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Ibuprofen transdermal medicated plaster

Presentation

Medicated plaster formulation of ibuprofen.

Drugs List

  • ibuprofen 200mg medicated plaster
  • NUROFEN JOINT & MUSCULAR PAIN RELIEF 200mg medicated plaster
  • Therapeutic Indications

    Uses

    Relief of pain and inflammation due to trauma

    Dosage

    The maximum daily dose is 1 medicated plaster.

    The duration of the use should not exceed 5 days.

    Adults

    1 medicated plaster to be applied once a day.

    Children

    Children aged 16 years and older
    1 medicated plaster to be applied once a day.

    Contraindications

    Children under 16 years
    Third trimester of pregnancy

    Precautions and Warnings

    Allergic disposition
    Elderly
    Haemorrhagic diathesis
    Asthma
    Breastfeeding
    Cardiac impairment
    First trimester of pregnancy
    Hepatic impairment
    History of peptic ulcer
    Inflammatory bowel disease
    Renal impairment
    Second trimester of pregnancy

    Avoid application to broken skin
    Avoid contact with eyes, lips or mouth
    Avoid occlusive dressings
    Discontinue treatment if rash occurs
    Maintain treatment for the shortest possible duration
    Only recommended for short term use (up to 5 days)
    Advise patient that photosensitivity possible
    Advise patient to seek medical advice if symptoms persist for > 5 days
    Avoid exposure to sunlight/ UV rays during and for 1 day after treatment

    The medicated plaster should be used whole and not cut.

    Avoid getting medicated plaster wet.

    Pregnancy and Lactation

    Pregnancy

    Ibuprofen is contraindicated in the third trimester of pregnancy.

    Use of any NSAID is considered contraindicated during the third trimester of pregnancy.

    First trimester exposure to NSAIDs has been associated with an increased risk spontaneous abortions and of birth defects (notably cardiac septal defects). There is conflicting evidence, however, from various studies and the risk appears to be low (Briggs, 2015).

    Ibuprofen should be used with caution in the first and second trimesters. Schaefer (2015) considers that use of NSAIDs in early pregnancy does not require termination of pregnancy or invasive diagnostic procedures.

    Ibuprofen is a prostaglandin synthetase inhibitor and may have effects during the second and third trimesters, including pulmonary and cardiac toxicity in the foetus/newborn from the beginning of the sixth month and increases in risk if administration is close to full term. Other effects also include, functional renal injury in the foetus, inhibition of uterine contractions with delayed onset and prolongation of labour, increased possibility of bleeding in mother and child, and increased risk of maternal oedema formation. When used in the perinatal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.

    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 ibuprofen with caution in breastfeeding.

    Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breastfed infant adversely. Because of its extremely low levels in breast milk and short half-life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers (Schaefer, 2015).

    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

    Abdominal pain
    Application site reaction
    Bronchospasm
    Dyspepsia
    Hypersensitivity reactions
    Photosensitivity
    Renal impairment

    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: September 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: Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster. Reckitt Benckiser Healthcare UK Limited. Revised November 2017.

    NICE - Evidence Services
    Available at: www.nice.org.uk
    Last accessed: 14 September 2018

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