Glibenclamide 2.5 mg
Metformin hydrochloride 400 mg
Glimet is indicated in the treatment of type 2 diabetes mellitus where diet alone or diet and montherapy cannot satisfactorily lower blood glucose levels.
Dosage and Administration
Daily doses, type and duration of treatment must be established by the physician on the basis of the patient's metabolism:
• The usual starting dose is 2 tablets per day at the main meals.
• In any event, it is inadvisable to exceed 2 g daily of metformin.
• The daily dose should then be gradually decreased until the minimum amount needed to control blood glucose levels is achieved.
Glimet is contraindicated in patients with:
• Known hypersensitivity to glibenclamide or metformin.
• Latent diabetes; suspected diabetes; diabetes in pregnancy; type 1 diabetes mellitus; diabetic ketoacidosis; diabetic coma and precoma.
• Serum creatinine levels exceeding 12 mg/L; previous lactic acidosis in diabetes.
• Seriously impaired liver and or renal function.
• During treatment with diuretics or antihypertensive agents that may cause alterations in renal function or during intravenous urography.
• Serious cardiocirculatory disorders (cardiac decompensation, cardiogenic or toxinfective shock; peripheral arterial circulation disorders).
• Serious respiratory disorders.
• Adrenal insufficiency.
• Chronic alcoholism.
• Very low caloric diets, and mainly fasting.
• Serious dystrophic diseases.
• Serious acute hemorrhage.
• During the two days immediately preceding and following surgery.
- Hypoglycemia may occur rarely especially in debilitated, or elderly patients; in cases of unusual physical effort: irregular eating or when drinking alcoholic beverages, in case of impaired renal and or liver function (see contraindications).
- Headache and gastrointestinal reactions such as nausea, anorexia, gastralgia, vomiting or diarrhea have been reported; in these cases treatment must be interrupted.
- There have been rare reports of transitory cutaneous reactions which generally disappear spontaneously as the treatment is continued.
- There have been a few rare reports in the literature of lactic acidosis during metformin treatment in patients with predisposing factors such as renal insufficiency or cardio circulatory collapse which requires immediate interruption of treatment and appropriate care. Lactic acidosis can be favoured by alcohol consumption.
- Alterations in the hematopoietic system are very rare and are generally reversible
- There have been reports of cases with high serum levels of lactic acid, increased lactate/ piruvate ratio; lowered hematic pH, and azotemia that were fatal.
- The glucose-lowering effect of sulfonylurea can be increased by dicumarol and dicumarol derivatives, by mono-aminoxidase inhibitors, by sulfa drugs, phenylbutazone and its derivatives, chloramphenicol, phenyramidol and salicylates, oral miconazole, sulfinpyrazone, perhexiline, probenecid and large amounts of alcohol, it is decreased by adrenaline, corticosteroids, oral contraceptives, thiazide diuretics and barbiturates.
- Caution must be exercised when administering along with beta-blockers.
- Biguanides may increase the effects of anticoagulants.
Pregnancy and Lactation
Warning and Precaution
- All treatments (first treatment or switch to other glucose lowering agents) must be prescribed by physicians.
- The patient must follow the physician's instructions concerning doses, methods of taking the drug as well as diet and exercise regimens.
- Patients must be monitored closely to identify any factors or conditions that may induce or aggravate cellular hypoxia and they favour the onset of lactic acidosis.
- The risk of lactic acidosis is more frequent in patients over 60 years of age, in subjects with impaired renal and or liver function, cardiorespiratory insufficiency, alcoholism, prolonged fasting, undergoing treatment with diuretics and in case of gastrointestinal disorders.
- In any event, patients must be fully instructed on how to recognize the early symptoms of lactic acidosis (anorexia, nausea, fever, vomiting, muscular cramps, increased respiratory frequency, malaise, abdominal pain, diarrhea, blackout or loss of consciousness) and of hypoglycemia (headache, irritability, sleep disorders, depression, tremors, sweating) so that they can immediately contact their physician who should also be informed of any feverish states or digestive problems.
- The physician, in these cases, must immediately order appropriate tests (serum electrolytes, arterial blood pH, lactate, piruvate, blood sugar and ketonemia).
- Since even slight impairments of renal function can considerably increase the risk of lactic acidosis, kidney function must be checked before the start of treatment and then at least every eight weeks during the first six months of treatment and then every six months.
- Since lactic acidosis can be lethal, treatment must be interrupted at the first suspicious signs and the patient must be hospitalized. Observation of metabolic acidosis with evidence of ketoacidosis in a diabetic without any particular exogenous intoxication (from salicytates, alcohol, etc.) should be considered suspicious.
- Since the drug contains a sulfonylureic derivative, it should only be used in patients with symptomatic diabetes mellitus and non ketogenic diabetes mellitus that developed when they were adults, and which cannot be controlled by diet and when insulin is not indicated.
- In the event of symptoms of hypoglycemia (see above), give carbohydrates (sugar); in more serious cases, although loss of consciousness is rare, slow intravenous infusion of glucose solution is required.
- In the event of trauma, injuries, iorgery, infectious diseases and fever, it may be necessary to give insulin to maintain adequate metabolic control.
- It is important to bear in mind that an abuse reaction may occur after drinking alcoholic beverages. Treatment must be suspended 48 hours prior to any angiographic or urographic examinations, and maybe resumed 48 hours after the test.
- Effects on ability to drive and to use machines:
- No limitations have been reported.
- Incompatibility: None has been reported.
Package and Storage
- Package: A carton box containing 30 tablets of Glimet 2.5 mg/400 mg.
- Storage: In a dry place.