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Pramlintide

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Warning

Pramlintide may increase the risk of very low blood sugar when used with insulin, particularly in patients with type 1 diabetes. This reaction is most likely to occur within 3 hours after an injection. Your doctor may decrease your insulin dose when you start pramlintide. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery, or safely participate in other activities that include a risk of hurting yourself or others. (See also Side Effects and Precautions sections.)

Precautions

Before using pramlintide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative metacresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal disorders (for example, digestion problems such as gastroparesis), attacks of low blood sugar (hypoglycemia) that required treatment.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages because alcohol can affect your blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if pramlintide passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

Nausea, vomiting, tiredness, and upset stomach may occur as your body adjusts to the medication. Nausea can be reduced by starting at a low dose and increasing the dose slowly. Redness, swelling and itching at the injection site may occur and usually go away in a few days. If any of these effects last or get worse, contact your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Though pramlintide does not cause low blood sugar (hypoglycemia) by itself, this effect can occur because it is used with insulin. This may also occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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