Metronidazole 500 mg / 100 ml Intravenous Infusion

… syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole (see section 4.8). Active Central Nervous System disease: Metronidazole should be used with caution in patients with active disease of the Peripheral and Central Nervous System. Severe neurological disturbances (including seizures and peripheral and optic neuropathies) have been reported in patients treated with metronidazole. Stop metronidazole treatment if any abnormal neurologic symptoms occur such as ataxia, hypoacusis, dizziness, confusion, or any other CNS adverse reaction. The risk of aggravation of the neurological state should be considered in patients with fixed or progressive paraesthesia, epilepsy and active disease of the central nervous system except for brain abscess. Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, dysarthria, and accompanied by CNS lesions seen on magnetic resonance imaging (MRI). CNS …

… used with caution in patients with evidence or history of blood dyscrasia as agranulocytosis, leukopenia and neutropenia have been observed following metronidazole administration. Renal Disease: Metronidazole is removed during haemodialysis and should be administered after the procedure is finished. Patients with renal impairment, including patients receiving peritoneal dialysis, should be monitored for signs of toxicity due to the potential accumulation of toxic metronidazole metabolites. So …

… ningitis can occur with metronidazole. Symptoms can start within hours of dose administration and generally resolve after metronidazole therapy is discontinued (see section 4.8). Blood Dyscrasias Metronidazole should be used with caution in patients with evidence or history of blood dyscrasia as agranulocytosis, leukopenia and neutropenia have been observed following metronidazole administration. Renal Disease: Metronidazole is removed during haemodialysis and should be administered after the procedure is finished. Patients with renal impairment, including patients receiving peritoneal …

… metabolites. Sodium restricted patients: This medicinal product contains 13.5 mmol (310 mg) sodium per 100 mL. To be taken into consideration by patients on a controlled sodium diet. Alcohol: Patients should be advised to discontinue consumption of alcoholic beverages or alcohol-containing products before, during, and up to 72 hours after taking metronidazole because of a disulfram-like effect (abdominal cramps, nausea, headaches, flushing, vomiting and tachycardia). See section 4.5. Intensive or prolonged Metronidazole therapy: As a rule, the usual duration of therapy with i.v Metronidazole or other imidazole derivatives is usually less than 10 days. This period may only be …

Liver disease: Caution is needed in patients with severe hepatic impairment. The dose of metronidazole should be reduced as necessary. Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairm …

… ysarthria, and accompanied by CNS lesions seen on magnetic resonance imaging (MRI). CNS symptoms and CNS lesions, are generally reversible within days to weeks upon discontinuation of metronidazole. Aseptic meningitis can occur with metronidazole. Symptoms can start within hours of dose administration and generally resolve after metronidazole therapy is discontinued (see section 4.8). Blood Dyscrasias Metronidazole should be used with caution in patients with evidence or history of blood dyscrasia as agranulocytosis, leukopenia and neutropenia have been observed following metr …

… dazole should be used with caution in patients with evidence or history of blood dyscrasia as agranulocytosis, leukopenia and neutropenia have been observed following metronidazole administration. Renal Disease: Metronidazole is removed during haemodialysis and should be administered after the procedure is finished. Patients with renal impairment, including patients receiving peritoneal dialysis, should b …

… halopathy metabolize metronidazole slowly, with resultant accumulation of metronidazole. This may cause exacerbation of CNS adverse effects. The dose of metronidazole should be reduced as necessary. Hepatotoxicity in patients with Cockayne Syndrome Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with …

… Metronidazole therapy and at least 72 hours afterwards because of a disulfram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Concomitant therapy requiring special precautions: Oral anticoagulants (warfarin): metronidazole may increase the anticoagulant effects of warfarin and other oral anticoagulants, resulting in a prolongation of the prothrombin time and increased risk of haemorrhage (decrease in its liver catabolism). Patients taking metronidazole and warfarin or other oral coumarins concomitantly should have their prothrombin time and international normalized ratio (INR) monitored more frequently. Patients should be monitored for signs and symptoms of bleeding. A large number of patients have been reported showing an increase in oral anticoagulant activity whilst receiving concomitant antibiotic therapy. The infectious and inflammatory status of the patien …

… amiodarone, tacrolimus, cyclosporine, carbamazepine, and quinidine) may increase respective CYP3A4-substrate plasma levels. Monitoring of plasma concentrations of CYP3A4 substrates may be necessary. Busulfan: Plasma concentrations of busulfan may increase during concomitant treatment with metronidazole, which can result in serious busulfan toxicity such as sinusoidal obstruction syndrome, gastrointestinal mucositis, and hepatic veno-occlusive disease. Laboratory tests: Metronidazole may immobilise Treponema and thus may lead to falsely positive Nelson's test. Metronidazole may interfere with serum aspartate transaminase (AST), alanine transam …

… amiodarone, tacrolimus, cyclosporine, carbamazepine, and quinidine) may increase respective CYP3A4-substrate plasma levels. Monitoring of plasma concentrations of CYP3A4 substrates may be necessary. Busulfan: Plasma concentrations of busulfan may increase during concomitant treatment with metronidazole, which can result in serious busulfan toxicity such as sinusoidal obstruction syndrome, gastrointestinal mucositis, and hepatic veno-occlusive disease. Laboratory tests: Metronidazole may immobilise Treponema and thus may lead to falsely positive Nelson's test. Metronidazole may interfere with serum aspartate transaminase (AST), alanine transam …

… amiodarone, tacrolimus, cyclosporine, carbamazepine, and quinidine) may increase respective CYP3A4-substrate plasma levels. Monitoring of plasma concentrations of CYP3A4 substrates may be necessary. Busulfan: Plasma concentrations of busulfan may increase during concomitant treatment with metronidazole, which can result in serious busulfan toxicity such as sinusoidal obstruction syndrome, gastrointestinal mucositis, and hepatic veno-occlusive disease. Laboratory tests: Metronidazole may immobilise Treponema and thus may lead to falsely positive Nelson's test. Metronidazole may interfere with serum aspartate transaminase (AST), alanine transam …

… olene to the mother may be associated with a carcinogenic or mutagenic risk for the unborn or newborn child. Therefore Metronidazole should not be given during pregnancy unless clearly necessary. Lactation Metronidazole is excreted in breast milk. During lactation either breast-feeding or Metronidazole should be discontinued. Fertility There are no clinical data relating to the effect of metronid …

… ould not be given during pregnancy unless clearly necessary. Lactation Metronidazole is excreted in breast milk. During lactation either breast-feeding or Metronidazole should be discontinued. Fertility There are no clinical data relating to the effect of metronidazole on fertility. Animal studies demonstrated adverse effects on the male reproductive system that are wholly or partially reversible …

Pregnancy Metronidazole crosses the placental barrier. Clinical data on a large number of exposed pregnancies and animal data did not show a teratogenic or foetotoxic effect. However unrestricted administra …

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