Apidra

DRUG DESCRIPTION

APIDRA (insulin glulisine rdna origin inj) (insulin glulisine [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Chemically, insulin glulisine is 3B-lysine- 29B-glutamic acid-human insulin, has the empirical formula C258H384N64O78S6 and a molecular weight of 5823 and has the following structural formula:

APIDRA (insulin glulisine [rDNA origin]) Structural Formula Illustration

APIDRA (insulin glulisine rdna origin inj) is a sterile, aqueous, clear, and colorless solution. Each milliliter of APIDRA (insulin glulisine rdna origin inj) contains 100 units (3.49 mg) insulin glulisine, 3.15 mg metacresol, 6 mg tromethamine, 5 mg sodium chloride, 0.01 mg polysorbate 20, and water for injection. APIDRA (insulin glulisine rdna origin inj) has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.

What are the possible side effects of insulin glulisine (Apidra, Apidra OptiClik Cartridge, Apidra SoloStar Pen)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glulisine. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating,...

Read All Potential Side Effects and See Pictures of Apidra

What are the precautions when taking insulin glulisine [rdna origin] inj (Apidra)?

Before using insulin glulisine, 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...

Read All Potential Precautions of Apidra


Apidra Consumer (continued)

SIDE EFFECTS: 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 you have used too much insulin glulisine. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. 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 glulisine can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or 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.

PRECAUTIONS: Before using insulin glulisine, 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 using 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.

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.

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.


Apidra Patient Information Including Side Effects

Brand Names: Apidra, Apidra OptiClik Cartridge, Apidra SoloStar Pen

Generic Name: insulin glulisine (Pronunciation: IN su lin GLOO lis een)

  • What is insulin glulisine (Apidra)?
  • What are the possible side effects of insulin glulisine (Apidra)?
  • What is the most important information I should know about insulin glulisine (Apidra)?
  • What should I discuss with my healthcare provider before using insulin glulisine (Apidra)?
  • How should I use insulin glulisine (Apidra)?
  • What happens if I miss a dose (Apidra)?
  • What happens if I overdose (Apidra)?
  • What should I avoid while using insulin glulisine (Apidra)?
  • What other drugs will affect insulin glulisine (Apidra)?
  • Where can I get more information?

What is insulin glulisine (Apidra)?

Insulin glulisine is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glulisine is a faster-acting form of insulin than regular human insulin.

Insulin glulisine is used to treat diabetes in adults and children who are at least 4 years old. It is usually given together with a long-acting insulin.

Insulin glulisine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of insulin glulisine (Apidra)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glulisine. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Insulin glulisine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glulisine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about insulin glulisine (Apidra)?

Insulin glulisine is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin glulisine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

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