GLUCOTROL XL Extended-release tablet (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Roerig

Λέξεις κλειδιά

0049-0170 0049-0174 0049-0178 0049-1550 0049-1560 0049-1620

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.1 Limitations of Use GLUCOTROL XL is not recommended for the treatment ...

2. Dosage and Administration

2.1 Recommended Dosing GLUCOTROL XL should be administered orally with breakfast or the first main meal of the day. The recommended starting dose of GLUCOTROL XL is 5 mg once daily. Start patients at increased ...

3. Dosage Forms and Strengths

GLUCOTROL XL (glipizide) Extended Release tablets: 2.5 mg, blue and imprinted with GLUCOTROL XL 2.5 or GXL 2.5 on one side. 5 mg, white and imprinted with GLUCOTROL XL 5 or GXL 5 on one side. 10 mg, white ...

4. Contraindications

Glipizide is contraindicated in patients with: Known hypersensitivity to glipizide or any of the products ingredients. Hypersensitivity to sulfonamide derivatives.

5. Warnings and Precautions

5.1 Hypoglycemia All sulfonylurea drugs, including GLUCOTROL XL, are capable of producing severe hypoglycemia [see Adverse Reactions (6)]. Concomitant use of GLUCOTROL XL with other anti-diabetic ...

6. Adverse Reactions

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1)] Hemolytic anemia [see Warnings and ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of GLUCOTROL XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs Affecting Glucose Metabolism A number of medications affect glucose metabolism and may require GLUCOTROL XL dose adjustment and close monitoring for hypoglycemia or worsening glycemic control. ...

8.1. Pregnancy

Risk Summary Available data from a small number of published studies and postmarketing experience with GLUCOTROL XL use in pregnancy over decades have not identified any drug associated risks for major ...

8.2. Lactation

Risk Summary Breastfed infants of lactating women using GLUCOTROL XL should be monitored for symptoms of hypoglycemia (see Clinical Considerations). Although glipizide was undetectable in human ...

8.4. Hepatic Impairment

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 ...

8.4. Pediatric Use

Safety and effectiveness in children have not been established.

8.5. Geriatric Use

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 ...

10. Overdosage

Overdosage of sulfonylureas including GLUCOTROL XL can produce severe hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated with oral glucose. ...

11. Description

GLUCOTROL XL (glipizide) is 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 ...

12.1. Mechanism of Action

Glipizide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Sulfonylureas bind to the sulfonylurea ...

12.2. Pharmacodynamics

The insulinotropic response to a meal is enhanced with GLUCOTROL XL administration in diabetic patients. The postprandial insulin and C-peptide responses continue to be enhanced after at least 6 months ...

12.3. Pharmacokinetics

Absorption The absolute bioavailability of glipizide was 100% after single oral doses in patients with type 2 diabetes mellitus. Beginning 2 to 3 hours after administration of GLUCOTROL XL, plasma drug ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

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 ...

15. References

1. Diabetes, 19, SUPP. 2: 747–830, 1970

16.1. How Supplied

GLUCOTROL XL (glipizide) Extended Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows: Table 2. GLUCOTROL XL Tablet Presentations: ...

16.2. Storage and Handling

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]. ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the potential adverse reactions of GLUCOTROL XL including hypoglycemia. Explain the risks of hypoglycemia, ...