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Glipizide (Glipizide)

Trade Name : Glipizide

Bryant Ranch Prepack

TABLET, FILM COATED, EXTENDED RELEASE

Strength 5 mg/1

GLIPIZIDE Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glipizide (Glipizide) which is also known as Glipizide and Manufactured by Bryant Ranch Prepack. It is available in strength of 5 mg/1 per ml. Read more

Glipizide (Glipizide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Glipizide extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
  • Glipizide extended-release tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.
  • No data
  • Recommended starting dose is 5 mg once daily. Dose adjustment can be made based on the patientu2019s glycemic control. Maximum recommended dose is 20 mg once daily .
  • Administer with breakfast or the first meal of the day .
  • For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia .
  • Glipizide Extended-Release Tablets:
  • 5 mg, pink, film-coated, round tablets, with an indentation hole on one side, with u201cCu201d and u201c745u201d in black on one side and plain on the other side.
  • 10 mg, white, film-coated, round tablets, with an indentation hole on one side, with u201cCu201d and u201c746u201d in black on one side and plain on the other side.
  • Tablets: 5 mg, 10 mg .
  • Glipizide is contraindicated in patients with:
  • Known hypersensitivity to glipizide or any of the productu2019s ingredients n
  • Hypersensitivity to sulfonamide derivatives n
  • No data
  • Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications .
  • Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative .
  • Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives .
  • Macrovascular Outcomes: No clinical studies have established conclusive evidence of macrovascular risk reduction with glipizide extended-release tablets or any other anti-diabetic drug .
  • The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
  • Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence .
  • www.fda.gov/medwatch
  • No data
  • Certain medications may affect glucose metabolism, requiring glipizide extended-release tablets dose adjustment and close monitoring of blood glucose n
  • Miconazole: Monitor patients closely. Severe hypoglycemia can occur when glipizide and oral miconazole are used concomitantly .
  • Fluconazole: Monitor patients closely. An increase in glipizide AUC was seen after fluconazole administration .
  • Colesevelam: glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam .
  • No data
  • Geriatric, Hepatically Impaired Patients: At risk for hypoglycemia with glipizide extended-release tablets. Use caution in dose selection and titration, and monitor closely .
  • Overdosage of sulfonylureas including glipizide can produce severe hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated with oral glucose. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment are medical emergencies requiring immediate treatment. The patient should be treated with glucagon or intravenous glucose. 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.
  • Glipizide extended-release tablets are an oral sulfonylurea. 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, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 NaOH; it is freely soluble in dimethylformamide.
  • Inert ingredients in the 5 mg and 10 mg formulations are: anhydrous lactose, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, glyceryl monostearate, hypromellose, magnesium stearate, methacrylic acid copolymer (Type B Powder), polyethylene glycol,u00a0 polyethylene oxide, polysorbate 80, propylene glycol, sodium chloride, sodium starch glycolate (Type A), iron oxide black, titanium dioxide and triacetin. Additionally, the 5 mg strength also contains FD&C yellow #6 aluminum lake and FD&C red #40 aluminum lake.
  • System Components and Performance
  • Glipizide extended-release tablets are 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 u201cactiveu201d layer containing the drug, and a u201cpushu201d 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 u201cpushesu201d 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 function of the glipizide extended-release tablets depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.
  • No data
  • 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 tou00a020 times the human dose based on body surface area,u00a0showed no effects on fertility.
  • 1. , 19, SUPP. 2: 747 to 830, 1970
  • Product: 71335-0388
  • NDC: 71335-0388-1 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0388-2 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0388-3 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0388-4 100 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • Product: 71335-0851
  • NDC: 71335-0851-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0851-2 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0851-3 100 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0851-4 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • NDC: 71335-0851-5 180 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling ().
  • Inform patients of the potential adverse reactions of glipizide extended-release tablets including hypoglycemia. Explain the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development to patients and responsible family members. Also inform patients about the importance of adhering to dietary instructions, of a regular exercise program, and of regular testing of glycemic control.
  • Inform patients that glipizide extended-release tablets should be swallowed whole. Inform patients that they should not chew, divide or crush tablets and they may occasionally notice in their stool something that looks like a tablet. In the glipizide extended-release tablets, the medication is contained within a non-dissolvable shell that has been specially designed to slowly release the drug so the body can absorb it.
  • Pregnancy
  • Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [].
  • Lactation
  • Advise breastfeeding women taking glipizide extended-release tablets to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, hypothermia, excessive sleepiness, poor feeding, seizures) [].
  • This product's label may have been updated. For full prescribing information, please contact Par Pharmaceutical at 1-800-828-9393 or visit .
  • GlipiZIDE (glip' i zide) Extended-Release Tablets
  • What is Glipizide Extended-Release Tablets?
  • Who Should Not Take Glipizide Extended-Release Tablets? Do not use glipizide extended-release tablets if you:
  • What should I tell my doctor before taking glipizide extended-release tablets?
  • Before you take glipizide extended-release tablets, tell your healthcare provider if you:
  • Tell your doctor about all the medicines you take,
  • Glipizide extended-release tablets may affect the way other medicines work, and other medicines may affect how glipizide extended-release tablets works.
  • Some medicines can affect how well glipizide extended-release tablets works or may affect you blood sugar level.
  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take glipizide extended-release tablets?
  • What should I avoid while taking glipizide extended-release tablets?
  • What are the possible side effects of glipizide extended-release tablets? Glipizide extended-release tablets can cause serious side effects, including:
  • If you have signs or symptoms of low blood sugar, eat or drink something with sugar in it right away. If you do not feel better or your blood sugar level does not go up, call your healthcare provider or go to the nearest emergency room.
  • The most common side effects of glipizide extended-release tablets include:
  • These are not all the possible side effects of glipizide extended-release tablets. For more information, ask your healthcare provider or pharmacist.
  • 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 extended-release tablets?
  • Keep glipizide extended-release tablets and all medicines out of reach of children. General information about the safe and effective use of glipizide extended-release tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use glipizide extended-release tablets for a condition for which it was not prescribed. Do not give glipizide extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.
  • This Patient Information summarizes the most important information about glipizide extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about glipizide extended-release tablets that is written for healthcare professionals.
  • For more information about glipizide extended-release tablets, you can contact Par Pharmaceutical at 1-800-828-9393 or visit the Par internet site at .
  • What are the ingredients in glipizide extended-release tablets? Active ingredient:
  • Inactive ingredients: anhydrous lactose, butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, glyceryl monostearate, hypromellose,u00a0 magnesium stearate, methacrylic acid copolymer (Type B Powder), polyethylene glycol,u00a0 polyethylene oxide, polysorbate 80, propylene glycol, sodium chloride, sodium starch glycolate (Type A), iron oxide black, titanium dioxide and triacetin. Additionally, the 5 mg strength also contains FD&C yellow #6 aluminum lake and FD&C red #40 aluminum lake.
  • This Patient Information has been approved by the U.S. Food and Drug Administration
  • Trademarks are the properties of their respective owners.
  • For Patient Information Leaflet, please visit n
  • Rx Only
  • Manufactured by:
  • Par Pharmaceutical
  • Chestnut Ridge, NY 10977
  • Revised 10/2019u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 OS744A-01-50-06
  • No data
  • No data

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