Glipizide XL, (glipizide), extended-release tablets, For Oral Use

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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: 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. Glipizide XL is the Greenstone brand name 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).

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Glipizide XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

CONTRAINDICATIONS

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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Glipizide is contraindicated in patients with: Known hypersensitivity to glipizide or any excipients in the GITS tablets.
Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

In U.S. controlled studies the frequency of serious adverse experiences reported was very low and causal relationship has not been established. The 580 patients from 31 to 87 years of age who received Glipizide XL extended-release tablets in doses from 5 mg to 60 mg in both controlled and open trials were included in the evaluation of adverse experiences. All adverse experiences reported were tabulated independently of their possible causal relation to medication.

OVERDOSAGE

id: a64c5428-5f7a-439b-abdf-1b8b41144bb2
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

There is no well-documented experience with Glipizide XL overdosage in humans. There have been no known suicide attempts associated with purposeful overdosing with Glipizide 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.

DOSAGE AND ADMINISTRATION

id: eb33e087-fdb1-4fce-9ee8-9ca6040b5a11
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

There is no fixed dosage regimen for the management of diabetes mellitus with Glipizide XL extended-release tablet or any other hypoglycemic agent. Glycemic control should be monitored with hemoglobin A_1C 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 Glipizide XL extended-release tablet may be sufficient during periods of transient loss of control in patients usually controlled on diet. In general, Glipizide XL should be given with breakfast.

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Glipizide XL (glipizide) extended-release tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink. They are supplied by State of Florida DOH Central Pharmacy as follows:

PATIENT INFORMATION

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displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

