I am diabetic

Sulfonylureas

Sulfonylureas stimulate the beta cells of the pancreas to release more insulin. Sulfonylurea drugs have been in use since the 1950s. Chlorpropamide (brand name Diabinese) is the only first-generation sulfonylurea still in use today. The second generation sulfonylureas are used in smaller doses than the first-generation drugs. There are three second-generation drugs: glipizide (brand names Glucotrol and Glucotrol XL), glyburide (Micronase, Glynase, and Diabeta), and glimepiride (Amaryl). These drugs are generally taken one to two times a day, before meals. All sulfonylurea drugs have similar effects on blood glucose levels, but they differ in side effects, how often they are taken, and interactions with other drugs.

Product Description

Most important information about Glucotrol XL

Pharmacokinetics

Possible Side Effects

To get more information about Glucotrol XL: GLUCOTROL XL MEDICATION.

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Possible side effects

Stop taking glipizide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Other, less serious side effects from glipizide result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency situation.
Low blood sugar may occur when too much glipizide is taken; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.

Hypoglycemia or Low blood sugar has the following symptoms:

• shaking; .
• headache; .
• cold sweats; .
• pale, cool skin; .
• anxiety; and.
• difficulty concentrating.

Keep hard, sugary candy; chocolate; fruit juice; or glucose tablets on hand to treat episodes of low blood sugar.
Increased blood sugar may occur when not enough glipizide is taken; if you eat significantly more food than usual; if you exercise less than usual; if you take other medications; during fever or other illness; and in other situations.

Hyperglycemia or High blood sugar has the following symptoms:

• increased thirst,
• increased hunger, and
• increased urination.

There may be an increased risk of death due to cardiovascular (heart and blood vessels) complications with the use of glipizide when compared to the treatment of diabetes with diet or diet plus insulin. The long-term use of glipizide should be discussed with your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.s What other drugs will affect Glucotrol XL (Glipizide)?

Many other medicines may increase or decrease the effects of glipizide or affect your condition. Before taking glipizide, tell your doctor if you are taking any of the following medicines:

• aspirin or another salicylate such as magnesium/choline salicylate (Trilisate), salsalate (Disalcid, others), choline salicylate (Arthropan), magnesium salicylate (Magan), or bismuth subsalicylate (Pepto-Bismol);
• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), diclofenac (Voltaren, Cataflam), etodolac (Lodine), indomethacin (Indocin), nabumetone (Relafen), oxaprozin (Daypro), naproxen (Anaprox, Naprosyn, Aleve), and others;
• a sulfa-based drug such as sulfamethoxazole-trimethoprim (Bactrim, Septra), sulfisoxazole (Gantrisin), or sulfasalazine (Azulfidine);
• a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil);
• a beta-blocker such as propranolol (Inderal), atenolol (Tenormin), acebutolol (Sectral), metoprolol (Lopressor), and others;
• a diuretic (water pill) such as hydrochlorothiazide (HCTZ, Hydrodiuril), chlorothiazide (Diuril), and others;
• a steroid medicine such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol, others), prednisolone (Prelone, Pediapred, others), and others;
• a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Prolixin, Permitil), prochlorperazine (Compazine), promethazine (Phenergan), and others;
• phenytoin (Dilantin);
• isoniazid (Nydrazid); or
• prescription, over-the-counter, or herbal cough, cold, allergy, or weight loss medications.

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with glipizide or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products. What should I avoid while taking Glucotrol XL (Glipizide)?

Follow diet, medication, and exercise routines closely. Changing any of these things can effect blood sugar levels.
Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
Tell your doctor and dentist that you are taking this medication before you undergo any surgery.
Do not take any prescription, over-the-counter, or herbal cough, cold, allergy, pain, or weight loss medications without first talking to your doctor.

