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Metronidazole parenteral

Presentation

Infusions of metronidazole.

Drugs List

  • metronidazole 500mg/100ml infusion
  • Therapeutic Indications

    Uses

    Post operative anaerobic bacterial infection - prophylaxis
    Serious infect. caused by susceptible anaerobic pathogens i.e. Bacteroides

    Metronidazole is active against a range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.

    Dosage

    The duration of intravenous metronidazole treatment will depend on severity of the condition as assessed from the clinical and bacteriological data by the clinician.

    Treatment with metronidazole for seven to ten days is suitable for most patients. Treatment may be prolonged in some cases (e.g. the eradication of infections from sites which cannot be drained or where endogenous recontamination from the gut, oropharynx or genital tract is likely.)

    Parenteral treatment should be replaced by oral therapy as soon as possible.

    Adults

    Prophylaxis against anaerobic infection
    Various schedules are possible.

    1000mg to 1500mg 30 to 60 minutes before the procedure.

    An alternative schedule is 500mg immediately before, during or after the procedure. Then 500mg every 8 hours. Continue prophylaxis post-operatively for the shortest time. This may be for 24 hours post-operatively but not more than 48 hours.

    Treatment of established or suspected anaerobic infection
    Various schedules are possible.

    500mg every 8 hours.

    Alternatively 1000mg to 1500mg once daily.

    Children

    Prophylaxis against anaerobic infection
    Children aged 12 to 18 years
    (See Dosage; Adult).

    Children aged 1 month to 12 years
    20mg/kg to 30mg/kg as a single dose, 1 to 2 hours before surgery.

    Treatment of established or suspected anaerobic infection
    Children aged 12 to 18 years
    (See Dosage; Adult).

    Children aged 8 weeks to 12 years
    20mg/kg to 30 mg/kg once daily.

    Alternatively 7.5 mg/kg every 8 hours.

    The dose may be increased up to 40mg/kg daily, depending on the severity of the infection.

    Duration of treatment is usually 7 days.

    Children under 8 weeks
    15mg/kg once daily.

    Alternatively 7.5 mg/kg every 12 hours.

    The following alternative dosing schedule may also be suitable:

    Children aged 1 to 2 months
    15mg/kg as a single loading dose. Then 7.5mg/kg every 8 hours. duration of treatment is usually 7 days.

    Neonates

    Accumulation of metronidazole may occur during the first week of life in newborns with the gestational age of less than 40 weeks. Consider measuring metronidazole serum concentration after a few days of treatment.

    Prophylaxis against anaerobic infection
    Gestational age 40 weeks and over
    20mg/kg to 30mg/kg as a single dose given 1 to 2 hours before surgery.

    Gestational age under 40 weeks
    10mg/kg as a single dose before operation.

    Treatment of established or suspected anaerobic infection
    15mg/kg once daily.

    Alternatively 7.5 mg/kg every 12 hours.

    The following alternate doses may be suitable:
    Gestational age 34 weeks and over
    15mg/kg as a single loading dose. Then 7.5 mg/kg every 8 hours. Duration of treatment is usually 7 days.

    Gestational age 26 to 34 weeks
    15mg/kg as a single loading dose. Then 7.5 mg/kg every 12 hours. Duration of treatment is usually 7 days.

    Gestational age under 26 weeks
    15mg/kg as a single loading dose. Then 7.5 mg/kg every 24 hours. Duration of treatment is usually 7 days.

    Patients with Renal Impairment

    Metronidazole should be administered immediately after haemodialysis.

    No dose adjustments are needed in patients receiving intermittent peritoneal dialysis or continuous ambulatory peritoneal dialysis.

    Patients with Hepatic Impairment

    Severe hepatic impairment: Reduce dose and consider monitoring metronidazole serum level.

    Hepatic encephalopathy: Reduced dose by two thirds of daily dose. Administer once daily.

    Administration

    For intravenous infusion only.

    Therapeutic Drug Monitoring

    Accumulation of metronidazole may occur during the first week of life in newborns with the gestational age of less than 40 weeks. Consider measuring metronidazole serum concentration after a few days of treatment.

    In severe hepatic impairment consider monitoring metronidazole serum levels.

