GLIPIZIDE ER- glipizide tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

Dostupné s:

State of Florida DOH Central Pharmacy

INN (Mezinárodní Name):

GLIPIZIDE

Složení:

GLIPIZIDE 10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets are contraindicated in patients with: - Known hypersensitivity to glipizide or any excipients in the tablets. Known hypersensitivity to glipizide or any excipients in the tablets. - Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Přehled produktů:

Glipizide Extended-Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 2.5 mg tablets are light orange and printed with WPI and 900, . 5 mg tablets are orange and printed with WPI and 844, . 10 mg tablets are white to off-white and printed with WPI and 845, . They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Mfd. for:          Watson Laboratories, Inc.                         Corona, CA  92880 USA Mfd. by:           Patheon Pharmaceuticals, Inc.                         Cincinnati, OH  45237 USA This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States PATIENT INFORMATION Glipizide ER (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 ER? Glipizide ER is a medicine you take by mouth. It is used to treat type 2 diabetes (also called non-insulin-dependent diabetes mellitus). Your healthcare provider has prescribed Glipizide ER 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 ER 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 ER, you must continue to follow your program of diet and exercise. Who Should Not Use Glipizide ER? Do not use Glipizide ER if you: have a condition called diabetic ketoacidosis have ever had an allergic reaction to glipizide or any of the other ingredients in Glipizide ER. Ask your healthcare provider or pharmacist for a list of these ingredients. Only your healthcare provider can decide if Glipizide ER is right for you. Before you start Glipizide ER, tell the healthcare provider if you: are taking or using any prescription medicines or nonprescription 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 ER during the last month of pregnancy. are breast-feeding. Glipizide ER may pass to the baby through your milk and cause harm. How Should I Take Glipizide ER? Glipizide ER 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 ER 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. It is important to take Glipizide ER 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 ER. You must also have your blood and urine tested regularly to be sure Glipizide ER is working. Glipizide ER may not work for everyone. If it does work, you may find that Glipizide ER is not working as well for you after you have used it for a while. Tell your healthcare provider if Glipizide ER is not working well. What Should I Avoid While Taking Glipizide ER? Some medicines can affect how well Glipizide ER 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 ER. What are the Possible Side Effects of Glipizide ER? Low blood sugar. Glipizide ER 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 ER 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: 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 ER may cause other side effects in some people. However, the incidence of serious side effects with Glipizide ER is very low. Other than the signs of low blood sugar listed above, possible side effects include: feeling jittery diarrhea gas Glipizide ER 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 ER, 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 ER, be sure to see your healthcare provider for regular checkups. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How To Store Glipizide ER Keep Glipizide ER and all medicines out of the reach of children. Store Glipizide ER in a dry place, in its original container, and at room temperature (between 68°-77°F or 20°-25°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 ER, ask your healthcare provider. Your healthcare provider or pharmacist can give you information about Glipizide ER that was written for healthcare professionals. Do not use Glipizide ER for a condition for which it was not prescribed. Do not share Glipizide ER with other people. Mfd.for: Watson Laboratories, Inc.                 Corona, CA 92880 USA Mfd.by: Patheon Pharmaceuticals Inc.                 Cincinnati, OH 45237 USA This Product was Repackaged By: State of

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

GLIPIZIDE ER- GLIPIZIDE TABLET, EXTENDED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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GLIPIZIDE EXTENDED-RELEASE TABLETS
RX ONLY
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 C
H N O S; 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 extended-release tablets are formulated as a polymer matrix
based once-a-day controlled
release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or
10 mg of glipizide. Each tablet
contains the following inactive ingredients: acetyltributyl citrate,
edible black ink, hydroxyethyl
cellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium
stearate, methacrylic acid
copolymer type A and polyethylene glycol.
The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6.
CLINICAL PHARMACOLOGY
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 glipizide
administration in diabetic patients. The
postprandial insulin and C-peptide responses continue to be enhanced
after at least 6 months of