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Pramlintide (pramlintide acetate) injection is an anti-diabetic medication for use in patients with diabetes treated with insulin. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine).
The structural formula of pramlintide acetate is shown below:
Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe-Leu-Val-His-Ser-Ser-Asn-Asn-Phe- Gly-Pro-Ile-Leu-Pro-Pro-Thr-Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2 acetate (salt) with a disulfide bridge between the two Cys residues.
Pramlintide acetate is a white powder that has a molecular formula of C171H267N51O53S2• × C2H4O2 (3≤≤× ≤8); the molecular weight is 3949.4. Pramlintide acetate is soluble in water.
SYMLIN is formulated as a clear, isotonic, sterile solution for subcutaneous administration. The disposable multidose SymlinPen® pen-injector contains 1000 mcg/mL of pramlintide (as acetate). The formulation contains 2.25 mg/mL of metacresol as a preservative, D-mannitol as a tonicity modifier, acetic acid, sodium acetate as pH modifiers, and water for injection. SYMLIN has a pH of approximately 4.0.
pramlintide is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
Angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, Lotensin HCT), captopril (Capoten, Capozide), and enalapril (Vasotec, Vaseretic)
beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)clonidine (Catapres)disopyramide (Norpace)fenofibrate (Lofibra, Tricor)fluoxetine (Prozac, Sarafem)gemfibrozil (Lopid guanethidine (Ismelin)other medications for diabetesmonoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate) pentoxifylline (Trental reserpine (Serpalan, Serpasil)salicylate pain relievers such as aspirin.sulfonamide antibiotics such as trimethoprim/sulfamethoxazole (Bactrim, Septra).
This is not a complete list of pramlintide drug interactions. Ask your doctor or pharmacist for more information.
DOSAGE AND ADMINISTRATION
Important Considerations Pertaining To pramlintide And Insulin Dose Adjustments
pramlintide dosage differs depending on whether the patient has type 1 or type 2 diabetes [see Patients With Type 2 Diabetes Using Mealtime Insulin and Patients With Type 1 Diabetes].
pramlintide should be used only in patients who can fully understand and adhere to proper insulin adjustments and glucose monitoring.
Insulin and pramlintide dose adjustments should be made only as directed by a healthcare professional skilled in the use of insulin.
When initiating pramlintide, reduce mealtime insulin doses, including premixed insulins, by 50% to reduce the risk of hypoglycemia.
To reduce the risk of nausea, wait at least 3 days before titrating pramlintide to the next dose increment.
Monitor blood glucoses frequently, including pre- and post-meals and at bedtime, particularly when initiating pramlintide or increasing the pramlintide dose. After the initial 50% reduction in mealtime insulin dose, individualize insulin dose adjustments based on glycemic control and tolerability (e.g., if nausea occurs it may affect the dose of insulin required). An increased frequency of mild-to-moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia.
If pramlintide therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN therapy is reinstituted Patients With Type 2 Diabetes Using Mealtime Insulin
Reduce mealtime insulin doses (including premixed insulins) by 50%, then initiate pramlintide at 60 mcg subcutaneously, injecting immediately prior to each major meal.
Increase the pramlintide dose from 60 to 120 mcg prior to each major meal when no clinically significant nausea has occurred for at least 3 days.
If significant nausea persists at the 120 mcg dose, the pramlintide dose should be decreased to 60 mcg.
Patients With Type 1 Diabetes
Reduce mealtime insulin doses by 50%, then initiate pramlintide at 15 mcg subcutaneously, injecting immediately prior to each major meal.
Increase the pramlintide dose to the next increment (30, 45, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days.
If significant nausea persists at the 45 or 60 mcg dose level, the pramlintide dose should be decreased to 30 mcg. If the 30 mcg dose is not tolerated, discontinuation of pramlintide therapy should be considered.
pramlintide should be administered subcutaneously immediately prior to each major meal (≥250 kcal or containing ≥30 grams of carbohydrate).
pramlintide should be at room temperature before injecting to reduce potential injection site reactions. Each pramlintide dose should be administered subcutaneously into the abdomen or thigh. Administration into the arm is not recommended because of variable absorption. Injection sites should be rotated so that the same site is not used repeatedly. The injection site selected should also be distinct from the site chosen for any concomitant insulin injection.
pramlintide and insulin should always be administered as separate injections.
pramlintide should not be mixed with any type of insulin.
