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Nicotinamide topical gel 4%

Presentation

Gel formulation of nicotinamide

Drugs List

  • FREEDERM gel
  • FREEDERM TREATMENT gel
  • nicotinamide 4% topical gel
  • Therapeutic Indications

    Uses

    Acne vulgaris

    Dosage

    Adults

    Apply nicotinamide gel to the affected area twice daily.

    The affected area should be washed thoroughly with soap and warm water prior to application. Apply enough gel to cover the affected area thinly.

    Treatment should continue for as long as necessary. Courses of treatment may take several weeks depending on the severity of the condition.

    Elderly

    Apply nicotinamide gel to the affected area twice daily.

    The affected area should be washed thoroughly with soap and warm water prior to application. Apply enough gel to cover the affected area thinly.

    Treatment should continue for as long as necessary. Courses of treatment may take several weeks depending on the severity of the condition.

    Children

    Apply nicotinamide gel to the affected area twice daily.

    The affected area should be washed thoroughly with soap and warm water prior to application. Apply enough gel to cover the affected area thinly.

    Treatment should continue for as long as necessary. Courses of treatment may take several weeks depending on the severity of the condition.

    Contraindications

    None known

    Precautions and Warnings

    Breastfeeding
    First trimester of pregnancy
    Severe acne vulgaris

    Avoid contact with eyes
    Avoid contact with mucous membranes
    Reduce dose if excessive dryness/irritation/peeling occurs
    If symptoms do not improve after 12 weeks, consult a doctor

    Frequency of application should be reduced to once daily or once every other day if excessive dryness, irritation or peeling occurs.

    Pregnancy and Lactation

    Pregnancy

    Use nicotinamide with caution in the first trimester of pregnancy.

    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 to 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

    Use nicotinamide with caution in breastfeeding.

    Nicotinamide is excreted in 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

    Burning sensation (local)
    Dry skin
    Erythema
    Irritation (localised)
    Pruritus

    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: June 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 12 June 2015.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 12 June 2015.

    Summary of Product Characteristics: Nicam 4% w/w Gel. Diomed Developments Ltd. Revised May 2015.

    Summary of Product Characteristics: Freederm Gel. Diomed Developments Ltd. Revised March 2015.
    Summary of Product Characteristics: Freederm Treatment 4% w/w Gel. Diomed Developments Ltd. Revised June 2015.

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