I am diabetic

Drug Name
Glucotrol XL (Glipizide)

Generic Name
Glipizide Tablets (GLIP-i-zide)

Manufacturer / Distributor
Pfizer Inc.

Looks like
Glipizide is available with a prescription under the brand names Glucotrol and Glucotrol XL. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Glucotrol XL 2.5 mg-blue, round, biconvex tablets
• Glucotrol XL 5 mg–round, white, biconvex tablets
• Glucotrol XL 10 mg–round, white, biconvex tablets

Dosage Form
Tablets

Route Of Administration
ORAL

Imprint Code
GLUCOTROL;XL;2,5 / GLUCOTROL;XL;5 / GLUCOTROL;XL;10

Size
8mm / 8mm / 10mm

Alternatives
Amaryl

Drug Uses
Glucotrol is an oral antidiabetic medication used to treat type 2 (non-insulin-dependent) diabetes. In diabetics either the body does not make enough insulin or the insulin that is produced no longer works properly.
There are actually two forms of diabetes: type 1 insulin-dependent and type 2 non-insulin-dependent. Type 1 usually requires insulin injections for life, while type 2 diabetes can usually be treated by dietary changes and/or oral antidiabetic medications such as Glucotrol. Apparently, Glucotrol controls diabetes by stimulating the pancreas to secrete more insulin. If you suffer from type 1 diabetes, you will need to use insulin and will not be able to use Glucotrol. Occasionally, type 2 diabetics must take insulin injections on a temporary basis, especially during stressful periods or times of illness.

Drug class
Glucotrol is in a class of drugs called sulfonylureas. It is used to help control blood sugar levels. Glucotrol is used to treat noninsulin-dependent (Type II) diabetes mellitus (NIDDM) along with diet, exercise, and insulin therapy, if necessary.
Glucotrol may also be used for purposes other than those listed in this medication guide.

Contains
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).

Chemical formula
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:

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.

Mechanism of Action
Glipizide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects also may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Two extrapancreatic effects shown to be important in the action of glipizide are an increase in insulin sensitivity and a decrease in hepatic glucose production. However, the mechanism by which glipizide lowers blood glucose during long-term administration has not been clearly established. Stimulation of insulin secretion by glipizide in response to a meal is of major importance. The insulinotropic response to a meal is enhanced with Glucotrol XL administration in diabetic patients. The postprandial insulin and C-peptide responses continue to be enhanced after at least 6 months of treatment. In 2 randomized, double-blind, dose-response studies comprising a total of 347 patients, there was no significant increase in fasting insulin in all Glucotrol XL-treated patients combined compared to placebo, although minor elevations were observed at some doses. There was no increase in fasting insulin over the long term.
Some patients fail to respond initially, or gradually lose their responsiveness to sulfonylurea drugs, including glipizide. Alternatively, glipizide may be effective in some patients who have not responded or have ceased to respond to other sulfonylureas.

How Taken
Take glipizide exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Glipizide is usually taken before breakfast if it is taken once a day, or before meals if it is taken multiple times each day. Follow your doctor’s instructions.
The Glucotrol XL extended release tablets (glipizide extended release tablets) should be swallowed whole. Do not chew, divide, or crush the tablets.
If you are taking Glucotrol XL extended release tablets (glipizide extended release tablets), do not be concerned if something that looks like a tablet occasionally appears in the stool. The medication is contained in a non-absorbable shell that has been specially designed to slowly release the drug so the body can absorb it. When this process is completed, the empty tablet is eliminated from the body.
It is important to take glipizide regularly to get the most benefit.
Do not change your dose of glipizide without first talking to your doctor.
Your healthcare provider may recommend regular monitoring of blood sugar levels with blood or urine tests.

Dosage and Administration
There is no fixed dosage regimen for the management of diabetes mellitus with Glucotrol XL Extended Release Tablet or any other hypoglycemic agent. Glycemic control should be monitored with hemoglobin A1C and/or blood-glucose levels to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Home blood-glucose monitoring may also provide useful information to the patient and physician. Short-term administration of Glucotrol XL Extended Release Tablet may be sufficient during periods of transient loss of control in patients usually controlled on diet.
In general, Glucotrol XL should be given with breakfast.

