60, Ogunlana Drive, Surulere, Lagos, Nigeria.
Tel: 234-1-8139385, 08033019432.
Plot No. 1409, Phase-III, GIDC, Vatva, Ahmedabad 382 445, Guajarat, India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: A4-4580): Pioglitazone HCl 30 mg.
Pack size: 1 x 20 tablets.
Pioglitazone effects may be mediated by a reduction of insulin resistance.
Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to 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.
Actovista is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
Pioglitazone is contraindicated in patients with:
- hypersensitivity to the active substance or to any of the excipients
- cardiac failure or history of cardiac failure (NYHA stages I to IV)
- hepatic impairment
- diabetic ketoacidosis.
There is no adequate human data to determine the safety of Pioglitazone during pregnancy and lactation. It is therefore not recommended for pregnant and breastfeeding mothers.
Congestive heart failure: Thiazolidinediones, including Actovista, cause or exacerbate congestive heart failure in some patients.
After initiation of Actovista , and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema).
If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of Actovista must be considered.
Actovista is not recommended in patients with symptomatic heart failure.
Initiation of Actovista in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.
- Interaction studies have shown that Pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
- Co-administration of Pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylureas.
- Studies in man suggest no induction of the main inducible cytochrome P450, IA, 2C8/9 and 3A4. In vitrostudies have shown no inhibition of any subtype of cytochrome P450. Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporine, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
- Co-administration of Pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of Pioglitazone. Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of Pioglitazone may be needed when gemfibrozil is concomitantly administered. Close monitoring of glyceamic control should be considered.
- Co-administration of Pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of Pioglitazone. The Pioglitazone dose may need to be increased when rifampicin is concomitantly administered. Close monitoring of glyceamic control should be considered.
Infections: Upper respiratory tract infection, bronchitis, sinusitis
Blood and lymphatic system dlsorden: Anaemia.
Metabolism and nutrition disorders: Hypoglycaemia, appetite increased.
Nervous system disorders: Hypo-aesthesia headache, dizziness, insomnia.
Eye disorder: Visual disturbance, maccular oedema
Ear and labyrinth disorder: Vertigo
Cardiac disorder: Heart failure.
Dosage & Administration
Pioglitazone may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily.
In combination with insulin, the current insulin dose can be continued upon initiation of Pioglitazone therapy. If patients report hypoglycemia, the dose of insulin should be decreased.
Store at 15 - 30oC. Keep container tightly closed.
Protect from light and out of the reach of children.