PRAMLINTIDE

PRAMLINTIDE
Symlin
Classifications: antidiabetic agent; amylin analog;
Therapeutic: antidiabetic
; amylin analog
Pregnancy Category: C

Availability

0.6 mg/mL injection

Action

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.

Therapeutic Effect

Pramlintide is an antihyperglycemic drug that controls postprandial blood glucose levels.

Uses

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.

Contraindications

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.

Cautious Use

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 3–7 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 3–7 d. If nausea or vomiting persists at 120 mcg, reduce to 60 mcg.

Administration

Subcutaneous
  • 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: Dizziness, fatigue, headache. GI: Abdominal pain, anorexia, nausea, vomiting. Musculoskeletal: Arthralgia. Respiratory: Coughing, pharyngitis. Body as a Whole: Allergic reaction, inflicted injury.

Interactions

Drugs: Pramlintide can decrease rate and/or extent of GI absorption of other oral drugs. Significant slowing of gastric motility with antimuscarinics.

Pharmacokinetics

Absorption: 30–40% bioavailability. Peak: 20 min. Distribution: 40% protein bound. Metabolism: Extensive renal metabolism. Half-Life: 48 min.

Nursing Implications

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).

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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