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Metronidazole cream 0.75%

Presentation

Cream containing metronidazole.

Drugs List

  • metronidazole 0.75% cream
  • ROZEX 0.75% cream
  • Therapeutic Indications

    Uses

    Treatment of rosacea

    Dosage

    Adults

    1 application twice a day. Duration of treatment varies according to brand but should not exceed 4 months.

    Children

    Children aged 1 to 18 years (unlicensed)
    1 application twice a day.

    Contraindications

    Children under 1 year
    Breastfeeding

    Precautions and Warnings

    Children aged 1 to 18 years
    Central nervous system disorder
    Haematological disorder
    History of haematological disorder
    Pregnancy
    Severe hepatic impairment

    Some formulations contain propylene glycol
    Avoid contact with mucous membranes
    Avoid use in or near eyes
    If accidental contact with the eyes occurs, rinse thoroughly with water
    Marked skin irritation - interrupt treatment/reduce application frequency
    Advise patient to avoid alcohol during treatment
    Advise pt. to minimise exposure to sunlight & avoid sunlamps during therapy

    Pregnancy and Lactation

    Pregnancy

    Use metronidazole cream with caution during pregnancy.

    One manufacturer advises that metronidazole cream is contraindicated during the first trimester of pregnancy. However, another manufacturer advises that this medication should only be used in pregnancy if clearly needed. At the time of writing there is limited human data available. With oral administration, metronidazole crosses the placental barrier and enters the foetal circulation. Some studies have indicated an increased risk of malformations and carcinogenic risk but these have not been clarified.

    Lactation

    Metronidazole cream is contraindicated during breastfeeding.

    The manufacturer advises discontinuing breastfeeding or discontinuing metronidazole. Metronidazole is excreted into human breast milk. Up to 100% of the plasma value can be reached after oral use. In topical application of metronidazole, these plasma levels are lower.

    Side Effects

    Anaphylaxis
    Angioedema
    Burning sensation (local)
    Contact dermatitis
    Dry skin
    Erythema
    Hypoesthesia
    Metallic taste
    Nausea
    Pain
    Paraesthesia
    Pruritus
    Rash
    Skin exfoliation
    Skin irritation
    Stinging
    Watering eyes
    Worsening of rosacea

    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: December 2019

    Reference Sources

    Summary of Product Characteristics: Rozex 0.75% w/w cream. Galderma (U.K.) Ltd. Revised August 2013.

    Summary of Product Characteristics: Rosiced 7.5mg/g cream. Pierre Fabre Dermatologie. Revised March 2015.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.