INN monograph
Gliclazide / Metformin
Biguanide antidiabetic · POM
Review pending · Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Biguanide antidiabetic)
Verify before clinical use
This monograph does not yet include a traceable source link. Confirm dose, contraindications, interactions, and regulatory status against the current SmPC and Kenya STG/EML.
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [From component Metformin] Diabetic comma
- severe renal impairment
- hepatic impairment
- keto-acidosis
- cardiac failure
- excessive alcoholic intake
- pancreatitis
- severe infections and trauma
- pregnancy and lactation
- dehydration
- pre-desposition to lactic acidosis
- conditions associated with hypoxaemia
Precautions
- [From component Metformin] Discontinue 2-3 days before surgery
- conditions causing dehydration
- infections
- low calorie diet
- monitor vitamin B12 annually
- patients to be stabilized in hospital when combination therapy is used.
Point of care
Dosing
Adult
Initial dose: 2.5 mg/500 mg BD. Maintenance Dose: Increase at the rate of 2.5 mg-500 mg/day 14 days depending on the response (Max.10 mg-2000 mg/day in divided doses)
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Dose by eGFR; stop if severe impairment or acute kidney injury.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Avoid in significant hepatic impairment (lactic acidosis risk).
Safety
Drug interactions
- [Gliclazide] First-line type 2 diabetes pharmacotherapy in most guidelines unless contraindicated.
- Educate on sick-day rules.
- Review eGFR at least annually or more if CKD. [Metformin] First-line type 2 diabetes pharmacotherapy in most guidelines unless contraindicated.
- Educate on sick-day rules.
- Review eGFR at least annually or more if CKD.
Safety
Adverse effects
- [From component Metformin] Lactic acidosis in presence of renal failure
- nausea and vomiting
- anorexia
- diarrhoea
- metallic taste
- urticaria
- decreased vitamin B12 absorption.
Use
Indications
- Uncomplicated and non-ketonic diabetes mellitus [maturity onset type II diabetes].
- Clinical selection for Gliclazide / Metformin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Biguanide antidiabetic.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Metformin): A biguanide that acts by de-creasing gluconeogenesis and by increasing peripheral metabolism of glucose. Metformin decreases hepatic gluconeogenesis, improves peripheral insulin sensitivity, and reduces intestinal glucose absorption. Does not stimulate insulin secretion — low intrinsic hypoglycaemia risk alone.
ADME
Pharmacokinetics & PD
| Onset | Days for glycaemic effect |
|---|---|
| Duration | Taken daily chronically |
| Route | ORAL |
| Absorption | saturable. Not metabolised; renally excreted unchanged. Accumulation in renal impairment drives lactic acidosis risk. [Metformin] Oral absorption saturable. Not metabolised; renally excreted unchanged. Accumulation in renal impairment drives lactic acidosis risk. |
Full PK/PD text
[Gliclazide] Oral absorption saturable. Not metabolised; renally excreted unchanged. Accumulation in renal impairment drives lactic acidosis risk. [Metformin] Oral absorption saturable. Not metabolised; renally excreted unchanged. Accumulation in renal impairment drives lactic acidosis risk.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Gliclazide] Increasingly used in GDM/PCOS pathways per specialist protocols; insulin remains standard in many settings. [Metformin] Increasingly used in GDM/PCOS pathways per specialist protocols; insulin remains standard in many settings.
Lactation
Generally considered compatible.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Biguanide antidiabetic)
Clinical review date not recorded.
No traceable source URL is currently attached.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.