Name of Medicine
Rosiglitazone maleate
Presentation
- Rosiglitazone 4mg and 8mg tablets.
Key Practice Points
Therapeutic Indications:
- Treatment of type 2 diabetes where physical activity and dietary management has not resulted in adequate glycaemic targets.
For the most up to date PBS therapeutic indications for sitagliptin, please see
https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/psd/2007-11/pbac-psd-rosiglitazone-nov07Dose:
- Rosiglitazone can be started at 4mg daily.
- Dose can be increased to 8mg per day after 6-8 weeks.
- Dose can be given as once or twice a day with or without food.
- Renal insufficiency - No dose adjustment is required in individuals with any degrees of renal insufficiency.
- Liver insufficiency - No dosage adjustment is required in individuals with mild hepatic impairment. However, it is not recommended. with moderate to severe hepatic impairment.
Elderly:
- No dose adjustment is required in the elderly.
Precautions:
- Bone Fractures – An increased incidence of bone fracture was noted in females taking rosiglitazone. The risk is also associated with men although it is suggested it is not as great.
- Eye Disorders – There is an increased risk of possibility of macular oedema.
- Increased risk of cardiac failure when rosiglitazone was added to treatment regimens that contained insulin or sulfonylureas. (annual cycle of care-cardiac screening, Diabetes MedsCheck referral back to GP for screening)
- Hypoglycaemia – Rosiglitazone in combination with insulin or oral hypoglycaemic agents that cause hypoglycaemia. may be at risk of increased low glucose levels (link to hypoglycaemia information). Encourage blood glucose monitoring and referral to appropriate health care professional for further advise on hypoglycaemia treatment.
Consider Diabetes MedsCheck - Oedema
- Weight gain (Diabetes MedsCheck, increase knowledge of how weight gain is occurring and referral pathway for help with healthy eating plan)
- Hypercholesterolemia (Diabetes MedsCheck, annual cycle of care, referral for cholesterol check, cholesterol monitoring in pharmacy)
- Bone fractures (monitoring for calcium and strong bones in pharmacy, referral pathways back to GP)
Contraindications:
- Hypersensitivity to rosiglitazone or any active ingredient
- Type 1 diabetes
- Individuals under the age of 18 years
- Pregnancy and lactation
- With NYHA Class I to IV heart failure, or history of cardiac failure
- Experiencing an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI)
Pharmacokinetic Properties-Summary
Absorption:
- Rosiglitazone is nearly completely absorbed approximately one hour after it is presented to the stomach and is not affected by food.
Distribution:
- Rosiglitazone is almost completely protein bound.
Metabolism:
- Metabolism of rosiglitazone is extensive with the metabolites not thought to be clinically relevant.
Excretion:
- The half-life of rosiglitazone is 3-4 hours with approximately 75% of eliminated in urine (25% in faeces).
For more detailed information on this product please consult the product information.
More Information
For more detailed information on this product please consult the product information.
