Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3591
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SYMLIN (Injection)
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SYMLIN dosage differs depending on whether the patient has type 2 or type 1 diabetes (see below). When initiating therapy with SYMLIN, initial insulin dose reduction is required in all patients (both type 2 and type 1) to reduce the risk of insulin-induced hypoglycemia. As this reduction in insulin can lead to glucose elevations, patients should be monitored at regular intervals to assess SYMLIN tolerability and the effect on blood glucose, so that individualized insulin adjustments can be initiated. If SYMLIN therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN therapy is re-instituted (see below).<br/>Initiation of SYMLIN therapy:<br/>Patients With Insulin-Using Type 2 Diabetes: In patients with insulin-using type 2 diabetes, SYMLIN should be initiated at a dose of 60 mcg and increased to a dose of 120 mcg as tolerated. Patients should be instructed to:<br/>Patients With Type 1 Diabetes: In patients with type 1 diabetes, SYMLIN should be initiated at a dose of 15 mcg and titrated at 15-mcg increments to a maintenance dose of 30 mcg or 60 mcg as tolerated. Patients should be instructed to:<br/>Once Target Dose of SYMLIN is Achieved in Type 2 or Type 1 Patients: After a maintenance dose of SYMLIN is achieved, both insulin-using patients with type 2 diabetes and patients with type 1 diabetes should be instructed to:<br/>Administration: SYMLIN should be administered subcutaneously immediately prior to each major meal (���250 kcal or containing���30 g of carbohydrate). SYMLIN should be at room temperature before injecting to reduce potential injection site reactions. Each SYMLIN 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.<br/>SymlinPen pen-injector: The SymlinPen pen-injector is available in two presentations: See the accompanying Patient Instructions for Use for instructions for using the SymlinPen pen-injector. The patient should be advised:<br/>SYMLIN vials: To administer SYMLIN from vials, use a U-100 insulin syringe (preferably a 0.3 mL [0.3 cc] size) for optimal accuracy. If using a syringe calibrated for use with U-100 insulin, use the chart below (Table 8) to measure the microgram dosage in unit increments. Always use separate, new syringes and needles to give SYMLIN and insulin injections.<br/>Discontinuation of Therapy: SYMLIN therapy should be discontinued if any of the following occur:<br/>Preparation and Handling: SYMLIN should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit.
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Amylin Physiology: Amylin is co-located with insulin in secretory granules and co-secreted with insulin by pancreatic beta cells in response to food intake. Amylin and insulin show similar fasting and postprandial patterns in healthy individuals (Figure 1). Amylin affects the rate of postprandial glucose appearance through a variety of mechanisms. Amylin slows gastric emptying (i.e., the rate at which food is released from the stomach to the small intestine) without altering the overall absorption of nutrients. In addition, amylin suppresses glucagon secretion (not normalized by insulin alone), which leads to suppression of endogenous glucose output from the liver. Amylin also regulates food intake due to centrally-mediated modulation of appetite. In patients with insulin-using type 2 or type 1 diabetes, the pancreatic beta cells are dysfunctional or damaged, resulting in reduced secretion of both insulin and amylin in response to food.<br/>Mechanism of Action: SYMLIN, by acting as an amylinomimetic agent, has the following effects: 1) modulation of gastric emptying; 2) prevention of the postprandial rise in plasma glucagon; and 3) satiety leading to decreased caloric intake and potential weight loss.<br/>Gastric Emptying: The gastric-emptying rate is an important determinant of the postprandial rise in plasma glucose. 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. This effect lasts for approximately 3 hours following SYMLIN administration.SYMLIN does not alter the net absorption of ingested carbohydrate or other nutrients.<br/>Postprandial Glucagon Secretion: In patients with diabetes, glucagon concentrations are abnormally elevated during the postprandial period, contributing to hyperglycemia. SYMLIN has been shown to decrease postprandial glucagon concentrations in insulin-using patients with diabetes.<br/>Satiety: SYMLIN administered prior to a meal has been shown to reduce total caloric intake. This effect appears to be independent of the nausea that can accompany SYMLIN treatment.