Exenatide for Injection

Pharmaco-principle and Toxicant Principle The product is a kind of a product which is analogue to incretin, whose effect is similar to that of GLP-1. Exenatide for Injection can promote insulin secretion dependent on amylaceum, restrain undue glucagon secretion dependent on amylaceum, slow gastric emptying, improve the sensitivity which periphery tissue stimulates insuline, and control completely blood sugar. Pharmacokinetics Following hypodermic injection with 10mg exenatide, reaches median peak plasma concentration in 2.1h. The mean peak exenatide concentration (Cmax) was 211pg/ mL, overall mean area under the time-concentration curve was 1036 pg·h/mL. Similar exposure is achieved with administration of Exenatide for Injection in the abdomen, thigh, or upper arm. The mean clearance rate of Exenatide for Injection is 9.1L/h. Exenatide for Injection is exhausted by glomerular filtration, then by protein degradation, and the mean elimination half life is 4h. Indication Exenatide for Injection is indicated for people with type2 diabetes mellitus, whose blood sugar isn’t fully controlled by dimethyl biguanide, sulfonylurea, usage of dimethyl biguanide associated with sulfonylurea. Dosage and Administration 1. Each dose should be administered as a subcutaneous injection is in the abdomen, thigh, and upper arm. The intermission of per twice jection sites should be 1cm. 2. Exenatide for Injection should be initiated at 5μg administered twice daily at any within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approxinmately 6 hours or more apart). Exenatide for Injection should not be administered after a meal. The dose of Exenatide for Injection can be increased to 10μg twice daily after 1 month of therapy. 3. Preparation and Usage First clean hands, take off the plastic protective cap of freeze-dried power’s container, find out the rubber cork, and polish with alcohol cotton ball with 75% concentration. Draw off the special dilution attached by a single-use syringe with 2ml, and infuse it into the freeze-dried power container (100 mg/per vial). Shake or turn the container gentlly. The freeze-dried power dissolves quickly into colorless, clear liquor. Check if there is any air bubble before drawing out the pinhead. If any, make the pinhead vertical and up, knock gentlly the ectotheca of the pin pipe so that the air bubble can be discarded. Make the pinhead not touch anything when drawn out. 4. Choose the injection site, and sterilize the site with alcohol swab, pinch or press the circumference of the site to fix it, make the pinhead form the angle 45° with the site, inject the drug into the site, pull out the pinhead, press the site with alcohol swab for several seconds, but not knead the injected site prevented from hurting subcutaneous tissue and making physic liquor leak out. Store at 2-8°C,protected from light before dissolving the freeze-dried power. After dissolving, store at cool and dark place (the place where temperature is not higher than 20°C), not to be freezed. The physic liquor must be used up within 10 days when prepared. Adverse Reaction Main adverse reactions include nausea, emesia, diarrhoea, nervous, dizzy, dyspepsia and so on. Constraindications Exenatide for Injection is contraindicated in patients with prior severe sensitivity reactions to exenatide or to any the product components. Precautions 1. Exenatide for Injection can’t replace insulin treatment for the patients dependent on insulin. 2. Exenatide for Injection can’t be used for the treatment for the patients with type 1 diabetes and the patients with ketoacidosis. 3. Exenatide for Injection should not be used in patients with end-stage renal disease or severe renal impairement (creatinine clearance <30mL/min). 4. Exenatide for Injection should not be used in patients with severe gastrointestinal disease. 5. When use Exenatide for Injection with sulfonylurea at the same time, if incidence rate of hypoglycemia increases, sulfonylurea should be reduced in doses. 6. It was reported abroad that exenatide for injection has been associated with acute pancreatitis. It should be told to patients that there will be signs and symptoms of pancreatitis when using Exenatide for Injection, including persistent emesia, persistent severe abdominal pain. If pancreatitis is suspected, Exenatide for Injection should promptly be discontinued and other any suspected drug, and appropriate test and management should be initiated. If pancreatitis is confirmed, but the etiology is not unknown, Exenatide for Injection should not be recommended to continue to use. Adminstration for Pregnancy and Nursing Women Pregnancy and nursing women should be cautious for using Exenatide for Injection. Administration for Children It’s not clear to administrate children. Administration for Gerontal Patient In general, Exenatide for Injection is no abnormalities on effect and safety for gerontal patient. Drug Interactions The effect of Exenatide for Injection to slow gastric emptying can reduce the extent and rate of absorption of orally administered drugs. For oral medications that require rapid gastrointestinal absorption and oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics and so on, patients should be advised to take those drugs at least 1hour before Exenatide for Injection. Overdose Effects of the overdoses included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations. Appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Specification 100mg/ per vial. (Attached the special diluted dissolvant with 2.0ml/ vial.) Storage Protected from light, closed tightly, stored between 2 -8 °C. Packaging 1 vial/ box(Attached 1container of the special diluted dissolvant .) Validity Period Tentatively set on half and a year.