Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Drug information provided by: Amaryl US Brand Name Amaryl Descriptions Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone, or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using this medicine will help lower blood sugar when it is too high and help restore the way you use food to make energy. . Some people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of glimepiride you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: Tablet In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of glimepiride in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glimepiride in the elderly. However, elderly patients are more likely to have low blood sugar and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving glimepiride. Pregnancy Information about this glimepiride-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Alatrofloxacin Balofloxacin Ciprofloxacin Clinafloxacin Disopyramide Enoxacin Entacapone Fleroxacin Fluconazole Flumequine Gatifloxacin Gemifloxacin Grepafloxacin Isoniazid Levofloxacin Lomefloxacin Metreleptin Miconazole Moxifloxacin Norfloxacin Ofloxacin Pefloxacin Prulifloxacin Rufloxacin Sparfloxacin Temafloxacin Tosufloxacin Trovafloxacin Mesylate Voriconazole Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Acebutolol Aceclofenac Acemetacin Alprenolol Amtolmetin Guacil Aspirin Atenolol Betaxolol Bevantolol Bisoprolol Bitter Melon Bromfenac Bucindolol Bufexamac Carteolol Carvedilol Celecoxib Celiprolol Choline Salicylate Clonixin Colesevelam Dexibuprofen Dexketoprofen Diclofenac Diflunisal Dilevalol Dipyrone Esmolol Etodolac Etofenamate Etoricoxib Felbinac Fenofibrate Fenoprofen Fenugreek Fepradinol Feprazone Floctafenine Flufenamic Acid Flurbiprofen Glucomannan Guar Gum Ibuprofen Ibuprofen Lysine Indomethacin Iproniazid Isocarboxazid Ketoprofen Ketorolac Labetalol Levobunolol Linezolid Lornoxicam Loxoprofen Lumiracoxib Meclofenamate Mefenamic Acid Meloxicam Mepindolol Methylene Blue Metipranolol Metoprolol Moclobemide Morniflumate Nabumetone Nadolol Naproxen Nebivolol Nepafenac Nialamide Niflumic Acid Nimesulide Oxaprozin Oxprenolol Oxyphenbutazone Parecoxib Penbutolol Phenelzine Phenylbutazone Piketoprofen Pindolol Piroxicam Pranoprofen Procarbazine Proglumetacin Propranolol Propyphenazone Proquazone Psyllium Rasagiline Rofecoxib Salicylic Acid Salsalate Selegiline Sodium Salicylate Sotalol Sulindac Talinolol Tenoxicam Tertatolol Tiaprofenic Acid Timolol Tolfenamic Acid Tolmetin Tranylcypromine Valdecoxib Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Alcohol, excessive use or Underactive adrenal glands or Underactive pituitary gland or Undernourished condition or Weakened physical condition—These conditions could make you more sensitive to the effects of low blood sugar. Diabetic ketoacidosis (ketones in the blood) or Sulfonamide allergy (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®), or history of or Type 1 diabetes—Should not be used in patients with these conditions. Fever or Infection or Surgery or Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—May cause hemolytic anemia (blood disorder) in patients with this condition. Heart disease—Use with caution. May make this condition worse. Kidney disease—Use with caution. Higher blood levels of this medicine may occur, which may cause serious problems. Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed. You should take this medicine with breakfast or the first main meal of the day. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets): For type 2 diabetes: Adults—At first, 1 to 2 milligrams (mg) once a day. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 8 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. It is very important to follow carefully any instructions from your health care team about: Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team. Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy. Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times. In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines. Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack. Too much glimepiride can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice. Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness. If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it. This medicine may cause dizziness, drowsiness, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert or able to think well. This medicine may cause serious types of allergic reactions, including anaphylaxis. These conditions may be life-threatening and require immediate medical attention. Stop using this medicine and check with your doctor right away if you have a blistering, peeling, or red skin rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Rare Difficulty with swallowing dizziness fast heartbeat hives itching puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue shortness of breath skin rash tightness in the chest unusual tiredness or weakness wheezing Incidence not known Abdominal or stomach pain agitation back, leg, or stomach pains bleeding gums blistering, peeling, or loosening of the skin bloating of abdomen blood in the urine or stools bloody, black, or tarry stools chest pain chills coma confusion cough or hoarseness dark urine decreased urine output depression diarrhea difficulty with breathing fever with or without chills fluid-filled skin blisters general body swelling general tiredness and weakness headache high fever hostility irritability joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lethargy light-colored stools loss of appetite lower back or side pain muscle twitching nausea and vomiting nosebleeds painful or difficult urination pale skin pinpoint red spots on the skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rapid weight gain red, irritated eyes red skin lesions, often with a purple center seizures sensitivity to the sun skin thinness sore throat sores, ulcers, or white spots on the lips or in the mouth stupor swelling of face, ankles, or hands swollen or painful glands unusual bleeding or bruising upper right abdominal or stomach pain yellow eyes or skin Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose Anxiety blurred vision cold sweats cool, pale skin increased hunger nightmares shakiness slurred speech Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common Lack or loss of strength Incidence not known Redness or other discoloration of the skin severe sunburn Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.