Pramlintide Acetate, Injection

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KEY POINTS

• This medicine is given by injection to treat type 1 and type 2 diabetes.
• Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse. Call your healthcare provider if you often have high or low blood sugar levels.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic

Generic and brand names: pramlintide acetate, injection; Symlin; SymlinPen

What is this medicine used for?

This medicine is given by injection (shots) along with insulin to treat type 1 and type 2 diabetes. It is used when your mealtime insulin dose has not controlled your blood sugar well enough.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Hypoglycemic episodes (low blood sugar)
• Gastroparesis (slow stomach emptying)

Tell your healthcare provider if you have recently had surgery, an infection, or a fever. Tell your provider if you get sick or injured, or if you are scheduled to have surgery. Your medicine dose may need to be adjusted.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Your healthcare provider will adjust your dosage based on your blood sugar levels. Your healthcare provider may adjust the dose of your other diabetes medicines while you are taking this medicine. Do not change your dose of other diabetes medicine without your provider’s approval. Tell your healthcare provider about all the medicines you take.

Do not stop taking this medicine without your healthcare provider's approval. If you stop taking this medicine for any reason, such as surgery or illness, talk to your healthcare provider about how to re-start this medicine.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is injected 3 times a day, right before each major meal. If you skip a meal, also skip the dose that you would have taken before that meal. Do not use this medicine if your blood sugar is too low.

Do not mix this medicine with insulin in the same syringe. They must be given as 2 separate injections.

This medicine comes in a disposable prefilled pen-injector. Be sure you know when to take the medicine and how much medicine you should take. Your provider will teach you how to use this medicine. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Do not use this medicine if the liquid in the pen-injector looks cloudy or has changed color. Never share needles, pens, or delivery devices with anyone else.

What if I miss a dose?

If you miss a dose, skip the missed dose and take your next one at the next prescribed time. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, loss of appetite, diarrhea, flushing, dizziness.

What should I watch out for?

This medicine may increase your risk of low blood sugar, even when it is carefully added to your mealtime insulin. The risk may be higher in people with type 1 diabetes and usually happens within 3 hours after a dose of this medicine. Call your healthcare provider if you often have high or low blood sugar levels.

Follow the diet and exercise program prescribed by your healthcare provider. Eat regular meals and do not skip meals, even when you travel or are sick. Your dosage of this medicine is based on your food intake.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Do not drive or operate machinery unless you know how this medicine affects your blood sugar.

Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, use too much of this medicine or too much insulin, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Call your healthcare provider if nausea or low blood sugar continues.

Alcohol may affect your response to medicine and food. Do not drink alcohol unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness), constant nausea or vomiting.

Other: Mild nausea, vomiting, or stomach cramps; mild headache; sore throat; cough; loss of appetite; tiredness; dizziness; indigestion; redness, itching, or pain at the spot where an injection has been given; joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), linezolid (Zyvox), ofloxacin, sulfadiazine, and sulfamethoxazole/trimethoprim (Bactrim, Septra)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), belladonna, benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), ipratropium/tiotropium (Spiriva), methscopolamine (Pamine), propantheline, scopolamine (Transderm Scop), and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), thioridazine, and trifluoperazine
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Cholesterol-lowering medicines such as fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide) and gemfibrozil (Lopid)
• Clonidine (Catapres, Kapvay)
• Diabetes medicines such as acarbose (Precose), chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Disopyramide (Norpace)
• Doxepin (Silenor)
• Lanreotide (Somatuline)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Octreotide (Sandostatin)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Pentoxifylline
• Reserpine

This medicine can slow down how other medicines pass through your stomach and may affect how much of them get into your body. You may have to change the times you take certain medicines, such as certain antibiotics, pain medicines, or birth control pills. Talk with your healthcare provider if you should take other oral medicines at least 1 hour before or 2 hours after this medicine.

Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Refrigerate unopened prefilled pens but do not freeze them. Take the medicine out of the refrigerator and allow it to warm to room temperature before using it.

Mark the date you open the medicine. Once opened, the medicine may be stored in the refrigerator or at room temperature for up to 1 month. Discard opened medicine after a month, even if the pen is not empty.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.