Levemir Flextouch

The recommended dose of insulin depends on how much natural insulin your pancreas is producing and how well your body is able to use the insulin. 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) exactly as instructed by your doctor or diabetes educator. Do not inject insulin detemir into the vein and do not use insulin detemir in insulin infusion pumps. Each 1 mL of insulin contains 100 units. Insulin detemir is injected under the skin once or twice daily. In addition to insulin detemir, a fast-acting insulin is usually used to control the impact of food intake on blood glucose levels during the day. There are many variations of insulin dosing.

Insulin detemir 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. It is not necessary to shake or rotate the vial before use. It should not be mixed with any other insulins.

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.

Do not stop using Levemir Flextouch (Insulin-detemir-long-acting) without consulting your doctor. When insulin detemir, or any other insulin, is stopped, blood glucose levels can become dangerously high.

It is important to take Levemir Flextouch (Insulin-detemir-long-acting) exactly as prescribed by your doctor. The timing of insulin with respect to your meals is crucial to keeping blood glucose under control and preventing unwanted side effects. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store unopened bottles of insulin or disposable insulin pens in the refrigerator until needed. They may be used until the expiry date on the label. Never allow insulin to freeze. Insulin that is currently in use may be kept at room temperature (below 30°C) for no more than 42 days and then discarded. Do not expose insulin to extremely hot temperatures or to sunlight. Keep insulin out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each mL of sterile, aqueous, clear, colourless and neutral solution, contains 100 units of salt-free anhydrous insulin detemir (14.2 mg/mL). One unit of Levemir corresponds to one IU of human insulin. Nonmedicinal ingredients: disodium phosphate dihydrate, glycerol, mannitol, metacresol, phenol, sodium chloride, acetate, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (approximately 7.4).

Do not use insulin detemir if you:

• are allergic to insulin or any ingredients of the medication
• have low blood glucose (Hypoglycemia)

There may be an interaction between insulin detemir and any of the following:

• acetylsalicylic acid (Asa)
• alcohol
• androgens (e.g., testosterone)
• angiotensin-converting enzyme inhibitors (ACE inhibitors; e.g., Enalapril, Lisinopril, Ramipril)
• antipsychotics (e.g. Aripiprazole, Clozapine)
• beta-blockers (e.g., Atenolol, Metoprolol, Pindolol, Propranolol, Sotalol)
• birth control pills
• Buserelin
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Danazol
• decongestants (e.g., Pseudoephedrine)
• Epinephrine
• glucagon
• Goserelin
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydrochlorothiazide
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• Lanreotide
• Leuprolide
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Octreotide
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone, Prednisolone)
• oral medications for diabetes (e.g., Gliclazide, Glyburide, Pioglitazone, Rosiglitazone)
• Pasireotide
• Pegvisomant
• pentamidine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• somatostatin
• Somatropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• thyroid replacement therapy (if starting or changing dose)
• Vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Levemir Flextouch (Insulin-detemir-long-acting). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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 Levemir Flextouch (Insulin-detemir-long-acting).

Allergic reactions: If you notice signs of a serious allergic reaction (swelling of face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat, itchy skin rash and dizziness), stop using the medication and seek immediate medical attention.

Appearance of insulin: The contents of the vial of insulin detemir should be clear and colourless. Do not use Levemir Flextouch (Insulin-detemir-long-acting) if you notice anything unusual about its appearance, such as cloudiness, discoloration, or clumping.

Blood glucose monitoring: For anyone using insulin, it is important to monitor 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 at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:

• certain medical conditions (e.g., infections, Thyroid conditions, or kidney or liver disease)
• certain medications that increase or decrease blood glucose levels
• diet
• exercise
• illness
• injury
• stress
• surgery
• travelling over time zones

It is important to tell your doctor about 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 or you lose consciousness.

High blood glucose (hyperglycemia): Hyperglycemia may occur if your insulin dose is too low or you miss a dose of insulin. Symptoms of hyperglycemia generally build up over hours or days. If you experience symptoms of hyperglycemia, such as increased need to urinate, nausea, vomiting, drowsiness, Dry Mouth, flushed dry skin, loss of appetite and a fruity odour to your breath, contact your doctor or diabetes educator.

If hyperglycemia is permitted to continue, a condition known as diabetic ketoacidosis may occur. In this condition, your body starts to use body fat as fuel, eventually leading to a large concentration of acid in the blood stream. This can result in unconsciousness, coma or death. To prevent this from occurring, you may need to have your insulin dose adjusted.

Kidney function: Kidney Disease or reduced kidney function may change the amount of insulin needed by the body. If you have kidney problems, discuss with your doctor how Levemir Flextouch (Insulin-detemir-long-acting) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your kidney function regularly with blood tests while you are taking Levemir Flextouch (Insulin-detemir-long-acting).

Liver function: Liver disease or reduced liver function may change the amount of insulin needed by the body. If you have liver problems, discuss with your doctor how Levemir Flextouch (Insulin-detemir-long-acting) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Levemir Flextouch (Insulin-detemir-long-acting).

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, and numbness or tingling (tongue, lips, or fingers). Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). If you experience symptoms of hypoglycemia, eat one of these sources of sugar and then rest. If you feel symptoms of hypoglycemia coming on, don't take insulin.

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.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters. Therefore, contact your doctor if you are pregnant or are thinking about pregnancy.

Breast-feeding: It is not known if insulin detemir passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Breast-feeding mothers may require adjustments in their insulin dose or diet.

Children: The safety and effectiveness of using this medication has not been established in children less than 2 years of age.