Contraindications

Glipizide is contraindicated in patients with:

• Known hypersensitivity to glipizide or any excipients in the GITS tablets.
• Type 1 diabetes, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Warnings

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with type 2 diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups.
UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2? times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy.
Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
As with any other non-deformable material, caution should be used when administering Glucotrol XL Extended Release Tablets in patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of another drug in this non-deformable sustained release formulation.

Precautions

Renal and Hepatic Disease
The pharmacokinetics and/or pharmacodynamics of glipizide may be affected in patients with impaired renal or hepatic function. If hypoglycemia should occur in such patients, it may be prolonged and appropriate management should be instituted.

GI Disease
Markedly reduced GI retention times of the Glucotrol XL Extended Release Tablets may influence the pharmacokinetic profile and hence the clinical efficacy of the drug.

Hypoglycemia
All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Renal or hepatic insufficiency may affect the disposition of glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. Therapy with a combination of glucose-lowering agents may increase the potential for hypoglycemia.

Loss of Control of Blood Glucose
When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue glipizide and administer insulin.
The effectiveness of any oral hypoglycemic drug, including glipizide, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.

Information For Patients

Carcinogenesis/ Mutagenesis/ Impairment of Fertility
A twenty month study in rats and an eighteen month study in mice at doses up to 75 times the maximum human dose revealed no evidence of drug-related carcinogenicity. Bacterial and in vivo mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 75 times the human dose showed no effects on fertility.

Pregnancy
Pregnancy Category C
Glipizide was found to be mildly fetotoxic in rat reproductive studies at all dose levels (5-50 mg/kg). This fetotoxicity has been similarly noted with other sulfonylureas, such as tolbutamide and tolazamide. The effect is perinatal and believed to be directly related to the pharmacologic (hypoglycemic) action of glipizide. In studies in rats and rabbits no teratogenic effects were found. There are no adequate and well controlled studies in pregnant women. Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because recent information suggests that abnormal blood-glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood-glucose levels as close to normal as possible.

Nonteratogenic Effects
Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. If glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.

Nursing Mothers
Although it is not known whether glipizide is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If the drug is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use
Safety and effectiveness in children have not been established.

Geriatric Use
Of the total number of patients in clinical studies of Glucotrol XL, 33 percent were 65 and over. Approximately 1-2 days longer were required to reach steady-state in the elderly. There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. As such, it should be noted that elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency, are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly. In addition, in elderly, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.

Product Description

Most important information about Glucotrol XL

Pharmacokinetics

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Absorption
Glipizide is rapidly and completely absorbed following oral administration in an immediate release dosage form. The absolute bioavailability of glipizide was 100% after single oral doses in patients with type 2 diabetes.

Distribution
Beginning 2 to 3 hours after administration of Glucotrol XL Extended Release Tablets, plasma drug concentrations gradually rise reaching maximum concentrations within 6 to 12 hours after dosing. With subsequent once daily dosing of Glucotrol XL Extended Release Tablets, effective plasma glipizide concentrations are maintained throughout the 24 hour dosing interval with less peak to trough fluctuation than that observed with twice daily dosing of immediate release glipizide. The mean relative bioavailability of glipizide in 21 males with type 2 diabetes after administration of 20 mg Glucotrol XL Extended Release Tablets, compared to immediate release Glucotrol (10 mg given twice daily), was 90% at steady-state. Steady-state plasma concentrations were achieved by at least the fifth day of dosing with Glucotrol XL Extended Release Tablets in 21 males with type 2 diabetes and patients younger than 65 years. Approximately 1 to 2 days longer were required to reach steady-state in 24 elderly (?65 years) males and females with type 2 diabetes. No accumulation of drug was observed in patients with type 2 diabetes during chronic dosing with Glucotrol XL Extended Release Tablets. Administration of Glucotrol XL with food has no effect on the 2 to 3 hour lag time in drug absorption. In a single dose, food effect study in 21 healthy male subjects, the administration of Glucotrol XL immediately before a high fat breakfast resulted in a 40% increase in the glipizide mean Cmax value, which was significant, but the effect on the AUC was not significant. There was no change in glucose response between the fed and fasting state. Markedly reduced GI retention times of the Glucotrol XL tablets over prolonged periods (e.g., short bowel syndrome) may influence the pharmacokinetic profile of the drug and potentially result in lower plasma concentrations. In a multiple dose study in 26 males with type 2 diabetes, the pharmacokinetics of glipizide were linear over the dose range of 5 to 60 mg of Glucotrol XL in that the plasma drug concentrations increased proportionately with dose. In a single dose study in 24 healthy subjects, four 5 mg, two 10 mg, and one 20 mg Glucotrol XL Extended Release Tablets were bioequivalent. In a separate single dose study in 36 healthy subjects, four 2.5-mg Glucotrol XL Extended Release Tablets were bioequivalent to one 10-mg Glucotrol XL Extended Release Tablet.

