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| Drug class description : | PPAR gamma agonists (peroxisomal proliferator activated receptor gamma agonists). |
| Generic Name : | Rosiglitazone |
| Drug description : | 4mg: orange film-coated tablets marked 'SB' on one side and '4' on the other. 8mg: red-brown film-coated tablets marked 'SB' on one side and '8' on the other. |
| Presentation : | Tablets, rosiglitazone (as maleate) 4mg , 8mg . |
| 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 : | Usually initiated at 4mg daily. Combination with metformin: dose can be increased to 8mg per day after eight weeks if greater after eight weeks if greater glycaemic control is required. Combination with sulphonylurea: maximum dose, 4mg per day. Can be given in one or two divided doses, with or without food. |
| Child Dosage : | Under 18 years, not recommended. |
| Contra Indications : | Known hypersensitivity to rosiglitazone or to any of the excipients. Cardiac failure or history of cardiac failure (NYHA stages I to IV). Hepatic impairment. Use in combination with insulin. Severe renal insufficiency. Pregnancy, lactation. |
| Special Precautions : | No clinical experience of use in triple combination with other oral anti-diabetics. 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 and haemoglobin levels. Mild to moderate renal impairment. |
| Interactions : | Insulin, NSAIDs, paclitaxel. |
| Adverse Reactions : | Oedema. In combination with metformin: commonly, anaemia, hypo- or hyper-glycaemia, headache, diarrhoea, flatulence, nausea, abdominal pain, dyspepsia, fatigue. Uncommonly, hyperlipemia, lactic acidosis, aggravated diabetes mellitus, hypercholesterolaemia, dizziness, vomiting, anorexia, constipation. In combination with a sulphonylurea: commonly, hypo- or hyper-glycaemia, weight increase. Uncommonly, anaemia, thrombocytopenia, hypercholesterolaemia, hypertriglyceridaemia, somnolence, dizziness, headache, paraesthesia, dyspnoea, abdominal pain, flatulence, nausea, increased appetite, alopecia, rash, fatigue, asthenia. |
| Manufacturer : | GlaxoSmithKline(GSK) |
| Drug Availability : | (POM) |
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