Metronidazole 500 mg/100 ml Solution for infusion

… r to any of the excipients listed in section 6.1. • Pregnancy - metronidazole should not be used in the first trimester in patients with trichomoniasis or bacterial vaginosis (see section 4.6). • Breast feeding should be discontinued for 12-24 hours when single high dose (e.g. 2g) therapy is used (see section 4.6).

… ravation, metronidazole should also be used in patients with active or chronic severe peripheral and central nervous system diseases only if its expected benefits clearly outweigh potential hazards. Convulsive seizures, myoclonus and peripheral neuropathy, the latter mainly characterized by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The appearance of abnormal neurological signs demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see section 4.8). In the case of severe hypersensitivity reactions (e.g. anaphylactic shock; see also section 4.8), treatment with Metronidazole must be discontinued immediately and established emergency treatment mu …

… anaphylactic shock; see also section 4.8), treatment with Metronidazole must be discontinued immediately and established emergency treatment must be initiated by qualified healthcare professionals. Severe persistent diarrhoea occurring during treatment or during the subsequent weeks may be due to pseudomembranous colitis (in most cases caused by Clostridium difficile), see section 4.8. This intestinal disease, precipitated by the antibiotic treatment, may be life-threatening and requires immediate appropriate treatment. Anti-peristaltic medicinal products must not be given. The duration of therapy with metronidazole or drugs containing other nitroimidazoles should not exceed 10 days. Only in specific elective case …

… tly because the possibility of metronidazole developing mutagenic activity cannot be safely excluded and because in animal experiments an increase of the incidence of certain tumours has been noted. Prolonged therapy with metronidazole may be associated with bone marrow depression, leading to an impairment of haematopoiesis. Manifestations see section 4.8. Blood cell counts should be carefully monitored during prolonged therapy. Interference with laboratory tests Metronidazole interferes with the enzymatic-spectrophotometric determination of aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydr …

Regular clinical and laboratory monitoring (including full blood count) are advised in cases of high-dose or prolonged treatment, in case of antecedents of blood dyscrasia, in case of severe infection and in severe hepatic insufficiency. In patients with severe liver damage or impaired haematopoiesis (e.g. granulocytopenia) metronidazole should only be used if its expected benefits clearly outweigh potential hazards. Metronidazole …

Regular clinical and laboratory monitoring (including full blood count) are advised in cases of high-dose or prolonged treatment, in case of antecedents of blood dyscrasia, in case of severe infection and in severe hepatic insufficiency. In patients with severe liver damage or impaired haematopoiesis (e.g. granulocytopenia) metronidazole should only be used if its expected benefits clearly outweigh potential hazards. Metronidazole …

… 4.8. This intestinal disease, precipitated by the antibiotic treatment, may be life-threatening and requires immediate appropriate treatment. Anti-peristaltic medicinal products must not be given. The duration of therapy with metronidazole or drugs containing other nitroimidazoles should not exceed 10 days. Only in specific elective cases and if definitely needed, the treatment period may be extended, accompanied by appropriate clinical and laboratory monitoring. Repeat therapy should be restricted as much as possible and to specific elective cases only. These restrictions must be observed strictly because the possibility of metronidazole developing mutagenic activity cannot be safely excluded and because in animal experiments an increase of the incidence of certain tumours has been noted. Prolonged therapy with metronidazole may be associated with bone marrow depression, leading to an impairment of haematopoiesis. Manifestations see section 4.8. Blood cell counts should be carefully …

… ported in patients treated with metronidazole. The appearance of abnormal neurological signs demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see section 4.8). In the case of severe hypersensitivity reactions (e.g. anaphylactic shock; see also section 4.8), treatment with Metronidazole must be discontinued immediately and established emergency treatment must be initiated by qualified healthcare professionals. Severe persistent diarrhoea occurring during treatment or during the subsequent weeks may be due to pseudomembranous colitis (in most cases caused by Clostridium difficile), see section 4.8. This in …

… dosage adjusted accordingly, particularly following initiation or discontinuation of metronidazole therapy in patients who are stabilized on their tacrolimus regimen. Other forms of interaction Alcohol: Intake of alcoholic beverages must be avoided during metronidazole therapy since adverse reactions such as dizziness and vomiting may occur (disulfiram-like effect).

… the bile. There are case reports of oral contraceptive failure in association with different antibiotics, e.g. ampicillin, amoxicillin, tetracyclines and also metronidazole. Coumarin derivatives: Concomitant treatment with metronidazole may potentiate the anticoagulant effect of these and increase the risk for bleeding as a consequence of decreased hepatic degradation. Dose adjustment of the anticoagulant can be necessary. Cyclosporine: During simultaneous therapy with cyclosporine and metronidazole there is a risk for increased serum concentrations of cyclosporine. Frequent monitoring of cyclosporine and creatinine …

Interactions to be used with caution: Amiodarone: QT interval prolongation and torsade de pointes have been reported with the co administration of metronidazole and amiodarone. It may be appropriate to monitor QT interval on the ECG if amiodarone is used in combination with metronidazole. Patients treated on an outpatient basis should be advised to seek medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, palpitatio …

… entiate the anticoagulant effect of these and increase the risk for bleeding as a consequence of decreased hepatic degradation. Dose adjustment of the anticoagulant can be necessary. Cyclosporine: During simultaneous therapy with cyclosporine and metronidazole there is a risk for increased serum concentrations of cyclosporine. Frequent monitoring of cyclosporine and creatinine is required. Lithium: Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be taper …

… nfections, if there is no safer alternative. During second and third trimester, Metronidazole may also be used to treat other infections if its expected benefits clearly outweigh any possible risk. Breast-feeding Since metronidazole is secreted into breast milk, nursing should be stopped during therapy. Also after the end of the therapy with metronidazole, nursing should not be resumed before another 2 – 3 …

… be stopped during therapy. Also after the end of the therapy with metronidazole, nursing should not be resumed before another 2 – 3 days because of the prolonged half-life period of metronidazole. Fertility Animal studies only indicate a potential negative influence of metronidazole on the male reproductive system if high doses lying well above the maximum recommended dose for humans were administered …

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