Brand Name

    US Brand Name

    Amaryl


    Description

    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

    Before Using

    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.

    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.

    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Alogliptin
    • Aspirin
    • Bexagliflozin
    • Capecitabine
    • Carbamazepine
    • Chloroquine
    • Chlorothiazide
    • Chlorthalidone
    • Ciprofloxacin
    • Delafloxacin
    • Desmopressin
    • Disopyramide
    • Dulaglutide
    • Enoxacin
    • Entacapone
    • Fluconazole
    • Furosemide
    • Gatifloxacin
    • Gemifloxacin
    • Grepafloxacin
    • Hydrochlorothiazide
    • Hydroflumethiazide
    • Hydroxychloroquine
    • Indapamide
    • Insulin
    • Insulin Aspart, Recombinant
    • Insulin Bovine
    • Insulin Degludec
    • Insulin Detemir
    • Insulin Glargine, Recombinant
    • Insulin Glulisine
    • Insulin Lispro, Recombinant
    • Isoniazid
    • Ivacaftor
    • Lanreotide Acetate
    • Levofloxacin
    • Levoketoconazole
    • Liraglutide

    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
    • Aminolevulinic Acid
    • Atenolol
    • Betaxolol
    • Bisoprolol
    • Bitter Melon
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Colesevelam
    • Esmolol
    • Fenugreek
    • Glecaprevir
    • Glucomannan
    • Guar Gum
    • Isocarboxazid
    • Labetalol
    • Levobunolol
    • Linezolid
    • Methylene Blue
    • Metipranolol
    • Metoprolol
    • Nadolol
    • Nebivolol
    • Oxprenolol
    • Ozanimod
    • Penbutolol
    • Phenelzine
    • Pibrentasvir
    • Pindolol
    • Practolol
    • Procarbazine
    • Propranolol
    • Psyllium
    • Rasagiline
    • Safinamide
    • Saxagliptin
    • Selegiline
    • Sotalol
    • Timolol

    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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    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.

    Proper Use

    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.


    Precautions

    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.


    Side Effects

    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. You may report side effects to the FDA at 1-800-FDA-1088.






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