Usual Starting Dose
The usual starting dose of Glucotrol XL as initial therapy is 5 mg per day, given with breakfast. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose.

Usual Maintenance Dose
Dosage adjustment should be based on laboratory measures of glycemic control. While fasting blood-glucose levels generally reach steady-state following initiation or change in Glucotrol XL dosage, a single fasting glucose determination may not accurately reflect the response to therapy. In most cases, hemoglobin A1C level measured at three month intervals is the preferred means of monitoring response to therapy.
Hemoglobin A1C should be measured as Glucotrol XL therapy is initiated and repeated approximately three months later. If the result of this test suggests that glycemic control over the preceding three months was inadequate, the Glucotrol XL dose may be increased. Subsequent dosage adjustments should be made on the basis of hemoglobin A1C levels measured at three month intervals. If no improvement is seen after three months of therapy with a higher dose, the previous dose should be resumed. Decisions which utilize fasting blood glucose to adjust Glucotrol XL therapy should be based on at least two or more similar, consecutive values obtained seven days or more after the previous dose adjustment.
Most patients will be controlled with 5 mg to 10 mg taken once daily. However, some patients may require up to the maximum recommended daily dose of 20 mg. While the glycemic control of selected patients may improve with doses which exceed 10 mg, clinical studies conducted to date have not demonstrated an additional group average reduction of hemoglobin A1C beyond what was achieved with the 10 mg dose.

Combination Use
When adding other blood-glucose-lowering agents to Glucotrol XL for combination therapy, the agent should be initiated at the lowest recommended dose, and patients should be observed carefully for hypoglycemia. Refer to the product information supplied with the oral agent for additional information.
When adding Glucotrol XL to other blood-glucose-lowering agents, Glucotrol XL can be initiated at 5 mg. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose. Titration should be based on clinical judgment.

Patients Receiving Insulin
As with other sulfonylurea-class hypoglycemics, many patients with stable type 2 diabetes receiving insulin may be transferred safely to treatment with Glucotrol XL Extended Release Tablets. When transferring patients from insulin to Glucotrol XL, the following general guidelines should be considered:
For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and Glucotrol XL therapy may begin at usual dosages. Several days should elapse between titration steps.
For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and Glucotrol XL therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between titration steps.
During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when the patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.

Patients Receiving Other Oral Hypoglycemic Agents
As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to Glucotrol XL Extended Release Tablets. Patients should be observed carefully (1-2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to Glucotrol XL due to potential overlapping of drug effect.

Missed Dose
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose.
Do not take a double dose of this medication.

Overdose
There is no well-documented experience with Glucotrol XL overdosage in humans. There have been no known suicide attempts associated with purposeful overdosing with Glucotrol XL. In nonclinical studies the acute oral toxicity of glipizide was extremely low in all species tested (LD50 greater than 4 g/kg). Overdosage of sulfonylureas including glipizide can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma may be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
Seek emergency medical attention if you think you have used too much of this medicine. 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.
Storage
Store Glucotrol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light.
Do not store in the bathroom.
Keep Glucotrol out of the reach of children and away from pets.

How Supplied
Glucotrol XL (glipizide) Extended Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows:

2.5 mg tablets are blue and imprinted with “Glucotrol XL 2.5″ on one side.
Bottles of 30 – NDC 0049-1620-30

5 mg tablets are white and imprinted with “Glucotrol XL 5″ on one side.
Bottles of 100 – NDC 0049-1550-66
Bottles of 500 – NDC 0049-1550-73

10 mg tablets are white and imprinted with “Glucotrol XL 10″ on one side.
Bottles of 100 – NDC 0049-1560-66
Bottles of 500 – NDC 0049-1560-73

Most important information about Glucotrol XL

Pharmacokinetics

Possible Side Effects

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