tells you to do so. Follow your healthcare provider's instructions carefully if you need to apply a wrap or bandage.

If you're applying TOPICORT to a baby's diaper area, avoid dressing your child in plastic pants or tight-fitting diapers.

Don't use this medicine on your face, underarms, or groin area unless your doctor tells you otherwise.

Try not to get TOPICORT in your eyes. If you do, flush them immediately with water.

TOPICORT Overdose

If you suspect an overdose of TOPICORT or accidentally swallow this medicine, contact a poison control center or emergency room immediately.

Missed Dose of TOPICORT

If you miss a dose of TOPICORT, apply it as soon as you remember.

But if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular application schedule.

Don't apply extra medicine to make up for a missed dose.

Before using TOPICORT, tell your doctor if you have, or have ever had:

• Diabetes
• Cushing's syndrome (an overproduction of cortisol by the adrenal gland)
• Circulation problems
• Any condition that affects your immune system, such as HIV/AIDS or severe combined immunodeficiency (SCID)
• Intracranial hypertension (increased pressure in the head)
• A skin infection
• Thinning of the skin or other skin conditions
• Liver disease
• A recent vaccination
• Measles
• Tuberculosis (TB)
• Chickenpox or shingles
• Glaucoma or cataracts (eye conditions)
• Allergies to medicines

If you have diabetes, TOPICORT may raise your blood sugar levels. Be sure to monitor your condition carefully.

Treatment with TOPICORT may lead to an increase or decrease in the level of steroid hormones in your body.

Don't use this medicine for longer than four consecutive weeks, unless your doctor tells you otherwise.

Using too much TOPICORT — or using this medicine for a long period of time — may raise your risk of developing adrenal gland problems.

Tell your doctor right away if you experience any of the following symptoms:

• Blurred vision
• Dizziness or fainting
• Fast or irregular heartbeat
• Irritability, depression, or anxiety
• Unusual tiredness or weakness
• Increased thirst or urination
• Unusual weight gain, especially in the face or abdomen
• New or worsening high blood pressure
• Loss of appetite or weight loss
• Muscle weakness

Steroids may affect growth in some children and teens. Talk to your doctor if this is a concern.

Don't use this medicine on a child under age 10 without consulting with a doctor.

Tell your healthcare provider you're using TOPICORT before having any type of medical or dental procedure.

Let your doctor know if your symptoms worsen or don't improve after a few days of treatment with TOPICORT.

If you use this medicine long-term, your healthcare provider will check your blood often to monitor your condition. Keep all appointments with your doctor and laboratory.

Pregnancy and TOPICORT

It's not known whether TOPICORT could harm an unborn baby if used during pregnancy.

Tell your doctor if you're pregnant, or might become pregnant, while using this medicine.

It's also unknown whether TOPICORT passes into breast milk. Talk to your doctor before breastfeeding a baby while using this drug.

Common Side Effects of TOPICORT

Tell your doctor if any of the following side effects become severe or don't go away:

• Mild skin itching, dryness, burning, or peeling
• Irritation around the mouth
• Swollen hair follicles
• Unwanted hair growth
• Blisters, pimples, or crusting of the skin
• Stretch marks
• Changes in color of the treated skin

Serious Side Effects of TOPICORT

Tell your doctor right away if you experience any of the symptoms listed in the TOPICORT Warnings section above, or the following serious side effects:

• Severe skin irritation or rash
• Insomnia
• Signs of an infection, which may include redness, swelling, or oozing of the skin
• Signs of anaphylaxis, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Medication that suppresses the immune system, such as Imuran or Azasan (azathioprine), Gengraf, Neoral, or Sandimmune (cyclosporine), Rheumatrex or Trexall (methotrexate), Rapamune (sirolimus), or Prograf (tacrolimus)
• Other medicines that contain corticosteroids
• Other topical medicines
• Vitamins

TOPICORT comes as an ointment, cream, spray, or gel to apply to the skin.

It's typically applied twice a day.

Follow the instructions on your package label carefully. Don't use more or less TOPICORT than is recommended.

Wash your hands before and after using this medicine, unless your hands are being treated.

Apply a small amount of TOPICORT to the affected area, and rub it in gently.

Don't apply this medicine over a large area of the skin.

Ask your doctor before using cosmetics or other skin products on areas of your body that are being treated with TOPICORT.

Don't wrap or bandage treated areas of your skin unless your doctor tells you to do so. Follow your healthcare provider's instructions carefully if you need to apply a wrap or bandage.

