Drug Interaction:
Sulfonylureas- include- First generation - Acetohexamide, Chlorpropamide, Tolazamide, Tobutamide Second generation - Glipizide, Glyburide ( Glibenclamide ), GlimepIride,Gliclazide Refer Chlorpropamide
Interacting drugs- summary
+ Glibenclamide
Metformin-
Following coadministration of single doses, decrease in glyburide AUC and Cmax were observed. In view of lack of adequate information on the pharmacolodynamic effects, the clinical significance is uncertain
Warfarin,salicylates,sulphonamides and alcohol potentiate hypoglycaemic effect. Glucocorticoids, diuretics and oestrogen reduce hyploglycaemic effect. Beta blckrs (propanolol)mask early symptoms of hypoglycaemia. Synergestic hypoglcaemic action with metformin.
Indication:
LIST OF DRUGS DURING 2004
Sr.No- 228
Name of the Drug- FDC of Glibenclamide 2.5mg/5mg+
Metformin SR 500mg tablet Pharmacological Classification- Anti-diabetic
Date of Approval- 20-08-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2007
Sr.No- 18
Name of the Drug- Glibenclamide 5mg+
Metformin SR 850mg tablet
(Addl.stgth)
Pharmacological Classification- As approved
Date of Approval- 15-02-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
New drugs approved For Marketing by Drug Controller General of India(DCGI ) during the period January 1988 to November 2014 (Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Glibenclamide 5mg 23-02-2009
+ Pioglitazone 15mg
+ Metformin 500mg
Film coated tabs
As 3rd line treatment of type II diabetes mellitus when diet,
excercise and single agents and the second line therapy
with two drugs do not result in adequate glycemic control
2. Glibenclamide 5mg 15-02-2007
+ Metformin SR 850mg 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.Glibenclamide 2.mg/5mg + 20-08-2004
Metformin 500mg/500mg SR tablet
Non insulin dependent Diabetes Mellitus patients
poorly controlled with Sulphonylureas or biguanide
alone
2.Glibenclamide 2.5mg + 30-11-1995
Metformin 400mg film coated tablets
Non insulin dependent Diabetes Mellitus patients
poorly controlled with sulphonylyureas or biguanide
alone
3.Gibenclamide 5mg + 23-02-2009
Pioglitazone 15mg +
Metformin 500mg film coated tablets
As 3rd line treament of type II diabetes Mellitus when
diet, excercise and the single agents and the second
line therapy with two drugs do not result in adequate
glycemic control
4.Glibenclamide5mg + 26-11-1996
Metformin 500mg tablets
Non-insulin dependent diabetes Mellitus poorly
controlled with Sulphonylureas or biguanide alone
5.Glibenclamide IP 2.5mg + 06-02-1996
Metformin IP 400mg film coated tablets
For the management of type II diabetes Mellitus
when single drug therapy, diet and excercise do
not result in adequate glycemic control
Diabetes
Adverse Reaction:
Seen in elderly debiliterated patients with hepatic/renal diseases.
Blood dyscrasias(reversible), liver dysfunction, Hypoglycaemia
GI symptoms, Allergic skin reactions.
Contra-Indications:
Juvenille diabetes, ketoacidosis, pre-coma and pre-diabetic coma, impaired renal function., adrenocortical insufficiency and pregnancy.
Special precautions:
Various factors can potentiate the action,eg.,overdosage, dietary errors,renal disorders,impaired alertness.Avoid alcohol.
Dosages/ Overdosage Etc:
Indications:
Diabetes
Dosage:
2.5 to 5mg daily administered with breakfast or the first meal. For more sensitive patients, start at 1.25mg daily.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
Sulfonylureas- include- First generation - Acetohexamide, Chlorpropamide, Tolazamide, Tobutamide Second generation - Glipizide, Glyburide ( Glibenclamide ), GlimepIride,Gliclazide Refer Chlorpropamide
1. Patients must receive full and complete instructions about the nature of diabetes.
2. Strict adherence to prescribed diet, an excercise program personal hygiene and avoidance of infection are essential
3. It is important to teach patients to self-monitor blood glucose
4. Do not discontinue medication except on advice of a physicain
5. May cause GI upset, may be taken with food. take glipizide ,30 minutes before a meal to increse effectiveness.
6. Avoid alcohol (disulfram reaction and interference with blood sugar control ) and salicylates except on professional advice
7. Monitor urine for glcose and ketones as prescribed, monitor blood glucose as prescribed.
8. Notify physician if any of the following occurs- Hypoglycemia- fatigue, excessive thirst or urination, profuse sweating, numbness of extremities Hypoglycemia- excessive thirst or urination, urinary glucose or ketones Other- sore throat, rash, unusual bruising, or bleeding
Manufacturer Details