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Rosiglitazone Maleate - 2mg (Avandia)

Trade Name : AVANDIA

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 2 mg/1

ROSIGLITAZONE MALEATE Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rosiglitazone Maleate - 2mg (Avandia) which is also known as AVANDIA and Manufactured by GlaxoSmithKline LLC. It is available in strength of 2 mg/1 per ml. Read more

Rosiglitazone Maleate - 2mg (Avandia) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: CONGESTIVE HEART FAILURE
  • See full prescribing information for complete boxed warning.
  • Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (). After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered.
  • AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. (, )
  • AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with typeu00a02 diabetes mellitus.
  • Important Limitations of Use:
  • 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:
  • 1n- 5.1n- 5.2
  • AVANDIA may be administered at a starting dose of 4u00a0mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12u00a0weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8u00a0mg daily. Increases in the dose of AVANDIA should be accompanied by careful monitoring for adverse events related to fluid retention . AVANDIA may be taken with or without food.
  • The total daily dose of AVANDIA should not exceed 8u00a0mg.
  • Patients receiving AVANDIA in combination with other hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.
  • Renal Impairment
  • No dosage adjustment is necessary when AVANDIA is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and AVANDIA is also contraindicated in patients with renal impairment.
  • Hepatic Impairment
  • Liver enzymes should be measured prior to initiating treatment with AVANDIA. Therapy with AVANDIA should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of AVANDIA, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. n
  • Pediatric
  • Data are insufficient to recommend pediatric use of AVANDIA .
  • Pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows:
  • Pentagonal, film-coated tablets in the following strengths: 2u00a0mg and 4u00a0mg ()
  • No data
  • No data
  • 5.3n- 5.4
  • The following adverse reactions are discussed in more detail elsewhere in the labeling:
  • Common adverse reactions (>5%) reported in clinical trials without regard to causality were upper respiratory tract infection, injury, and headache. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • 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, if an inhibitor or an inducer of CYP2C8 is started or stopped during treatment with rosiglitazone, changes in diabetes treatment may be needed based upon clinical response. n
  • Inhibitors of CYP2C8 (e.g., gemfibrozil) may increase rosiglitazone levels; inducers of CYP2C8 (e.g., rifampin) may decrease rosiglitazone levels. ()
  • No data
  • 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 20u00a0mg and was well tolerated. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patientu2019s clinical status.
  • 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 maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors.
  • Chemically, rosiglitazone maleate is (u00b1)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, ()-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The structural formula of rosiglitazone maleate is:
  • The molecular formula is CHNOSu2022CHO. Rosiglitazone maleate is a white to off-white solid with a melting point range of 122u00b0 to 123u00b0C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range.
  • Each pentagonal film-coated TILTAB tablet contains rosiglitazone maleate equivalent to rosiglitazone 2u00a0mg or 4u00a0mg for oral administration. Inactive ingredients are: hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: synthetic red and yellow iron oxides and talc.
  • No data
  • No data
  • No data
  • No data
  • 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: orange, debossed with GSK on one side and 4 on the other; bottles of 30: NDC 0173-0863-13.
  • Store at 25u00b0C (77u00b0F); excursions 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). Dispense in a tight, light-resistant container.
  • 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 medication should be taken into account when choosing a particular diabetes medication for a given patient.
  • Patients should be informed of the following:
  • Trademarks are owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • AVD:34PI
  • This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2019n n
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0861-18
  • Arrayn- AVANDIAn
  • Arrayn- ROSIGLITAZONE MALEATE TABLETS
  • Arrayn- 2 mg
  • Arrayn- 60 Tiltab Tablets
  • R only
  • Federal Law requires dispensing of AVANDIA with the Medication Guide provided with this bottle.
  • Store at 25C (77F); excursions 15 u2013 30C (59 u2013 86F).
  • Do not use if printed safety seal under cap is broken or missing.
  • Each Tiltab tablet contains rosiglitazone maleate equivalent to 2 mg rosiglitazone.
  • Dispense in a tight, light-resistant container.
  • Dosage:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Canada
  • Rev. 1/17
  • 10000000143763
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0863-13
  • Arrayn- AVANDIAn
  • Arrayn- ROSIGLITAZONE MALEATE TABLETS
  • Arrayn- 4 mg
  • Arrayn- 30 Tiltab Tablets
  • R only
  • Federal Law requires dispensing of AVANDIA with the Medication Guide provided with this bottle.
  • Store at 25C (77F); excursions 15 u2013 30C (59 u2013 86F).
  • Do not use if printed safety seal under cap is broken or missing.
  • Each Tiltab tablet contains rosiglitazone maleate equivalent to 4 mg rosiglitazone.
  • Dispense in a tight, light-resistant container.
  • Dosage:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in Canada
  • Rev. 1/17
  • 10000000143762

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