In the three studies, from a mean baseline body weight of 75.3 kg, 73.3 kg, and 76.6 kg, respectively, after randomization there were corresponding mean reductions of –0.8 kg, –1.6 kg, and –1.3 kg (60 mcg TID) and –0.8 kg (60 mcg QID) in the Symlin treatment group compared to mean increases of +0.8 kg, +0.4 kg, and +0.7 kg in the placebo treatment group. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Amylin is colocated with insulin in secretory granules and cosecreted with insulin by pancreatic beta cells in response to food intake. In vitro and in vivo studies, mainly performed in rodents, have demonstrated effects of amylin on glucose metabolism (rev. A randomized, single-blind, placebo-controlled, 5-way crossover pharmacodynamic study evaluated the effect of pramlintide in combination with insulin lispro or regular insulin on postprandial glucose concentrations in adult patients with type 15 or type 26 diabetes who underwent a standardized mixed meal test for 5 consecutive days. No study has been conducted to evaluate the effect of gender on pramlintide pharmacokinetics. In some instances, these reactions may be related to factors other than Symlin, such as irritants in a skin cleansing agent or improper injection technique. SYMLIN® (pramlintide acetate) Injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin. Before initiating Symlin, the patient's HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight should be reviewed. Advise the patient to read the FDA-approved patient labeling (Medication Guide). This affects how fast sugar enters your blood after eating. Most common adverse events reported in ≥5% of patients treated with SYMLIN plus insulin and with greater incidence than in patients treated with placebo plus insulin were: Incidence for severe hypoglycemic adverse events in placebo-controlled trials with SYMLIN plus insulin vs placebo plus insulin and with greater incidence than in patients treated with placebo plus insulin were: Pregnant and Nursing Women: No adequate and well-controlled studies have been conducted in pregnant women. Pramlintide was not clastogenic in the in vivo mouse micronucleus test or in the chromosomal aberration assay utilizing Chinese hamster ovary cells. Symlin did not significantly affect acetaminophen Tmax or Cmax when acetaminophen was administered 1 to 2 hours before Symlin injection. The following adverse reactions have been identified during post-approval use of Symlin. Patients with a mean baseline HbA1c of 8.1% (range 6.5%-10.7%) were randomized to receive either Symlin or placebo, both administered before major meals as add-on to insulin therapy. We all know that insulin, either naturally from beta cell or injected from outside, affects the level of glucose in the blood. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. Mean body mass index was 32.9 kg/m2 for Symlin and 32.2 kg/m2 for placebo. Placebo-Subtracted LSM change in HbA1c at 6 Months (%), Insulin Dose at Baseline: Mealtime/Bolus (U) (SE). There may be new information. in 15).In the rat skeletal muscle, amylin leads to insulin resistance by impairing glycogen synthase activity and increasing glycogen breakdown and subsequently glycolysis, the latter resulting in increased lactate output. Inhibiting the action of glucagon 2. Monitor blood glucoses frequently, including pre- and post-meals and at bedtime, particularly when initiating Symlin or increasing the Symlin dose. SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies. 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. Ex-vivo studies using term perfused human, rabbit, and rat placentas indicate that Symlin has low potential to cross the maternal/fetal placental barrier. SYMLIN ® (pramlintide acetate) injection is an adjunctive treatment for adults with type 1 or type 2 diabetes who have failed to achieve desired glucose control despite optimal insulin therapy. SD: standard deviation; LSM: least squares mean; SE: standard error; U: Units; NM: not measured; TID: 3 times a day; QID: 4 times a day. Before you use Symlin, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. SYMLIN should only be used in pregnancy or while nursing if the potential benefit justifies the potential risk. SYMLIN does not alter the net absorption of ingested carbohydrate or other nutrients. 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). Do not share your SymlinPen with other people, even if the needle is changed. SYMLIN slows the rate at which food is released from the stomach to the small intestine following a meal and, thus, it reduces the initial postprandial increase in plasma glucose. Symlin®(pramlintide acetate) injection is an anti-diabetic medication for use in patients with diabetes treated with insulin. Administer concomitant oral medications at least 1 hour before or 2 hours after SYMLIN if rapid onset or threshold concentration is critical. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high risk activities. Each Symlin dose should be administered subcutaneously into the abdomen or thigh. Generic Name: pramlintide acetate He only dedicated a page to the topic. SYMLIN slows gastric emptying which may delay absorption of concomitantly administered oral medications. The primary metabolite, Des-lys1 pramlintide (2-37 pramlintide), is biologically active in vitro. Concomitant use of a sulfonylurea and/or metformin was permitted. Upon initiation of Symlin, the insulin dose (mostly the mealtime insulin) was reduced by 30% to 50% in order to minimize the occurrence of hypoglycemia. Pramlintide was not mutagenic in the Ames test and did not increase chromosomal aberration in the human lymphocytes assay. Amylin is secreted, along with insulin, by normal functioning pancreatic beta cells in response to food intake. No study has been conducted to evaluate the effect of ethnicity on pramlintide pharmacokinetics. EXPLORE THE KOMBIGLYZE XR MECHANISM OF ACTION Discover how KOMBIGLYZE XR improves glycemic control by incorporating the mechanism of saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, with metformin, a biguanide. Severe Hypoglycemia: Increased risk, particularly for type 1 diabetes. MDs answer your diabetes questions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. SYMLIN + insulin may provide your patients with A1C reductions Two disposable multidose pen-injectors pramlintide acetate 1000 mcg/mL, 1.5 mL. Mixing Symlin and insulin can alter the pharmacokinetics of both products which may result in inadequate glucose control or hypoglycemia. