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Glucotrol XL

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Glucotrol XL

GLUCOTROL XL ®
(glipizide) Extended Release Tablets For Oral Use

DRUG DESCRIPTION

Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.

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:

GLUCOTROL XL® (glipizide) Structural Formula Illustration

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. GLUCOTROL XL® is a registered trademark for glipizide GITS. Glipizide GITS (Gastrointestinal Therapeutic System) is formulated as a once-a-day controlled release tablet for oral use and is designed to deliver 2.5, 5, or 10 mg of glipizide.

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 black ink (S-1-8106).

System Components and Performance

GLUCOTROL XL (glipizide extended release) 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 GLUCOTROL XL (glipizide extended release) Extended Release Tablet is designed to provide a controlled rate of delivery of glipizide into the gastrointestinal lumen which is independent of pH or gastrointestinal motility. The function of the GLUCOTROL XL (glipizide extended release) 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. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.

What are the possible side effects of glipizide (GlipiZIDE XL, Glucotrol, Glucotrol XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking glipizide and call your doctor at once if you have a serious side effect such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums), feeling tired or short of breath, rapid heart rate;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, fever, confusion;...

Read All Potential Side Effects and See Pictures of Glucotrol XL »

What are the precautions when taking glipizide extended release (Glucotrol XL)?

Before taking glipizide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, thyroid disease, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), electrolyte imbalance (hyponatremia), stomach/intestine problems (such as gastrointestinal stenosis or stricture, impaired emptying).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do...

Read All Potential Precautions of Glucotrol XL »

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

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Glucotrol XL - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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