(and dosage form):
Each tablet contains 500 mg Tolbutamide.
A 21.2 Oral hypoglycaemics.
Tolbutamide is a hypoglycaemic agent which is effective when given by mouth. It probably acts by making more insulin available to the tissues as it has no effect on muscle-glucose metabolism. It is not a substitute for insulin as it is effective only in the presence of functioning islet tissue. After a single dose the blood sugar level falls within two to four hours and the reduced level is maintained for eight to ten hours.
Tolbutamide is indicated in uncomplicated diabetes mellitus of the stable, mild or moderately severe, non-ketotic, maturity onset type, which cannot be controlled by diet alone. Evaluation of response in patients is done by a therapeutic trial of at least 7 days. During this period the absence of ketonuria together with a satisfactory reduction of glycosuria and hyperglycaemia or maintenance of previously satisfactory control, indicates that the patient is responsive and amenable to control with the medicine. The development of ketonuria within 24 hours after withdrawal of insulin usually will be indicative of a poor response. The patient is considered non-responsive if he fails to achieve satisfactory lowering of blood sugar levels or fails to obtain objective or subjective clinical improvement and if he develops ketonuria or glycosuria. Insulin is indicated for the therapy of such patients.
Use of tolbutamide as the sole specific agent of therapy is not indicated in patients having juvenile or growth-onset type of diabetes mellitus, unstable or severely brittle type of diabetes and adult or maturity-onset type of diabetes complicated by ketosis, acidosis, diabetic coma, fever, severe trauma, gangrene Raynauds disease or serious impairment of renal, hepatic or thyroid function. Tolbutamide is also contra-indicated in pregnancy.
DOSAGE AND DIRECTIONS FOR USE:
The usual initial daily dosage is 1 to 4 grams by mouth in divided doses. The dose and frequency of administration, is subsequently adjusted to achieve a suitable balance adequate for controlling the blood-sugar level and preventing glycosuria: the maintenance dose is usually 0,5 to 1,5 grams daily in divided doses. In diabetic patients receiving less than 40 units of insulin per day, when oral antidiabetic therapy is indicated, insulin administration may be discontinued or decreased. During the insulin withdrawal period urine examinations will serve to check on the progress of the patient and his response to therapy.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The majority of the side-effects have been dose-related transient and have responded to dose reduction or withdrawal of the medication. However, clinical experience thus far has shown that, as with other sulfonylureas, some side-effects associated with hypersensitivity may be severe, although less so than with chlorpropamide therapy.
Rashes gastro-intestinal disturbances and intolerance to alcohol may occur and rarely blood dyscrasias and jaundice. Corticosteroid therapy may be necessary in severe cases. The occurrence singly or together of any of the hypersensitivity manifestations should constitute an indication for prompt termination of the medicine.
Cases of aplastic anaemia and agranulocytosis, generally similar to blood dyscrasias associated with other sulfonylureas have been reported. Since animal studies suggest that the action of barbiturates may be prolonged by therapy with tolbutamide, barbiturates should be used with caution. Caution should also be exercised when anti-bacterial sulfonamides, phenylbutazone, salicylates, probenecid, dicoumarol or MAO inhibitors are administered concomitantly with tolbutamide as hypoglycaemia resultant from either potentiation or accumulation of sulphonylureas has been reported. Tolbutamide should not be used to replace dietetic therapy in the obese. Ether and suxamethonium antagonise the hypoglycaemic action of tolbutamide.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In severe cases of accidental poisoning or overdosage due note should be taken of the fact that plus-minus 3 days are required for complete elimination of tolbutamide from the body, and the patient should be kept under close observation for this period of time despite apparent recovery. The anorectic patient or the profoundly hypoglycaemic patient should be hospitalised. Hypoglycaemic symptoms should be treated as for insulin with dextrose by mouth, stomach tube or intravenously.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
White scored tablets with a bevelled edge, engraved with a mortar and pestle on one side.
Packs of 30 and 200 tablets.
Store in a well-closed container, below 25°C.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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