GLIPIZIDE XL- glipizide tablet, extended release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Northwind Pharmaceuticals, LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

GLIPIZIDE XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLIPIZIDE XL is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Glipizide is contraindicated in patients with: - Known hypersensitivity to glipizide or any of the product's ingredients. - Hypersensitivity to sulfonamide derivatives. Risk Summary Available data from a small number of published studies and postmarketing experience with GLIPIZIDE XL use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, GLIPIZIDE XL should be discontinued at least two weeks before expected delivery (see Clinical Considerations). Poorly controlled diabetes in pregnancy is also associated with risks to the mother and fetus (see Clinical Considerations). In animal studies, there were no effects on embryofetal development following administration of glipizide to pregnant rats and rabbits during organogenesis at doses 833 times and 8 times the human dose based on body surface area, respectively. However, increased pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation at doses 2 times the maximum human dose based on body surface area (see Data) . The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20–25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, miscarriage, preterm delivery, stillbirth, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Fetal/Neonatal Adverse Reactions Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. Prolonged severe hypoglycemia, lasting 4–10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly. Dose adjustments during pregnancy and the postpartum period Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, Glipizide XL should be discontinued at least two weeks before expected delivery (see Fetal/Neonatal Adverse Reactions) . Data Animal Data In teratology studies in rats and rabbits, pregnant animals received daily oral doses of glipizide during the period of organogenesis at doses up to 2000 mg/kg/day and 10 mg/kg/day (approximately 833 and 8 times the human dose based on body surface area), respectively. There were no adverse effects on embryo-fetal development at any of the doses tested. In a peri- and postnatal study in pregnant rats, there was a reduced number of pups born alive following administration of glipizide from gestation day 15 throughout lactation through weaning at doses ≥5 mg/kg/day (about 2 times the recommended maximum human dose based on body surface area). Risk Summary Breastfed infants of lactating women using GLIPIZIDE XL should be monitored for symptoms of hypoglycemia (see Clinical Considerations) . Although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study. There are no data on the effects of glipizide on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for GLIPIZIDE XL and any potential adverse effects on the breastfed child from GLIPIZIDE XL or from the underlying maternal condition. Clinical Considerations Monitoring for adverse reactions Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures). Safety and effectiveness in children have not been established. There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. Elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. Hypoglycemia may be difficult to recognize in these patients. Therefore, dosing should be conservative to avoid hypoglycemia [see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . There is no information regarding the effects of hepatic impairment on the disposition of glipizide. However, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with hepatic impairment. If hypoglycemia occurs in such patients, it may be prolonged and appropriate management should be instituted [see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] .

Обзор продуктов:

GLIPIZIDE XL (glipizide) Extended Release Tablets are supplied as 5 mg round, biconvex tablets and imprinted with black ink as follows: Recommended Storage: The tablets should be protected from moisture and humidity. Store at 68–77°F (20–25°C); excursions permitted between 59°F and 86°F (15°C and 30°C) [see USP Controlled Room Temperature].

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

GLIPIZIDE XL- GLIPIZIDE TABLET, EXTENDED RELEASE
NORTHWIND PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIPIZIDE XL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLIPIZIDE XL.
GLIPIZIDE XL (GLIPIZIDE) EXTENDED RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
GLIPIZIDE XL is a sulfonylurea indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus. (1)
Limitations of Use: Not for treatment of type 1 diabetes or diabetic
ketoacidosis. (1)
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).
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg ( 3).
CONTRAINDICATIONS
Known hypersensitivity to glipizide or any of the product's
ingredients ( 4).
Hypersensitivity to sulfonamide derivatives ( 4).
WARNINGS AND PRECAUTIONS
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 (
5.1).
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase
(G6PD) deficient. Consider a non-
sulfonylurea alternative ( 5.2).
Potential Increased Risk of Cardiovascular Mortality with
Sulfonylureas: Inform patient of risks, benefits
and treatment alternatives ( 5.3).
Macrovascular Outcomes: No clinical studies have established
conclusive evidence of macrovascular
risk reduction with GLIPIZIDE XL or any other anti-diabetic drug (
5.4).
ADVERSE REACTIONS
Most common adverse reactions (incidence > 3%) are dizziness,
diarrhea, nervousnes