Miglitol apollo

Transcription

1 Miglitol apollo Miglitol apollo Miglitol CAS Number : Molecular Weight : g/mol Molecular Formula : C8H17NO5 Systematic (IUPAC) : (2R,3R,4R,5S)-1-(2- hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol Type : small molecule Description : Miglitol is an oral anti-diabetic drug that acts by inhibiting the ability of the patient to breakdown complex carbohydrates into glucose. It is primarily used in diabetes mellitus type 2 for establishing greater

2 glycemic control by preventing the digestion of carbohydrates (such as disaccharides, oligosaccharides, and polysaccharides) into monosaccharides which can be absorbed by the body. Miglitol inhibits glycoside hydrolase enzymes called alpha-glucosidases. Since miglitol works by preventing digestion of carbohydrates, it lowers the degree of postprandial hyperglycemia. It must be taken at the start of main meals to have maximal effect. Its effect will depend on the amount of non-monosaccharide carbohydrates in a person s diet. In contrast to acarbose (another alpha-glucosidase inhibitor), miglitol is systemically absorbed; however, it is not metabolized and is excreted by the kidneys. Taxonomy Kingdom : Organic Classes Glycerol and Derivatives Piperidines Substructures Glycerol and Derivatives Hydroxy Compounds Alcohols and Polyols Aliphatic and Aryl Amines Heterocyclic compounds Piperidines

3 Pharmacology Indication : For use as an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be managed with diet alone. Pharmacodynamics : Miglitol, an oral alphaglucosidase inhibitor, is a desoxynojirimycin derivative that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, miglitol reduce levels of glycosylated hemoglobin in patients with Type II (noninsulin-dependent) diabetes mellitus. Systemic nonenzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time. Because its mechanism of action is different, the effect of miglitol to enhance glycemic control is additive to that of sulfonylureas when used in combination. In addition, miglitol diminishes the insulinotropic and weightincreasing effects of sulfonylureas. Miglitol has minor inhibitory activity against lactase and consequently, at the recommended doses, would not be expected to induce lactose intolerance. Mechanism of action : vin contrast to sulfonylureas, miglitol does not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal a- glucoside hydrolase enzymes. Membrane-bound intestinal a-glucosidases hydrolyze oligosaccharides and

4 disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia. Absorption : Absorption of miglitol is saturable at high doses with 25 mg being completely absorbed while a 100-mg dose is only 50-70% absorbed. No evidence exists to show that systemic absorption of miglitol adds to its therapeutic effect. Volume of distribution : 0.18 L/kg Protein binding : The protein binding of miglitol is negligible (<4.0%). Metabolism : Miglitol is not metabolized in man or in any animal species studied. Route of elimination : Miglitol is not metabolized in man or in any animal species studied. It is eliminated by renal excretion as an unchanged drug. Half life : The elimination half-life of miglitol from plasma is approximately 2 hours. Toxicity : Unlike sulfonylureas or insulin, an overdose will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdomi-nal discomfort. Because of the lack of extra-

5 intestinal effects seen with miglitol, no serious systemic reactions are expected in the event of an overdose. Affected organisms : Humans and other mammals Drug Class And Mechanism Miglitol is an oral medication used to control blood glucose (sugar) levels in type II diabetes. It belongs to a class of drugs called alpha-glucosidase inhibitors which also includes acarbose(precose). Miglitol was approved for use in Carbohydrates that are eaten are digested by enzymes in the intestine into smaller sugars which are absorbed into the body and raise blood sugar levels. The process of carbohydrate digestion requires the pancreas to release into the intestine alpha-amylase enzymes which digest the large carbohydrates into smaller carbohydrates called oligosaccharides. The cells lining the small intestine then release alpha-glucosidase enzymes that further digest the oligosaccharides into smaller sugars, like glucose, that can be absorbed. Miglitol is a manmade oligosaccharide designed to slow down the actions of alpha-amylase and alpha-glucosidase enzymes thereby slowing the appearance of sugar in the blood after a meal. Dosing The initial miglitol dose may start at 25 mg three times daily and then increase after four to eight weeks to mg three times daily. Miglitol should be taken at the first bite of each meal. Smaller doses may be adequate for patients with severe kidney dysfunction. Miglitol therapy is not advised in

