Apidra Insulin Vial (Insulin Glulisine)

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Apidra Insulin Vial Dosage (Insulin Glulisine) and Side Effects

APIDRA is used to reduce high blood sugar in adults and children (6 years or older) with diabetes mellitus.

Proper Use of this medication

Usual dose:

The dosage of APIDRA should be individualized and determined based on your health professional’s advice in accordance with your needs.

APIDRA should be given by subcutaneous injection within 15 minutes before a meal or within 20 minutes after starting a meal.

Many factors may affect your usual APIDRA dose, which may include changes in your diet, activity, or work schedule. Follow your health professional’s instructions carefully. Consult your health professional if you notice your insulin requirements changing markedly. Other factors that may affect your dose of insulin or your need to do additional blood/urine testing are:

Illness:

Illness, especially with nausea and vomiting, diarrhea and/or fever, may change how much insulin you need. Even if you are not eating, you will still require insulin. You and your health professional should establish a sick day plan for you to use in case of illness. When you are sick, test your blood/urine frequently and call your health professional as instructed.

Pregnancy:

If you are planning to have a baby, are pregnant, or are nursing a baby, consult your health professional. Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult.

Medication:

Always discuss any medications you are taking, prescription or “over-the-counter”, with your health professional. To prevent drug interactions, volunteer the names of everything you are taking even before they ask if there have been any changes. Insulin requirements may be increased in the presence of drugs with hyperglycemic activity, such as contraceptives (for example, birth control pills, injections and patches) and hormone replacement therapies, corticosteroids, thyroid replacement therapy, and sympathomimetic agents such as decongestants and diet pills. Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, blood pressure medications including ACE inhibitors, and certain psychiatric medications including MAO inhibitors or antidepressants and anti-anxiety medications.

Substances including beta-blockers, used for conditions including blood pressure, heart arrhythmias, palpitations and headache, and alcohol may enhance or weaken the blood-glucose-lowering effect of insulins, and signs of hypoglycemia may be reduced or absent.

Exercise:

If your exercise routine changes, discuss with your health professional the possible need to adjust your insulin regimen. Exercise may lower your body's need for insulin during and for some time after the activity. As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables.

Travel:

Consult your health professional concerning possible adjustments in your insulin schedule if you will be traveling across time zones. You may want to take along extra insulin and supplies whenever you travel.

Missed dose:

If you have missed a dose of APIDRA or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycemia). Check your blood sugar frequently. Do not take a double dose to make up for a forgotten dose.

Overdose:

If you have injected too much APIDRA, your blood sugar level may become too low (hypoglycemia). Check your blood sugar frequently. In general, to prevent hypoglycemia you must eat more food and monitor your blood sugar.

Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both.

In severe cases, coma, seizure and brain disorders may be seen and treated with glucagon (injected in the muscle or subcutaneous tissue) or glucose (injected in the vein).

You should continue checking your blood sugar even if you feel better because hypoglycemia may recur.

In case of drug overdose, contact a health professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side Effects

Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin.

Hyperglycemia can be brought about by:

  • intercurrent conditions (illness, stress, or emotional disturbances),
  • not taking your insulin or taking less than recommended by your health professional,
  • malfunction and/or misuse of medical devices,
  • eating significantly more than your meal plan suggests,
  • a new insulin type or schedule,
  • some new medications, including prescriptions, over-the-counter medications, herbs, vitamins and street drugs.

Symptoms of hyperglycemia include:

  • confusion or drowsiness,
  • increased thirst,
  • decreased appetite, nausea, or vomiting,
  • rapid heart rate,
  • increased urination and dehydration (too little fluid in your body),
  • blurred vision,
  • flushed dry skin,
  • acetone odour of breath.

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.

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, itching, swelling, or hemorrhage 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 APIDRA, contact your health professional.

Interactions with this 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 healthcare professional.

Warnings and Precautions

Serious Warnings and Precautions

  • Hypoglycemia (low blood sugar) is the most common adverse effect of insulin, including APIDRA.
  • Blood glucose (blood sugar) monitoring is recommended for all patients with diabetes.
  • Uncorrected hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) reactions can cause loss of consciousness, coma, or death.
  • Any change of insulin should be made cautiously and only under medical supervision. This may result in dosage adjustment.
  • When used as a meal time insulin, the dose of APIDRA should be given within 15 minutes before or within 20 minutes after starting a meal.
  • APIDRA given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin. APIDRA can also be used alone in insulin infusion pump therapy to maintain adequate glucose control.
  • APIDRA can be mixed with NPH human insulin (except when administered with pump).
  • Insulin products 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.

In some situations, your need in insulin may change, for example if you are stress or suffering from other illnesses (e.g. infections).

Your diabetes may also be more difficult to control if you suffer from acromegaly (too much growth hormone), Cushing’s syndrome (too much cortisol hormone), hyperthyroidism (too much thyroid hormone) or have a pheochromocytoma (tumor of the adrenal glands).

If you also take other oral drugs to reduce your blood sugar, their dose 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.

Hypokalemia (low potassium) is a possible side effect. You might be more at risk if you are on potassium lowering drugs or losing potassium (e.g. diarrhea).

Always keep an extra supply of insulin as well as the appropriate injection supplies on hand. Always wear medical alert identification and carry information about your diabetes so that appropriate treatment can be given if complications occur away from home.

Accidental mix-ups between insulin glulisine and other insulins, particularly long-acting insulins, have been reported. To avoid medication errors between insulin glulisine and other insulins, patients should be instructed to always check the insulin label before each injection.

Your needles and syringes are only for you and must not be shared to avoid disease transmission.

BEFORE you use APIDRA talk to your health professional if:

  • you are planning to have a baby, are pregnant, or are nursing a baby;
  • you drink alcohol;
  • you are ill;
  • you exercise more than usual or if you want to change your usual diet;
  • you are traveling;
  • you drive or use tools or machine;
  • you have trouble with your kidneys or liver;
  • you are taking any other medication.

Your ability to concentrate or react may be reduced if you have hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). Please keep these possible problems in mind in all situations where you might put yourself or others at risk (for example driving a car or operating machinery).

You should contact your doctor about the advisability of driving if you have:

  • frequent episodes of hypoglycemia
  • reduced or absent warning signs of hypoglycemia.

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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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