Insulin is a naturally occurring hormone made by the pancreas that helps your body use or store glucose (sugar) it gets from food. For people with diabetes, either the pancreas does not make enough insulin to meet the body's requirements, or the body cannot properly use the insulin that is made. As a result, glucose cannot be used or stored properly and accumulates in the bloodstream. Insulin injected under the skin helps to lower blood glucose levels.

Insulin glulisine is used to treat adults with type 1 or type 2 diabetes mellitus when insulin is required. It is also used to treat children 6 years or older with type 1 diabetes mellitus.

There are many different types of insulin and they are absorbed at different rates and work for varying periods of time. Insulin glulisine is a rapid-acting insulin. It takes 5 minutes to begin working after the injection, has its maximum effects between 30 and 90 minutes, and stops working after 2 to 4 hours.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

Your required 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) 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 100 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. Open vials may also be stored at room temperature for up to 28 days as long as the temperature is not greater than 25°C. Opened prefilled pens should not be refrigerated but should be kept at room temperature for no more than 28 days, as long as the temperature is not greater than 25°C. Insulin sets (reservoirs, tubing, and catheters) used with insulin pumps, and the insulin within them, should be discarded after no more than 2 days of use or after exposure to temperatures that are greater than 37°C.

Insulin must not be exposed to extremely hot temperatures or to sunlight. Keep insulin out of the reach of children.

SoloSTAR disposable prefilled pen
Each mL contains 100 units of insulin glulisine. Nonmedicinal ingredients: m-cresol, polysorbate 20, sodium chloride, trometamol, and water for injection. May also contain aqueous solutions of hydrochloric acid and sodium hydroxide to adjust pH.

Vial
Each mL contains 100 units of insulin glulisine. Nonmedicinal ingredients: m-cresol, polysorbate 20, sodium chloride, trometamol, and water for injection. May also contain aqueous solutions of hydrochloric acid and sodium hydroxide to adjust pH.

Cartridge
Each mL contains 100 units of insulin glulisine. Nonmedicinal ingredients: m-cresol, polysorbate 20, sodium chloride, trometamol, and water for injection. May also contain aqueous solutions of hydrochloric acid and sodium hydroxide to adjust pH.

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.

The following side effects have been reported by at least 1% of people taking this medication. 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.

• redness, itching, swelling, or bleeding at the place of injection
• thickening of the skin at the injection site

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.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of low blood glucose:
• anxiety
• blurred vision
• confusion
• difficulty concentrating
• difficulty speaking
• dizziness
• drowsiness
• fast heartbeat
• headache
• hunger
• nausea
• nervousness
• numbness or tingling of the lips, fingers, or tongue
• sweating
• tiredness
• trembling
• weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

• rash or blisters all over the body
• seizures
• symptoms of a severe allergic reaction (e.g., hives, difficulty breathing, wheezing, fast heart rate, sweating, swelling of the face and throat)
• unconsciousness

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 you 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:

• 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 keep your doctor informed about 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. They should also monitor their blood glucose levels more frequently. Talk to your doctor or pharmacist if you are having frequent episodes of low blood glucose or are having difficulty recognizing the symptoms.

Mixing insulins: Your doctor or diabetes educator may suggest mixing NPH insulin with insulin glulisine in the same syringe, to reduce the number of injections necessary each day. This is only possible if you are drawing the insulins out of vials into an insulin syringe for injection. Insulin glulisine should not be mixed with other insulins for use in an insulin pump or pen.

Potassium: Insulin can cause low levels of potassium in the body. This is more likely to happen if you are taking medications that reduce potassium or you are experiencing excessive loss of potassium through vomiting or diarrhea. Symptoms of low potassium include leg cramps, tiredness, constipation, and slowed heartbeat. Report any of these effects to your doctor as soon as possible.

Skin reactions at injection site: Injecting insulin can cause a little depression in the skin; skin thickening; or skin redness, swelling, or itching. You can reduce the chance of getting these reactions if you change the injection site each time you inject insulin. If you experience these skin reactions, contact your doctor or diabetes educator.

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 glulisine passes into breast milk. If you are breast-feeding 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 insulin dose or diet.

Children: The safety and effectiveness of using this medication has not been established for children under 6 years of age.

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

• ACE inhibitors (e.g., ramipril, enalapril, lisinopril)
• acetylsalicylic acid
• alcohol
• atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
• beta-blockers (e.g., propranolol, labetalol, atenolol)
• clarithromycin
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• danazol
• diabetes medications (e.g., canagliflozin, chlorpropamide, gliclazide, glyburide, insulin, liraglutide, metformin, rosiglitazone, sitagliptin)
• disopyramide
• diuretics (e.g., furosemide, hydrochlorothiazide)
• epinephrine
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• glucagon
• hepatitis C antivirals (e.g., glecaprevir and pibrentasvir, ledipasvir, sofosbuvir, voxilaprevir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• isoniazid
• lanreotide
• mifepristone
• monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, selegiline, tranylcypromine)
• niacin
• octreotide
• oral contraceptives
• pasireotide
• pegvisomant
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• somatostatin
• somatropin
• sulfamethoxazole
• sunitinib
• tacrolimus
• testosterone
• thyroid replacement hormones (e.g., levothyroxine)

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 this medication. 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.