Glucoryl® Tablet 3 mg, each tablet contains : Glimepiride 3 mg.
Glucoryl® containing Glimepiride is available in 1 mg, 2 mg, 3 mg and 4 mg tablets.
Glucoryl® is indicated for :
- Adjunct to diet and exercise to lower the blood glucose in patients with Noninsulin-Dependent (Type II) Diabetes Mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.
- May be used concomitantly with Metformin when diet, exercise, and Glimepiride or Metformin alone do not result in adequate glycemic control.
- Used in combination with insulin to lower the blood glucose in patients whose hyperglycemia can not be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined used of Glimepiride and insulin may increase the potential for hypoglycemia.
DOSAGE AND ADMINISTRATIONS :
- In principle, the dosage of Glucoryl® 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 Glucoryl® must be initiated and monitored by a doctor. Glucoryl® 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 mistake (in particular forgetting a dose or skipping a meal) or situations where a dose can not be taken at the prescribed time must be discussed and agreed between doctor and patient before-hand. 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 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 1 – 2 weeks and carried out stepwise, as follows : 1 mg – 2 mg – 3 mg – 4 mg, and (in exceptional cases) 8 mg.
- Dose range in patients with well controlled diabetes : The usual dose is 1-4 mg daily. Only some patients benefit from daily doses of more than 6 mg.
- Distribution of doses : Timing and distribution of doses are decided by the doctor, taking into consideration of the patient’s current life-style. Normally, a single dose of Glimepiride 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 Glimepiride.
- 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 Glimepiride 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 an excessive increase in blood sugar levels (hyperglycaemia) arise.
- Duration of treatment : Treatment with Glimepiride is normally a long-term therapy.
- Changeover from other oral antidiabetics to Glimepiride : There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride 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 agents. Any Glimepiride dose increase should be in accordance with guidelines given above in “initial dose and dose titration”.
- 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 Glimepiride 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 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 can not be controlled adequately with the maximum daily dose of Glimepiride, insulin may be given concomitantly. In this case, the current dose of Glimepiride 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. Long-term efficacy should be monitored by measurement of Hb-Alc levels, for example every 3 – 6 months. Short-term administration of Glimepiride may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.
- Administration : Glucoryl® tablets must be swallowed without chewing and with sufficient amounts of liquid (approx. 1/2 glass).
Glimepiride overdose may lead to severe and sometimes life-threatening hypoglycaemia and may require hospitalization even as a precautionary measure. Significant overdose with severe reactions is a medical emergency and will necessitate immediate treatment and hospitalization.
Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustment in dosage, meal patterns or physical activity may be necessary. More severe episodes with coma, seizure or neurologic impairment may be treated with glucagons (intramuscular or subcutaneous) or concentrated glucose solution (intravenous). If life-threatening amounts have been ingested, detoxification (by, e.g., gastric lavage, activated charcoal) will be necessary.
Sustained administration of carbohydrate and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
- Glimepiride is not suitable for the treatment of insulin-dependent (type 1) diabetes mellitus (e.g. for the treatment of diabetics with a history of ketoacidosis), of diabetic ketoacidosis, or of diabetic precoma or coma.
- Must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, or any of the exipients.
- No experience has been gained concerning the use of Glimepiride in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of renal or hepatic function, a changeover to insulin is indicated, not least to achieve optimal metabolic control.
- Use in pregnancy and lactation : To avoid risk of harm to the child, Glimepiride must not been taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their doctor, and should change over to insulin. Ingestion of Glimepiride with the breast milk may harm the child. Therefore, Glimepiride must not be taken by breast-feeding women and a changeover to insulin or discontinuation of breast-feeding is necessary.
WARNING AND PRECAUTIONS :
- To achieve optimal control of blood sugar, a correct diet, regular and sufficient physical exercise and if necessary, reduction of body weight are just as important as regular intake of Glimepiride. Clinical signs of hyperglycaemia are increased urinary frequency, intense thirst, dryness of the mouth and dry skin.
When starting treatment, the patient must be informed about the effects and risks of Glimepiride and about its role in conjunction with dietary measures and physical exercise; the importance of adequate cooperation must also be stressed.
- In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates especially careful monitoring. Factors favouring hypoglycaemia include :
- Unwillingness or (more commonly in older patients) incapacity of the patient to cooperate,
- Undernutrition, irregular mealtimes or skipped meals,
- Imbalance between physical exertion and carbohydrate intake,
- Alterations of diet,
- Consumption of alcohol, especially in combination with skipped meals,
- Impaired renal function,
- Severe impairment of liver function,
- Overdosage with Glimepiride,
- Certain uncompensated disorders of the endocrine system affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (e.g., in certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency),
- Concurrent administration of certain other medicines (see Interactions).
- The doctor must be informed about such factors and about hypoglycaemic episodes, since these require particularly careful monitoring.
- If such risk factors for hypoglycaemia are present, it may be necessary to adjust the dosage of Glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient’s lifestyle changes.
- Those symptoms of hypoglycaemia which reflect the body’s adrenergic counter-regulation (see Adverse Reactions) may be milder or absent in those situations where hypoglycaemia develops gradually, in the elderly, and in patients with a certain type of nervous disease (autonomic neuropathy) or those receiving concurrent treatment with β-blockers, Clonidine, Reserpine, Guanethidine or other sympatholytic drugs.
- Hypoglycaemia can almost always be promptly controlled by immediate intake of sugar e.g., in the form of glucose, sugar cubes or sugar-sweetened beverages. Patients should always carry at least 20 g of glucose with them for this purpose (food or beverages containing artificial sweeteners e.g., diet foods or drinks, are ineffective in controlling hypoglycaemia). They may require the assistance of other persons to avoid complications. It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Therefore, continued close observation is necessary. Severe hypoglycaemia requires, in addition, immediate treatment and follow-up by a physician and, in some circumstances, hospitalization.
- If treated by different physicians (e.g., upon admission to hospital after an accident, illness while on holiday), the patients must inform them of their diabetic condition and previous treatment.
- In exceptionally stressful situations (e.g., trauma, surgery, infections with fever), blood sugar control may deteriorate and a temporary change to insulin may be necessary.
- During treatment with Glimepiride, fasting glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycosylated haemoglobin. Usually every 3 – 6 months to more precisely assess long-term glycaemic control.
- Pediatric use : Safety and effectiveness in pediatric patients have not been established.
- Alertness and reactions may be impaired due to hypo-or hyperglycaemia, especially when beginning or after altering treatment or when Glimepiride is not taken regularly. Such impairment may, for example, affect the ability to operate a vehicle or machinery.
|Glucoryl® Tablet 3 mg||Box, 3 blisters @ 10 tablets||Reg. No. DKL0802340110C1|
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia