Glimepiride Tablet 4 mg, each tablet contains : Glimepiride 4 mg.
Glimepiride containing Glimepiride is available in 1 mg, 2 mg, 3 mg and 4 mg tablets.
Glimepiride is indicate for :
Adjunct to diet and exercise to lower the blood glucose in patients with Non Insulin-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 Glimepiride 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 Glimepiride must be initiated and monitored by a doctor. Glimepiride 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 (hypoglycemia), 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 hypoglycemia or to an excessive increase in blood sugar levels (hyperglycemia) 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 hypoglycemia.
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 cannot 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-A1c 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 : Glimepiride 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 hypoglycemia 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 hypoglycemia 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 hypoglycemia 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 Sulphonylureas, other Sulfonamides, or any of the excipients.
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 changeover 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.
WARNINGS 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 hypoglycemia 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 hypoglycemia may be increased and necessitates especially careful monitoring. Factors favouring hypoglycemia 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 caounter-regulation of hypoglycemia (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 hypoglycemic episodes, since these require particularly careful monitoring.
If such risk factors for hypoglycemia 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 hypoglycemia which reflect the body’s adrenergic counter-regulation (see Adverse Reactions) may be milder or absent in those situations where hypoglycemia 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.
Hypoglycemia 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 such as diet foods or drinks, are ineffective in controlling hypoglycemia). They may require the assistance of other persons to avoid complications. It is known from other Sulphonylureas that, despite initially successful countermeasures, hypoglycemia may recur. Therefore, continued close observation is necessary. Severe hypoglycemia 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 exceptional 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 glycemic control.
Pediatric use : Safety and effectiveness in pediatric patients have not been established.
Alertness and reactions may be impaired due to hypo- or hyperglycemia, 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.
DRUG INTERACTIONS :
Patients who take or discontinue taking certain other medicines while undergoing treatment with Glimepiride may experience changes in blood sugar control.
The following interactions must be considered :
Potentiation of the blood sugar-lowering effect and thus, in some instances, hypoglycemia may occur when one of the following medicines is taken e.g., Insulin and other oral antidiabetics, ACE inhibitors, Allopurinol, anabolic steroids and male sex hormones, Chloramphenicol, Coumarin derivatives, Cyclophosphamide, Disopyramide, Fenfluramine, Fenyramidol, Fibrates, Fluoxetine, Guanethidine, Ifosfamide, MAO inhibitors, Miconazole, Para-aminosalicylic acid, Pentoxifylline (high-dose parenteral), Phenylbutazone, Azapropazone, Oxyphenbutazone, Probenecid, Quinolones, Salicylates, Sulfinpyrazone, Sulfonamides, Tetracyclines, Tritoqualine and Trofosfamide.
Weakening of the blood sugar-lowering effect and thus, raised blood sugar levels may occur when one of the following medicines is taken e.g., Acetazolamide, Barbiturates, Corticosteroids, Diazoxide, diuretics, Epinephrine (Adrenaline) and other sympathomimetic agents, glucagon, laxatives (after protacted use, Nicotinic acid (in high doses), Oestrogens and Progestogens, Phenothiazines, Phenytoin, Rifampicin and thyroid hormones.
H2-Receptor antagonists, Clonidine and Reserpine may lead to either potentiation or weakening of the blood sugar-lowering effect.
Beta-blockers decrease glucose tolerance. In patients with diabetes mellitus, this may lead to deterioration of metabolic control. In addition, β-blockers may increase the tendency to hypoglycemia (due to impaired counter-regulation).
Under the influence of sympatholytic drugs e.g., β-blockers, Clonidine, Guanethidine and Reserpine, the signs of adrenergic counter-regulation to hypoglycemia may be reduced or absent.
Both acute and chronic alcohol intake may potentiate or weaken the blood sugar-lowering action of Glimepiride unpredictably.
The effect of Coumarin derivatives may be potentiated or weakened.
ADVERSE REACTIONS :
Hypoglycemia : As a result of the blood sugar-lowering action of Glimepiride, hypoglycemia may occur and may also be prolonged. Possible symptoms of hypoglycemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, alertness and reactions, depression, confusion, difficulty in speaking and even speech loss, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and slow heart rate (bradycardia). In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, rapid heart rate (tachycardia), hypertension, palpitations, angina pectoris and cardiac arrhythmias. The clinical picture of a severe hypoglycemic attack may resemble that of a stroke. The symptoms of hypoglycemia nearly always subside when hypoglycemia is corrected.
Eyes : Especially at the start of treatment, temporary visual impairment may occur due to the change in blood sugar levels.
Digestive tract : Occasionally, gastrointestinal symptoms may occur e.g., nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhea.
In rare cases, liver enzyme levels may increase. In isolated cases, impairment of liver function (e.g., with cholestasis and jaundice) and hepatitis may develop, leading to liver failure.
Blood : Severe changes in blood picture may occur : Rarely, thrombocytopenia and in isolated cases, leucopenia, haemolytic anaemia or e.g., erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia (e.g., due to myelosuppression) may develop.
Others : Occasionally, allergic or pseudoallergic reactions may occur e.g., itching, urticaria or rashes (e.g., erythema, morbilliform or maculopapular eruptions), if skin reactions persist, Glimepiride should be discontinued. Such reactions may be mild, but also may become more serious and may be accompanied by dyspnoea and a fall in blood pressure, sometimes progressing to shock. If urticaria occurs, a physician must be notified immediately.
In isolated cases, a decrease in serum, inflammation of blood vessels (allergic vasculitis) and hypersensitivity of the skin to light may occur.
Consult the physician if any of the adverse effects listed previously or any other undesired effects or unexpected changes occur.
Since some adverse effects (e.g., severe hypoglycemia, certain changes in blood picture, severe allergic or pseudoallergic reactions or liver failure) may under certain circumstances, become life-threatening, it is essential that, if sudden or severe reactions do occur, inform a physician at once and on no account, continue taking the drug without a physician’s express guidance.
Further to the above-mentioned adverse effects of Glimepiride, the following events have been reported with Sulphonylureas : Porphyria cutanea tarda, hepatic porphyria reaction, disulfiram-like reaction, syndrome of inappropriate antidiuretic hormone (SIADH) secretion. It has been suggested that these Sulphonylureas may augment the peripheral action of ADH and/or increase the release of ADH.
|Glimepiride Tablet 4 mg||Box, 10 blisters @ 10 tablets||Reg. No. GKL0802340210D1|
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia