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| Drug class description : | PPAR gamma agonists (peroxisomal proliferator activated receptor gamma agonists). |
| Generic Name : | Pioglitazone |
| Drug description : | White to off-white, round, convex tablets marked '15' or '30' on one face. |
| Presentation : | Tablets, pioglitazone (as hydrochloride) 15mg , 30mg . |
| Indications : | Indicated only in oral combination treatment of type 2 diabetes mellitus in patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea: in combination with metformin only in obese patients; in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated. |
| Adult Dosage : | Combination with metformin: 15mg to 30mg once daily. The current dose of metformin can be continued on initiation of pioglitazone. Combination with a sulphonylurea: 15mg to 30mg once daily. The 15mg to 30mg once daily. The current dose of sulphonylurea can be continued on initiation of pioglitazone; if patient reports hypoglycaemia, the dose of sulphonylurea should be decreased. |
| Child Dosage : | Under 18 years, not recommended. |
| Contra Indications : | Known hypersensitivity to pioglitazone or to any of the excipients of the tablet. Cardiac failure or history of cardiac failure (NYHA stages I to IV). Hepatic impairment. Contraindicated for use in combination with insulin. Pregnancy and lactation. |
| Special Precautions : | No clinical experience of use in triple combination with other oral antidiabetics. Should not be used in monotherapy. Monitor for fluid retention or other signs of heart failure - discontinue if deteriorates. Monitor for signs of hepatic dysfunction - monitor liver enzymes before initiation of treatment and every two months for the first 12 months of treatment, and periodically thereafter. If ALT levels rise to three times the upper limit of normal, reassess as soon as possible; if levels remain raised to this degree, discontinue therapy. Monitor weight. Use with insulin - pioglitazone in combination with insulin may increase risk of heart failure. Use of pioglitazone with NSAIDs may increase risk of oedema. |
| Adverse Reactions : | In combination with metformin: commonly, anaemia, weight increase, headache, abnormal vision, arthralgia, haematuria, impotence; uncommonly, flatulence. In combination with a sulphonylurea: commonly, weight increase, dizziness, flatulence; uncommonly, glycosuria, hypoglycaemia, increase in lactic dehydrogenase, appetite increase, headache, vertigo, abnormal vision, sweating, proteinuria, fatigue. In general: oedema, small isolated cases of elevated liver enzymes (incidence of elevations of ALT to three times the upper limit of normal was equal to placebo) and hepatocellular dysfunction. |
| Manufacturer : | Takeda |
| Drug Availability : | (POM) |
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