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Symlin

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Symlin

SYMLIN®
(pramlintide acetate) Injection

Symlin

WARNING

SYMLIN (pramlintide acetate injection) 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 SYMLIN (pramlintide acetate injection) use occurs, it is seen within 3 hours following a SYMLIN (pramlintide acetate injection) 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.

DRUG DESCRIPTION

SYMLIN® (pramlintide acetate) Injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine).

The structural formula of pramlintide acetate is as shown:


Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe- Leu-Val-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-Ile-Leu-Pro-Pro-Thr- Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2 acetate (salt) with a disulfide bridge between the two Cys residues.

Pramlintide acetate is a white powder that has a molecular formula of C171H267N51O53S2· x C2H4O2 (3< x <8); the molecular weight is 3949.4. Pramlintide acetate is soluble in water.

SYMLIN (pramlintide acetate injection) is formulated as a clear, isotonic, sterile solution for subcutaneous (SC) administration. SYMLIN (pramlintide acetate injection) vials contain 0.6 mg/mL of pramlintide (as acetate), 2.25 mg/mL of metacresol as a preservative, D-mannitol as a tonicity modifier, and acetic acid and sodium acetate as pH modifiers. SYMLIN (pramlintide acetate injection) has a pH of approximately 4.0.

What are the possible side effects of pramlintide (Symlin, SymlinPen 120, SymlinPen 60)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe nausea that lasts for 3 to 7 days; or
  • more frequent high blood sugar levels.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • nausea, loss of appetite;
  • headache, tired feeling; or
  • joint pain.

This is not a...

Read All Potential Side Effects and See Pictures of Symlin »

What are the precautions when taking pramlintide acetate injection (Symlin)?

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 (e.g., 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...

Read All Potential Precautions of Symlin »

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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Symlin - User Reviews

Symlin User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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