INN monograph
Rosiglitazone / Metformin
Biguanide antidiabetic · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; RxNorm (NLM RxNav); PubChem; Component monographs (multi-source pipeline)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Severe renal impairment (thresholds per label, often eGFR <30).
- Acute conditions predisposing to hypoxia/acidosis (shock, severe HF, severe infection).
- Acute alcohol intoxication.
- Hypersensitivity.
Precautions
- Hold around iodinated contrast if eGFR low (local protocol).
- B12 deficiency with long-term use — monitor if anaemic/neuropathy.
- GI titration improves tolerability.
- XR formulations reduce GI effects.
Point of care
Dosing
Adult
The starting dose is rosiglitazone 2 mg/metformin 500 mg OD or BD (Max. 8 mg/2000 mg /day)
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
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Rosiglitazone, Metformin.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [Rosiglitazone] Adverse reactions vary by agent.
- Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
- Report suspected ADRs via national pharmacovigilance channels. [Metformin] Diarrhoea, nausea, abdominal discomfort, metallic taste.
- Serious: lactic acidosis (rare, high mortality if occurs).
Use
Indications
- Uncomplicated and non-ketonic diabetes mellitus (maturity onset type II diabetes).
- Clinical selection for Rosiglitazone / 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
See under Rosiglitazone and Metformin respectively Metformin decreases hepatic gluconeogenesis, improves peripheral insulin sensitivity, and reduces intestinal glucose absorption.
Full mechanism text
See under Rosiglitazone and Metformin respectively 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. |
| Elimination | are product-specific. Consider food effects, protein binding, hepatic CYP/UGT |
| Half-life | when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. [Metformin] Oral |
Full PK/PD text
[Rosiglitazone] Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. [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
[Rosiglitazone] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [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; RxNorm (NLM RxNav); PubChem; Component monographs (multi-source pipeline)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.