Drug Information

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

Adverse Reaction:

Dizziness, asthenia, headache, nausea, gastrointestinal pain, cholesstatic jaundice, pruritus, urticaria

Contra-Indications:

Hypersensitivity to the drug Diabetic ketoacidosis with or without coma.

Special precautions:

Long term efficacy of glimepiride should be monitored Not recommended for use during pregnancy, nursing mothers, or children. Patients planning pregnancy are recommended to change over to Insulin therapy for the entire course of pregnancy. Elderly, debilated or mal nourished patients, hepatic insufficiency Impaired renal function

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.

Patient Information:

Sulfonylureas- include- First generation - Acetohexamide, Chlorpropamide, Tolazamide, Tobutamide Second generation - Glipizide, Glyburide ( Glibenclamide ), GlimepIride,Gliclazide Refer Chlorpropamide

Not to be used during pregnancy and lactation

Pharmacology/ Pharmacokinetics:

Pharmacology Glimepiride differs from other sulphonylureas in exhibiting its preferences in receptor binding properties .

Pharmacokinetics following oral administration, glimepiride was found to be completely absorbed from the GI tract. Peak plasma levels were attained within 2-3 hours of administration.

Interaction with Food:

Equally effective in reducing concentrations of fasting, post-breakfast and post-dinner plasma glucose.

Pregnancy and lactation:

Not recommended during pregnancy and lactation Not recommended for use in children

Glimepiride-@-( ** )-Sulfonylureas-Hypoglycemic- (FDC- List )- (Nov 1995)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation