Description:

Pioglitazone Accord tablets are a generic oral antidiabetic medication used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is indicated as monotherapy (when metformin is inappropriate due to contraindications or intolerance), dual therapy (with metformin or a sulfonylurea), triple therapy (with metformin and a sulfonylurea), or in combination with insulin (when metformin is inappropriate). It belongs to the thiazolidinedione (glitazone) class and works by decreasing insulin resistance in peripheral tissues (muscle and fat) and the liver, enhancing insulin-dependent glucose disposal and reducing hepatic glucose output. It requires endogenous insulin to be effective and is not for type 1 diabetes or diabetic ketoacidosis.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from an endocrinologist or diabetologist) with monitoring of blood glucose/HbA1c, liver function, and heart status. In Ghana, available through pharmacies via importers/distributors.

Therapeutic Category:

Antidiabetic / Thiazolidinedione / PPAR-gamma agonist (oral blood glucose-lowering agent for type 2 diabetes).

Active Ingredients/Composition: Active ingredient: Pioglitazone hydrochloride equivalent to pioglitazone base. Strengths (common):

• 15 mg pioglitazone per tablet
• 30 mg pioglitazone per tablet
• 45 mg pioglitazone per tablet Excipients: Lactose monohydrate (37.24 mg in 15 mg tablet, 74.46 mg in 30 mg, 111.70 mg in 45 mg), carmellose calcium, hydroxypropylcellulose, magnesium stearate (film-coated tablets; white to off-white, round/biconvex, debossed e.g., ‘P’/’15’, ‘PIO’/’30’, ‘PIO’/’45’).

Vitamins: None.

Minerals: None.

Variant: Film-coated tablets in 15 mg, 30 mg, and 45 mg strengths (starting dose often 15-30 mg; max 45 mg once daily; pack sizes vary, e.g., 28 or 30 tablets).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without meals/food).

Directions/Usage: Adults: Starting dose 15 mg or 30 mg once daily (without regard to meals). May increase in increments to 45 mg once daily if needed for better glycemic control (after 3-6 months review of HbA1c/response). In combination with insulin/sulfonylurea: Monitor for hypoglycemia and reduce insulin/secretagogue dose if needed. With strong CYP2C8 inhibitors (e.g., gemfibrozil): Max 15 mg daily. Review after 3-6 months; discontinue if inadequate response. Not for type 1 diabetes/DKA. Regular monitoring of HbA1c, liver tests, weight, and heart failure signs required.

Common Side Effects:

• Fluid retention/edema (dose-related, especially with insulin)
• Weight gain
• Upper respiratory tract infection
• Headache
• Heart failure exacerbation (in susceptible patients)
• Hypoglycemia (when combined with insulin/sulfonylurea)
• Fracture risk (women, long-term use)
• Bladder cancer risk (limited evidence; monitor)
• Rare: Liver enzyme elevation, macular edema, anemia. Serious: Congestive heart failure (monitor for dyspnea, rapid weight gain, edema); discontinuation if develops.

Package Type:

Blister packs (e.g., 28 or 30 tablets; tablets white to off-white, round/biconvex/uncoated or film-coated, debossed with strength identifiers).

Storage Advice: Store at room temperature (below 25-30°C), in original packaging to protect from moisture/light. Keep tightly closed. Keep out of reach of children.

Safety Advice:

• Boxed warning: Causes/exacerbates heart failure—monitor closely (contraindicated in NYHA Class III/IV); not for symptomatic heart failure.
• Risk of bladder cancer (limited data; avoid in active/history).
• Liver monitoring: Baseline LFTs; caution in liver disease (discontinue if ALT >3x ULN).
• Fracture risk (long-term, especially women).
• Hypoglycemia risk with insulin/sulfonylurea.
• Pregnancy: Avoid (may cause fetal harm). Breastfeeding: Caution.
• Interactions: Strong CYP2C8 inhibitors (e.g., gemfibrozil—max 15 mg); rifampicin (reduces efficacy).
• Report edema, dyspnea, rapid weight gain, or jaundice promptly.
• Not for type 1 diabetes/DKA.

Product Substitutes: Other pioglitazone tablets: Generic pioglitazone (various importers), Actos (original Takeda), or combinations like pioglitazone + metformin (e.g., Competact generics). Alternatives for type 2 diabetes: Metformin, sulfonylureas, DPP-4 inhibitors (sitagliptin), SGLT2 inhibitors (dapagliflozin), GLP-1 agonists—consult endocrinologist per guidelines (e.g., Ghana diabetes protocols favor metformin first-line; glitazones second/third-line due to risks).

Manufacturer/Marketer:

Accord Healthcare (Accord Healthcare S.L.U. or affiliates; European marketing authorization holder with production in Poland or other EU sites; generics exported to Africa including Ghana via importers/distributors).

Country of Origin:

European Union (e.g., Poland or Spain manufacturing sites per EMA; imported to Ghana/Africa markets).