Generic Name: pramlintide (Subcutaneous route)
Pramlintide acetate is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with pramlintide acetate use occurs, it is seen within 3 hours following a pramlintide acetate injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk .
Pramlintide acetate is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia. When severe hypoglycemia associated with pramlintide acetate use occurs, it is seen within 3 hours following a pramlintide acetate injection. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidiabetic
Pramlintide is used to treat high blood sugar in patients with type 1 and type 2 diabetes. This medicine will decrease the time it takes for food to move through the stomach. It also works to prevent the liver from making sugar. Pramlintide is always used together with insulin to lower the high blood sugar that occurs after meals.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of pramlintide in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pramlintide in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain pramlintide. It may not be specific to SymlinPen. Please read with care.
When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.
This medicine should come with a medication guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You will be using pramlintide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected. Tell your doctor if you have dexterity (skill in using the hands) or vision problems.
This medicine is available in 2 forms. You may use a vial or a SymlinPen™ pen-injector. Your doctor will tell you which dosage form is right for you.
You should never mix your insulin and pramlintide injections together. These injections are always given separately. Also, this medicine should not be used in an insulin infusion pump. If you have questions about this, ask your doctor or pharmacist.
This medicine is given as a shot under the skin of your stomach or upper thigh. Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Never inject insulin and pramlintide in the same site.
Allow the medicine to warm at room temperature before you inject it. If the medicine in the vial or pen-injector has changed color, looks cloudy, or if you see particles in it, do not use it.
Use a new needle and syringe each time you inject your medicine.
Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary for the medicine to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Store the unopened vial or pen-injector in the refrigerator until you are ready to use it. Protect the vial or pen-injector from bright light.
A vial or pen-injector that has been used may be kept in the refrigerator or at room temperature for up to 30 days. Throw away any medicine that has not been used after 30 days.
It is very important that your doctor check your progress at regular visits, especially during the first few weeks you receive this medicine. Blood tests may be needed to see how well you have adjusted to the medicine.
It is very important to follow carefully any instructions from your health care team about:
In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:
When used together with insulin, pramlintide may cause low blood sugar (also called hypoglycemia or insulin reaction), especially in patients with type 1 diabetes. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn what symptoms of low blood sugar you usually have so that you can treat it quickly.
High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. If you have any symptoms of high blood sugar, contact your health care team right away. If high blood sugar is not treated, severe hyperglycemia can occur, leading to ketoacidosis (diabetic coma) and death.
You may have some skin redness, swelling, or itching at the injection site. If this irritation is severe or does not go away, call your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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