6 the presence of certain medical conditions such as inflammatory bowel disease or intestinal obstruction and chronic intestinal diseases involving difficulty with digestion or absorption such ascrohn's disease. Acarbose doses should be adjusted based upon blood glucose levels taken one hour after a meal and blood HbA1c levels taken about three months after starting or changing the dose. (HbA1c is a chemical in the blood that is a good indicator of blood glucose control.) Drug Interactions Miglitol may interfere with digoxin absorption thereby decreasing digoxin blood levels and its effect. Therefore, the digoxin dose may need to be increased if miglitol is begun. Miglitol also may reduce the effectiveness of ranitidine (Zantac) andpropranolol (Inderal). An adjustment in dose based on monitoring of the patient may be necessary if miglitol is used with either of these drugs. Adding a sulfonylurea during therapy with miglitol may lower blood glucose further, and the risk for developing hypoglycemia is greater. Caution should be used when combining these drugs. If mild to moderate hypoglycemia occurs while taking miglitol in combination with a sulfonylurea, oral glucose (dextrose) should be used for treatment instead of sucrose (table sugar). Since miglitol blocks the digestion of sucrose to glucose, hypoglycemia will not be rapidly corrected if sucrose is given. Miglitol alone does not produce hypoglycemia. Uses

7 Miglitol is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Miglitol works by slowing the absorption of carbohydrates from your diet, so that your blood sugar does not rise as much after a meal. How To Use? Take this medication by mouth, usually 3 times daily with the first bite of a meal, or as directed by your doctor. The dosage is based on your medical condition and response to therapy.use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Why is this medication prescribed? Miglitol is used, alone or with other drugs, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood), particularly in people whose diabetes cannot be controlled by diet alone. It slows the breakdown and absorption of table sugar and other complex sugars in the small intestine. This process results in decreased blood sugar (hypoglycemia) levels following meals. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

8 How should this medicine be used? Miglitol comes as a tablet to take by mouth. It is usually taken three times a day with the first bite of a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take miglitol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. What special precautions should I follow? Before taking miglitol, tell your doctor and pharmacist if you are allergic to miglitol or any other drugs. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other medications for diabetes, digestive enzymes (Viokase, Pancrease, or Ultrase), digoxin (Lanoxin), propranolol (Inderal), ranitidine (Zantac), and vitamins. tell your doctor if you have or have ever had a chronic intestinal disease, inflammatory bowel disease, intestinal obstruction, or kidney disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking miglitol, call your doctor. What special dietary instructions should I follow? Miglitol is used in combination with proper diet and exercise to control blood sugar. Skipping or delaying meals or exercising more than usual may cause your blood sugar to fall too low (hypoglycemia). Maintaining the diet and exercise program suggested by your doctor will ensure that the drug works properly.

9 Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking miglitol. What should I do if I forget a dose? Take the missed dose as soon as you remember it. Remember that miglitol should only be taken with a meal. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. What side effects can this medication cause? When used in combination with insulin or other medications used to treat diabetes, miglitol may cause excessive lowering of blood sugar levels. If you have any of the following symptoms, glucose products (Insta-Glucose or B-D Glucose tablets) should be used and you should call your doctor. Because miglitol blocks the breakdown of table sugar and other complex sugars, fruit juice or other products containing these sugars will not help to increase blood sugar. It is important that you and other members of your household understand this difference between miglitol and other medications used to treat diabetes. shakiness dizziness or lightheadedness sweating nervousness or irritability sudden changes in behavior or mood headache numbness or tingling around the mouth weakness

10 pale skin hunger clumsy or jerky movements If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately. confusion seizures loss of consciousness Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar): extreme thirst frequent urination extreme hunger weakness blurred vision If high blood sugar is not treated, a serious, lifethreatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms: dry mouth upset stomach and vomiting shortness of breath breath that smells fruity decreased consciousness Miglitol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: gas diarrhea stomach pain skin rash

11 What storage conditions are needed for this medicine? Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. What other information should I know? Keep all appointments with your doctor and the laboratory. Your blood sugar should be checked regularly to determine your response to miglitol. Your doctor will order certain lab tests to check your response to miglitol. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully. You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

12 apollo asia Division APOLLO Pharmaceuticals API Manufacturer INDIA [P] Ltd. asia Division Mr.Vipin Saxena CEO Cellular: Cellular: Direct : FAX : Wireline Purchase HELPDESK: Wireline Sales HELPDESK: Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58 apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in

13 Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena Google mail:vipinrsaxena BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West, Mumbai, INDIA Pin: Manufacturing Unit Address:

14 Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

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