Glucotrol XL Extended-Release Tablets

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Glucotrol XL Extended-Release Tablets


Generic Name: Glipizide Extended-Release Tablets (GLIP-ih-zide)
Brand Name: Glucotrol XL

Glucotrol XL Extended-Release Tablets is used for:

Treating patients with type 2 diabetes who cannot control blood sugar levels by diet and exercise alone. It may be used alone or with other antidiabetic medicines.

Glucotrol XL Extended-Release Tablets is a sulfonylurea-type antidiabetic medicine. It works by stimulating the release of your body"s natural insulin from the pancreas, which in turn helps to lower your blood sugar levels.

Do NOT use Glucotrol XL Extended-Release Tablets if:

  • you are allergic to any ingredient in Glucotrol XL Extended-Release Tablets
  • you are in the late stages of pregnancy (at least one month before the expected delivery date)
  • you have certain problems associated with diabetes (eg, diabetic ketoacidosis, diabetic coma), severe burns, severe acidosis, or type 1 diabetes

Contact your doctor or health care provider right away if any of these apply to you.

Before using Glucotrol XL Extended-Release Tablets:

Some medical conditions may interact with Glucotrol XL Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines or other substances
  • if you have liver, kidney, thyroid, or heart problems
  • if you have stomach or bowel problems (eg, severe narrowing of your stomach or bowel, stomach or bowel blockage, stomach paralysis), severe diarrhea, or are malnourished
  • if you are debilitated, have a high fever, have a severe infection, have suffered from severe trauma (eg, injury), or will be having surgery
  • if you have certain hormonal problems (eg, adrenal or pituitary problems), an electrolyte imbalance, acidosis, or high blood pressure

Some MEDICINES MAY INTERACT with Glucotrol XL Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Birth control pills, certain asthma medicines (eg, albuterol), calcium channel blockers (eg, diltiazem), charcoal-containing preparations (eg, activated charcoal), corticosteroids (eg, prednisone), decongestants (eg, pseudoephedrine), diazoxide, diet pills, diuretics (eg, furosemide or hydrochlorothiazide), epinephrine, estrogen, isoniazid, niacin, phenothiazines (eg, promethazine), rifampin, seizure medicine (eg, phenytoin), thyroid supplements (such as levothyroxine) because the effectiveness of Glucotrol XL Extended-Release Tablets may be decreased
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), antacids (eg, sodium bicarbonate), azole antifungals (eg, ketoconazole), beta blockers (eg, propranolol), blood thinners (eg, warfarin or heparin), chloramphenicol, cimetidine, clofibrate, ethanol, fenfluramine and derivatives, fluoxetine, nonsteroidal anti-inflammatory medicines (eg, ibuprofen), macrolide antibiotics (eg, erythromycin), miconazole, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenylbutazone, probenecid, quinolone antibiotics (eg, ciprofloxacin), ranitidine, salicylates (eg, aspirin), or sulfonamides (eg, sulfamethoxazole) because side effects such as low blood sugar (hypoglycemia) may occur
  • Cyclosporine because kidney harm may occur
  • Gemfibrozil because side effects such as increased or decreased blood sugar levels may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Glucotrol XL Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Glucotrol XL Extended-Release Tablets:

Use Glucotrol XL Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Glucotrol XL Extended-Release Tablets with breakfast, unless your doctor tells you otherwise.
  • Swallow Glucotrol XL Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
  • Do not take charcoal-containing medicines within 2 hours of Glucotrol XL Extended-Release Tablets.
  • Take Glucotrol XL Extended-Release Tablets regularly to receive the most benefit from it. Taking Glucotrol XL Extended-Release Tablets at the same time each day will help you to remember to take it.
  • If you miss a dose of Glucotrol XL Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Glucotrol XL Extended-Release Tablets.

