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Glucotrol

Generic name: glipizide
Brand names: Glucotrol, Glucotrol XL
Drug class: Sulfonylureas

Medically reviewed by  A Ras MD.

What is Glucotrol used for?

Glucotrol is a prescription medicine that is used to lower blood sugar in patients with high blood sugar (diabetes).

Description

GLUCOTROL XL (glipizide) is an oral sulfonylurea.

The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below:

Chemical Structure

Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide.

Each tablet contains 2.75 mg glipizide to provide a 2.5 mg dose.

Each tablet contains 5.49 mg glipizide to provide a 5 mg dose.

Each tablet contains 10.98 mg glipizide to provide a 10 mg dose.

Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red ferric oxide, cellulose acetate, polyethylene glycol, Opadry® blue (OY-LS-20921)(2.5 mg tablets), Opadry® white (YS-2-7063)(5 mg and 10 mg tablet) and Opacode® Black Ink (S-1-17823).

 

System Components and Performance

GLUCOTROL XL Extended Release Tablet is similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water but not to drug or osmotic excipients. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet.

The function of the GLUCOTROL XL Extended Release Tablet depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.

Mechanism of Action

Glipizide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

Before taking Glucotrol, tell your doctor:

  • If you have a sulfa allergy.
  • If you are allergic to Glucotrol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: Acidic blood problem or type 1 diabetes.
  • If you have G6PD deficiency.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Glucotrol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Glucotrol?

  • Tell all of your health care providers that you take Glucotrol. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Glucotrol affects you.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Glucotrol.
  • Follow the diet and workout plan that your doctor told you about.
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Avoid drinking alcohol while taking Glucotrol.
  • If you also take colesevelam, take it at least 4 hours after you take Glucotrol.
  • It may be harder to control blood sugar during times of stress such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar.
  • This medicine may raise the chance of death from heart disease. Talk with your doctor.
  • Low blood sugar may happen with Glucotrol. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • If you are 65 or older, use Glucotrol with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Glucotrol while you are pregnant.
  • Low blood sugar has happened in infants born to women who took a drug like this one until the birth date. If Glucotrol is used during pregnancy, you will need to stop taking it some time before your due date. Talk with your doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Glucotrol best taken?

Use Glucotrol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take 30 minutes before meals.
  • Take Glucotrol 30 minutes before the first meal of the day, if taking once a day.
  • Be sure you know what to do if you do not eat as much as normal or if you skip a meal.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Glucotrol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight.
  • Slurred speech.
  • Tingling.
  • Feeling very tired or weak.
  • Low blood sugar can happen. The chance may be raised when Glucotrol is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

What are some other side effects of Glucotrol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Diarrhea.
  • Feeling nervous and excitable.
  • Gas.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Glucotrol?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

PRINCIPAL DISPLAY PANEL – 5 MG TABLET BOTTLE LABEL – NDC 0049-0174

  • Pfizer
    NDC 0049-0174-02
  • Glucotrol XL ®
    (glipizide) extended release
    Tablets
  • 5 mg
  • GITS
  • 100 Tablets
    Rx only
Glucotrol 5 mg

Imprint PFIZER 411 - Glucotrol 5 mg

PRINCIPAL DISPLAY PANEL – 10 MG TABLET BOTTLE LABEL – NDC 0049-0178

  • Pfizer
    NDC 0049-0178-07
  • Glucotrol XL ®
    (glipizide) extended release
    Tablets
  • 10 mg
  • GITS
  • 100 Tablets
    Rx only
Glucotrol 10 mg
Imprint PFIZER 412 - Glucotrol 10 mg

SRC: NLM .

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