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Figure 1: Secretion Profile of Amylin and Insulin in Healthy Adults. I first learned about Symlin in Dr. Bernstein’s Diabetes Solution Book. When a single dose of a combination oral contraceptive product, containing 30 mcg ethinyl estradiol and 300 mcg norgestrel, was administered 15 minutes after Symlin injection (90 mcg dose) in healthy female subjects, there was no statistically significant change in the Cmax and AUC of ethinyl estradiol. A two-year carcinogenicity study was conducted in CD-1 mice with doses of 0.2, 0.5, and 1.2 mg/kg/day of pramlintide (32, 67, and 159 times the exposure resulting from the human dose of 360 mcg/day based on area under the plasma concentration curve or AUC, respectively). Using Symlin and insulin with type 1 diabetes: Using Symlin and insulin with type 2 diabetes: What are the possible side effects of Symlin? Amylin also regulates food intake due to centrally-mediated modulation of appetite. The efficacy and safety of Symlin were evaluated in 3 (26-52-week), randomized, double-blind, placebo-controlled trials in patients with type 1 diabetes. If you are having problems using your SymlinPen, go to www.Symlin.com or call Information Support at 1-800-236-9933. THE ROLE OF INCRETINS. LSM Change in HbA1c at Week 29 Relative to Baseline (%), Placebo-Subtracted LSM change in HbA1c at 6 Months (%) (SE), Mean Insulin Doses at Baseline: Mealtime/Bolus (U) (SD), Mean Percent Change in Insulin Doses (U) at 6 Months: Mealtime/Bolus (SE), Mean Insulin Doses at Baseline: Basal (U) (SD). Appropriate patient selection. Storage conditions are summarized in Table 9. Buse JB, Polonsky KS, Burant CF. It is unknown whether SYMLIN is excreted in human milk. The effects of premixing on pramlintide pharmacokinetics varied across the different insulin products with a maximum decrease of 40% in pramlintide Cmax and a maximum increase of 36% in pramlintide AUC0-∞. Local allergy may occur at injection site, Incidence for severe hypoglycemic adverse events, Both hormones are secreted by pancreatic beta cells, Both are secreted in response to food intake, In patients with type 1 and type 2 diabetes, there is reduced secretion from pancreatic beta cells of both insulin and amylin in response to food, Insulin and amylin may need to be replaced, Serious hypersensitivity reaction to SYMLIN or its ingredients. Oxybutynin is an oral drug that is used for treating urinary bladder spasm. In the 1960s, researchers discovered that almost twice a… This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Symlin has the potential to delay the absorption of concomitantly administered oral medications. Pramlintide reduces postprandial glucose excursions when added to regular insulin or insulin lispro in subjects with type 1 diabetes. Symlin therapy should be discontinued if there is: Symlin should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit. While this effect is meant to be therapeutic, it can also cause side effects that may be harmful. This Medication Guide has been approved by the U.S. Food and Drug Administration. Table 8 summarizes the 6-month results for each trial for those patients assigned to the 120 mcg dose of Symlin and placebo. A single, subcutaneous dose of 30 mcg of Symlin to patients with type 1 diabetes and 120 mcg of Symlin to patients with type 2 diabetes administered 1 hour prior to an unlimited buffet meal was associated with reductions in total caloric intake (placebo-subtracted mean changes of ~21% and 23%, respectively), which occurred without decreases in meal duration. Amylin acts in several ways to control blood glucose. 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). You can ask your pharmacist or healthcare provider for information about Symlin that is written for health professionals. We comply with the HONcode standard for trustworthy health information -. SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. The injection site selected should also be distinct from the site chosen for any concomitant insulin injection. Do not inject your dose of Symlin if you: See “Disposing of used SymlinPens and needles” at the end of these Instructions for Use. For more information, ask your healthcare provider or pharmacist. Do not use if product has been frozen. To reduce the risk of nausea, wait at least 3 days before titrating Symlin to the next dose increment. Inform patients about the importance of self-management practices including glucose monitoring and timing of dosing. The physiological effects of endogenous amylin and the administered pramlintide are similar. Symlin and SymlinPen are registered trademarks of the AstraZeneca group of companies. Increase the Symlin dose to the next increment (30, 45, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days. Symlin also lowers the amount of glucose (sugar) your liver produces. Amylin affects the rate of postprandial glucose appearance through a variety of mechanisms, as determined by nonclinical studies. Prescribe with caution in patients with visual or dexterity impairment. Use 29, 30, or 31 gauge disposable pen needles. (No Insulin Dose-Reduction During Initiation), Refrigerated or Temperature up to 86°F (30°C), Symlin can cause serious side effects, including. All other trademarks are property of their respective owners. SYMLIN dosage differs depending on whether the patient has type 1 or type 2 diabetes [see Dosage and Administration (2.2, 2.3)]. We encourage you to read the privacy policy of every website you visit. Diabetic patients should be given a 'sick-day' plan to take appropriate action with blood glucose monitoring and pramlintide and insulin therapy when acute illness is present. Never mix SYMLIN and insulin. Symlin should be at room temperature before injecting to reduce potential injection site reactions. SD: standard deviation; LSM: least squares mean; SE: standard error; U: Units. Onset averaged approximately 63 days after initiating protease inhibitor therapy, but has occurred as early as 4 days after beginning therapy. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. Pramlintide has a short half-life (approximately 48 minutes in healthy individuals). Refer patients to the Symlin Medication Guide and Patient Instructions for Use for additional information.
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