Brand Name

    US Brand Name

    Glucotrol

    Glucotrol XL


    Description

    Glipizide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

    Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glipizide belongs to a class of drugs called sulfonylureas. It stimulates the release of insulin from the pancreas, directing your body to store blood sugar. This helps lower blood sugar and restore the way you use food to make energy.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet, Extended Release
    • 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 glipizide 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 glipizide in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution in patients receiving glipizide.

    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
    • Acarbose
    • Alogliptin
    • Asciminib
    • Aspirin
    • Bexagliflozin
    • Carbamazepine
    • Ceritinib
    • Chloroquine
    • Chlorothiazide
    • Chlorthalidone
    • Ciprofloxacin
    • Dabrafenib
    • 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
    • Ivacaftor
    • Lanreotide Acetate
    • Levofloxacin

    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
    • Cimetidine
    • Clarithromycin
    • Colesevelam
    • Cyclosporine
    • Esmolol
    • Fenugreek
    • Gemfibrozil
    • Glecaprevir
    • Glucomannan
    • Isocarboxazid
    • Labetalol
    • Levobunolol
    • Linezolid
    • Methylene Blue
    • Metipranolol
    • Metoprolol
    • Nadolol
    • Nebivolol
    • Oxprenolol
    • Ozanimod
    • Penbutolol
    • Phenelzine
    • Pibrentasvir
    • Pindolol
    • Practolol
    • Procarbazine
    • Propranolol
    • Psyllium
    • Ranitidine
    • Rasagiline
    • Safinamide

    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 intoxication or
    • Underactive adrenal glands or
    • Underactive pituitary gland or
    • Undernourished condition or
    • Weakened physical condition or
    • Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glipizide.
    • Diabetic ketoacidosis (ketones in the blood) or
    • Type I 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 (an enzyme problem)—May cause hemolytic anemia (blood disorder) in patients with this condition.
    • Heart or blood vessel disease—Use with caution. May make this condition worse.
    • Kidney disease or
    • Liver disease—Higher blood levels of this medicine may occur, which may cause serious problems.
    • Narrowed or blocked food passages (e.g., esophagus, stomach, or intestines), severe—Use with caution. The extended-release tablet may cause obstruction in patients with this condition.

    Proper Use

    Follow carefully the special meal plan your doctor gave you. This is the most 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.

    This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

    Swallow the extended release tablet whole. Do not split, crush, or chew it.

    If you are taking the extended release tablet, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

    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 type 2 diabetes:
      • For oral dosage form (extended-release tablets):
        • Adults—At first, 5 milligrams (mg) once a day taken with breakfast. Your doctor may adjust your dose if needed. The dose is usually not more than 20 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • For oral dosage form (tablets):
        • Adults—At first, 5 milligrams (mg) once a day taken at least 30 minutes before breakfast. Your doctor may adjust your dose if needed. The dose is usually not more than 40 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.

    Glipizide can cause hypoglycemia (low blood sugar). However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take glipizide with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly.

    Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with 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.

    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:

    Less common

    • Anxiety
    • blurred vision
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • chills
    • cold sweats
    • coma
    • confusion
    • cool, pale skin
    • depression
    • difficulty with moving
    • dizziness
    • fainting
    • fast heartbeat
    • headache
    • increased hunger
    • joint pain
    • leg cramps
    • muscle aching or cramping
    • muscle pain or stiffness
    • nausea
    • nervousness
    • nightmares
    • pain in the joints
    • problems in urination or increase in the amount of urine
    • seizures
    • shakiness
    • slurred speech
    • sweating
    • swollen joints
    • unusual tiredness or weakness

    Rare

    • Abdominal or stomach pain
    • bloating
    • bloody or black, tarry stools
    • body aches or pain
    • burning, dry, or itching eyes
    • clay-colored stools
    • congestion
    • constipation
    • cough
    • dark urine
    • decreased vision or other changes in vision
    • diarrhea
    • difficult or labored breathing
    • difficult or painful urination
    • dryness or soreness of the throat
    • excessive tearing
    • fainting
    • fast, slow, or irregular heartbeat
    • feeling of warmth
    • fever
    • heartburn
    • hoarseness
    • indigestion
    • itching
    • loss of appetite
    • pain in the eye
    • pounding in the ears
    • rash
    • redness of the face, neck, arms and occasionally, upper chest
    • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
    • runny nose
    • severe stomach pain
    • shortness of breath
    • tender, swollen glands in the neck
    • tightness in the chest
    • trouble in swallowing
    • unpleasant breath odor
    • voice changes
    • vomiting of blood or material that looks like coffee grounds
    • wheezing
    • yellow eyes or skin

    Incidence not known

    • Agitation
    • back or leg pains
    • bleeding gums
    • blood in the urine or stools
    • chest pain
    • convulsions
    • decreased urine output
    • fluid-filled skin blisters
    • general body swelling
    • general feeling of tiredness or weakness
    • high fever
    • hostility
    • increased thirst
    • irritability
    • lethargy
    • light-colored stools
    • lower back or side pain
    • muscle twitching
    • nosebleeds
    • pinpoint red pots on the skin
    • rapid weight gain
    • sensitivity to the sun
    • skin thinness
    • sores, ulcers, or white spots on the lips or in the mouth
    • stupor
    • swelling of the face, ankles, or hands
    • unusual bleeding or bruising

    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:

    More common

    • Indigestion
    • passing of gas

    Less common

    • Acid or sour stomach
    • belching
    • excess air or gas in the stomach or intestines
    • full feeling
    • pain
    • sleeplessness
    • sneezing
    • stuffy nose
    • trouble sleeping
    • unable to sleep

    Rare

    • Decreased interest in sexual intercourse
    • dizziness or lightheadedness
    • excessive muscle tone
    • feeling of constant movement of self or surroundings
    • flushing or redness of the skin
    • headache, severe and throbbing
    • hives or welts
    • inability to have or keep an erection
    • loss in sexual ability, desire, drive, or performance
    • mood or mental changes
    • muscle stiffness
    • muscle tension or tightness
    • sensation of spinning
    • skin rash, encrusted, scaly, and oozing
    • sleepiness or unusual drowsiness
    • unusually warm skin
    • walking in unusual manner
    • weight loss

    Incidence not known

    • Increased sensitivity of the skin to sunlight
    • 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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