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|Exubera Powder

Exubera Powder

Exubera Powder is used for:

Controlling high blood sugar in patients with diabetes mellitus. Certain patients (type 1 diabetics and some type 2 diabetics) may need to use Exubera Powder with a longer-acting form of insulin or with other oral antidiabetic medicines.

Exubera Powder is an inhaled form of insulin. It works by replacing the body"s own insulin when it does not make enough. This helps to lower high blood sugar.

Do NOT use Exubera Powder if:

• you are allergic to any ingredient in Exubera Powder
• you are having an episode of low blood sugar
• you have uncontrolled or poorly controlled lung or breathing problems
• you smoke or you stopped smoking less than 6 months ago

Contact your doctor or health care provider right away if any of these apply to you.

Before using Exubera Powder:

Some medical conditions may interact with Exubera Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver or kidney problems; lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], asthma, bronchitis); an infection; or adrenal, pituitary, or thyroid gland problems
• if you are regularly exposed to secondhand smoke or drink alcohol

Some MEDICINES MAY INTERACT with Exubera Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, pentoxifylline, propoxyphene, salicylates (eg, aspirin), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
• Atypical antipsychotics (eg, olanzapine, clozapine), corticosteroids (eg, propranolol), danazol, diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, glucagon, HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Exubera Powder"s effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Exubera Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Exubera Powder:

Use Exubera Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Exubera Powder comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Exubera Powder refilled.
• A health care provider will teach you how to use Exubera Powder. Be sure you understand how to use Exubera Powder. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Be sure that you have blisters that contain the correct amount of medicine that you need. Do NOT use three 1 mg blisters in place of one 3 mg blister. If you need a 3 mg blister and do not have one, use two 1 mg blisters and check your blood sugar levels closely, unless your doctor tells you otherwise.
• Do NOT open the medicine blister or swallow Exubera Powder. Exubera Powder is a powder for inhalation into the lungs. Use it only with the inhaler device provided. Do not use it with any other type of inhaler device.
• To prepare the inhaler device - Hold it so that the words " Exubera Inhaler" face you. Pull the black ring at the bottom of the base to pull the base out of the chamber. You should hear a click when the inhaler device is fully extended. The bottom of the chamber must be above the gray button.
• To load the inhaler device - Hold a medicine blister with the printed side up and the notch pointed toward the inhaler. Insert it into the slot on the inhaler device. Push it in as far as it will go. Make sure the mouthpiece is closed. Pull the blue handle out from the bottom as far as it will go, and then squeeze the blue handle until it snaps shut.
• To use Exubera Powder - Stand or sit up straight. Hold the inhaler upright, with the blue button facing toward you. Push the blue button until it clicks and watch for the insulin cloud to fill the chamber.
• After the cloud appears, breathe out normally and turn the mouthpiece so that it is facing toward you. Place the mouthpiece fully in your mouth and form a seal around the mouthpiece with your lips. Do NOT blow into the mouthpiece. Do not block the opening with your tongue or teeth. Breathe in slowly and deeply through your mouth to inhale the insulin cloud and then take the inhaler device out of your mouth. Close your mouth and hold your breath for 5 seconds, and then breathe out normally.
• Turn the mouthpiece to the closed position. Press the gray button, pull out the used medicine blister, and throw it away. Do not reuse a medicine blister. If you need to inhale another blister to complete your dose, repeat the steps above. Inhale only one blister at a time.
• To store the inhaler device - Squeeze the 2 chamber release buttons on the side of the base at the same time. Push the base back into the chamber.
• Carefully follow the instructions for cleaning and caring for the inhaler device. Replace the Exubera release unit every 2 weeks to ensure that the inhaler device will work properly.
• Exubera Powder begins to lower blood sugar about 15 minutes after you use a dose. The peak effect occurs about 30 to 90 minutes after you use a dose.
• If you are using Exubera Powder with meals, use your dose within 10 minutes before the meal begins.
• If you also use bronchodilators or other inhaled products, they may increase the risk of high or low blood sugar. It is important to time your doses consistently with regard to Exubera Powder. Ask your doctor how to use bronchodilators or other inhaled products with Exubera Powder.
• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Exubera Powder.

Important safety information:

• Exubera Powder may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Exubera Powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.
• Do not smoke while you use Exubera Powder. Smoking may increase your risk of developing low blood sugar. If you start smoking while you are using Exubera Powder, contact your doctor right away.
• Do not exceed the recommended dose of Exubera Powder, use it more often than prescribed, change the type or dose of any other insulin you are using, or change the dose of any of your other diabetes medicines without checking with your doctor.
• Illness, especially with nausea and vomiting, emotional problems, stress, or changes in diet or activity level, may cause your insulin needs to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick-day plan to use in case of illness. When you are sick, test your blood or urine often and call your doctor as instructed.
• If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
• Proper diet, regular exercise, and regular testing of blood sugar are important for best results while you are using Exubera Powder. Follow your doctor"s instructions carefully. If your blood sugar level is often higher or lower than it should be and you are using Exubera Powder exactly as prescribed, check with your doctor.
• Low blood sugar levels may occur if you take too much insulin, skip a meal, or exercise more than usual. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar, like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Carry an ID card at all times that says you have diabetes.
• If you have type 1 diabetes, you should use Exubera Powder along with a long-acting insulin as directed by your doctor.
• Lab tests, including lung function, fasting blood glucose levels, or glycosylated hemoglobin, may be performed while you use Exubera Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Exubera Powder with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.
• Exubera Powder should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Exubera Powder can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Exubera Powder while you are pregnant. Exubera Powder is found in breast milk. If you are or will be breast-feeding while you use Exubera Powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Exubera Powder:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; dry mouth; increased sputum; mild chest discomfort; throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; chest pain; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; increased hunger; increased sweating; nervousness; shortness of breath; tremors; vision changes; weakness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm) or emergency room immediately. Symptoms may include chills; coma; dizziness; drowsiness; fainting; headache; increased heartbeat; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Store Exubera Powder at room temperature, below 86 degrees F (30 degrees C). Do NOT refrigerate or freeze. Throw away any frozen blisters. Store away from heat, moisture, and light. Do not store in the bathroom. Blisters must be used within 3 months after opening the foil wrap. Store inside the wrap to protect the blisters from moisture. The inhaler may be used for up to 1 year from the date of first use. Keep Exubera Powder, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Exubera Powder, please talk with your doctor, pharmacist, or other health care provider.
• Exubera Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Exubera Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.