pramlintide, Symlin

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GENERIC NAME: pramlintide

BRAND NAME: Symlin

DRUG CLASS AND MECHANISM: Pramlintide is an injectable drug that lowers the level of sugar (glucose) in blood. It is used for treating type 1 and type 2 diabetes. Pramlintide is a synthetic (man-made) hormone that resembles human amylin. Amylin is a hormone that is produced by the pancreas and released into the blood after meals where it helps the body to regulate levels of blood glucose. Amylin acts in several ways to control blood glucose. It slows the rate at which food (including glucose) is absorbed from the intestine. Amylin reduces the production of glucose by the liver by inhibiting the action of glucagon, a hormone produced by the pancreas that stimulates the production of glucose by the liver. Amylin also reduces appetite. In studies, pramlintide-treated patients achieved lower blood glucose levels and experienced weight loss. Pramlintide was approved by the FDA in March 2005.

PRESCRIPTION: Yes.

GENERIC AVAILABLE: No.

PREPARATIONS: Sterile injection: 5 ml vials, 600 mcg/ml. Multidose SymlinPen: 1000 mcg/ml (1.5 and 2.7 ml).

STORAGE: Unopened vials and pen-injectors should be refrigerated between 2-8 C (36-46 F). Opened (in use) vials and pen-injectors should be refrigerated or kept at room temperature (no greater than 86 F, 30 C ) and used within 28 days.

PRESCRIBED FOR: Pramlintide is used in combination with insulin in patients with type 1 diabetes who use mealtime insulin and have not achieved adequate glucose control. It is also used in patients with type 2 diabetes who use mealtime insulin and have uncontrolled blood glucose levels despite maximal insulin therapy, with or without sulfonylurea and/or metformin (Glucophage).

DOSING: Pramlintide should be administered under the skin (subcutaneously) prior to major meals. Patients with type 1 diabetes should start treatment with a dose of 15 mcg that is increased by 15 mcg increments to 30 or 60 mcg as tolerated.

Treatment of type 2 diabetes should start with 60 mcg, the dose increasing to 120 mcg as needed. Insulin doses should be reduced when pramlintide is started.

DRUG INTERACTIONS: Pramlintide slows the transit of food through the intestine and, therefore, it should not be administered with other drugs that slow down the intestine (for example, atropine) or slow the absorption of food (for example, acarbose [Precose]). Pramlintide may interfere with (slow) the absorption of orally administered drugs. To avoid this interaction, orally administered drugs that require rapid absorption should be administered 1 hour before or 2 hours after injections of pramlintide. Insulin alters the chemical properties of pramlintide. Therefore, pramlintide and insulin should not be mixed in the same syringe.

PREGNANCY: There are no adequate studies of pramlintide in pregnant women.

NURSING MOTHERS: There are no adequate studies of pramlintide in nursing mothers, and it is not known if pramlintide is excreted in human breast milk.

SIDE EFFECTS: Common side effects of pramlintide include nausea, hypoglycemia (excessively low blood glucose), vomiting, headache, abdominal pain, weight loss, and fatigue. Nausea decreases with continued administration of pramlintide and is less severe when pramlintide is slowly increased to the desired dose. When used with insulin, especially in patients with type 1 diabetes, severe hypoglycemia may occur. If severe hypoglycemia occurs, it usually manifests within 3 hours after receiving pramlintide.

Reference: FDA Prescribing Information


Last Editorial Review: 7/19/2012




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