Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Remedica Ltd, Aharnon Str.,Limassol Industrial Estate, 3056 Limassol, Cyprus
Glitisol is a sulphonylurea hypoglycaemic agent indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures alone.
The dosage of glibenclamide is governed by the desired blood glucose level.
The dosage of glibenclamide must be the lowest possible dose which is effective.
Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
The usual total daily dosage is 2.5 to 15 mg daily with a usual initial dose of 5 mg daily. Weekly adjustments can be made to increase the dosage to the optimal level. Doses of 10 mg or less may be taken as a single dose immediately before/after breakfast, but should the daily dose exceed 10 mg, the remainder should be taken immediately before/after the evening meal.
The elderly usually require lower dosage.
The safety of Glitisol in the paediatric population has not been established.
Currently available data are described in sections 4.8 but no recommendations on a posology can be made.
A physician should be consulted in the event that a dose has not been taken at the prescribed time, a meal has been skipped or an extra dose has been taken.
It is very important not to skip meals after the tablets have been taken.
As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glibenclamide requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glitisol therapy must therefore be considered.
Correction of dosage must also be considered, whenever:
Changeover from other oral antidiabetic agents to Glitisol should be done under the supervision of a specialist, and due to the potential summation of effects of both medications, entails a risk of hypoglycaemia. A break from medication may therefore be required when changing over medications. This should be decided by the attending physician.
Acute overdose as well as long-term treatment with too high a dose of glibenclamide may lead to severe, protracted, life-threatening hypoglycaemia.
As soon as an overdose of glibenclamide has been discovered, a physician must be notified without delay. The patient must immediately take sugar, if possible in the form of glucose.
Careful monitoring is essential until the physician is confident that the patient is out of danger. It must be remembered that hypoglycaemia and its clinical signs may recur after initial recovery.
Admission to hospital may sometimes be necessary even as a precautionary measure. In particular, significant overdoses and severe reactions with signs such as loss of consciousness or other serious neurological disorders are medical emergencies and require immediate treatment and admission to hospital.
If, for example, the patient is unconscious, an intravenous injection of concentrated glucose solution is indicated (for adults starting with 40 ml of 20 % solution, for example). Alternatively in adults, administration of glucagon, e.g. in doses of 0.5 to 1 mg i.v., s.c. or i.m., may be considered.
In particular when treating hypoglycaemia in infants and young children, the dose of glucose given must be very carefully adjusted in view of the possibility of producing dangerous hyperglycaemia, and must be controlled by close monitoring of blood glucose.
Patients who have ingested life-threatening amounts of Glitisol require detoxification (e.g. by gastric lavage and medicinal charcoal).
After acute glucose replacement has been completed, it is usually necessary to give an intravenous glucose infusion in lower concentration so as to ensure that the hypoglycaemia does not recur. The patient’s blood glucose level should be carefully monitored for at least 24 hours. In severe cases with a protracted course, hypoglycaemia, or the danger of slipping back into hypoglycaemia, may persist for several days.
5 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack-sizes of 40, 100, and 1000 tablets.
PP containers with PE closure. Pack sizes of 1000 tablets.
Not all pack sizes may be marketed.
No special requirements.
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