Amaryl Dosage/Direction for Use

General: Dosage: In principle, the dosage of Amaryl is governed by the desired blood sugar level. The dosage of glimepiride must be the lowest which is sufficient to achieve the desired metabolic control.
Treatment with Amaryl must be initiated and monitored by a doctor. Amaryl must be taken at the times and in the doses prescribed.
Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose. Measures for dealing with such mistakes (in particular forgetting a dose or skipping a meal) or situations where a dose cannot be taken at the prescribed time must be discussed and agreed between doctor and patient beforehand. A doctor must be notified immediately if the dose taken is too high, or an extra dose has been taken.
The initial and the maintenance doses are set based on the results of regular checks of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: The usual initial dose is 1 mg Amaryl once daily.
If necessary, the daily dose can be increased. Any increase should be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of one to two weeks, and carried out stepwise, as follows: 1 mg - 2 mg - 3 mg - 4 mg - 6 mg, and - in exceptional cases - 8 mg.
Dose range in patients with well controlled diabetes: The usual dose range in patients with well controlled diabetes is 1 to 4 mg Amaryl daily. Only some patients benefit from daily doses of more than 6 mg.
Distribution of doses: Timing and distribution of doses are to be decided by the doctor, taking into consideration the patient's current life-style. Normally, a single daily dose of Amaryl is sufficient. This dose should be taken immediately before a substantial breakfast or - if none is taken - immediately before the first main meal. It is very important not to skip meals after taking Amaryl.
Secondary dosage adjustment: As the control of diabetes improves, sensitivity to insulin increases; therefore, Glimepiride requirements may fall as treatment proceeds. To avoid an excessive reduction in blood sugar (hypoglycaemia), a timely dose reduction or cessation of Amaryl therapy must be considered.
A dose adjustment must also be considered whenever the patient's weight or life-style changes or other factors causing an increased susceptibility to hypoglycaemia or to and excessive increase in blood sugar levels (hyperglycaemia) arise (see under "Precautions").
Duration of treatment: Treatment with Amaryl is normally a long-term therapy.
Changeover from other oral antidiabetics to Amaryl: There is no exact dosage relationship between Amaryl and other oral blood-sugar-lowering agents. When substituting Amaryl for other such agents, the initial daily dose is 1 mg; this applies even in changeovers from the maximum dose of another oral blood-sugar-lowering agent. Any Amaryl dose increase should be in accordance with guidelines given previously in "Initial dose and dose titration".
Changeover from Insulin to Amaryl: In exceptional cases, where type 2 diabetic patients are regulated on insulin, a changeover to Amaryl may be indicated. The changeover should be undertaken under close medical supervision.
Consideration must be given to the potency and duration of action of the previous blood-sugar-lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Use in combination with metformin: Whenever blood sugar levels cannot be controlled adequately with the maximum daily dose of either Amaryl or a metformin-containing antidiabetic alone, both medicines may be used concomitantly. In such cases, the dose of the established medicine remains unchanged. Treatment with the additional medicine is started at a low dose, which - depending on the desired blood sugar level - may then be increased gradually up to the maximum daily dose. Combined treatment should be initiated under close medical supervision.
Use in combination with insulin: Whenever blood sugar levels cannot be controlled adequately with the maximum daily dose of Amaryl, insulin may be given concomitantly. In this case, the current dose of Amaryl remains unchanged. Insulin treatment is started at a low dose, which is subsequently increased stepwise according to the desired blood sugar level. Combined treatment should be initiated under close medical supervision.
Children and adolescents: There are no data available on the use of glimepiride in patients under 8 years of age. For children aged 8 to 17 years, there are limited data on glimepiride as monotherapy.
An active controlled clinical trial (glimepiride up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 285 children (8-17 years of age) with type 2 diabetes.
Both glimepiride and metformin exhibited a significant decrease from baseline in HbA1c. No significant difference was observed between treatment groups. Glimepiride failed to demonstrate noninferiority to metformin.
Following glimepiride treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus. No long-term efficacy and safety data are available in paediatric patients.
A study evaluating the pharmacokinetics, safety, and tolerability of a 1 mg single dose of glimepiride in 30 paediatric patients (aged 10 to 17 years) with type 2 diabetes showed mean AUC(0-last), Cmax and t¹/₂ similar to that previously observed in adults.
The available data on safety and efficacy are insufficient in the paediatric population and therefore such use is not recommended.
Administration: Amaryl tablets must be swallowed without chewing and with sufficient amounts of liquid (approximately ¹/₂ glass).
Special Populations: Renal Insufficiency: There is limited information available on the use of Amaryl in renal insufficiency. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of Amaryl.