Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2020 Publisher: Pfizer Australia Pty Ltd, Level 17, 151 Clarence Street, Sydney NSW 2000, Toll Free Number: 1800 675 229, www.pfizer.com.au
MINIDIAB is indicated as an adjunct to diet and exercise for the control of hyperglycaemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory.
In initiating treatment for non-insulin-dependent diabetes, diet should be emphasised as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycaemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose the use of an oral sulphonylurea or insulin should be considered.
Use of MINIDIAB must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone also may be transient, thus requiring only short-term administration of MINIDIAB. During maintenance programs, MINIDIAB should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations.
Generally speaking, the drug should be taken about 30 minutes before meals in order to achieve the greatest reduction in postprandial hyperglycaemia. There is no fixed dosage regimen for the management of diabetes mellitus with MINIDIAB or any other hypoglycaemic agent. In addition to the usual monitoring of urinary glucose the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient to detect primary failure, i.e. inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e. loss of an adequate blood glucose lowering response after an initial period of effectiveness. Monitoring of glycosylated haemoglobin levels may also be of value.
The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
Dosage adjustments should ordinarily be in increments of 2.5 mg-5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg.
Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. Total daily doses above 15 mg should ordinarily be divided. Total daily doses above 30 mg have been safely given on a twice daily basis to long-term patients. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions (see section 4.4 Special precautions and warnings for use).
As with other sulphonylurea class hypoglycaemics, many stable non-insulin-dependent diabetic patients receiving insulin may be safely placed on MINIDIAB.
As with other sulphonylurea class hypoglycaemics, no transition period is necessary when transferring patients to MINIDIAB. Patients should be observed carefully (1-2 weeks) for hypoglycaemia when being transferred from longer half-life sulphonylureas (e.g. chlorpropamide) to MINIDIAB due to potential overlapping of drug effect.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
There is no well documented experience with MINIDIAB overdosage. Overdosage of sulphonylureas, including MINIDIAB can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalisation.
If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 5.55 mmol/L. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycaemia may recur after apparent clinical recovery.
Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal may reduce absorption of the medicine if given within one hour after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. Clearance of MINIDIAB from plasma would be prolonged in people with liver disease. Because of the extensive protein binding of MINIDIAB, dialysis is unlikely to be of benefit.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Store below 30°C.
The tablets are blister packed and available in pack size of 100 tablets.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.
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