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Glemax

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Glemax

Manufacturer

Joswe Medicals, Na'ur Jordan

Therapeutic Class

Antidiabetic, Sulfonylureas

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet 3.0 (NRN:04-8718): Glimepiride 3 mg.

Pack size: Box of 30 tablets.

glemax

Tablet 4.0 (NRN:04-8676): Glimepiride 4 mg.

Pack size: Box of 30 tablets.

glemax4

Pharmacology

Glimepiride, the active ingredient of Glemax, is a blood-sugar lowering agent belonging to the sulfonylurea group. The decrease in blood sugar is achieved principally by means of the stimulation of insulin release from pancreatic beta cells. This effect is predominantly based on improved responsiveness of these cells to the physiological glucose stimulus.

Glimepiride auguments the normal action of insulin on peripheral glucose uptake. Moreover, it mimics such action as well as the glucose output of the liver.

Good metabolic control over 24 hours can be achieved with a single dose of glimepiride. In patients with insufficient response to the maximum dose, combined use with an additional oral antidiabetic containing Metformin or with Insulin improves metabolic control.

Indications

Non-insulin dependent (type 2) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone.

Glemax may also be used in combination with an oral antidiabetic containing Metformin or with Insulin.

Contra-indications

Glemax 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.

Glemax must not be used in patients hypersensitive to glimepiride, other sulfonylureas, other sulfonamides, or to any of the excipients (see Composition).

No experience has been gained concerning the use of Glemax 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.

Pregancy and lactation:

To avoid risk of harm to the child, Glemax must not be taken during pregancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, 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.

Precautions/Warnings

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 Glemax. Clinical signs of hyperglycaemia are, e.g., increased urinary frequency, intense thirst, dryness of 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 co-operation 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 co-operate, undernutrition, irregular mealtimes, or skipped meals. Imbalance between physical exertion and carbohydrate intake. Alterations of diet. Consumption of alcohol, especially in combination with meals. Impaired renal function. Severe impairment of liver function.

Overdosage with Glemax; certain uncompensated disorders of the endocrine affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (as, for example, in certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency). The physician must be informed about 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 Glemax 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 under Adverse Effects) may be milder or absent in those situations where hypoglycaemia develops gradually, in the elderly, and in the patients with nervous disease (autonomic neuropathy) or those receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytic medicines.

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 grams of glucose with them for this purpose (food or beverages containing artificial sweeteners such as diet foods or drinks are ineffective in controlling hypoglycaemia). They may require 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, hospitilization. If treated by different physicians (upon, e.g., admission to hospital after an accident, illness while on holiday) the patient must inform them about their diabetes and previous treatment. In exceptional stress 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 Glemax, glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycated haemoglobin. Alertness and reactions may be impaired due to hypo-or hyperglycaemia, especially when beginning or after altering treatment, or when Glemax is not taken regularly. Such impairment may, for example, affect the ability to operate a vehicle or machinery.

Interactions

In order to avoid possible interactions with other medicines, inform your physician or pharmacist about any other current treatment. Patients who take or discontinue taking certain other medicines while undergoing treatment with Glimepiride may experience changes in blood sugar control. Based on experience with Glimepiride and on what is known of other sulfonylureas, the following interactions must be considered.

Potentiation of the blood sugar lowering effect and thus in some instances hypoglycaemia may occur when one of the following medicines is taken, for example: insulin and other, oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroid and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, MAO inhibitors, miconazole, para-aminosalicyclic acid, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, tetracyclines, tritoqualine, trofosfamide.

Weakening of the blood sugar lowering effect and thus raised blood levels may occur when one of the following medicines is taken. For example, acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagon, laxatives (after protracted use), nicotinic acid (in high doses), oestrogens and progesterones, phenothiazines, phenytoin, rifampicin, 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, beta-blockers may increase the tendency to hypoglycaemia (due to impaired counter-regulation). Under the influence of sympatholytic medicines such as beta blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia 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 Effects

Hypoglycaemia: As a result of the blood sugar lowering action of Glimepiride, hypoglycaemia may occur, and may also be prolonged. Possible symptoms of hypoglycaemia include headache, ravenous hunger, diarrhoea, 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 hypoglycaemia attack may resemble that of a stroke. The symptoms of hypoglycaemia nearly always subside when hypoglycaemia 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 such as the following may occur, nausea, vomiting, sensations of pressure of fullness in the epigastrium, abdominal pain, and diarrhoea. In rare cases, liver enzyme levels may increase. In isolated cases, impairment of liver function (e.g. with cholestatis and jaundice) and hepatitis may develop, possibly leading to liver failure.

Blood: Severe changes in the 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 myelosuppresson) may develop.

Other undesirable effects: Occasionally, allergic or pseudoallergic reactions may occur, e.g. in the form of itching, urticaria or rashes. Skin reactions may be mild, but also 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 sodium, inflammation of blood vessels (allergic vasculitis) and hypersensitivity of the skin to light may occur.

Since some adverse effects (e.g. severe hypoglycaemia, certain changes in the 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, you inform a physician at once, and on no account continue taking the drug without a physician's express guidance.

Dosage & Administration

In principle, the dosage of Glemax 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 Glemax must be initiated and monitored by a physician. Glemax 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 physician and patient beforehand.

A physician must be notified immediately if the dose taken is too high, or an extra dose has been taken. The initial and 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 faliure of therapy.

Initial dose and dose titration: The usual initial dose is 1 mg Glemax 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 - 5 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 Glemax 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 physician, taking into consideration the patient's currrent lifestyle. Normally, a single daily dose of Glemax 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 Glemax.

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 Glemax therapy must be considered. A dose adjustment must also be considered whenever the patients weight or lifestyle changes, or other factors causing an increased susceptibility to hypoglycaemia or excessive increase in blood sugar levels (hyperglycaemia) arise (see under Warnings and Precautions).

Duration of treatment: Treatment with Glemax is normally a long term therapy.

Changeover from other antidiabetics to Glemax: There is no exact dosage relationship between Glemax and other oral blood-sugar-lowering agents. When substituting Glemax for other such agents, the initial dose is 1 mg; this applies even in changeovers from the maximum dose of another oral blood-sugar-lowering agent. Any Glemax 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 maxiumum daily dose of the either Glemax 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 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 maxiumum daily dose of Glemax, insulin may be given concomitantly. In this case, the current dose of Glemax 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.

Adminstration: Glemax tablets must be swallowed without chewing and with sufficient amounts of liquid (approximately ½ glass).

Overdosage:

Glemax overdose may lead to severe and sometimes life threatening hypoglycaemia and may require hospitalization even as a precautionary measure. Significant overdose with severe reaction 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 glucagon (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 carbohydrates and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

Storage/Handling Recommendations

Store below 30oC and out of the reach of children.

Review Date

2017-09-20 02:54:49