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|Pramlintide

Pramlintide

Pramlintide is used for:

Helping to lower blood glucose levels, in combination with insulin, in certain diabetic patients.

Pramlintide is an amylinomimetic agent. It works like amylin, a naturally occurring hormone in the body, that helps reduce the levels of blood sugar after eating by slowing down the rate of food digestion, decreasing the release of sugar from the liver, and promoting a feeling of fullness.

Do NOT use Pramlintide if:

• you are allergic to any ingredient in Pramlintide
• you cannot tell when your blood sugar is low
• you have a condition that causes your stomach to empty very slowly (gastroparesis)

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

Before using Pramlintide :

Some medical conditions may interact with Pramlintide . 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 are on dialysis, have had severe low blood sugar within the past 6 months, have diabetic nerve disease, or have difficulty using insulin therapy or difficulty monitoring your blood glucose levels

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

• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fibrates (eg, clofibrate), fluoxetine, insulin, monoamine oxidase (MAO) inhibitors (eg, phenelzine), pentoxifylline, propoxyphene, salicylates (eg, aspirin), sulfonamide antibiotics (eg, sulfamethoxazole/trimethoprim), or sulfonylureas (eg, glipizide) because low blood sugar may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pramlintide 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 Pramlintide :

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

• Use Pramlintide immediately before meals.
• Pramlintide comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Pramlintide refilled.
• If you are using Pramlintide at home, carefully follow the injection procedures taught to you by your health care provider.
• If Pramlintide contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
• Never touch the rubber stopper of the vial or the needle of the syringe with your fingers. Carefully check that you have drawn the correct dose before administration.
• Do not mix Pramlintide in the same syringe with insulin.
• Administer Pramlintide and insulin as separate injections at least 2 inches apart from one another or in different areas.
• Rotate injection sites so you do not use the same site repeatedly.
• Pramlintide may affect the way other medicines are absorbed into your body, especially if you take them within 1 hour before or 2 hours after using Pramlintide . Talk with your doctor or pharmacist about how thou should take any other medicines with Pramlintide .
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• Continue to use Pramlintide even if you feel well. Do not miss any doses.
• If you miss a dose of Pramlintide , skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Pramlintide may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pramlintide . Using Pramlintide alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Nausea is a common side effect with Pramlintide . Mild nausea is more likely during the first weeks of starting Pramlintide and usually does not last long. Tell your doctor immediately if nausea continues or is bothersome.
• Do NOT use Pramlintide if your blood sugar is too low; you do not plan to eat or you are skipping a meal; you plan to eat a meal with fewer than 250 calories or 30 grams of carbohydrates; you are sick and cannot eat your usual meal; you are having surgery or a medical test in which you cannot eat; you are pregnant or breastfeeding and you have not talked to your doctor.
• If you stop using Pramlintide for any reason, contact your doctor. Follow your doctor"s instructions for restarting Pramlintide .
• If you use more than your prescribed dose of Pramlintide , you may have nausea or vomiting, and you may not be able to eat the amount of food you usually eat. Pay close attention to the amount of insulin you use at this time because you may be more at risk for low blood sugar. Contact your doctor for more information.
• During times of stress such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medicine may be required.
• Pramlintide may cause low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you do not have a reliable source of glucose available, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To prevent low blood sugar, eat meals on a regular schedule and do not skip meals.
• Use of alcohol may increase your risk of low blood sugar.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pramlintide .
• Carry an identification card at all times that says you are taking Pramlintide .
• LAB TESTS, including glycosylated hemoglobin and blood sugar levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Pramlintide is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pramlintide , discuss with your doctor the benefits and risks of using Pramlintide during pregnancy. It is unknown if Pramlintide is excreted in breast milk. If you are or will be breast-feeding while you are using Pramlintide , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pramlintide :

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:

Coughing; decreased appetite; dizziness; indigestion; nausea; redness, swelling, itching, or pain at the injection site reaction; sore throat; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting, irritability, difficulty concentrating); severe or continuing nausea.

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 diarrhea; dizziness; flushing; severe nausea; vomiting.

Store unused vials of Pramlintide in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened (in-use) vials either in the refrigerator or at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). If you store in-use medicine in the refrigerator, allow it to warm to room temperature before using it. Store away from heat, moisture, and light. Throw away any unused medicine after the vial has been open for 28 days. Do not use Pramlintide if it has been frozen, heated above room temperature, or if the vial is beyond the expiration date. Do not store in the bathroom. Keep Pramlintide out of the reach of children and away from pets.

General information:

• If you have any questions about Pramlintide , please talk with your doctor, pharmacist, or other health care provider.
• Pramlintide 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 Pramlintide . 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.