Site Providence: Insulin aspart, recombinant Subcutaneous

IN-su-lin AS-part, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Novolog

Novolog FlexPen

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Ultra Rapid Acting

Uses For insulin aspart, recombinant

Insulin aspart is a fast-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. If you have diabetes, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health. Since insulin aspart acts faster than regular human insulin, you normally should use insulin aspart with a longer-acting insulin.

insulin aspart, recombinant is available only with your doctor's prescription.

Before Using insulin aspart, recombinant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For insulin aspart, recombinant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to insulin aspart, recombinant or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin aspart in children. However, safety and efficacy of insulin aspart mix 50/50 and 70/30 in the pediatric population have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin aspart have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of insulin aspart in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dosage in patients receiving insulin aspart.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking insulin aspart, recombinant, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using insulin aspart, recombinant with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin

Balofloxacin

Ciprofloxacin

Clinafloxacin

Enoxacin

Fleroxacin

Flumequine

Gatifloxacin

Gemifloxacin

Grepafloxacin

Levofloxacin

Lomefloxacin

Moxifloxacin

Norfloxacin

Ofloxacin

Pefloxacin

Prulifloxacin

Rufloxacin

Sparfloxacin

Temafloxacin

Tosufloxacin

Trovafloxacin Mesylate

Using insulin aspart, recombinant with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alprenolol

Atenolol

Betaxolol

Bevantolol

Bisoprolol

Bitter Melon

Bucindolol

Carteolol

Carvedilol

Celiprolol

Clorgyline

Dilevalol

Esmolol

Fenugreek

Glucomannan

Guar Gum

Iproniazid

Isocarboxazid

Labetalol

Levobunolol

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Psyllium

Selegiline

Sotalol

Talinolol

Tertatolol

Timolol

Toloxatone

Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of insulin aspart, recombinant

Each package of insulin aspart contains a patient information sheet. Read this sheet carefully before beginning treatment and each time you refill for any new information, and make sure you understand:

How to prepare the medicine.

How to inject the medicine.

How to use disposable insulin delivery device.

How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

When used as a mealtime insulin, insulin aspart should be taken within 5-10 minutes before the meal or immediately before the meal.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

When used in an insulin pump: Carefully read and follow the external insulin pump instructions. This insulin should not be mixed with any other insulin or diluted when used in an insulin pump. If you do not understand how you are to use the insulin pump, contact your health care professional.

You should never mix insulin aspart with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.

insulin aspart, recombinant can also be given as an intravenous (IV) infusion only by a healthcare professional in a clinic or hospital.

Dosing

The dose of insulin aspart, recombinant will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of insulin aspart, recombinant. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For diabetes mellitus:
  - Adults—The dose is based on your blood sugar and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using insulin aspart, recombinant

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take insulin aspart, recombinant. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.

Other medicines—Do not take other medicines during the time you are taking insulin aspart unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.

Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Insulin aspart may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.

Too much insulin aspart can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; depression; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

Low blood sugar also can occur if you use insulin aspart with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

insulin aspart, recombinant Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Anxious feeling

behavior change similar to being drunk

blurred vision

cold sweats

confusion

convulsions (seizures)

depression

difficulty in thinking

dizziness or lightheadedness

drowsiness

excessive hunger

fast heartbeat

headache

irritability or abnormal behavior

low blood sugar

nervousness

nightmares

restless sleep

shakiness

slurred speech

tingling in the hands, feet, lips, or tongue

unconsciousness

Less common or rare

Depression of the skin at the place of injection

dryness of the mouth

fast or weak pulse

feeling of pressure, itching, redness, soreness, stinging, swelling, or tingling at the place of injection

increased thirst

irregular heartbeat

loss of appetite

mood or mental changes

muscle cramps or pain

nausea or vomiting

shortness of breath

skin rash or itching over the whole body

sweating

thickening of the skin at the place of injection

unusual tiredness or weakness

wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Wednesday, October 26, 2016

Insulin aspart, recombinant Subcutaneous