If you're applying TOPICORT to a baby's diaper area, avoid dressing your child in plastic pants or tight-fitting diapers.

Don't use this medicine on your face, underarms, or groin area unless your doctor tells you otherwise.

Try not to get TOPICORT in your eyes. If you do, flush them immediately with water.

TOPICORT Overdose

If you suspect an overdose of TOPICORT or accidentally swallow this medicine, contact a poison control center or emergency room immediately.

Missed Dose of TOPICORT

If you miss a dose of TOPICORT, apply it as soon as you remember.

But if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular application schedule.

Don't apply extra medicine to make up for a missed dose.

Severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious may require an injection of glucagon or should be treated with intravenous administration of glucose by medical personnel. Without immediate medical help, serious reactions or even death could occur.

Hyperglycemia can be mild or severe. It can progress to high glucose levels, diabetic ketoacidosis (DKA), and result in unconsciousness and death.

Diabetic ketoacidosis (DKA):

The first symptoms of diabetic ketoacidosis usually come on over a period of hours or days. With ketoacidosis, urine tests show large amounts of glucose and acetone.

Symptoms of diabetic ketoacidosis include:

First symptoms:

• drowsiness,
• flushed face,
• thirst,
• loss of appetite,
• fruity smelling breath,
• rapid, deep breathing,
• abdominal (stomach area) pain.

Severe symptoms:

• heavy breathing,
• rapid pulse.

Prolonged hyperglycemia or diabetic ketoacidosis can lead to:

• nausea,
• vomiting,
• dehydration,
• loss of consciousness,
• death.

Severe or continuing hyperglycemia or DKA requires prompt evaluation and treatment by your health professional. LANTUS should not be used to treat DKA, and the persons treating you should be advised you are taking a long-acting insulin and about your regimen.

Allergic reactions:

In rare cases, a patient may be allergic to an insulin product. Severe insulin allergies may be life-threatening. If you think you are having an allergic reaction, seek medical help immediately.

Signs of insulin allergy include:

• a rash all over your body,
• shortness of breath,
• wheezing (trouble breathing),
• a fast pulse,
• sweating,
• low blood pressure.

Possible reactions on the skin at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

• a little depression in the skin (lipoatrophy),
• skin thickening (lipohypertrophy),
• redness, swelling, or itching at injection site.

In some instances, these reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. You can reduce the chance of getting an injection site reaction if you change the injection site each time. If you have local injection site reactions, contact your health professional.

This is not a complete list of side effects. For any unexpected effects while taking LANTUS, contact your health professional.

Serious Warnings and Precautions

• Hypoglycemia is the most common adverse effect of insulin, including LANTUS.
• Glucose monitoring is recommended for all patients with diabetes.
• Uncorrected hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma, or death.
• Any change of insulin should be made cautiously and only under medical supervision.
• LANTUS is not intended for intravenous or intramuscular administration.
• LANTUS must not be mixed with any other insulin or diluted with any other solution because it might not work as intended.
• This insulin product shall not be used if it is not water-clear and colourless or if it has formed a deposit of solid particles on the wall of the vial or cartridge.

Concomitant oral antidiabetic treatment may need to be adjusted.

The use of thiazolidinediones (such as rosiglitazone and pioglitazone), alone or in combination with other antidiabetic agents (including insulin), has been associated with heart failure and swelling of the lower extremities. Please contact your physician immediately if you develop symptoms of shortness of breath, fatigue, exercise intolerance, or swelling of the lower extremities while you are on these agents.

Accidental mix-ups between insulin glargine and other insulins, particularly short-acting insulins, have been reported. To avoid medication errors between insulin glargine and other insulins, check your insulin labels before every injection.

Hypokalemia (low potassium) is a possible side effect with all insulins. You might be more at risk if you are using potassium lowering drugs or losing potassium through other means (e.g. diarrhea). Symptoms of hypokalemia may include: Fatigue, muscle weakness or spasms, constipation, tingling or numbness, feeling of skipped heart beats or palpitations.

If you have diabetic retinopathy (condition affecting the retina of the eye) and you have a marked change in blood glucose levels, the retinopathy may temporary get worse. Ask your doctor about this.

BEFORE you use LANTUS talk to your health professional if:

• You are planning to have a baby, are pregnant, or are nursing a baby;
• You are taking any medication.

Other medicines, including non-prescription medicines, and dietary supplements (such as vitamins) can change the way insulin works. Your dose of insulin or other medications may need to be changed in consultation with your health professional.