Rosiglitazone -@ Thiazolidienediones- Antidiabetic Agents- (FDC- List )- (Dec 2006)
Drug Interaction:
Concomittant administration of glyburide and rosiglitazone does seem to alter the mean steady state 24 hour plasma glucose concentrations in diabetic patients stabilisized on glyburidetherapy
Pharmacokinetics of Rosiglitazone was not altered following concurrent administration
with metformin in healthy volunteers
Co-administration of acarbose(100mg three times daily) for 7 days in healthy volunteers had no clinically relavent effect on the pharmacokinetics of rosiglitazone
A single administration of moderate amount of alcohol did not increase the risk of acute
hypoglycemia in type 2 diabetes melitus patients treated with rosiglitazone
Should not be used during poregnancy unless the potential benefit justifies the potential risk
to the fetus.
Not to be administred to nursing woman
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 93
Name of the Drug- Rosiglitazone (as maleate ) 2mg+
Glibenclamide 5mg +
Metformin 500mg tablet Pharmacological Classification- Anti Diabetic
Date of Approval- 08-08-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
LIST OF DRUGS DURING 2007
Sr.No- 15
Name of the Drug- Rosiglitazone 1mg +
Metformin Hcl 500mg tabet
(addl.stgth)
Pharmacological Classification- As approved
Date of Approval- 08-02-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Type II diabetes mellitus
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Rosiglitazone Maleate Anti Diabetic 28-06-2001
2.Rosiglitazone Anti Diabetic 14-07-2000
3.Rosiglitazone maleate 2mg 08-08-2006
+ Glibenclamide 5mg
+ Metfrormin 500mg tablet
Anti-diabetic
4.Rosiglitazone 1mg 08-02-2007
+ Metformin Hcl 500mg tablet
Addl.stgth
As approved
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Rosiglitazone 4mg + 21- 02-2002
Metformin 500mg tablet
Patients with type 2 diabetes mellitus when diet,
excercise and the single agent do not result
Rosiglitazone 2mg in adequate glycemic control
2. Rosiglitazone 2mg/4mg + 20-05-2003
Metformin SR 1000mg /1000mg tablet
For the treatment of patients with type 2 Diabetes
mellitus single agent do not result in adequate
glycemic control
3.Rosiglitazone maleate eq.to 11-10-2001
Rosiglitazone 2mg +
Metformin 500mg tablet
Patients with type 2 diabetes mellitus when diet,
excercise and the single agent do not result
Resiglitazone 2mg in adequate glycemic control
4.Rosigltazone maleate eq.to 14-11-2002
Rosiglitazone 2mg +
Glimepiride 1mg tablet
Type II diabetes Mellitus where diet , excercise
do not result adequate glycemic control
5.Rosiglitazone maleate eq.to 11-09-2002
Rosiglitazone 2mg/4mg +
Metformin Hcl SR 500mg/500mg tablet
Treatment of patients with type II diabetes
Mellitus where diet, excercise and the single
agent do not result in adequate glycemic
control
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Rosiglitazone Diabetes GlaxoSmithKline 30-08-2008
Rosiglitazone Diabetes GlaxoKlineBeecham 30-08-2008
Adverse Reaction:
May cause hypoglycemia , headache, weight gain, and anemia
Also cause dizziness, gastro disturbances, muscle cramps, dynoea, pruritus, and hypercholesteromia
Odema, worsen or precipitate heart failure
To be used with caution in such patients
Concomittant use with insulin is considered to be contra-indicated, because of risk of heart failure
Monitor liver function periodically
To be used with caution in patients with hepatic impairment
Contra-Indications:
Hypersensitivity
Concomittant use with insulin is considered to be contra-indicated, because of risk of heart failure
Special Precautions:
Not recommended in type II diabetes
May result in resumption of ovulation in premenopausal, anovulatory women with insulin
resistance. Therefore contraceptive measures are to be considered. If unexpected menstrual dysfunction occurs, then the benefits of continuing therapy must be reconsidered.
Decreases in haemoglobin and hemocrit were observed in both monotherapy and in
combination with metformin.
Caution to be excercised in patients with edema.
Monitor liver enzymes every 2 months for the first 12 months and periodically thereafter.
Perform periodic fasting blood glucose to monitor response.
Monitor liver function periodically
To be used with caution in patients with hepatic impairment
Dosages/ Overdosage Etc:
Type II diabetes mellitus
Dosage-
Adults: Usual staring dose is 4mg administered either as a single dose once daily or in divided doses twice daily.
Dose may be increased to 8mg OD or in divided doses twice daily, if required
Patient Information:
Caution in patients with edema
Pharmacology/ Pharmacokinetics:
Pharmacology:
Rosiglitazone is an oral antidiabetic agent, which acts primarily by increasing insulin sensitivity. It improves glycemic control and simultaneously reduces circulating insulin levels
Pharmacokinetics
Following oral administration the bioavailability of rosiglitazone was found to be 99% and peak plasma concentration was seen in 1 hour of post administration. The drug is extensively metabolised with no unchanged drug excreted in the urine
Interaction with Food:
May be taken with or without food.
Pregnancy and lactation:
Not to used during pregnancy, on nursing woman.