If a pramlintide dose is missed, wait until the next scheduled dose and administer the usual amount.
Discontinuation Of Therapy
pramlintide therapy should be discontinued if there is:
recurrent unexplained hypoglycemia that requires medical assistance.
persistent clinically significant nausea.
noncompliance with self-monitoring of blood glucose concentrations.
noncompliance with insulin dose adjustments.
noncompliance with scheduled healthcare provider contacts or recommended clinic visits.
Preparation And Handling
pramlintide should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit.
Dosage Forms And Strengths
pramlintide is supplied as a sterile injection in the following dosage forms:
1.5 mL disposable multidose SymlinPen® 60 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
2.7 mL disposable multidose SymlinPen® 120 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
pramlintide Injection is available in the following package sizes:
SymlinPen® 60 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) Two 1.5 mL disposable multidose pen-injectors (NDC 0310-6615-02)
SymlinPen® 120 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) Two 2.7 mL disposable multidose pen-injectors (NDC 0310-6627-02)
Storage And Handling
pramlintide Pen-Injectors Not In Use
Refrigerate (2°C to 8°C; 36°F to 46°F), and protect from light. Do not freeze. Do not use if product has been frozen. Unused pramlintide (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
SYMLIN Pen-Injectors In Use
After first use, refrigerate or keep at a temperature not greater than 86°F (30°C) for 30 days. Use within 30 days, whether or not refrigerated.
Pramlintide is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
Pramlintide is given at mealtimes. The use of pramlintide does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
Even when pramlintide is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this low blood sugar (severe hypoglycemia) happens, it is seen within 3 hours after a pramlintide injection. Severe low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others.
Pramlintide should only be used by people with type 2 and type 1 diabetes who:
already use their insulin as prescribed, but still need better blood sugar control.
will follow their doctor’s instructions exactly.
will follow up with their doctor often.
will test their blood sugar levels before and after every meal, and at bedtime.
understand how to adjust pramlintide and insulin doses.
Do not drive or operate dangerous machinery until you know how pramlintide affects your blood sugar. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others. Discuss with your doctor what activities you should avoid.
Alcohol may increase the risk of low blood sugar.
Your doctor will tell you which medicines you can take while using pramlintide. Do not take other medicines that slow stomach emptying.
Do not use pramlintide if you:
cannot tell when your blood sugar is low (hypoglycemia unawareness).
have a stomach problem called gastroparesis. This is when your stomach does not empty as fast as it should.are allergic to pramlintide or any ingredients in pramlintide.
Low blood sugar (hypoglycemia):
Pramlintide is used with insulin to lower your blood sugar, but your blood sugar may drop too low, especially if you have type 1 diabetes.
When starting pramlintide, reduce your doses of insulin before meals as recommended by your doctor to reduce the chance of low blood sugar. You and your doctor should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon with you at all times. Call your doctor if you have low blood sugar more often than normal or severe low blood sugar.
Your chance for low blood sugar is higher if you:
do not reduce your insulin dose before meals at the beginning of pramlintide treatment, as directed by your doctor.use more pramlintide or insulin than prescribed by your doctor.change your insulin dose without checking your blood sugar.eat less food than your usual meal.are sick and cannot eat.are more active than usual.have a low blood sugar level before eating.drink alcohol.
Always have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon available to treat low blood sugar.
Nausea is the most common side effect with pramlintide. Mild nausea is more likely during the first weeks after starting pramlintide and usually does not last long. It is very important to start pramlintide at a low dose and increase it as directed by your doctor. If nausea continues or bothers you, call your doctor right away.
Pramlintide also may cause the following side effects:
decreased appetite,vomiting,stomach pain,tiredness,dizziness,indigestion,redness, bruising, pain at injection site
Tell your doctor if you have any side effects that bother you or that do not go away.
These are not all the side effects with pramlintide. Ask your doctor or pharmacist for more information.
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