Insulin (Human Recombinant) Inhalation powder

What is this medicine?

INSULIN (IN su lin) is a human-made form of insulin. This medicine lowers the amount of sugar in your blood. It is a short-acting insulin that starts working about an hour after it is inhaled.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • cigarette smoker

  • episodes of hypoglycemia (low blood sugar)

  • kidney disease

  • liver disease

  • lung cancer

  • lung or breathing disease, like asthma or COPD (such as emphysema)

  • using other inhaled medicines

  • an unusual or allergic reaction to insulin, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for inhalation through the mouth. Take this medicine at the beginning of a meal. It is important to follow the directions given to you by your doctor or health care professional. You will be taught how to use this medicine and how to adjust doses for activities and illness. Make sure that you are using your inhaler correctly. Do not use more insulin than prescribed. Do not use more or less often than prescribed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.

What may interact with this medicine?

  • albuterol or other inhaled medicines

  • other medicines for diabetes

Many medications may cause an increase or decrease in blood sugar, these include:

  • alcohol containing beverages

  • aspirin and aspirin-like drugs

  • chloramphenicol

  • chromium

  • diuretics

  • female hormones, like estrogens or progestins and birth control pills

  • heart medicines

  • isoniazid

  • male hormones or anabolic steroids

  • medicines for weight loss

  • medicines for allergies, asthma, cold, or cough

  • medicines for mental problems

  • medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl

  • niacin

  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

  • pentamidine

  • phenytoin

  • probenecid

  • quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin

  • some herbal dietary supplements

  • steroid medicines like prednisone or cortisone

  • thyroid medicine

Some medications can hide the warning symptoms of low blood sugar. You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

  • beta-blockers such as atenolol, metoprolol, propranolol

  • clonidine

  • guanethidine

  • reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your health care professional or doctor for regular checks on your progress.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • signs and symptoms of high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination

  • signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • cough

  • sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

The inhaler device can be used for up to 15 days from the date of first use. Throw away your inhaler after 15 days and get a new one. Between uses, store the inhaler between 2 and 25 degrees C (36 and 77 degrees F).

Store unopened foil cartridge packages in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). These may be used until the expiration date. If unopened insulin cartridges in foil packages are not refrigerated, the cartridges must be used within 10 days.

Opened foil insulin cartridge packages that are in use should be stored at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Sealed (unopened) blister cards and strips must be used within 10 days. Cartridges left over in an opened strip must be used within 3 days.

Before use, the inhaler and the cartridges should be at room temperature for 10 minutes.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


Insulin (Human Recombinant) Inhalation powder, Insulin (Human Recombinant) Inhalation powder

What is this medicine?

INSULIN (IN su lin) is a human-made form of insulin. This medicine lowers the amount of sugar in your blood. It is a short-acting insulin that starts working about an hour after it is inhaled.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • cigarette smoker

  • episodes of hypoglycemia (low blood sugar)

  • kidney disease

  • liver disease

  • lung cancer

  • lung or breathing disease, like asthma or COPD (such as emphysema)

  • using other inhaled medicines

  • an unusual or allergic reaction to insulin, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for inhalation through the mouth. Take this medicine at the beginning of a meal. It is important to follow the directions given to you by your doctor or health care professional. You will be taught how to use this medicine and how to adjust doses for activities and illness. Make sure that you are using your inhaler correctly. Do not use more insulin than prescribed. Do not use more or less often than prescribed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.

What may interact with this medicine?

  • albuterol or other inhaled medicines

  • other medicines for diabetes

Many medications may cause an increase or decrease in blood sugar, these include:

  • alcohol containing beverages

  • aspirin and aspirin-like drugs

  • chloramphenicol

  • chromium

  • diuretics

  • female hormones, like estrogens or progestins and birth control pills

  • heart medicines

  • isoniazid

  • male hormones or anabolic steroids

  • medicines for weight loss

  • medicines for allergies, asthma, cold, or cough

  • medicines for mental problems

  • medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl

  • niacin

  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

  • pentamidine

  • phenytoin

  • probenecid

  • quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin

  • some herbal dietary supplements

  • steroid medicines like prednisone or cortisone

  • thyroid medicine

Some medications can hide the warning symptoms of low blood sugar. You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

  • beta-blockers such as atenolol, metoprolol, propranolol

  • clonidine

  • guanethidine

  • reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your health care professional or doctor for regular checks on your progress.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • signs and symptoms of high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination

  • signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • cough

  • sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

The inhaler device can be used for up to 15 days from the date of first use. Throw away your inhaler after 15 days and get a new one. Between uses, store the inhaler between 2 and 25 degrees C (36 and 77 degrees F).

Store unopened foil cartridge packages in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). These may be used until the expiration date. If unopened insulin cartridges in foil packages are not refrigerated, the cartridges must be used within 10 days.

Opened foil insulin cartridge packages that are in use should be stored at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Sealed (unopened) blister cards and strips must be used within 10 days. Cartridges left over in an opened strip must be used within 3 days.

Before use, the inhaler and the cartridges should be at room temperature for 10 minutes.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.