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Novolog Mix 70-30

"Nov. 21, 2012 -- The number of children and teens with type 1 and type 2 diabetes is expected to spike dramatically in the next 40 years, creating what one expert calls a potential catastrophe for the nation's health care system.

Rat"...

NovoLog Mix 70/30

Novolog Mix 70-30 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is used to treat type 1 (insulin-dependent) diabetes in adults. Insulin is a hormone that is produced in the body. Common side effects include redness, swelling or itching at the injection site. Effects usually go away after a few days or weeks.

NovoLog Mix 70/30 is typically dosed on a twice-daily basis (with each dose intended to cover 2 meals or a meal and a snack). Dosage is individualized. NovoLog Mix 70/30 may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. Many other medicines can increase or decrease the effects of insulin aspart and insulin aspart protamine on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Tell your doctor if you are pregnant before using NovoLog Mix 70/30. Consult your doctor to manage blood sugars before becoming pregnant. Your doctor may switch the type of insulin used during pregnancy. It is unknown if this drug passes into breast milk. Insulin needs may change while breast-feeding. Consult your doctor before breast-feeding.

Our NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Novolog Mix 70-30 in Detail - Patient Information: Side Effects

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. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

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

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

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

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.

Read the entire detailed patient monograph for Novolog Mix 70-30 (Insulin Aspart Protamine and Insulin Aspart (rDNA origin)) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Novolog Mix 70-30 Overview - Patient Information: Side Effects

SIDE EFFECTS: See also the How to Use section.

Redness, swelling or itching at the injection site may occur. These effects usually go away after a few days or weeks. 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.

Too much insulin can cause low blood sugar (hypoglycemia). This effect may also occur if you do not consume enough calories. The symptoms include chills, cold sweats, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose (sugar) tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent low blood sugar, eat meals on a regular schedule and do not skip meals.

Too little insulin can cause high blood sugar (hyperglycemia). Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your treatment plan may need to be changed.

This medication may cause low potassium levels in the blood (hypokalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following signs of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, 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.

Read the entire patient information overview for Novolog Mix 70-30 (Insulin Aspart Protamine and Insulin Aspart (rDNA origin))»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Novolog Mix 70-30 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Clinical trials are conducted under widely varying designs, therefore, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

  • Hypoglycemia
    Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including NovoLog Mix 70/30 [see WARNINGS AND PRECAUTIONS]. NovoLog Mix 70/30 should not be used during episodes of hypoglycemia [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
  • Insulin initiation and glucose control intensification
    Intensification or rapid improvement in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
  • Lipodystrophy
    Long-term use of insulin, including NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy.
    Weight gain
    Weight gain can occur with some insulin therapies, including NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
  • Peripheral Edema
    Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
  • Frequencies of adverse drug reactions
    The frequencies of adverse drug reactions during a clinical trial with NovoLog Mix 70/30 in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below. The trial was a three-month, open-label trial in patients with Type 1 or Type 2 diabetes who were treated twice daily (before breakfast and before supper) with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) .

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 diabetes mellitus (Adverse events with frequency ≥ 5% are included.)

Preferred Term NovoLog Mix70/30
(N=55)
Novolin 70/30
(N=49)
N % N %
Hypoglycemia 38 69 37 76
Headache 19 35 6 12
Influenza-like symptoms 7 13 1 2
Dyspepsia 5 9 3 6
Back pain 4 7 2 4
Diarrhea 4 7 3 6
Pharyngitis 4 7 1 2
Rhinitis 3 5 6 12
Skeletal pain 3 5 2 4
Upper respiratory tract infection 3 5 1 2

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 diabetes mellitus (Adverse events with frequency ≥ 5% are included.)

Preferred Term NovoLog Mix70/30 (N=85) Novolin 70/30 (N=102)
N % N %
Hypoglycemia 40 47 51 50
Upper respiratory tract infection 10 12 6 6
Headache 8 9 8 8
Diarrhea 7 8 2 2
Neuropathy 7 8 2 2
Pharyngitis 5 6 4 4
Abdominal pain 4 5 0 0
Rhinitis 4 5 2 2

Postmarketing Data

Additional adverse reactions have been identified during post-approval use of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. They include medication errors in which other insulins have been accidentally substituted for NovoLog Mix 70/30 [see PATIENT INFORMATION].

Read the entire FDA prescribing information for Novolog Mix 70-30 (Insulin Aspart Protamine and Insulin Aspart (rDNA origin)) »

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NovoLog Mix 70/30 - User Reviews

NovoLog Mix 70/30 User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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