Humulin 70/30

What is Humulin 70/30?

Humulin 70/30 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.

Description

HUMULIN 70/30 (human insulin isophane suspension and human insulin injection) is a mixture of 70% human insulin isophane, an intermediate-acting human insulin, and 30% human insulin, a short-acting human insulin. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN 70/30 is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation and mixing with human insulin injection. The amino acid sequence of HUMULIN 70/30 is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5808.

HUMULIN 70/30 is a sterile, white and cloudy suspension that contains human insulin isophane suspension (NPH) and human insulin injection (regular) for subcutaneous use. Each milliliter of HUMULIN 70/30 contains 100 units of insulin human, 0.24 mg of protamine sulfate, 16 mg of glycerin, 3.78 mg of dibasic sodium phosphate, 1.6 mg of metacresol, 0.65 mg of phenol, zinc oxide content adjusted to provide 0.025 mg zinc ion, and Water for Injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.

Mechanism of Action

HUMULIN 70/30 lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

What is the most important information I should know about Humulin 70/30?

Do not share your Humulin 70/30 KwikPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Who should not use Humulin 70/30?

Do not use Humulin 70/30 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to Humulin 70/30 or any of the ingredients in Humulin 70/30.

What should I tell my healthcare provider before using Humulin 70/30?

Before using Humulin 70/30, tell your healthcare provider about all your medical conditions including, if you:

• have liver or kidney problems.
• take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humulin 70/30.
• are pregnant, planning to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breast-feeding or plan to breastfeed. Humulin 70/30 may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using Humulin 70/30.
• are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start using Humulin 70/30, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use Humulin 70/30?

• Read the Instructions for Use that come with your Humulin 70/30.
• Use Humulin 70/30 exactly as your healthcare provider tells you to. Humulin 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the exact same spot for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Know the type and strength of insulin you use. Do not change the type of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not share your Humulin 70/30 KwikPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Your Humulin 70/30 dose may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet.

What should I avoid while using Humulin 70/30?

While using Humulin 70/30 do not:

• drive or operate heavy machinery, until you know how Humulin 70/30 affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Humulin 70/30?

Humulin 70/30 may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger.
• serious allergic reaction (whole body reaction). Get medical help right away, if you have any of these symptoms of an allergic reaction:
  • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humulin 70/30 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Humulin 70/30. Your healthcare provider should monitor you closely while you are taking TZDs with Humulin 70/30. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain.Treatment with TZDs and Humulin 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Humulin 70/30 include:

• low blood sugar (hypoglycemia), allergic reactions including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, weight gain, and swelling of your hands and feet. These are not all the possible side effects of Humulin 70/30. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Humulin 70/30

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Humulin 70/30 that is written for health professionals. Do not use Humulin 70/30 for a condition for which it was not prescribed. Do not give Humulin 70/30 to other people, even if they have the same symptoms that you have. It may harm them.

How should I store Humulin 70/30?

Vial

All unopened Humulin 70/30 vials:

• Store all unopened vials in the refrigerator.
• Do not freeze. Do not use if it has been frozen.
• Keep away from heat and out of direct light.
• Unopened vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator.
• Unopened vials should be thrown away after 31 days, if they are stored at room temperature.

After Humulin 70/30 vials have been opened:

• Store opened vials in the refrigerator or at room temperature below 86°F (30°C) for up to 31 days.
• Keep away from heat and out of direct light.
• Throw away all opened vials after 31 days of use, even if there is still insulin left in the vial.

KwikPen

Unused Pens

• Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze your insulin. Do not use if it has been frozen.
• Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the refrigerator.

In-use Pen

• Store the Pen you are currently using at room temperature [up to 86°F (30°C)]. Keep away from heat and light.
• Throw away the Humulin 70/30 Pen you are using after 10 days, even if it still has insulin left in it.

What are the ingredients in Humulin 70/30?

Active Ingredient: insulin human

Inactive Ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, phenol, zinc oxide, water for injection, hydrochloric acid or sodium hydroxide

Label

PACKAGE CARTON – HUMULIN 70/30 VIAL 10 ML