    Contraindications

    None known

    Precautions and Warnings

    Elderly
    Restricted sodium intake
    Breastfeeding
    Central nervous system disorder excluding brain abscess
    Cockayne syndrome
    Haematological disorder
    Hepatic encephalopathy
    History of haematological disorder
    Peripheral neuropathy
    Pregnancy
    Severe hepatic impairment

    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Consider pseudomembranous colitis if patient presents with severe diarrhoea
    Monitor for signs of bone marrow depression
    Monitor for signs of neurological toxicity
    Regular clinical and lab. tests recommended for treatment of > 10 days
    May affect results of some laboratory tests
    Discontinue if severe hypersensitivity reactions occur
    If new neurological symptoms occur suspend treatment and investigate
    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
    Advise patient urine may be discoloured

    In patients with Cockayne syndrome monitor liver function tests before initiating therapy, throughout treatment and after the end of treatment until the results are within normal ranges or baseline values are reached. Treatment should be discontinued if liver function tests become elevated. Patients with Cockayne syndrome should report any symptoms of potential liver disorder or liver injury immediately and treatment should be stopped.

    If metronidazole is administered for more than 10 days, history of blood dyscrasia, severe infection or severe hepatic impairment regular clinical and laboratory monitoring is advised.

    Patients with severe peripheral and central CNS disease should be treated with caution due to the risk of neurological aggravation. Discontinue if ataxia, confusion or dizziness occur.

    High dose regimens have been associated with transient epileptic seizures.

    Pregnancy and Lactation

    Pregnancy

    Use metronidazole with caution in pregnancy.

    During the first trimester, some manufacturers contraindicate the use of metronidazole. In the first trimester metronidazole should only be used to treat severe-life threatening injections, if there is no safer alternative. Use with caution in the second and third trimester for severe infections.

    Limited human data has not shown teratogenic effects.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Metronidazole should be used with caution.

    Metronidazole is found in breast milk but plasma levels of metronidazole and metabolite are lower than maternal plasma levels.

    There have been case reports of candidal infections and diarrhoea in infants exposed to metronidazole via breast milk.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Abnormal liver function tests
    Agranulocytosis
    Anaphylactic shock
    Anaphylaxis
    Angioedema
    Anorexia
    Aplastic anaemia
    Arthralgia
    Aseptic meningitis
    Ataxia
    Belching
    Candidiasis
    Cholestatic hepatitis
    Confusion
    Darkening of urine
    Depressed mood
    Diarrhoea
    Diplopia
    Disturbances of sensation
    Dizziness
    Drowsiness
    Dry mouth
    Dysarthria
    Dysphagia
    ECG changes
    Encephalopathy
    Epigastric discomfort
    Epigastric pain
    Epileptiform seizures
    Erythema multiforme
    Fever
    Furred tongue
    Gastro-intestinal disturbances
    Glossitis
    Granulocytopenia
    Hallucinations
    Headache
    Hypersensitivity reactions
    Insomnia
    Jarisch-Herxheimer reaction
    Jaundice
    Leucopenia
    Metallic taste
    Movement disturbances
    Myalgia
    Myoclonus
    Myopia
    Nausea
    Neuropathic pain
    Neutropenia
    Oculogyric crisis
    Optic neuritis
    Optic neuropathy
    Oral mucositis
    Pancreatitis
    Pancytopenia
    Paraesthesia
    Peripheral neuropathy
    Pruritus
    Pseudomembranous colitis
    Psychotic episodes
    Pustular rash
    Rash
    Seizures
    Somnolence
    Stevens-Johnson syndrome
    Stomatitis
    Thrombocytopenia
    Thrombophlebitis
    Tingling in extremities
    Toxic epidermal necrolysis
    Urticaria
    Vertigo
    Visual disturbances
    Vomiting
    Weakness

    Effects on Laboratory Tests

    May affect liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphate).

    Metronidazole may immobilise Treponema and thus may lead to a false positive Nelson's test.

    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: April 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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: Metronidazole 500mg/100ml Intravenous Infusion. Baxter Healthcare Ltd. Revised November 2016.

    Summary of Product Characteristics: Metronidazole 500mg/100ml Solution for Infusion. B. Braun Melsungen AG. Revised April 2017.

    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: February 04, 2016
    Last accessed: February 02, 2018

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 February 2018

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