GLIPIZIDE XL
(glipizide extended release tablets) Read this information carefully before you start taking this medicine. Read the information you get with your medicine each time you refill your prescription. There may be new information. This information does not take the place of your healthcare provider’s advice. Ask your healthcare provider or pharmacist if you do not understand some of this information or if you want to know more about this medicine. What is GLIPIZIDE XL? GLIPIZIDE XL is a medicine you take by mouth. It is used to treat type 2 diabetes (also called non-insulin-dependant diabetes mellitus). Your healthcare provider has prescribed GLIPIZIDE XL because your current treatment, including diet and exercise, has not been able to bring your blood sugar level under good control. Your body makes insulin to keep the amount of sugar (glucose) in your blood at the right level. With type 2 diabetes: your body may not be making enough insulin
your body may not be using the insulin that you have already made
the level of sugar in your blood is too high If your blood sugar level is not under control, it can lead to serious medical problems, such as kidney damage, nerve damage, blindness, problems with circulation (blood movement in your body), loss of feet, legs or other limbs, high blood pressure, heart attack, or stroke. GLIPIZIDE XL works mainly by: helping the body release more of its own insulin
helping the body respond better to its own insulin
lowering the amount of sugar (glucose) made by the body Even after you start taking GLIPIZIDE XL, you must continue to follow your program of diet and exercise. Who Should Not Use GLIPIZIDE XL? Do not use GLIPIZIDE XL if you: have a condition called diabetic ketoacidosis
have ever had an allergic reaction to glipizide or any of the other ingredients in GLIPIZIDE XL. Ask your healthcare provider or pharmacist for a list of these ingredients. Only your healthcare provider can decide if GLIPIZIDE XL is right for you. Before you start GLIPIZIDE XL, tell the healthcare provider if you: are taking or using any prescription medicines or non-prescription medicines, including natural or herbal remedies. Other medications can increase your chance of getting low blood sugar or high blood sugar. Be sure to tell your healthcare provider if you take the medicines miconazole or fluconazole, used to fight fungus infections.
have ever had a condition called diabetic ketoacidosis
have kidney or liver problems
have had blockage or narrowing of your intestines due to illness or past surgery
have chronic (continuing) diarrhea
are pregnant or might be pregnant. Your healthcare provider may switch you to insulin injections some time during your pregnancy. You should not take GLIPIZIDE XL during the last month of pregnancy
are breast-feeding. GLIPIZIDE XL may pass to the baby through your milk and cause harm.
have glucose-6-phosphate dehydrogenase (G6PD) deficiency. This condition usually runs in families. People with G6PD deficiency who take Glucotrol XL may develop hemolytic anemia (fast breakdown of red blood cells). How Should I Take GLIPIZIDE XL? GLIPIZIDE XL tablets come in three different strengths (2.5 mg, 5 mg and 10 mg). Your healthcare provider will prescribe the dose that is right for you. Take GLIPIZIDE XL once a day with breakfast. The tablet is designed to release the medicine slowly over 24 hours. This is why you have to take it only once a day.
Swallow the tablet whole. Never chew, crush or cut the tablet in half. This would damage the tablet and release too much medicine into your body at one time.
After all of the medicine has been released, the empty tablet shell will pass out of the body normally in a bowel movement. Do not be concerned if you see the empty tablet shell in your stool (bowel movement). It is important to take GLIPIZIDE XL every day to help keep your blood sugar level under good control. Your healthcare provider may adjust your dose depending on your blood glucose test results. If your blood sugar level is not under control, call your healthcare provider. Do not change your dose without your healthcare provider’s approval. In case of overdose, call the poison control center or your healthcare provider right away, or have someone drive you to the nearest emergency room. You must continue your diet and exercise program while taking GLIPIZIDE XL. You must also have your blood and urine tested regularly to be sure GLIPIZIDE XL is working. GLIPIZIDE XL may not work for everyone. If it does work, you may find that GLIPIZIDE XL is not working as well for you after you have used it for a while. Tell your healthcare provider if GLIPIZIDE XL is not working well. What Should I Avoid While Taking GLIPIZIDE XL? Some medicines can affect how well GLIPIZIDE XL works or may affect your blood sugar level. Check with your healthcare provider or pharmacist before you start or stop taking prescription or over-the-counter medicines, including natural/herbal remedies, while on GLIPIZIDE XL. What are the Possible Side Effects of GLIPIZIDE XL? Low blood sugar. GLIPIZIDE XL may lower your blood sugar to low levels that are dangerous (hypoglycemia). This can happen if you do not follow your diet, exercise too much, drink alcohol, are under stress, or get sick. This could also happen if your dose of GLIPIZIDE XL is higher than you need. Your healthcare provider may need to adjust it. Do not adjust the dose on your own. Be sure you know how to recognize your body’s signs that your blood sugar is too low. These signs include: a cold clammy feeling
unusual sweating
dizziness
weakness
trembling
shakiness
hunger
fast heartbeat
headache
blurred vision
slurred speech
tingling in the lips or hands If you notice any of these signs, eat or drink something with sugar in it right away, such as a regular (not diet) soft drink, orange juice, honey, sugar candy. You can also keep glucose tablets on hand that are available at your pharmacy. If you do not feel better shortly or your blood sugar level does not go up, call your healthcare provider. If you cannot reach your healthcare provider in an emergency, call 911 or have someone drive you to the nearest emergency room. Other side effects. GLIPIZIDE XL may cause other side effects in some people. However, the incidence of serious side effects with GLIPIZIDE XL is very low. Other than the signs of low blood sugar listed above, possible side effects include: feeling jittery
diarrhea
gas GLIPIZIDE XL may cause other less common side effects besides those listed here. For a list of all side effects that have been reported, ask your healthcare provider or pharmacist. While it has never been reported with GLIPIZIDE XL, another similar type of diabetes medicine has been linked to a higher risk of heart attacks. If you have risk factors for heart disease and take GLIPIZIDE XL, be sure to see your healthcare provider for regular checkups. How To Store GLIPIZIDE XL Keep GLIPIZIDE XL and all medicines out of reach of children. Store GLIPIZIDE XL in a dry place, in its original container, and at room temperature (between 59°–86° F or 15°–30° C). General Advice About Prescription Medicines Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. If you have any concerns about GLIPIZIDE XL, ask your healthcare provider. Your healthcare provider or pharmacist can give you information about GLIPIZIDE XL that was written for healthcare professionals. Do not use GLIPIZIDE XL for a condition for which it was not prescribed. Do not share GLIPIZIDE XL with other people. For more information about GLIPIZIDE XL, you can visit the Pfizer internet site at www.pfizer.com. This Product was Repackaged By: State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

Label Image 5mg

id: f92547a8-e4da-4969-9fb1-183d832f490d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 53808-0409-1

30 Tablets GREENSTONE^® BRAND Glipizide XL

(glipizide)
extended-release
tablets 5 mg Rx only

Label Image 10mg

id: 137c521f-b614-4749-8fdb-9665c68b0047
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 53808-0408-1

30 Tablets GREENSTONE^® BRAND Glipizide XL

(glipizide)
extended-release
tablets 10 mg Rx only