Metabolism
The major metabolites of glipizide are products of aromatic hydroxylation and have no hypoglycemic activity. A minor metabolite which accounts for less than 2% of a dose, an acetylamino-ethyl benzene derivative, is reported to have 1/10 to 1/3 as much hypoglycemic activity as the parent compound. The mean total body clearance of glipizide was approximately 3 liters per hour after single intravenous doses in patients with type 2 diabetes. The mean apparent volume of distribution was approximately 10 liters.

Excretion
Glipizide is eliminated primarily by hepatic biotransformation: less than 10% of a dose is excreted as unchanged drug in urine and feces; approximately 90% of a dose is excreted as biotransformation products in urine (80%) and feces (10%).

Special Populations

Geriatric
There were no significant differences in the pharmacokinetics of glipizide after single dose administration to older diabetic subjects compared to younger healthy subjects.

Pediatric
There were no significant differences in the pharmacokinetics of glipizide after single dose administration to older diabetic subjects compared to younger healthy subjects.

Gender
Elderly and debilitated patients are particularly susceptible to hypoglycemic action. Hypoglycemia may be difficult to recognize in elderly.

Renal Insufficiency
There is only limited information regarding the effects of renal impairment on the disposition of glipizide, and no information regarding the effects of hepatic disease. However, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with renal or hepatic impairment.

Hepatic Impairment
Use drug with caution and monitor liver function frequently.

Product Description

Most important information about Glucotrol XL

Possible Side Effects

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What is the most important information I should know about Glucotrol XL (Glipizide)?
Treatment with glipizide may increase the risk of death from cardiovascular disease compared to treatment of diabetes with diet alone or diet plus insulin. Discuss with your doctor the risks and benefits of treatment with glipizide.
Know the signs and symptoms of low blood sugar (hypoglycemia), which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
Follow diet, medication, and exercise routines closely. Changing any of them can affect blood sugar levels.
Always remember that Glucotrol is an aid to, not a substitute for, good diet and exercise. Failure to follow a sound diet and exercise plan can lead to serious complications, such as dangerously high or low blood sugar levels. Remember, too, that Glucotrol is not an oral form of insulin, and cannot be used in place of insulin.
Do not change your dose of glipizide without first talking to your doctor.
Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.
The Glucotrol XL extended release tablets (glipizide extended release tablets) should be swallowed whole. Do not chew, divide, or crush the tablets.

What should I discuss with my doctor before taking Glucotrol XL (Glipizide)?
Before taking glipizide, tell your doctor if you

• have kidney disease;
• have liver disease;
• have thyroid disease;
• have type 1 diabetes;
• have a serious infection, illness, or injury; or
• need surgery.

You may not be able to take glipizide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Patients 65 years of age and older may have a stronger reaction to glipizide and may require a reduced dose.
Glipizide is in the FDA pregnancy category C. This means that it is not known whether glipizide will be harmful to an unborn baby. Insulin is usually the drug of choice to control diabetes during pregnancy. Do not take glipizide without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether glipizide passes into breast milk. Do not take glipizide without first talking to your doctor if you are breast-feeding a baby.

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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

To buy GLUCOTROL XL click HERE: My Family Drugstore