<br/>Pharmacokinetics:<br/>Absorption: The absolute bioavailability of a single SC dose of SYMLIN is approximately 30 to 40%. Subcutaneous administration of different doses of SYMLIN into the abdominal area or thigh of healthy subjects resulted in dose-proportionate maximum plasma concentrations (C) and overall exposure (expressed as area under the plasma concentration curve or (AUC)) (Table 1). Injection of SYMLIN into the arm showed higher exposure with greater variability, compared with exposure after injection of SYMLIN into the abdominal area or thigh. There was no strong correlation between the degree of adiposity as assessed by BMI or skin fold thickness measurements and relative bioavailability. Injections administered with 6.0-mm and 12.7-mm needles yielded similar bioavailability.<br/>Distribution: SYMLIN does not extensively bind to blood cells or albumin (approximately 40% of the drug is unbound in plasma), and thus SYMLIN's pharmacokinetics should be insensitive to changes in binding sites.<br/>Metabolism and Elimination: In healthy subjects, the half-life of SYMLIN is approximately 48 minutes. SYMLIN is metabolized primarily by the kidneys. Des-lyspramlintide (2-37 pramlintide), the primary metabolite, has a similar half-life and is biologically active both in vitro and in vivo in rats. AUC values are relatively constant with repeat dosing, indicating no bioaccumulation.<br/>Special Populations:<br/>Pharmacodynamics: In clinical studies in patients with insulin-using type 2 and type 1 diabetes, SYMLIN administration resulted in a reduction in mean postprandial glucose concentrations, reduced glucose fluctuations, and reduced food intake. SYMLIN doses differ for insulin-using type 2 and type 1 patients .<br/>Reduction in Postprandial Glucose Concentrations: SYMLIN administered subcutaneously immediately prior to a meal reduced plasma glucose concentrations following the meal when used with regular insulin or rapid-acting insulin analogs (Figure 2). This reduction in postprandial glucose decreased the amount of short-acting insulin required and limited glucose fluctuations based upon 24-hour glucose monitoring. When rapid-acting analog insulins were used, plasma glucose concentrations tended to rise during the interval between 150 minutes following SYMLIN injection and the next meal .<br/>Reduced Food Intake: A single, subcutaneous dose of SYMLIN 120 mcg (type 2) or 30 mcg (type 1) administered 1 hour prior to an unlimited buffet meal was associated with reductions in total caloric intake (placebo-subtracted mean changes of ~23% and 21%, respectively), which occurred without decreases in meal duration.
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SYMLIN is supplied as a sterile injection in the following dosage forms: To administer SYMLIN from vials, use a U-100 insulin syringe (preferably a 0.3 mL [0.3 cc] size). If using a syringe calibrated for use with U-100 insulin, use the chart (Table 8) in the DOSAGE AND ADMINISTRATION section to measure the microgram dosage in unit increments. Do not mix SYMLIN with insulin. SYMLIN Injection is available in the following package sizes:
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WARNING: SYMLIN 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 SYMLIN use occurs, it is seen within 3 hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, 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.
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pramlintide acetate
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SYMLIN (Injection)
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Adverse events (excluding hypoglycemia, discussed below) commonly associated with SYMLIN when co-administered with a fixed dose of insulin in the long-term, placebo-controlled trials in insulin-using type 2 patients and type 1 patients are presented in Table 4 and Table 5, respectively. The same adverse events were also shown in the open-label clinical practice study, which employed flexible insulin dosing. Most adverse events were gastrointestinal in nature. In patients with type 2 or type 1 diabetes, the incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually titrated to the recommended doses .<br/>Severe Hypoglycemia: SYMLIN alone (without the concomitant administration of insulin) does not cause hypoglycemia. However, SYMLIN is indicated as an adjunct treatment in patients who use mealtime insulin therapy and co-administration of SYMLIN with insulin can increase the risk of insulin-induced hypoglycemia, particularly in patients with type 1 diabetes (see Boxed Warning). The incidence of severe hypoglycemia during the SYMLIN clinical development program is summarized in Table 6 and Table 7.<br/>Post Marketing Experience: Since market introduction of SYMLIN, the following adverse reactions have been reported. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General: Injection site reactions.
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SYMLIN is given at mealtimes and is indicated for:
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SYMLIN
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