Important safety information:

  • Glucotrol XL Extended-Release Tablets may cause dizziness, drowsiness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Glucotrol XL Extended-Release Tablets. Using Glucotrol XL Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Avoid alcoholic beverages while using Glucotrol XL Extended-Release Tablets because they can increase the risk of developing hypoglycemia (low blood sugar). Rarely, alcohol can interact with Glucotrol XL Extended-Release Tablets and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about the safe use of alcohol.
  • The tablet shell may be seen in the stool. This is normal.
  • Check blood sugar levels daily according to your doctor"s directions. Call your doctor if symptoms of low blood sugar develop (eg, tiredness; nausea; confusion; headache; blurred vision; dizziness; fainting; shaking; agitation; excessive hunger; chills; heavy sweating; rapid heart rate; numbness or tingling of lips, tongue, legs, arms, feet), or if symptoms of high blood sugar occur (eg, excessive thirst or urination, flushing, rapid breathing, fruity breath odor).
  • You can prevent low blood sugar by knowing the symptoms of low blood sugar, keeping track of your blood sugar levels, keeping a source of quick-acting sugar with you at all times (eg, glucose tablets or gel, table sugar, honey, candy, orange juice, or non-diet soda), maintaining an adequate diet, and knowing how diet and exercise affect your blood sugar level.
  • Proper diet, regular exercise, and blood sugar testing are important for best results. Glucotrol XL Extended-Release Tablets is not a substitute for them. Eat meals on a regular schedule and do not skip meals. Be sure to follow the diet plan provided by your doctor.
  • It is recommended that you attend a diabetes education program to better understand diabetes, prevention of complications, and the important aspects of its treatment. These include meals/diet, exercise, weight loss, personal hygiene, medicines, and blood glucose monitoring, and the need for regular eye, foot, and medical exams.
  • Use of similar medicines has been associated with an increased risk of heart problems. If you experience chest pain, irregular heartbeat, swelling in your hands or feet, or unusual or sudden weight gain, contact your doctor immediately. Talk to your doctor if you have any questions or concerns about taking Glucotrol XL Extended-Release Tablets.
  • Glucotrol XL Extended-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to Glucotrol XL Extended-Release Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
  • Carry an identification card at all times that says you are taking this medicine.
  • During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medicine may be required. Before you have any medical or dental treatments, emergency care, or surgery, tell your doctor or dentist that you are using Glucotrol XL Extended-Release Tablets.
  • LAB TESTS, including liver and kidney function, fasting blood glucose, glycosylated hemoglobin, and complete blood counts may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Glucotrol XL Extended-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially low blood sugar (hypoglycemia).
  • Glucotrol XL Extended-Release Tablets is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Glucotrol XL Extended-Release Tablets during pregnancy. Glucotrol XL Extended-Release Tablets is not recommended for use for at least 1 month before delivery due to the potential for fetal harm. Insulin may be preferred during pregnancy. Discuss all options with your doctor. It is unknown if Glucotrol XL Extended-Release Tablets is excreted in breast milk. Do not breast-feed while taking Glucotrol XL Extended-Release Tablets.

Possible side effects of Glucotrol XL Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; anxiety; constipation; decreased sensitivity to stimulation; depression; diarrhea; fainting; gas; headache; indigestion; itching; joint pain; leg cramps; loss of appetite; muscle pain; nausea; runny nose; sleeplessness; sweating; tremor; upset stomach; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or irregular heartbeat; dark urine; easy bleeding/bruising; fever; mental/mood changes; persistent sore throat; seizures; stomach pain; swelling of the hands or feet; unusual tiredness or weakness; unusual or sudden weight gain; yellowing eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; loss of consciousness; nausea; rapid heartbeat; shakiness; sweating; tingling of the lips and tongue; vomiting.

Proper storage of Glucotrol XL Extended-Release Tablets:

Store Glucotrol XL Extended-Release Tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, light, and humidity. Do not store in the bathroom. Keep Glucotrol XL Extended-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Glucotrol XL Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Glucotrol XL Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Glucotrol XL Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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