Pharmacy Diabetes

G-4.3 thiazolidinediones_glitazones-Formulations_Rosiglitazone Maleate

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-nov07
Dose:
  • 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 in 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 (https://www.ndss.com.au/wp-content/uploads/fact-sheets/fact-sheet-managing-hypoglycaemia.pdf ). 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.

https://gp2u.com.au/static/pdf/A/AVANDIA-PI.pdf

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