pramlintide acetate


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pramlintide acetate

Symlin

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.

Action

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

Availability

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%.

Contraindications

• Hypersensitivity to drug or its components
• Confirmed gastroparesis
• Hypoglycemia unawareness

Precautions

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).

Administration

• 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.

Adverse reactions

CNS: headache, dizziness, fatigue

EENT: pharyngitis

GI: nausea, vomiting, abdominal pain, anorexia

Metabolic: severe hypoglycemia

Musculoskeletal: arthralgia

Respiratory: cough

Other: allergic reaction

Interactions

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

Patient monitoring

• Monitor premeal and postmeal blood glucose levels closely; watch for hypoglycemia.

Patient teaching

• 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.

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References in periodicals archive ?
Pramlintide acetate, manufactured by San Diego-based Amylin Pharmaceuticals Inc.
The complaint alleges that on July 25, 2001, the Food and Drug Administration ("FDA") released medical and statistical reviews regarding Amylin's diabetes drug pramlintide acetate (SYMLIN) prior to an FDA Advisory Committee Meeting scheduled for July 26, 2001.