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Symlin, |Symlin Symlin

Symlin

Generic Name: pramlintide (pram len tide)
Brand Names: Symlin

What is pramlintide?

Pramlintide is an injectable medicine for adults with type 1 and type 2 diabetes to control blood sugar.

Pramlintide slows down the movement of food through your stomach. This affects how fast sugar enters your blood after eating. Pramlintide is always used with insulin to help lower blood sugar during the 3 hours after meals.

Pramlintide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about pramlintide?

Even when pramlintide is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this low blood sugar (severe hypoglycemia) happens, it is generally seen within 3 hours after a pramlintide injection. Severe low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others.

Pramlintide should only be used by people with type 1 or type 2 diabetes who already use their insulin as prescribed but still need better blood sugar control. Patients taking pramlintide should follow their doctor"s instructions exactly, follow up with their doctor often, test their blood sugar levels before and after every meal and at bedtime, and understand how to adjust pramlintide and insulin doses.

Never mix pramlintide and insulin. You must use different syringes for pramlintide and insulin because insulin can affect pramlintide when the two are mixed together.

What should I discuss with my health care provider before taking pramlintide ?

Do not use pramlintide if you:

• cannot tell when your blood sugar is low (hypoglycemia unawareness); or

• have a stomach problem called gastroparesis (the stomach does not empty as fast as it should);

You may not be able to take pramlintide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

How should I take pramlintide?

You must use pramlintide exactly as prescribed. The amount of pramlintide you use will depend on whether you have type 1 or type 2 diabetes. You and your doctor will decide if you can use pramlintide.

Never mix pramlintide and insulin. You must use different syringes for pramlintide and insulin because insulin can affect pramlintide when the two are mixed together.

Injecting pramlintide is similar to injecting insulin. Inject pramlintide under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Allow pramlintide to warm to room temperature before injecting. Use a U-100 insulin syringe (best to use 0.3 mL [0.3 cc] size) to draw-up and inject pramlintide. Always use a new syringe and needle for each pramlintide injection.

Do not use pramlintide if the liquid in the vial looks cloudy.

Always have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon available to treat low blood sugar.

Using pramlintide and insulin with Type 2 Diabetes: (See the table included with the product labeling to match your pramlintide dose to insulin syringe units.)

• Start pramlintide at 60 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

• Reduce your rapid-acting or short-acting insulin doses before meals by 50 percent, including fixed-mix insulins such as 70/30. This means half of the dose you usually use.

• You must check your blood sugar before and after every meal and at bedtime.

• Increase your dose of pramlintide to 120 mcg on your doctor"s instructions if you have not had any nausea for 3 days or more.

• Tell your doctor right away if you have nausea with the 120 mcg dose. Your doctor will tell you how to adjust your dose of pramlintide.

• Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 mcg dose of pramlintide. All insulin changes should be directed by your doctor.

Using pramlintide and insulin with Type 1 Diabetes: (See the table included with the product labeling to match your pramlintide dose to insulin syringe units.)

• Start pramlintide at 15 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

• When starting pramlintide, reduce your rapid-acting or short-acting insulin doses before meals by 50 percent, including fixed-mix insulins such as 70/30. This means half of the dose you usually use. All insulin changes should be directed by your doctor.

• You must check your blood sugar before and after every meal and at bedtime.

• Increase your dose of pramlintide to 30 mcg on your doctor"s instructions if you have not had any nausea for 3 days or more. If you have nausea with pramlintide at 30 mcg, call your doctor right away. Your doctor may decide that you should stop pramlintide.

• Increase your dose of pramlintide to 45 mcg on your doctor"s instructions if you have not had any nausea for 3 days or more while using the 30 mcg dose.

• Increase your dose of pramlintide to 60 mcg on your doctor"s instructions if you have not had any nausea for 3 days or more while using the 45 mcg dose.

• Call your doctor right away if you are bothered with nausea on the 45 mcg or 60 mcg dose. Your doctor may decide that you should reduce pramlintide to the 30 mcg dose.

• Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of pramlintide that is right for you. All insulin changes should be directed by your doctor.

Once you reach your recommended dose of pramlintide, talk to your doctor about changing your insulin doses to better control your blood sugar. You may have to increase your long-acting insulin to prevent high blood sugar (hyperglycemia) between meals. Insulin changes should be directed by your doctor based on blood sugar testing.

If you stop taking pramlintide for any reason, such as surgery or illness, call your doctor.

Store pramlintide vials in the refrigerator until you open them. Opened vials can be refrigerated or kept at room temperature for up to 28 days. Any opened vial should be thrown away after 28 days, even if it still has medicine in it. Throw away any vial that is out-of-date, has been frozen, heated above room temperature (77 F/25 C) or left at room temperature for more than 28 days.

What happens if I miss a dose?

If you miss or forget a dose of pramlintide, wait until the next meal and take your usual dose of pramlintide at that meal. Do not take more than your usual dose of pramlintide.

What happens if I overdose?

If you take more than your prescribed dose of pramlintide, you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.

What should I avoid while taking pramlintide?

Do not use pramlintide if:

• your blood sugar is too low;

• you do not plan to eat. Do not inject pramlintide if you skip a meal.

• you plan to eat a meal with less than 250 calories or 30 grams of carbohydrate;

• you are sick and can"t eat your usual meal;

• you are having surgery or a medical test where you cannot eat; or

• you are pregnant or breast-feeding and have not talked to your doctor.

Do not drive or operate dangerous machinery until you know how pramlintide affects your blood sugar. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others. Discuss with your doctor what activities you should avoid.

Pramlintide side effects

When starting pramlintide, reduce your doses of insulin before meals as recommended by your doctor to reduce the chance of low blood sugar. You and your doctor should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon with you at all times. Call your doctor if you have low blood sugar more often than normal or severe low blood sugar.

Your chance for low blood sugar is higher if you:

• do not reduce your insulin dose before meals at the beginning of pramlintide treatment, as directed by your doctor;

• use more pramlintide or insulin than prescribed by your doctor;

• change your insulin dose without checking your blood sugar;

• eat less food than your usual meal;

• are sick and cannot eat;

• are more active than usual;

• have a low blood sugar level before eating; or

• drink alcohol.

Nausea is the most common side effect with pramlintide. Mild nausea is more likely during the first weeks after starting pramlintide and usually does not last long. It is very important to start pramlintide at a low dose and increase it as directed by your doctor. If nausea continues or bothers you, call your doctor right away.

Pramlintide also may cause decreased appetite, vomiting, stomach pain, tiredness, dizziness, or indigestion. Pramlintide also can cause reactions at the injection site including redness, minor bruising, or pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect pramlintide?

Keep a list of all the medicines you take. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines including vitamins, minerals, and herbal products. Pramlintide can slow down how other medicines pass through your stomach and may affect how much of them get into your body. Therefore, you may have to change the times you take certain medicines.

Due to its effects on the stomach and intestines, pramlintide should not be taken with other drugs that change how your stomach empties (including atropine, acarbose (Precose), miglitol (Glycet) and others). Talk to your doctor about all the medicines you take including prescription and over-the-counter medicines including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about pramlintide written for health professionals that your may read.

What does my medication look like?

Pramlintide is available with a prescription under the brand name Symlin. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ("Multum") is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum"s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum"s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.