Pioglitazone

Registered South African indications:

• Diabetes mellitus 

Contraindications

• Hypersensitivity to the active ingredient of any of its excipients
• Hepatic impairment
• Cardiac failure or history thereof (NYHA stages I to IV)
• Diabetic ketoacidosis
• Current or history of bladder cancer
• Uninvestigated macroscopic haematuria

Cautions

• Pregnancy 
• Breastfeeding
• Severe renal impairment
• Elderly
• Diabetic macular oedema
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• Hypoglycaemia

Forms avail. in SA and covered in this monograph: tab

Non insulin-dependant diabetes mellitus

• Oral (tab): Initial: 15-30mg, dly; Max: 45mg/24hrs

Not established for use in children below 18 years

Pregnancy

• Caution; positive evidence of risk
• There are no adequate human data to determine the safety of pioglitazone during pregnancy. Foetal growth restriction was apparent in animal studies with pioglitazone. This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth. The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy

Breastfeeding

• Caution; not recommended
• Pioglitazone has been shown to be present in the milk of lactating rats. It is not known whether pioglitazone is secreted in human milk. Therefore, pioglitazone should not be administered to breastfeeding women
• A decision must be made whether to discontinue breastfeeding or discontinue pioglitazone taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother

Renal Impairment

• CrCl>4ml/min: No dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• Caution; no dose adjustment recommended
  Start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport 

• Permitted - No warnings

Central Nervous System Disorders

• Hypo-aesthesia
• Headache
• Dizziness
• Insomnia
• Fatigue

Cardiovascular Disorders

• Cardiac failure
• Oedema

Respiratory Disorders

• Dyspnoea
• Upper respiratory tract infection
• Bronchitis
• Sinusitis

Gastrointestinal Disorders

• Flatulence

Genitourinary Disorders

• Haematuria
• Glycosuria
• Proteinuria
• Erectile dysfunction

Endocrine and Metabolic Disorders

• Hypoglycaemia
• Increased appetite

Musculoskeletal Disorders

• Fractures 
• Back pain

Skin and Subcutaneous Tissue Disorders

• Sweating

Immune, Blood and Lympatic System Disorders

• Benign neoplasms
• Malignant neoplasms
• Bladder cancer
• Anaemia
• Hypersensitivity and allergic reactions

Sensory Disorders

• Visual disturbance
• Macular oedema
• Vertigo

• Gemfibrozil 
• Rifampicin
• Ketoconazole
• Midazolam
• Oral contraceptives

• Liver function

Pioglitazone acts via the activation of specific nuclear receptors leading to an increased insulin sensitivity of liver, fat and skeletal muscle cells in animals. Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.

Tablet 15mg 

• Accord Pioglitazone (Accord Healthcare) 
• Actos (Eli Lilly) origintaor
• Cipla Pioglitazone (Cipla Medpro)
• Pioglitazone Macleods (Macleods)

Tablet 30mg 

• Accord Pioglitazone (Accord Healthcare)
• Actos (Eli Lilly) originator
• Cipla Pioglitazone (Cipla Medpro)
• Pioglitazone Macleods (Macleods)

Tablet 45mg 

• Accord Pioglitazone (Accord Healthcare)