"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(pramlintide acetate) Injection
SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk.
SYMLIN® (pramlintide acetate) injection is an anti-diabetic medication 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 shown below:
Pramlintide acetate is a white powder that has a molecular formula of C171H267N51O53S2• × C2H4O2 (3 ≤ × ≤ 8); the molecular weight is 3949.4. Pramlintide acetate is soluble in water.
SYMLIN is formulated as a clear, isotonic, sterile solution for subcutaneous administration. The disposable multidose SymlinPen® pen-injector contains 1000 mcg/mL of pramlintide (as acetate). The formulation contains 2.25 mg/mL of metacresol as a preservative, D-mannitol as a tonicity modifier, acetic acid, sodium acetate as pH modifiers, and water for injection. SYMLIN 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...
What are the precautions when taking pramlintide acetate injection (Symlin)?
Last reviewed on RxList: 4/13/2015
This monograph has been modified to include the generic and brand name in many instances.
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