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Presentation

Oral formulations of nystatin

Drugs List

  • NYSTAN 100000unit/ml oral suspension
  • nystatin 100000unit/ml oral suspension
  • Therapeutic Indications

    Uses

    Candidal infection of the gastrointestinal tract
    Neonatal oral candidosis where mother has vaginal candidosis: prophylaxis
    Oropharyngeal candidiasis: treatment

    Dosage

    Treatment usually for 14 days and continue for 48 hours after lesions have healed.
    It is recommended to keep the medication in contact with the affected areas for as long as possible.
    Some manufacturers may recommend higher doses.

    Adults

    Prevention and treatment of oral candidiasis
    1 ml four times daily. Apply half of dose in each side of the mouth.

    Prevention and treatment of intestinal candidiasis
    5 ml four times daily. Apply half of dose in each side of the mouth.
    For prophylaxis, a total daily dose of 1 million units will suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy. Each ml contains 100,000 units.

    Elderly

    (See Dosage; Adult)

    Children

    Prevention and treatment of oral candidiasis
    Children aged 1 month to 18 years
    1 ml four times daily. Apply half of dose in each side of the mouth.

    Prevention and treatment of intestinal candidiasis
    Children aged 1 month to 18 years
    1 ml four times daily. Apply half of dose in each side of the mouth. Administer with milk or other liquid in children aged 1 month to 2 years.
    For prophylaxis, a total daily dose of 1 million units will suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy.

    Neonates

    Prevention and treatment of oral candidiasis
    Birth to 1 month
    1 ml four times daily. Apply half of dose in each side of the mouth.

    Prevention and treatment of intestinal candidiasis
    Birth to 1 month
    1 ml four times daily. Apply half of dose in each side of the mouth. Administer with milk or other liquid in children aged 1 month to 2 years.
    For prophylaxis, the suggested dose is 1 ml once daily.

    Contraindications

    Hereditary fructose intolerance

    Precautions and Warnings

    Breastfeeding
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Pregnancy

    Contains hydroxybenzoate
    Preparation contains sucrose
    Some brands contain metabisulfite, may cause bronchospasm/allergies
    Diabetic control may need adjustment

    Pregnancy and Lactation

    Pregnancy

    Use nystatin with caution in pregnancy.

    At the time of writing there is limited published information regarding the use of nystatin during pregnancy. The absorption of nystatin from the gastrointestinal tract is very low. It is not known whether nystatin can cause any harm to the foetus when taken by a pregnant woman.

    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 nystatin with caution in breastfeeding.

    At the time of writing there is limited published information regarding the use of nystatin during breastfeeding.

    Gastrointestinal absorption of nystatin is insignificant and plasma levels are minimal after oral administration. Secretion into milk is unlikely due to poor maternal absorption.

    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

    Angioedema
    Bronchospasm
    Diarrhoea
    Facial oedema
    Gastro-intestinal disturbances
    Hypersensitivity reactions
    Nausea
    Oral irritation
    Oral sensitisation
    Rash
    Stevens-Johnson syndrome
    Urticaria
    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 2017

    Reference Sources

    Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.

    Paediatric Formulary Committee. BNF for Children 2016-2017. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2016.

    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.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas..

    Summary of Product Characteristics: Nystatin Oral Suspension. Sandoz Ltd. Revised August 2015.

    Summary of Product Characteristics: Nystan Oral Suspension (Ready -Mixed). E.R.Squibb & Sons Ltd. Revised September 2015.

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