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Drug Catalog - Product Detail

GLIPIZIDE TB 10MG 100

NDC Mfr Size Str Form
00378-1110-01 MYLAN 100 10MG TABLET
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Generic Name
GLIPIZIDE
Substance Name
GLIPIZIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA074226
Description
DESCRIPTION Glipizide tablets, USP 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 21 H 27 N 5 O 4 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 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 5 mg and 10 mg strengths. Inert ingredients are: colloidal silicon dioxide, lactose (anhydrous), microcrystalline cellulose, pregelatinized starch (corn) and stearic acid. Glipizide Structural Formula
How Supplied
HOW SUPPLIED Glipizide Tablets, USP are available containing 5 mg or 10 mg of glipizide, USP. The 5 mg tablets are white, round, scored tablets debossed with MYLAN above the score and G1 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1105-01 bottles of 100 tablets NDC 0378-1105-05 bottles of 500 tablets The 10 mg tablets are white, round, scored tablets debossed with MYLAN above the score and G2 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1110-01 bottles of 100 tablets NDC 0378-1110-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brands listed are trademarks of their respective owners. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2016 GLIP:R13
Indications & Usage
INDICATIONS AND USAGE Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dosage and Administration
DOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of diabetes mellitus with glipizide tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically 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. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy. Short-term administration of glipizide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet. In general, glipizide tablets should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia. Initial Dose The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg. Titration Dosage adjustments should ordinarily be in increments of 2.5 mg to 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg. Maintenance Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. Total daily doses above 15 mg should ordinarily be divided. Total daily doses above 30 mg have been safely given on a b.i.d. basis to long-term patients. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section). Patients Receiving Insulin As with other sulfonylurea-class hypoglycemics, many stable non-insulin-dependent diabetic patients receiving insulin may be safely placed on glipizide tablets. When transferring patients from insulin to glipizide tablets, the following general guidelines should be considered: For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide tablets therapy may begin at usual dosages. Several days should elapse between glipizide tablets titration steps. For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide tablets therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between glipizide tablets titration steps. During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period. Patients Receiving Other Oral Hypoglycemic Agents As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide tablets. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide tablets due to potential overlapping of drug effect. When colesevelam is coadministered with glipizide extended-release, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide tablets should be administered at least 4 hours prior to colesevelam.