PRAMLINTIDE

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Pramlintide

Generic name: pramlintide (PRAM lin tide)
Brand name: SymlinPen 120, SymlinPen 60, Symlin
Dosage forms: subcutaneous solution (1000 mcg/mL)
Drug class: Amylin analogs

What is pramlintide?

Pramlintide (Symlin) is a parenteral medicine (available as a subQ injection) used in the management of hyperglycemia in type 1 and type 2 diabetes mellitus in combination with insulin or other drugs.

Pramlintide is a man-made form of a hormone that occurs naturally in the body. Pramlintide lowers blood sugar in three ways. It slows the rate that food moves from your stomach to your intestines, which keeps your blood sugar from rising too fast. Pramlintide also lowers the amount of glucose (sugar) your liver produces. Lastly, pramlintide triggers the feeling of fullness after meals to help control your appetite and decrease how much food you eat.

Pramlintide is used together with insulin to treat type 1 or type 2 diabetes. Pramlintide is usually given after other diabetes medicines have been tried without success.

Pramlintide may also be used for purposes not listed in this medication guide.



Warnings

You should not use pramlintide if you have a digestive condition called "delayed gastric emptying."

You should not use pramlintide if you cannot recognize symptoms of low blood sugar. Severely low blood sugar (hypoglycemia) may occur within 3 hours after your pramlintide injection. Symptoms may include headache, dizziness, drowsiness, vision problems, hunger, weakness, sweating, confusion, irritability, fast heart rate, or feeling jittery.


Pramlintide Uses (indications):

  • Diabetes mellitus (Type 1 and Type 2):

    • It is used as an adjunct treatment in patients with diabetes mellitus Type 1 or Type 2 who fail to achieve their desired post-prandial glucose targets despite optimal insulin therapy.

Note:

  • Reduce premeal insulin dose by 50% when initiating Pramlintide treatment to avoid hypoglycemia.
  • Re-initiation of treatment should be done following the same initial titration protocol.
  • In case a dose is missed, do not administer an extra dose, wait for the next scheduled dose (do not increase the dose)

Pramlintide Dose in the treatment of type 1 Diabetes mellitus:

  • SubQ injection:

    • 15 mcg immediately before the major meal initially
    • Titrate the dose in 15 mcg increments every three days to the target dose of 30 to 60 mcg before the major meal (if significant nausea does not occur)
    • The treatment may be discontinued if significant nausea occurs with the 30 mcg dose.

Pramlintide Dose in the treatment of type 2 Diabetes mellitus:

  • SubQ:
  • 60 mcg immediately before the major meal initially
  • Increase the dose to 120 mcg before each major meal after three days if no significant nausea occurs
  • Reduce the dose to 60 mcg, if significant nausea occurs at a dose of 120 mcg.

 

Use in children:

Not recommended.

 

Pregnancy Risk Factor C

    • Although it has a low chance of crossing the placental barrier (although adverse fetal outcomes were observed in animal reproduction studies),
    • Congenital malformations in pregnancy can lead to diabetes and other adverse effects for both the mother and the baby.
    • The mother’s blood sugar levels should not be elevated and should remain within normal limits.
    • Insulin is the best treatment for diabetic mothers. Diabetes should not be treated during pregnancy with Pramlintide alone.

    Use of pramlintide during breastfeeding

    • It is unknown if the drug will be excreted into breastmilk.
    • Manufacturers recommend that lactating mothers weigh the benefits and risks of the drug.

 

Pramlintide Dose in Kidney disease:

    • CrCl >=15 ml/minute

      • It is not necessary to adjust the dose.
    • End-stage renal disease (ESRD):

      • The manufacturer has not suggested any changes to the dosage.

 

Pramlintide Dose in Liver disease:

The manufacturer has not suggested any changes in the dose (it was not studied in patients suffering from liver disease).

Dose adjustment is not necessary, however, as it is metabolized in the kidneys.

 

Common Side Effects of Pramlintide:

  • Central Nervous System:

    • Headache
  • Endocrine & Metabolic:

    • Severe Hypoglycemia
  • Gastrointestinal:

    • Nausea
    • Anorexia
    • Vomiting
  • Miscellaneous:

    • Accidental Injury

Less Common Side Effects Of Pramlintide:

  • Central Nervous System:

    • Fatigue
    • Dizziness
  • Endocrine & Metabolic:

    • Severe Hypoglycemia
  • Gastrointestinal:

    • Abdominal Pain
  • Hypersensitivity:

    • Hypersensitivity Reaction
  • Neuromuscular & Skeletal:

    • Arthralgia
  • Respiratory:

    • Cough
    • Pharyngitis

 

Contraindications to Pramlintide:

      • Any component of the drug or formulation can cause serious allergic reactions.
      • Patients suffering from gastroparesis diagnosed
      • Hypoglycemic unawareness:

      Warnings and precautions

      • Allergy reactions:

        • It is possible to experience allergic reactions at the injection site. Redness, itching and swelling can all be signs of allergic reactions.
        • Most allergic symptoms disappear within days or weeks.
      • Bariatric surgery

        • Hypoglycemia:
          • Hypoglycemia may occur after gastric bypass, gastric band, or sleeve-gastrectomy.
          • Avoid hypoglycemia after bariatric surgery by choosing a drug that has the lowest hypoglycemic potential.
          • After bariatric surgery, insulin sensitivity and secretion can be partially restored. The gastric bypass is the most successful followed by gastric sleeve or band ligation.
          • The surgery may result in an improvement in insulin sensitivity over 3 to 12 months. However, improvements in liver sensitivity and first-phase insulin secretion can be seen immediately following gastric bypass or sleeve-gastrectomy.
      • Gastroparesis

        • Patients with gastric emptying conditions should not use it.
        • It shouldn’t be taken with anticholinergic medications, which can cause gastric emptying to be impaired.

 

Monitoring parameters:

  • Before you start the treatment:
    • Glycated hemoglobin
    • Body weight
    • Glycemic record

    Therapy:

    • Before and after treatment, monitor blood glucose
    • Patients with good glycemic control have their hemoglobin glycated twice annually, while patients who don’t achieve their glycemic goals three times a month get their hemoglobin glycated once a year.
    • Monitor hypoglycemia’s clinical signs.

 

How to administer Pramlintide?

SubQ injections are administered in the same way as insulin to the abdomen or anterior legs. Variable absorption should be avoided when administering it to the arms. Rotating injection sites is a good idea.

It should not be combined with insulin, and should be administered at locations distinct from the insulin injection site.

Allow the solution to cool before you administer the dose. This will reduce the risk of injection site reactions.

Preparation of oral medications that require rapid absorption or action should begin one hour prior to or two hours following administration of pramlintide.

 

Mechanism of action of Pramlintide:

  • It is a synthetic analog to endogenous amylin, which is secreted by beta cells of your pancreas in conjunction with insulin.

    The following mechanisms result in a decrease in post-prandial glucose:

    • It prolongs the time it takes for your gastric emptying to complete.
    • Reduces post-prandial secretion glucagon
    • Through its action on the brain’s appetite center, it suppresses appetite and caloric intake.

Duration:

  • about 3 hours

Protein binding:

  • about 60%

Metabolism:

  • It is metabolized primarily by the kidneys to des-lys pramlintide (active metabolite)

Bioavailability:

  • ~30% to 40%

Half-life elimination:

  • ~48 minutes

Time to peak plasma concentration:

  • 20 minutes

Excretion:

  • Primarily urine

 


International Brands of Pramlintide:

  • Symlin Pen 120
  • Symlin Pen 60

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