METRONIDAZOLE INTRAVENOUS INFUSION 500 MG/100 ML [SIN01260P]

Product Info

METRONIDAZOLE INTRAVENOUS INFUSION 500 MG/100 ML

[SIN01260P]

4.1 Therapeutic indications

Treatment and prophylaxis of infections caused by metronidazole susceptible microorganisms (mainly anaerobic bacteria).
Metronidazole is indicated in adults and children for the following indications:

• infections of the central nervous system (e. g. brain abscess, meningitis)

• infections of lung and pleura (e. g. necrotising pneumonia, aspiration pneumonia, lung abscess)

• endocarditis

• infections in the gastrointestinal tract and the abdominal area (e.g. peritonitis, liver abscess, postoperative infections after colonic and rectal surgery, purulent diseases in the abdominal and pelvic cavities)

• gynaecologic infections (e. g. endometritis, after hysterectomy or caesarean section, childbed fever, septic abortion)

• infections in the ear-nose-throat region (e. g. PLAUT-VINCENT-angina)

• bone and joint infections (e. g. osteomyelitis)

• gas gangrene

• septicaemia with thrombophlebitis.

In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Intravenous Infusion 500 mg.

A prophylactic use is always indicated prior to 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.

4.2 Posology and method of administration

The dosage is adjusted according to the patient’s individual response to therapy, her/his age and body weight and according to nature and severity of the disease.

The following dosage guidelines should be followed:

Adults and adolescents:

Treatment of anaerobic infections
Usually a single dose of 1500 mg (300 ml) is given on the first day of treatment followed by 1000 mg (200 ml) given as single doses on the subsequent days.
Alternatively, 500 mg (100 ml) may be given every 8 hours.
The duration of therapy is dependent on the effect of the treatment. In most cases a treatment course of 7 days will be sufficient. If clinically indicated, treatment may be continued beyond this time. (See also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

Prophylaxis against post-operative infection caused by anaerobic bacteria:
500 mg, with administration completed approximately one hour before surgery. The dose is repeated after 8 and 16 hours.

Paediatric population

Treatment of anaerobic infections

• Children > 8 weeks to 12 years of age:
  The usual daily dose is 20 – 30 mg per kg BW per day as a single dose or divided into 7.5 mg per kg BW every 8 hours.

Duration of treatment is usually 7 days.

Prophylaxis against postoperative infections caused by anaerobic bacteria:

• Children < 12 years:
  7.5 mg/kg (1.5 ml/kg) i.v. 8 hourly.

Patients with renal insufficiency
No dose reduction is required, see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

In patients undergoing haemodialysis the conventional dose of metronidazole should be
re-administered immediately after haemodialysis on dialysis days to compensate the escape of metronidazole during the procedure.

Patients with hepatic insufficiency
As serum half-life is prolonged and plasma clearance is delayed in severe hepatic insufficiency, patients with severe liver disease will require lower doses (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Intravenous use.
The contents of one bottle are to be infused slowly i.v., i.e. 100 ml max. over not less than 20 minutes, but normally over one hour.
Metronidazole Intravenous Infusion 500 mg can also be diluted before administration, adding the medicinal product to an i.v. vehicle solution such as 0.9 % sodium chloride or 5 % glucose infusion solution.
Concurrently prescribed antibiotics are to be administered separately.

4.3 Contraindications

Hypersensitivity to metronidazole or other nitroimidazole derivatives or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.