AVANDIA Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

GlaxoSmithKline LLC

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

AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: ...

2. Dosage and Administration

AVANDIA may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by ...

3. Dosage Forms and Strengths

Pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg – pink, debossed with GSK on one side and 2 on the other 4 mg – orange, debossed with GSK on one side and 4 on ...

4. Contraindications

Initiation of AVANDIA in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Boxed Warning]. Use in patients with a history of a hypersensitivity ...

5. Warnings and Precautions

5.1 Cardiac Failure AVANDIA, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should ...

6. Adverse Reactions

The following adverse reactions are discussed in more detail elsewhere in the labeling: Cardiac failure [see Warnings and Precautions (5.1)] Major adverse cardiovascular events [see Warnings ...

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 with rates in the clinical trials of ...

6.3. Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of AVANDIA. Because these events are reported voluntarily from a ...

7. Drug Interactions

7.1 CYP2C8 Inhibitors and Inducers An inhibitor of CYP2C8 (e.g., gemfibrozil) may increase the AUC of rosiglitazone and an inducer of CYP2C8 (e.g., rifampin) may decrease the AUC of rosiglitazone. Therefore, ...

8.1. Pregnancy

Risk Summary Limited data with AVANDIA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated ...

8.2. Lactation

Risk Summary There are no data on the presence of rosiglitazone in human milk, the effects on the breastfed infant, or the effects on milk production. Rosiglitazone is present in rat milk; however, due ...

8.3. Females and Males of Reproductive Potential

Discuss the potential for unintended pregnancy with premenopausal women as therapy with AVANDIA, like other thiazolidinediones, may result in ovulation in some anovulatory women.

8.4. Pediatric Use

After placebo run-in including diet counseling, children with type 2 diabetes mellitus, aged 10 to 17 years and with a baseline mean body mass index (BMI) of 33 kg/m 2, were randomized to treatment ...

8.5. Geriatric Use

Results of the population pharmacokinetic analysis showed that age does not significantly affect the pharmacokinetics of rosiglitazone [see Clinical Pharmacology (12.3)]. Therefore, no dosage ...

10. Overdosage

Limited data are available with regard to overdosage in humans. In clinical trials in volunteers, AVANDIA has been administered at single oral doses of up to 20 mg and was well tolerated. In the event ...

11. Description

AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. AVANDIA improves glycemic control while reducing circulating insulin levels. Rosiglitazone ...

12.1. Mechanism of Action

Rosiglitazone, a member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the ...

12.2. Pharmacodynamics

Patients with lipid abnormalities were not excluded from clinical trials of AVANDIA. In all 26-week controlled trials, across the recommended dose range, AVANDIA as monotherapy was associated with increases ...

12.3. Pharmacokinetics

Maximum plasma concentration (Cmax) and the area under the curve (AUC) of rosiglitazone increase in a dose-proportional manner over the therapeutic dose range (Table 8). The elimination half-life ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A 2-year carcinogenicity study was conducted in CD-1 mice at doses of 0.4, 1.5, and 6 mg/kg/day in the diet (highest dose equivalent to approximately 12 times human AUC at the MRHD). Sprague-Dawley ...

13.2. Animal Toxicology and/or Pharmacology

Heart weights were increased in mice (3 mg/kg/day), rats (5 mg/kg/day), and dogs (2 mg/kg/day) with rosiglitazone treatment (approximately 5, 22, and 2 times the MRHD based on AUC, respectively). Morphometric ...

14. Clinical Studies

14.1 Monotherapy In clinical trials, treatment with AVANDIA resulted in an improvement in glycemic control, as measured by FPG and HbA1c, with a concurrent reduction in insulin and C-peptide. Postprandial ...

15. References

1. Park JY, Kim KA, Kang MH, et al. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clin Pharmacol Ther. 2004;75:157-162.

16.1. How Supplied

Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg: pink, debossed with GSK on one side and 2 on the other; bottles of 60: NDC 0173-0861-18. 4 mg: ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). There are multiple medications available to treat type 2 diabetes. The benefits and risks of each available diabetes ...

BOXED WARNING SECTION

WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After ...