Drug Interaction:
Sulfonylureas- include-
First generation - Acetohexamide, Chlorpropamide, Tolazamide, Tobutamide
Second generation - Glipizide, Glyburide ( Glibenclamide ), GlimepIride,Gliclazide
Refer Chlorpropamide
Interacting drugs - summary
+ Metformin
Alcohol
Alcohol potentiates the effect of metformin on lactate metabolism.
Warn patients against excessive alcohol intake, while receing metformin
Cationic drugs
Cationic drugs( eg amiloride, digoxin, morphine, procainamide,
quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) eliminated by renal tubular secretion, have the potential for interaction with
metformin careful patient monitoring and dose adjustment of metformin recommended
Cimetidine
Cimetidine caused a 60% increase in peak metformin plasma and
whole blood concentrations and a 40% increase in plasma and
whole blood AUC
Furosemide + Metformin
Furosemide increased the metformin plasma and blood Cmax and
blood AUC , without any significant change in metformin renal clearance
Metformin +Furosemide
When administered with metformin, the Cmax and AUC of
furosemide were smaller than administered alone, and the terminal
half-life decreased, without any significant change in furosemide
renal clearance.
Iodinated contrast material
Parentral contrast studies with iodinated materials can lead to
acute renal failure and have been associated with lactic acidosis
in patients receiving metformin. Therefore withhold metformin for
at least 48 hours prior to and 48 hours subsequent to the procedure
Nifedipine
Co-administration increased plasma metformin Cmax and AUC
respy, and increased the amount excreted in the urine. Nifedipine
appears the absorption of metformin
Indication:
Approved by FDA November,1995
LIST OF DRUGS DURING 2007
Sr.No- 82
Name of the Drug- Glimepiride 1mg/2mg +
Metformin SR 1000mg tablet
(addl.stgth)
Pharmacological Classification- As approved
Date of Approval- 08-06-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Non-insulin dependent diabetes meilltus
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Glimepiride Anti-diabetic 22-01-1999
2.Glimepride 1mg/2mg 17-12-2009
+ Metformin 500mg
+ Atorvastatin 10mg tablets
For the treatment of Type II diabetes mellitus associated with
dyslipidema
3. Glimepride 1mg/2mg 08-06-2007
+ Metformin SR 1000mg tablet
( Addl.Strgth.)
As approved
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.FDC of Glimepiride 1mg/2mg+ 16-08-2005
Pioglitazone 15mg +
Metformin 500mg uncoated Tablet
As 3rd line treatment of type II diabetes mellitus when
diet, excercise and single agents and second line therapy
with two drugs do not result in adequate glycemic control
2.Glimeperide 1mg+ 12-12-2003
Rosgiltazone 4mg
For treament of type II NIDDH
3.Glimeperide 1mg/2mg + 13-11-2002
Metormin 500mg SR tablet
For the treatment of patients with Type II Diabetes
Mellitus, when diet, excercise and single agent do
not result in adequate glycemic control
4.Glmepiride IP 0.5mg + 20-01-2014
Metformin Hcl ER 500mg uncoated bilayered tablets
Addl.Stgth
As an adjunct to diet and excercise in type 2 Diabetes
Mellitus when,monotherapy is not able to acheive
glycemic control
5.Glimepiride 1mg/2mg + 13-11-2002
Metformin Hcl 500mg/500mg in SR form tablet
For patients with type Diabetes Mellitus when diet
excercise & the 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
Glimepiride Diabetes Hoechst AG 06-04-2005
Sulfonylureas- include- First generation - Acetohexamide, Chlorpropamide, Tolazamide, Tobutamide
Second generation - Glipizide, Glyburide ( Glibenclamide ), GlimepIride,Gliclazide
Refer Chlorpropamide
Dosages/ Overdosage Etc:
Approved by FDA November,1995
Indication-
Non-insulin dependent diabetes meilltus
Dosage:
Initial dose- 1 to 2mg once daily,given with breakfast or first main meal.
Patients sensitive to hypoglycaemic drugs may begin at 1mg once daily.
Maximum starting dose is less than 2mg.