Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

INSULIN ASPART PROTAMINE/INSULIN ASPART - INJECTABLE

(IN-sue-lin AS-part PRO-tah-meen/ IN-sue-lin AS-part)

COMMON BRAND NAME(S): NovoLog Mix 70/30

Uses

This medication is used to treat diabetes mellitus. Like other insulin products, it works by helping sugar (glucose) get into cells. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, circulation problems, and blindness.

How To Use

Learn all preparation and usage instructions including how to inject this medication properly and self- management procedures (e.g., blood glucose monitoring, symptoms and treatment(s) of high or low blood sugar). For additional information, consult your doctor or pharmacist. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid developing problem areas under the skin (lipodystrophy). Roll this product gently in your hands to mix immediately before injecting. Inject this medication under the skin (SC) immediately before eating a meal and as directed by your doctor. This medication should never be injected directly into a vein (IV). Because part of this product is fast-acting, not eating immediately after giving a dose of this insulin may lead to low blood sugar (hypoglycemia). The dosage is based on your medical condition and response to therapy. Measure each dose very carefully; even small changes in the amount of insulin may have a large effect on your blood sugar levels. If you experience any of the symptoms of low blood sugar (listed below in SIDE EFFECTS section), use a quick source of sugar such as glucose tablets, table sugar, orange juice, honey, or non-diet soda. Promptly contact your doctor. This product should not be mixed with other insulin products. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Side Effects

Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these serious side effects of low blood sugar (hypoglycemia) occur: fainting, cold sweats, shaking/tremor, unusually fast heartbeat, headache, slurred speech, seizures. Tell your doctor immediately if any of these serious side effects of high blood sugar (hyperglycemia) occur: unusual drowsiness, confusion, rapid breathing, fruity breath odor, increased urination, unusual thirst. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: kidney problems, liver problems, nerve disease (e.g., diabetic neuropathy), thyroid problems, any allergies (especially to other insulin products). Fever, serious infection or injury, emotional stress, or major surgery may increase your blood sugar level temporarily which may make this medication less effective. Consult your doctor for details and a treatment plan. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially: other insulin products (e.g., Regular, NPH, insulin aspart), oral diabetes medicine (e.g., glyburide, pioglitazone), ACE inhibitors (e.g., enalapril, lisinopril), beta-blockers (e.g., metoprolol, propranolol), disopyramide, fibrates (e.g., clofibrate, gemfibrozil), niacin, fluoxetine, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), propoxyphene, salicylates (e.g., aspirin), octreotide, sulfa antibiotics (e.g., sulfamethoxazole), corticosteroids (e.g., prednisone), danazol, "water pills" (e.g., furosemide, hydrochlorothiazide), sympathomimetic drugs (e.g., albuterol, epinephrine), isoniazid, certain psychiatric medicine (e.g., phenothiazines such as chlorpromazine), somatropin, thyroid medicine, estrogens and progestins (including birth control pills), clonidine, lithium, pentamidine, guanethidine, reserpine. Drinking alcohol may affect your blood sugar level. Limit alcoholic beverages. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: unusually fast heartbeat, unusual sweating, shakiness, seizures.

Notes

Do not share this medication with others. It is recommended that you attend a diabetes education program to understand diabetes and all the important aspects of its treatment including meals/diet, exercise, personal hygiene, medications and getting regular eye, foot, and medical exams. Consult your doctor or pharmacist. Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) will be performed to monitor for side effects and response to therapy. Regularly check your blood or urine for sugar, as directed by your doctor or pharmacist.

Missed Dose

It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Discuss specific instructions with your doctor now, in case you miss a dose of insulin in the future.

Storage

Store unopened vials/cartridges/syringes in a refrigerator between 36 and 46 degrees F (2 and 8 degrees C) away from light. Do not freeze. Keep away from children and pets. The current syringe/cartridge that you are using should be stored at room temperature below 86 degrees F (30 degrees C) for up to 14 days. Do not refrigerate the current syringe/cartridge you are using. If refrigeration is not possible, vials may be stored at temperatures less than 86 degrees F (30 degrees C) for 28 days.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).