Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Oethmaan Biosims (PTY) Ltd., 207A Sherwood House, Greenacres Office Park, c/o Victory and Rustenburg Roads, Victory Park, Johannesburg 2195
Hypersensitivityto metronidazole.
Active organic disease of central nervous system including epilepsy.
Blood dyscrasias or a history of blood dyscrasias.
Severe hepatic function impairment.
The safety in pregnancy and lactation has not been established.
Metronidazole is distributed into breast milk.
The safety in lactation has not been established.
Patients should be advised not to take alcohol during metronidazole therapy and for at least one day afterwards because of the possibility of disulfiram-reaction.
Metronidazole should be used with great care in patients with blood dyscrasias or with active disease of the central nervous system. All patients receiving metronidazole for more than 10 days should be monitored and treatment discontinued if signs of peripheral neuropathy or central nervous system toxicity develop. Dose should be reduced in patients with severe liver disease.
No information is available on the relationship of age to the effects of metronidazole in geriatric patients. However, elderly patients are more likely to have an age-related decrease in hepatic function, which may require an adjustment in dosage.
Following side-effects with metronidazole have been reported:
| Gastrointestinal system | Dryness of mouth, unpleasant metallic taste, diarrhoea, loss of appetite, nausea or vomiting, stomach pain orcramps, pancreatitis, pseudomembranous colitis. |
| Central nervous system | Ataxia, encephalopathy, headache, dizziness or light headedness, seizures, peripheral neuropathy, insomnia, changes in mood or mental state such as depression or confusion have been reported. |
| Hypersensitivity | Skin rash, hives, redness or itching. Anaphylaxis has been reported less frequently. |
| Hematological | Leukopenia, bone marrow aplasia, reduced erythropoiesis and granulopoiesis, aplastic anaemia. |
| Renal | Dark urine, dysuria, cystitis, sense of pelvic pressure. |
Raised liver enzyme values have been reported.
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