Drug information of Pramlintide


Pramlintide

Drug group:

Pramlintide is a relatively new adjunct treatment for diabetes (both type 1 and 2). It is derived from amylin, a hormone that is released into the bloodstream, in a similar pattern as insulin, after a meal. Like insulin, amylin is deficient in individuals with diabetes.

Mechanism of effect

Pramlintide is an amlyinomimetic, a functional analog of the naturally occurring pancreatic hormone amylin. Amylin has activity in a number of gastrointestinal and glucodynamic systems, and by mimicking its activity, pramlintide acts to improve glycemic control through modulation of the rate of gastric emptying, prevention of post-prandial rise in glucagon levels, and by increasing sensations of satiety, thereby reducing caloric intake and potentiating weight loss. There appears to be at least three distinct receptor complexes that bind with high affinity to amylin. All three complexes contain the calcitonin receptor at the core, plus one of three Receptor activity-modifying proteins, RAMP1, RAMP2, or RAMP3.

Pharmacodynamic

Pramlintide is a synthetic analog of amylin, a glucoregulatory hormone that is synthesized by pancreatic β-cells and released into the bloodstream, in a similar pattern as insulin, after a meal. Like insulin, amylin is deficient in individuals with diabetes.

Pharmacokinetics

Half-Life: 48 min

Bioavailability: 30-40%

Metabolism: kidneys

Excretion: Primarily urine

Duration: 3 hr

Protein binding: 60%

Dosage

Adult

Type 1 Diabetes

Initial: 15 mcg SC immediately prior to major meals

Increase by 15 mcg q3Days (if not significant nausea occur)

Reduce postprandial short-acting insulin dose by 50%

Maintenance: 30-60 mcg SC

Type 2 Diabetes

Initial: 60 mcg SC immediately prior to major meals

After 3-7 days increase to 120 mcg prior to meals (if not significant nausea occurs)

Reduce postprandial short-acting insulin dose by 50%

Maintenance: 60-120 mcg SC

Pediatric

Safety and efficacy not established

Drug contraindications

severe hypersensitivity reactions

Hypoglycemia unawareness

• insulin detemir • insulin glargine • insulin glulisine • insulin lispro • insulin nph • fesoterodine • henbane • miglitol

Alerts

Do not mix with insulin - administer the two separately

Slows gastric emptying, which may delay the absorption of concomitantly administered oral medications; administer the concomitant oral medication at least 1 hr prior or 2 hr after pramlintide

Slows gastric emptying; not recommended if taking other medications that alter gastrointestinal motility

Never share pen between patients even if needle is changed

Erythema, edema, or pruritus at site of injection reported; may be related to other factors, such as irritants in a skin cleansing agent or improper injection technique

Black Box Warnings

  • Pramlintide is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes
  • When severe hypoglycemia associated with pramlintide use occurs, it is seen within 3 hours following injection
  • If severe hypoglycemia occurs while operating a motor vehicle or heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk

Points of recommendation

Use Pramlintide exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. When you first start using Pramlintide, your insulin dose will change. Do not use your medicines in larger or smaller amounts or for longer than recommended.

Pramlintide is injected under the skin, at the same time as your insulin injection but in a separate injection. Do not self-inject your medicines if you do not fully understand how to give the injections and properly dispose of used needles and syringes.

Do not mix Pramlintide and insulin together in the same syringe.

Pramlintide is usually given just before each major meal. If you skip a meal, you should also skip your Pramlintide dose.

Use a different place on your stomach or thigh each time you give the injection. Inject your insulin in a separate skin area. Do not inject insulin or Pramlintide into the same place two times in a row.

Do not use Pramlintide if it has changed colors or looks cloudy. Call your pharmacist for new medication.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

Take care not to let your blood sugar get too low. Severely low blood sugar (hypoglycemia) may occur within 3 hours after your Pramlintide injection. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your dose of Pramlintide or dosage schedule without your doctor's advice.

Never share an injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high.

Pramlintide is only part of a treatment program that also includes diet, exercise, weight control, regular blood sugar testing, and special medical care. Keep a regular schedule when using your injections and testing your blood sugar. It is also important to plan your meals and physical activity. You may not be able to keep using Pramlintide if you do not follow the dosing instructions.

If you stop using Pramlintide for a short time, you may need to restart the medicine at a lower dose. Follow your doctor's instructions.

Storing unopened injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any Pramlintide not used before the expiration date on the medicine label. Do not freeze Pramlintide, and throw away the medication if it has become frozen.

Take an injection pen out of the refrigerator and allow it to reach room temperature before injecting your dose. Do not remove Pramlintide from an injector pen and put the medicine in a syringe. You may receive too high a dose.

Storing after your first use: You may keep "in-use" injection pens in the refrigerator or at room temperature. Use within 30 days.

Pregnancy level

Group c - Not adequate studies in pregnant women

Related drugs


Ask a Pharmacist


سوالات کاربران
    No comments yet.
Related drugs