NovoLog

DRUG DESCRIPTION

NovoLog (insulin aspart rdna origin inj) (insulin aspart [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. NovoLog (insulin aspart rdna origin inj) is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast). Insulin aspart has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8.

Figure 1 : Structural formula of insulin aspart.

NovoLog (insulin aspart [rDNA origin])  Structural Formula Illustration

NovoLog (insulin aspart rdna origin inj) is a sterile, aqueous, clear, and colorless solution, that contains insulin aspart 100 Units/mL, glycerin 16 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 mcg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.58 mg/mL and water for injection. NovoLog (insulin aspart rdna origin inj) has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

What are the possible side effects of insulin aspart (NovoLog, NovoLog FlexPen, NovoLog PenFill)?

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.

Call your doctor if you have a serious side effect such as:

  • swelling in your hands or feet; or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Hypoglycemia, or low...

Read All Potential Side Effects and See Pictures of NovoLog

What are the precautions when taking insulin aspart [rdna origin] inj (NovoLog)?

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...

Read All Potential Precautions of NovoLog


NovoLog 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 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.

PRECAUTIONS: 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.


NovoLog Patient Information Including Side Effects

Brand Names: NovoLog, NovoLog FlexPen, NovoLog PenFill

Generic Name: insulin aspart (Pronunciation: IN su lin AS part)

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

What is insulin aspart (NovoLog)?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin aspart is a fast-acting form of insulin.

Insulin aspart is used to treat type 1 (insulin-dependent) diabetes in adults and children who are at least 2 years old. Insulin aspart is usually given together with another long-acting insulin.

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

What are the possible side effects of insulin aspart (NovoLog)?

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.

Call your doctor if you have a serious side effect such as:

  • swelling in your hands or feet; or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Hypoglycemia, or low blood sugar, is the most common side effect of insulin aspart. 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 aspart 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.

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 aspart (NovoLog)?

Insulin aspart is a fast-acting insulin that begins to work very quickly. After using it, you should eat a meal within 5 to 10 minutes.

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, fruity breath odor, 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.

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