Pramlintide Acetate Solution for injection
What is this medicine?
PRAMLINTIDE (PRAM lin tide) is a man-made form of a hormone normally found in the body. It is used to treat type 1 and type 2 diabetes in adults. This medicine works with insulin to control blood sugar.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
HbA1c above 9
low blood sugar episodes
problems checking blood sugar
problems taking diabetes medicine
stomach problems like gastroparesis
trouble being able to tell when blood sugar is low
an unusual or allergic reaction to pramlintide, metacresol, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Do not mix this medicine with insulin in the same syringe. Take this medicine immediately before meals. Take your medicine at regular intervals. Do not take your medicine more often than directed.
Always check the appearance of this medicine before using it. Do not use it if it is cloudy or has solid particles in it.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.
What may interact with this medicine?
medicines for depression, anxiety, or psychotic disturbances
medicines used to treat stomach problems
narcotic medicines for pain
other medicines for diabetes like acarbose, miglitol
Many medications may cause changes in blood sugar, these include:
alcohol containing beverages
aspirin and aspirin-like drugs
female hormones, such as estrogens or progestins, birth control pills
male hormones or anabolic steroids
medications for weight loss
medicines for allergies, asthma, cold, or cough
medicines for mental problems
medicines called MAO inhibitors - Nardil, Parnate, Marplan, Eldepryl
NSAIDS, such as ibuprofen
quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin
some herbal dietary supplements
steroid medicines such as prednisone or cortisone
Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress.
A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.
Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.
Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.
Pramlintide pens and cartridges should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
loss of appetite
signs and symptoms of high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination
signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness
unusual stomach pain or upset
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
increase or decrease in fatty tissue under the skin due to overuse of a particular injection site
irritation at site where injected
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store unopened vials in the refrigerator between 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.
Store opened vials (vials currently in use) in the refrigerator or at room temperature at or below 25 degrees C (77 degrees F). Do not freeze. Keeping this medicine at room temperature decreases the amount of pain during injection. Throw away any opened vials of this medicine 28 days after opening.
March 21, 2017
U.S. FDA-approved Package Insert