Metronidazole Fresenius

/ Neopharm

The dose of metronidazole is dependent on the type and the severity of the infection, the age and the body weight of the patient, and the clinical response.
Unless prescribed otherwise, the following dose recommendations are applicable:
Adults and adolescents over 12 years of age
Maintenance dose: Approximately 7.5 mg Metronidazole/kg body weight over one hour every 8 hours, corresponding to 100 ml (500 mg) Metronidazole injection for a 70 Kg adult.
Loading dose: 15 mg/kg infused over one hour (appro- ximately 1 g for 70 kg adult): A maximum of 1.4 g should not be exceeded during 24 hours.
Safety and effectiveness in children have not been established.
In renal insufficiency the dose interval is to be extended to 12 hours.
In severe hepatic disease plasma metronidazole levels have to be monitored. The usually recommended dose may eventually have to be reduced.
Method of administration:
Intravenous use.
The contents of 1 bottle are to be infused slowly I. V., i.e. 100 ml max. in 20 minutes but usually in 60 minutes.
For preventive therapy prior to operations it is recommended to administer the single dose unit of 500 mg shortly before starting operation.
A concomitant intravenous administration of suitable antibiotics which have to be administered separately is possible.
Duration of administration: Treatment with Metronidazole Fresenius should not exceed 10 days.
However, in special, well-founded cases the treatment may be extended.
Repeat therapy should be restricted as much as possible and to specific elective cases only.
This limitation must be strictly observed because the possibility of metronidazole developing mutagenic and carcinogenic activity cannot be safely excluded.
Prophylactic use should be discontinued within 12 hours after surgery. If there are signs of infection, obtain specimens for cultures to identify the causative organisms.

Treatment and prophylaxis of infection which are or may be due to anerobic bacteria, especially Bacteriodes species, including Bacteriodes fragilis, Fusobacterium, Eurobacterium and Clostridium species.
The treatment is effective in cases of:
– Infections of the C.N.S (e.g. brain abscess, meningitis),
– Infections of the lung and pleura (e.g. necrotising pneumonia, aspiration pneumonia, lung abscess),
– Endocarditis,
– After operations (e.g. recto-colonic surgery) and infections of the G.I. tract,
– Suppurating diseases in the abdominal and pelvic area (peritonitis, liver abscess, endometritis),
– Gynaecologic infections (e.g. hysterectomy, caesarean section, childbed fever, septic abortus),
– Osteomyelitis,
– Septicaemia in thrombophlebitis,
– Severe form of intestinal and hepatic amoebiasis.
A prophylactic use is always indicated in operations with a high risk of anaerobic infections (gynaecologic and intra-abdominal operations).
Consideration should be given to official guidance on the appropriate use of antibacterial agents in the application of Metronidazole Fresenius.

Metronidazole Fresenius must not be used in patients with hypersensitivity to metronidazole or other nitroimidazole derivatives or any of the excipients of the medicinal product.

See prescribing information for full details.

The most frequent undesirable effects are nausea, taste disorders, and the risk of the development of neuropathies in case of long-term treatment. Frequency, type and severity of adverse reactions in children are the same as in adults.
See prescribing information for full details.

Cumarin derivates,  Alcohol, Disulfiram,  Lithium, Barbiturates, Phenytoin, Cimetidin, Ciclosporin, Busulfan,
Carbamazepine, Tacrolimus, Amiodarone, Mycophenolate mofetil, Other antibiotics.
See prescribing information for full details.

Pregnancy: Although there is no revealed evidence of embryotoxicity or foetotoxicity, Metronidazole Fresenius should only be used during the first trimester of pregnancy in cases of severe life-threatening infections. During the
second and third trimester of pregnancy, Metronidazole Fresenius should only be used after careful benefit/risk evaluation.
Lactation: Breast-feeding should be interrupted or treatment with metronidazole should be discontinued.