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Glipizide - Er (Glipizide)

Trade Name : Glipizide

PD-Rx Pharmaceuticals, Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 10 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 - Er (Glipizide) which is also known as Glipizide and Manufactured by PD-Rx Pharmaceuticals, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Glipizide - Er (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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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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  • No data
  • 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 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 (n n n ).n nn
  • Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis (n n n ).n nn
  • 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 (n n n ).n n n
  • Administer with breakfast or the first meal of the day (n n n ).n n n
  • For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia (n n n ).n n n
  • Glipizide extended-release tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, unscored, film-coated tablets and are printed with black ink as follows:
  • 2.5 mg tablets are light orange and printed with u201cn n n u201d and u201cn n n u201d.n nn
  • 5 mg tablets are orange and printed with u201cn n n u201d and u201cn n n u201d.n nn
  • 10 mg tablets are white to off-white and printed with u201cn n n u201d and u201cn n n u201d.n nn
  • Tablets: 2.5 mg, 5 mg, 10 mg (n n n ).n nn
  • Glipizide is contraindicated in patients with:
  • Known hypersensitivity to glipizide or any of the productu2019s ingredients (n n n )n n n
  • Hypersensitivity to sulfonamide derivatives (n n n )n n 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 (n n n ). n n n
  • Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative (n n n ).n n n
  • Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives (n n n ).n n n
  • Macrovascular Outcomes: No clinical studies have established conclusive evidence of macrovascular risk reduction with glipizide extended-release tablets or any other anti-diabetic drug (n n n ). n n n
  • 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 (n n n ). n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or n n n .n n n
  • No data
  • Certain medications may affect glucose metabolism, requiring glipizide extended-release tablets dose adjustment and close monitoring of blood glucose (n n n )n n n
  • Miconazole: Monitor patients closely. Severe hypoglycemia can occur when glipizide and oral miconazole are used concomitantly (n n n , n n n ).n n n
  • Fluconazole: Monitor patients closely. An increase in glipizide AUC was seen after fluconazole administration (n n n , n n n ).n n n
  • Colesevelam: Glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam (n n n , n n n ).n n n
  • 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 (n n n u00a0n n n ).n n n
  • Overdosage of sulfonylureas including glipizide extended-release tablets 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 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 Cn n n Hn n n Nn n n On n n S; the molecular weight is 445.55; the structural formula is shown below:n nn
  • 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 n n NaOH; it is freely soluble in dimethylformamide.n nn
  • 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, ammonia, butyl alcohol, edible black ink, ferrosoferric oxide, hydroxyethyl cellulose, hydroxypropyl cellulose, isopropyl alcohol, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type A, polyethylene glycol, propylene glycol and shellac.
  • The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6.
  • 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 n n n mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 20 times the human dose based on body surface area, showed no effects on fertility.n nn
  • 1. n n n 19, SUPP. 2: 747u2013830, 1970n n n
  • Glipizide Extended-Release Tablets are supplied as 10 mg round, unscored, film-coated tablets and are printed with black ink as follows:
  • 10 mg tablets are white to off-white and printed with u201cn n n u201d and u201cn n n u201d. They are available in the following package sizes:n n n Bottles of 90u00a0u00a0u00a0NDC 55289-301-90n n n Bottles of 180u00a0u00a0 NDC 55289-301-93n nn
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from moisture and humidity.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • 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 tablet, 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 n n n .n nn
  • 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) [n n n .n nn
  • This productu2019s label may have been updated. For full prescribing information, please visit www.actavis.com.
  • Brands listed are the trademarks of their respective owners.
  • Manufactured by:n n n Patheon Pharmaceuticals Inc.n n n Cincinnati, OH 45237 USAn nn
  • Distributed by:n n n Actavis Pharma, Inc.n n n Parsippany, NJ 07054 USAn nn
  • Rev. A 10/2018
  • This Patient Information has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Rev. A 10/2018
  • GlipiZIDEn n nExtended-releasen n nTabletsn n n10 mgn n nRx onlyn

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