Drug Catalog - Product Detail
GLIPIZIDE ER XL 2.5MG TB 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0335-06 | ZYDUS PHARMACEUTICALS (USA) | 30 | 2.5MG | TABLET |
PACKAGE FILES
Generic Name
GLIPIZIDE
Substance Name
GLIPIZIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203499
Description
11 DESCRIPTION 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 21 H 27 N 5 O 4 S; the molecular weight is 445.55; the structural formula is shown below: Glipizide, USP is a white to off-white powder, with a pKa of 5.9. It is freely soluble in dimethylformamide, soluble in 0.1N sodium hydroxide and slightly soluble in methylene chloride. Glipizide extended-release tablets are formulated as a once-a-day extended-release tablet for oral use and are designed to deliver 2.5 mg, 5 mg, or 10 mg of glipizide. Each glipizide extended-release tablet contains the following inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer and polyethylene glycol. Additionally each 2.5 mg tablet contains: FD&C yellow #5 aluminum lake and titanium dioxide. Each 5 mg tablet contains: FD&C yellow #6 aluminum lake and titanium dioxide. The tablet is imprinted with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. System Components and Performance Glipizide extended-release tablets are formulated as once-a-day extended-release tablets and are designed to deliver glipizide at a controlled rate over approximately 20 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet containing the drug which is surrounded by a seal coat followed by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters in the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases the drug at a controlled rate via diffusion and/or erosion. Glipezide USP
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Glipizide Extended-release Tablets, 2.5 mg are yellow colored, round, biconvex film-coated tablets imprinted with "2" on one side with black ink and plain on the other side and are supplied as follows: NDC 68382-335-06 in bottle of 30 tablets NDC 68382-335-14 in bottle of 60 tablets NDC 68382-335-16 in bottle of 90 tablets NDC 68382-335-01 in bottle of 100 tablets NDC 68382-335-05 in bottle of 500 tablets NDC 68382-335-10 in bottle of 1000 tablets NDC 68382-335-77 in cartons of 100 tablets (10 x 10 unit-dose) Glipizide Extended-release Tablets, 5 mg are orange colored, round, biconvex film-coated tablets imprinted with "3" on one side with black ink and plain on the other side and are supplied as follows: NDC 68382-336-06 in bottle of 30 tablets NDC 68382-336-14 in bottle of 60 tablets NDC 68382-336-16 in bottle of 90 tablets NDC 68382-336-01 in bottle of 100 tablets NDC 68382-336-05 in bottle of 500 tablets NDC 68382-336-10 in bottle of 1000 tablets NDC 68382-336-77 in cartons of 100 tablets (10 x 10 unit-dose) Glipizide Extended-release Tablets, 10 mg are white colored, round, biconvex film-coated tablets imprinted with "4" on one side and plain on the other side and are supplied as follows: NDC 68382-337-06 in bottle of 30 tablets NDC 68382-337-14 in bottle of 60 tablets NDC 68382-337-16 in bottle of 90 tablets NDC 68382-337-01 in bottle of 100 tablets NDC 68382-337-05 in bottle of 500 tablets NDC 68382-337-10 in bottle of 1000 tablets NDC 68382-337-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: The tablets should be protected from moisture and humidity. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Glipizide extended-release tablets is 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. Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.1 Limitations of Use Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Recommended starting dose is 5 mg once daily. Dose adjustment can be made based on the patient's glycemic control. Maximum recommended dose is 20 mg once daily ( 2.1 ). Administer with breakfast or the first meal of the day ( 2.1 ). For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia ( 2.2 ). 2.1 Recommended Dosing Glipizide extended-release tablets should be administered orally with breakfast or the first main meal of the day. The recommended starting dose of glipizide extended-release tablets is 5 mg once daily. Start patients at increased risk for hypoglycemia (e.g. the elderly or patients with hepatic insufficiency) at 2.5 mg [ see Use in Specific Population ( 8.5 , 8.6 ) ]. Dosage adjustment can be made based on the patient's glycemic control. The maximum recommended dose is 20 mg once daily. Patients receiving immediate-release glipizide may be switched to glipizide extended-release tablets once daily at the nearest equivalent total daily dose. 2.2 Use with Other Glucose Lowering Agents When adding glipizide extended-release tablets to other anti-diabetic drugs, initiate glipizide extended-release tablets at 5 mg once daily. Start patients at increased risk for hypoglycemia at a lower dose. When colesevelam is coadministered with glipizide extended-release tablets, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam.