SymlinPen 60

Pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. It is used when patients who are already using insulin need better blood sugar control. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Pramlintide acts like a certain natural substance called amyrin, which lowers blood sugar. This drug works by slowing the movement of food through your stomach. It also decreases your appetite and the amount of sugar your liver makes. Pramlintide does not replace insulin, but it may lower the amount of insulin you need.

Read the Medication Guide provided by your pharmacist before you start using pramlintide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Inject this medication under the skin of the thigh or abdomen just before each main meal. Do not use pramlintide if your blood sugar is too low, if you are planning to eat a small meal (less than 250 calories or 30 grams of carbohydrate), or if you are skipping a meal.

The liquid in the pre-filled injector is stronger than the liquid in the vial. Make sure you are using the correct product. Do not switch between products unless directed by your doctor.

Make sure you learn from your health care professional how to measure your dose and inject this drug. Always use a new needle for each injection. Consult your doctor or pharmacist if you have any questions. If you are storing this drug in the refrigerator, remove it and allow it to come to room temperature before injecting. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid problems under the skin. Never mix pramlintide and insulin in the same syringe or at the same injection site. Inject pramlintide in an area that is at least 2 inches (5 centimeters) away from your insulin injection site.

Your dosage is based on your medical condition, use of other medications, and response to treatment. To reduce the risk of nausea, your doctor may direct you to start at a low dose of pramlintide and gradually increase the dose. Your doctor may also direct you to lower your insulin dose and to check you blood sugar more often. Do not change your dosage without consulting your doctor. Use this medication regularly in order to get the most benefit from it.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

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 persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

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.

This medication should not be used if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have: stomach/intestinal disorders (for example, digestion problems such as gastroparesis).

This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (e.g., children).

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of: 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 any activity that requires 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 (e.g., 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 not known if pramlintide passes into breast milk. Consult your doctor before breast-feeding.

Store injectors you are not currently using in the refrigerator at 36-46 degrees F (2-8 degrees C). Protect from light. Do not freeze. Discard injectors that have been frozen or overheated. The injector you are currently using can be stored in the refrigerator or at room temperature for up to 30 days as long as the temperature is not higher than 86 degrees F (30 degrees C). Discard the injector 30 days after first use whether or not it has been refrigerated, even if some drug remains in the injector. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: diabetes drugs (including alpha glucosidase inhibitors such as acarbose/miglitol), darifenacin, drugs for high blood pressure that may make it harder to notice symptoms of low blood sugar (e.g., clonidine, guanethidine), drugs that slow down or speed up movement of food through your stomach (causing constipation or diarrhea; drugs such as atropine, exenatide, metoclopramide), solifenacin.

Some other medications may not work as well if used at the same time as pramlintide. If you are using any of the following drugs, use them at least 1 hour before or 2 hours after your injection: antibiotics, birth control pills, pain relievers (e.g., acetaminophen).

If you have any questions about when to take your other medications, ask your pharmacist.

If you are using a medication that needs to be taken with food, take it with a small meal or snack (less than 250 calories or 30 grams of carbohydrate) at a time when you do not normally inject pramlintide.

Beta blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea, vomiting, diarrhea, flushing, dizziness.

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication, syringes, or needles with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Lab and/or medical tests (such as fasting blood glucose, hemoglobin A1c) should be done while you are using this medication. Keep all medical and lab appointments. Check your blood sugar regularly as directed (usually before and after meals and at bedtime) and share the results with your doctor.