Glubitor/Glubitor-OD (PR tab): The following products/medicines are/can likely to increase the risk of hypoglycemia: Contraindicated combination: Miconazole (systemic route, oromucosal gel): Increases the hypoglycemic effect with possible onset of hypoglycemic symptoms, or even coma.
Combinations which are not recommended: Phenylbutazone (systemic route): Increases the hypoglycemic effect of sulfonylureas (displaces their binding to plasma proteins and/or reduces their elimination). It is preferable to use a different anti-inflammatory agent, or else to warn the patient and emphasize the importance of self-monitoring. Where necessary, adjust the dose of the antidiabetic active substance during and after treatment with the anti-inflammatory agent.
Alcohol: Increases the hypoglycemic reaction (by inhibiting compensatory reactions) that can lead to the onset of hypoglycemic coma. Alcohol or/and medicines containing alcohol/alcoholic medicinal products should be avoided.
Combinations requiring precautions for use: Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycemia may also occur when one of the following drugs/medicinal products is taken: other antidiabetic agents (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists), beta-blockers, fluconazole, angiotensin-converting enzyme (ACE) inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs (MAO inhibitors), sulfonamides, clarithromycin and non-steroidal anti-inflammatory agents.
The following medicinal products may cause an increase in blood glucose levels: Combination which is not recommended: Danazol: Diabetogenic effect of danazol. If the use of this active substance cannot be avoided, warn the patient and emphasize/inform the importance of urine and blood glucose monitoring. It may be necessary to adjust the dose of the antidiabetic agent during and after treatment with danazol.
Combinations requiring precautions during use: Chlorpromazine (neuroleptic agent): High doses (>100 mg per day of chlorpromazine) increase blood glucose levels (reduction of/reduced insulin release). Warn the patient and emphasize/inform the importance of blood glucose monitoring. It may be necessary to adjust the dose of the antidiabetic active substance during and after treatment with the neuroleptic agent.
Glucocorticoids (systemic and local route: intra-articular, cutaneous and rectal preparations) and tetracosactrin: Increase in blood glucose levels with possible ketosis (reduced tolerance to carbohydrates due to the glucocorticoids). Warn the patient and emphasize/inform the importance of blood glucose monitoring, particularly at the start of treatment. It may be necessary to adjust the dose of the antidiabetic active substance during and after treatment with glucocorticoids.
Ritodrine, salbutamol, terbutaline (I.V.): Increased blood glucose/sugar levels due to beta-2 agonist effects. Emphasize/inform the importance of monitoring blood glucose levels. If necessary, switch to insulin.
St. John's Wort (Hypericum perforatum) preparations: Gliclazide exposure is decreased by St. John's Wort (Hypericum perforatum). Emphasize the importance of blood glucose levels monitoring.
The following products may cause dysglycemia: Combinations requiring precautions during use: Fluoroquinolones: In case of a concomitant use of gliclazide and a fluoroquinolone, the patient should be warned of the risk of dysglycemia, and the importance of blood glucose monitoring should be emphasized.
Combination which has to/must be taken into account: Anticoagulant therapy (e.g., warfarin, etc.): Sulfonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the dose of the anticoagulant may be necessary.
Glubitor-OD (MR tab): Hepatic enzyme inhibitors such as sulfonamides, tuberculostatics, clarithromycin, phenylbutazone, clofibrate, coumarin derivatives, salicylates, nonsteroidal anti-inflammatory agents (NSAIDs), probenecid, beta-blockers (e.g., propranolol), tetracycline compounds, chloramphenicol, azole antifungal agents (e.g., miconazole, ketoconazole, itraconazole), H2-receptor antagonists (e.g., cimetidine), disopyramide and angiotensin-converting enzymes (ACE) inhibitors (e.g., captopril and enalapril), and monoamine oxidase (MAO) inhibitors may increase gliclazide's hypoglycemic effect.
Inducers of hepatic enzymes such as rifampicin, barbiturates, thyroid hormones and phenytoin may lower gliclazide's plasma concentration.
Concomitant administration with anticoagulants (warfarin and other anticoagulants) may lead to potentiation of anticoagulation. Adjustment of anticoagulant dosage may be necessary.
Drugs that induce hyperglycemia leading to a loss of control of blood sugar: diuretics (thiazides, furosemide), corticosteroids and tetracosactrin, danazol, chlorpromazine, ritodrine/salbutamol/terbutaline (IV), oral contraceptives (estrogens plus progestogens, and nicotinic acid in pharmacologic doses.
Acute or chronic alcohol intake may unpredictably potentiate or reduce the activity of gliclazide.
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