TOLBUTAMIDE

Posology The tablets may be taken as a single dose with, or immediately after, the first main meal of the day, or as a divided dose for optimum control of blood sugar.

Treatment of previously untreated diabetics:

Stabilisation can be achieved by commencing with 2 tablets (1g) daily. The subsequent dosage must depend on the patient’s individual response. 5 g) which can be taken as a single dose or divided doses as required. Generally, patients who do not respond to 4 tablets (2g) daily will not respond to higher doses.

Change-over from other oral hypoglycaemics:

It is possible to freely interchange hypoglycaemic agents (including chlorpropamide) without a break in treatment. Stabilisation can initially be achieved with 2 tablets (1g) daily, followed by a maintenance dose depending on response.

Combination with biguanides:

If adequate control is not achieved through diet and 4 tablets (2g) of tolbutamide daily, the concurrent use of a biguanide derivative can often re-establish control.

Change-over from insulin:

Some patients with non-insulin dependent diabetes, and who are already taking insulin, may be changed to tolbutamide. Low insulin doses (less than 20 units) can be replaced immediately. With higher doses, a gradual change is advisable by giving insulin and tolbutamide concurrently and gradually reducing the dose of insulin.

Paediatric population:

There is insufficient data on the efficacy and safety of tolbutamide in children and adolescents and therefore its use in this age group is not recommended.

Elderly:

Tolbutamide is particularly suitable for elderly patients as the risk of hypoglycaemia is lower with Tolbutamide than with other sulphonylureas. However, treatment should be initiated at a lower dose. Method of Administration For oral administration.

Based on the experience with tolbutamide and with other sulfonylureas, the following undesirable effects have to be mentioned. Blood and the lymphatic system disorders Blood disorders are also rare but may include leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, haemolytic anaemia and aplastic anaemia.

Immune system disorders Hypersensitivity reactions may develop usually in the first 6–8 weeks of starting treatment with tolbutamide. Allergic skin reactions may occur which progress rarely to erythema multiforme and exfoliative dermatitis and fever.

Photosensitivity may occur. Metabolism and nutrition disorders Hypoglycaemia and hypoglycaemic symptoms have occasionally been reported when tolbutamide has been administered without due regard to the dietary habits of the patient Nervous system disorders Paraesthesia and headache have been reported.

5). Ear and labyrinth disorders Tinnitus has been reported. Gastrointestinal disorders Nausea, vomiting, diarrhea, anorexia, increased appetite, weight gain and constipation have been reported in patients taking tolbutamide. Hepato-biliary disorders Disturbance in liver function and cholestatic jaundice have been reported in patients taking tolbutamide.

Class attribution effects As of other sulfonylureas, the following adverse events have been observed: Common or very common:- Abdominal pain Rare or very rare :- erythropenia Not known :- visual impairment Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

• Debilitated, aged, or those patients who have difficulty in metabolising the drug are more likely to become hypoglycaemic. • Elderly patients are especially sensitive to sulfonylurea-induced hypoglycaemia and the onset may be insidious and the impaired performance prolonged.

• Tolbutamide should not be used as a substitute for dietary treatment in obese diabetics. • If fever or sore throat occurs, a white cell count should be performed and repeated after five days as blood abnormalities may develop slowly.

• The possibility of thrombocytopenia should be borne in mind and a platelet count performed if indicated. Patients with mild to moderate renal impairment should start with lower doses and have careful monitoring of the blood glucose levels.

Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since tolbutamide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency and a nonsulfonylurea alternative should be considered.

Tolbutamide contains lactose This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 • Patients who have, or have ever had, diabetic ketoacidosis • Patients with insulin-dependent diabetes mellitus • Patients with serious impairment of renal, hepatic, adrenocorticoid or thyroid function. g. surgical operations or during pregnancy) when dietary treatment and insulin are essential.

• Patients with porphyria • Women who are breast feeding