Metronidazole rectal
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Suppositories containing metronidazole.
Drugs List
Therapeutic Indications
Uses
Post operative anaerobic bacterial infection - prophylaxis
Serious infect. caused by susceptible anaerobic pathogens i.e. Bacteroides
Metronidazole is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
Metronidazole is active against a range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria and anaerobic cocci especially in the following indications:
1) The prevention of post-operative infections due to anaerobic bacteria, particularly following appendectomy and elective colonic surgery.
2) Treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis or post-operative wound infections from which pathogenic anaerobes have been isolated.
Dosage
Suppositories are unsuitable for initiating treatment of serious conditions.
Adults
Treatment of anaerobic infections
1g suppository rectally three times daily (preferably every 8 hours) for three days.
It is recommended that if rectal administration is to continue for more than three days then the dosage interval should be increased to 12 hourly.
Oral medication (400mg three times daily) should be instituted as soon as the clinical condition of the patient permits.
Prevention of post-operative anaerobic infections in appendectomy and colonic surgery
1g suppository rectally 2 hours before surgery and repeated every 8 hours, until oral medication can be given to complete a 7 day course of treatment.
It is recommended that if rectal administration is to continue longer than the third post-operative day then the dosage interval should be increased to 12 hourly.
Children
Treatment of anaerobic infections
Children aged over 10 years
(See Dosage; Adult)
Children aged 5 to 10 years
One 500mg suppository rectally three times daily (preferably every 8 hours) for three days. When possible, oral medication should be substituted with 7.5mg/kg three times daily.
It is recommended that if rectal administration is to continue for more than three days then the dosage interval should be increased to 12 hourly.
Children aged 1 to 5 years
250mg (one half of a 500mg suppository) rectally three times daily (preferably every 8 hours) for three days.
It is recommended that if rectal administration is to continue for more than three days then the dosage interval should be increased to 12 hourly.
Children aged 1 month to 1 year
125mg (one quarter of a 500mg suppository) rectally three times daily (preferably every 8 hours) for three days.
It is recommended that if rectal administration is to continue for more than three days then the dosage interval should be increased to 12 hourly.
Oral medication should be instituted as soon as the clinical condition of the patient permits.
Prevention of post-operative anaerobic infections in appendectomy and colonic surgery
Children aged over 10 years
(See Dosage; Adult)
Children aged 5 to 10 years
One 500mg suppository to be administered rectally 2 hours before surgery and repeated every 8 hours, until oral medication (3.7mg/kg to 7.5mg/kg three times daily) can be given to complete a seven day course of treatment.
It is recommended that if rectal administration is to continue longer than the third post-operative day then the dosage interval should be increased to 12 hourly.
Patients with Renal Impairment
In patients undergoing intermittent peritoneal dialysis or continuous ambulatory peritoneal dialysis (CAPD) no routine dosage adjustment is required.
Patients with Hepatic Impairment
The dosage of metronidazole should be reduced to one third of the recommended daily dose and may be administered once daily with caution in patients with hepatic encephalopathy
Contraindications
Neonates under 1 month
Precautions and Warnings
Children aged 1 month to 1 year
Breastfeeding
Central nervous system disorder
Cockayne syndrome
Haematological disorder
Haemodialysis
Hepatic encephalopathy
Hepatic impairment
History of haematological disorder
Peripheral neuropathy
Pregnancy
Haemodialysis patients: administer drug after dialysis
May cause hepatic encephalopathy in patients with hepatic disease
Advise patient ability to drive or operate machinery may be impaired
Consider AGEP if feverish generalised erythema occurs
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor for symptoms of peripheral neuropathy
Regular clinical and lab. tests recommended for treatment of > 10 days
Discontinue treatment if Stevens-Johnson Syndrome suspected
Discontinue treatment if toxic epidermal necrolysis is suspected
Discontinue permanently if AGEP is diagnosed
Avoid repeated or prolonged use
Advise patient not to take alcohol during and for 48 hours after therapy
Advise patient that alcohol ingestion may cause a disulfiram-like reaction
Neurotoxic symptoms including peripheral or central neuropathy have sometimes been associated with prolonged and intensive treatment with metronidazole. If metronidazole is to be administered for more than 10 days, it is recommended that regular clinical and laboratory monitoring especially leucocyte count be carried out. Patients should also be monitored for adverse reactions such as peripheral or central neuropathy (such as paraesthesia, ataxia, dizziness, convulsive seizures).
In patients being treated for Trichomonas vaginalis, a gonococcal infection may persist after elimination of the original pathogen.
Liver function tests must be carried out in patients with Cockayne syndrome before initiating therapy, continuously throughout and at the end of treatment until the results are within normal ranges. Treatment should be discontinued if liver function tests become elevated. Any symptoms of potential liver injury in patients with Cockayne syndrome should be reported immediately and treatment should be stopped.
Pregnancy and Lactation
Pregnancy
Use metronidazole with caution in pregnancy.
The safety of metronidazole in pregnancy has not been adequately established. There is no proven evidence of damage to the embryo or foetus being caused by metronidazole. Metronidazole can be used during pregnancy if there are no other alternatives with established safety profiles (Briggs, 2015)
The manufacturer advises avoiding treatment with metronidazole in pregnancy unless considered essential. In these circumstances short, high dosage regimens are not recommended.
Lactation
Use metronidazole with caution in breastfeeding.
With maternal intravenous and oral therapy, breastfed infants receive metronidazole in doses that are less than those used to treat infections in infants, although the active metabolite adds to the total infant exposure. Plasma levels of the drug and metabolite are measurable, but less than maternal plasma levels. Case reports of candidal infections and diarrhoea have been reported, and a comparative trial suggested that oral and rectal colonization with Candida might be more common in infants exposed to metronidazole. Because of the well demonstrated genotoxicity and mutagenicity in bacteria, carcinogenicity in animals, and possible mutagenicity in humans, concern has been raised about exposure of healthy infants to metronidazole via breastmilk.
Manufacturer advises not to use metronidazole during breastfeeding unless the physician considers it essential. In these circumstances short, high dosage regimens are not recommended.
Side Effects
Abnormal liver function tests
Agranulocytosis
Anaphylaxis
Angioedema
Anorexia
Arthralgia
Ataxia
Cholestatic hepatitis
Confusion
Constipation
Convulsions
Darkening of urine
Diarrhoea
Diplopia
Dizziness
Drowsiness
Dysarthria
Encephalopathy
Erythema multiforme
Fever
Formation of pustules
Furred tongue
Hallucinations
Headache
Impaired co-ordination
Jaundice
Leucopenia (reversible)
Myalgia
Myopia
Nausea
Neck stiffness
Neutropenia
Nystagmus
Oral mucositis
Pancreatitis
Pancytopenia
Paralysis
Peripheral neuropathy
Photosensitivity
Pruritus
Psychotic episodes
Quincke's oedema
Rash
Subacute cerebellar syndrome
Taste disturbances
Thrombocytopenia
Tremor
Urticaria
Visual disturbances
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Flagyl 500mg Suppositories. Sanofi. Revised September 2018.
Summary of Product Characteristics: Flagyl 1g Suppositories. Sanofi. Revised September 2018.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Metronidazole. Last revised: 31 October 2018
Last accessed: 15 March 2019.
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