Classifications: antidiabetic agent; amylin analog; Therapeutic: antidiabetic; amylin analog
Pregnancy Category: C
0.6 mg/mL injection
Pramlintide is a synthetic analog of human amylin, a hormone secreted by pancreatic beta cells. In type 2 diabetic patients
using insulin and in type 1 diabetics, beta cells in the pancreas are either damaged or destroyed, resulting in reduced secretion
of both insulin and amylin after meals. Amylin reduces postmeal glucagon levels, thus lowering serum glucose level.
Pramlintide is an antihyperglycemic drug that controls postprandial blood glucose levels.
Adjunct treatment of diabetes mellitus type 1 and type 2 in patients who use mealtime insulin therapy and who have failed
to achieve desired glucose control despite optimal insulin therapy.
Hypersensitivity to pramlintide, cresol; noncompliance with insulin regime or medical care; HbA1C >9%; hypoglycemia; gastroparesis; concomitant use of drugs to stimulate GI motility; renal failure or dialysis; pregnancy
(category C). Safety and efficacy in children not established.
Osteoporosis; thyroid disease; lactation, alcohol.
Route & Dosage
|Type 1 Diabetes Mellitus
Adult: SC 15 mcg immediately before each major meal; may increase by 15 mcg increments if no clinically significant nausea for 37
d. If nausea or vomiting persists at 45 mcg or 60 mcg, reduce to 30 mcg.
Type 2 Diabetes Mellitus
Adult: SC 60 mcg immediately before each major meal; may increase to 120 mcg if no clinically significant nausea for 37 d. If nausea or vomiting persists at 120 mcg, reduce to 60 mcg.
- Give SC into the abdomen or thigh (not the arm) immediately before each major meal. Rotate injection sites.
- Never mix pramlintide and insulin in the same syringe. Separate injection sites.
- Use a U100 insulin syringe to administer. One Unit of pramlintide drawn from a 0.6 mg/mL vial contains 6 mcg of medication.
Thus, a 30 mcg dose is equal to 5 U in a U100 syringe.
- Do not administer to patients with HbA1C >9% or those taking drugs to stimulate GI motility.
- Note: When initiating pramlintide therapy, insulin dose reduction is required.
- Store at 2°8° C (36°46° F), and protect from light. Do not freeze. Discard vials that have
been frozen or overheated. Discard open vials after 28 d.
Adverse Effects (≥1%)CNS:
, headache. GI:
Abdominal pain, anorexia, nausea, vomiting. Musculoskeletal: Arthralgia
. Respiratory: Coughing,
pharyngitis. Body as a Whole: Allergic reaction, inflicted injury.
Pramlintide can decrease rate and/or extent of GI absorption of other oral drugs. Significant slowing of gastric motility
3040% bioavailability. Peak:
20 min. Distribution:
40% protein bound. Metabolism:
Extensive renal metabolism
Assessment & Drug Effects
- Monitor for severe hypoglycemia, which usually occurs within 3 h of injection. Hypoglycemia is worse in type 1 diabetics.
- Monitor diabetics for loss of glycemic control.
- Lab tests: Baseline and periodic HbA1C; frequent pre/postmeal plasma glucose levels.
- Withhold drug and notify physician for clinically significant nausea or increased frequency or severity of hypoglycemia.
Patient & Family Education
- Follow directions for taking the drug (see Administration). Use a new needle for each injection.
- Note: Patients should reduce a.c. rapid-acting or short-acting insulin dosages by 50% when pramlintide is initiated.
Check with physician.
- Do not drive or engage in potentially hazardous activities until response to drug is known.
- Report any of the following to physician: persistent, significant nausea; episodes of hypoglycemia (e.g., hunger, headache,
sweating, tremor, irritability, or difficulty concentrating).