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Pharmacologic class: Synthetic amylin
Therapeutic class: Hypoglycemic
Pregnancy risk category C
FDA Box Warning
• Drug is used with insulin and has been linked to increased risk of insulin-induced severe hypoglycemia, especially in patients with type 1 diabetes. When severe hypoglycemia occurs, it arises within 3 hours after injection. If it occurs while patient operates a motor vehicle or heavy machinery or performs other high-risk activities, serious injuries may occur. Careful patient selection, patient instruction, and insulin dosage adjustments are crucial to reduce risk.
Mimics amylin activity to modulate gastric emptying, prevent postprandial rise in plasma glucagons, and cause feeling of satiety leading to decreased caloric intake and potential weight loss
Solution for injection: 0.6 mg/ml in 5-ml vials; 1.5-ml disposable multidose pen-injector containing 1,000 mcg/ml; 2.7-ml disposable multidose 120 pen-injector containing 1,000 mcg/ml
Indications and dosages
➣ Type 1 diabetes mellitus as adjunct treatment in patients who take insulin with meals but haven't obtained desired glycemic control despite optimal insulin therapy
Adults: Initially, 15 mcg subcutaneous injection immediately before major meals; after 3 days, increase in 15-mcg increments to maintenance dosage of 30 or 60 mcg as tolerated. Decrease preprandial rapid- or short-acting insulin dosages (including fixed-mix insulins) by 50%.
➣ Type 2 diabetes mellitus as adjunct treatment in patients who take insulin with meals but haven't obtained desired glycemic control despite optimal insulin therapy, with or without concurrent sulfonylurea, metformin, or both
Adults: Initially, 60 mcg subcutaneous injection immediately before major meals; after 3 to 7 days, increase to 120 mcg as tolerated. Decrease preprandial rapid- or short-acting insulin dosages (including fixed-mix insulins) by 50%.
• Hypersensitivity to drug or its components
• Confirmed gastroparesis
• Hypoglycemia unawareness
Use cautiously in:
• patients with poor compliance to insulin therapy or hemoglobin A1c levels above 9%
• patients with recurrent or severe hypoglycemia who've required treatment during past 6 months
• concurrent insulin therapy for type 1 diabetes
• concurrent use of drugs that stimulate GI motility
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Administer immediately before major meals (at least 250 kcal or 30 g carbohydrates).
• Give pramlintide and insulin as separate injections.
• Inject pramlintide and insulin more than 2" apart.
CNS: headache, dizziness, fatigue
GI: nausea, vomiting, abdominal pain, anorexia
Metabolic: severe hypoglycemia
Other: allergic reaction
Drug-drug. Angiotensin-converting enzyme inhibitors, disopyramide, fibric acid derivatives, fluoxetine, monoamine oxidase inhibitors, oral hypoglycemics, pentoxifylline, propoxyphene, salicylates, sulfonamide antibiotics: increased hypoglycemic effect, increased risk of hypoglycemia
Beta-adrenergic blockers, clonidine, guanethidine, reserpine: blunting of early hypoglycemia symptoms
Drugs that delay gastric emptying (such as atropine) or slow food absorption (such as acarbose): exacerbated delay in gastric emptying, slow food absorption
Insulin: severe hypoglycemia (may occur within 3 hours of insulin administration)
Oral drugs for which rapid effect is desired (such as analgesics): delayed absorption of these drugs
• Monitor premeal and postmeal blood glucose levels closely; watch for hypoglycemia.
• Instruct patient to take drug immediately before major meals.
• Teach patient how to self-administer injection; describe proper storage, handling, and disposal of drug and supplies.
• Instruct patient to inject pramlintide and insulin separately, more than 2" apart. Caution patient not to mix them together.
☞ Teach patient to recognize and immediately report hypoglycemia symptoms; tell him these may occur within 3 hours after pramlintide injection.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.