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Ibuprofen topical

Presentation

Topical formulations of ibuprofen

Drugs List

  • FENBID 5% gel
  • IBUGEL 5% gel
  • IBUGEL FORTE 10% gel
  • IBULEVE gel
  • IBULEVE MAXIMUM STRENGTH 10% gel
  • ibuprofen 10% gel
  • ibuprofen 5% gel
  • ibuprofen 5% spray
  • IBUSPRAY 5% spray
  • MENTHOLATUM IBUPROFEN 5% gel
  • NUROFEN JOINT & BACK PAIN RELIEF MAX STRENGTH 10% gel
  • PHORPAIN 5% gel
  • PHORPAIN MAXIMUM STRENGTH 10% gel
  • RADIAN B IBUPROFEN 5% gel
  • Therapeutic Indications

    Uses

    Symptomatic relief of minor muscular sprains and cramps

    Dosage

    Therapy should be reviewed after few weeks.

    Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.

    Adults

    Gel
    The recommended dose of ibuprofen is 50 mg to 125 mg three to four times a day. The amount of gel to be applied varies with the brand used, consult specific product literature.
    Gently massage onto the skin in the affected area, until completely absorbed.

    Spray
    Spray over affected area holding bottle 4 to 6 inches from skin. After every 2 to 3 sprays, gently massage the preparation into the skin, spreading the product over a wide area around the affected site until it dries. The exact amount to be applied will vary, depending on the extent and severity of the condition, but it should normally be sufficient to apply between 5 and 10 sprays. This amount may be repeated 3 to 4 times daily, doses should be administered at least 4 hours apart. Do not apply more than 40 sprays in any 24 hour period.

    Elderly

    (See Dosage; Adult).

    Children

    Children over 12 years
    (See Dosage; Adult).

    Not all brands are licensed in all age groups.

    Contraindications

    Children under 12 years
    Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
    Third trimester of pregnancy

    Precautions and Warnings

    Children aged 12 to 14 years
    Asthma
    Breastfeeding
    First trimester of pregnancy
    Peptic ulcer
    Renal impairment
    Second trimester of pregnancy

    May precipitate bronchospasm in patients with asthma or allergy
    Not all available brands are licensed for all age groups
    Some formulations contain propylene glycol
    Advise patient to wash hands after use
    Avoid broken or inflamed skin
    Avoid contact with eyes
    Avoid contact with mucous membranes
    Avoid occlusive dressings
    Discontinue treatment if rash occurs
    Maintain treatment at the lowest effective dose
    Advise patient residue on clothing/bedding may cause fire hazard
    Advise patient that photosensitivity possible
    Fire hazard: Keep away from naked flames and potential sources of ignition
    Refer to doctor if symptoms persist after 2 weeks treatment

    Pregnancy and Lactation

    Pregnancy

    Ibuprofen is contraindicated during the 3rd trimester of pregnancy and should be used with caution in the first 2 trimesters.

    Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during the first and second trimesters should, if possible, be avoided. NSAIDs have been associated with spontaneous abortions and congenital abnormalities. During the 3rd trimester, Ibuprofen is contraindicated as there is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. There is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of systemic ibuprofen is therefore not recommended in women attempting to conceive (Schaefer, 2007).

    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.

    At the time of writing there are is limited published experience concerning the use of Ibuprofen during breast feeding. Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breast-fed 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.

    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
    Aggravation of existing asthma
    Allergic reaction
    Anaphylaxis
    Angioedema
    Application site reaction
    Asthma
    Bronchospasm
    Bullous dermatoses
    Dyspepsia
    Dyspnoea
    Erythema multiforme
    Hypersensitivity reactions
    Pruritus
    Purpura
    Rash
    Renal failure
    Renal impairment
    Toxic epidermal necrolysis
    Urticaria

    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 2013

    Reference Sources

    British National Formulary, 66th Edition (September 2013-March 2014) Pharmaceutical Press, London.

    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.

    Summary of Product Characteristics: Fenbid 5% Gel. Amdipharm Mercury Company Ltd. Revised September 2012.
    Summary of Product Characteristics: Fenbid Forte 10% Gel. Amdipharm Mercury Company Ltd. Revised September 2012.

    Summary of Product Characteristics: Ibuderm. Dermal Laboratories Ltd. Revised October 2010.

    Summary of Product Characteristics: Ibugel. Dermal Laboratories Ltd. Revised October 2007.
    Summary of Product Characteristics: Ibugel Forte 10%. Dermal Laboratories Ltd. Revised October 2007.

    Summary of Product Characteristics: Ibuleve Gel. Diomed Developments Ltd. Revised May 2010.
    Summary of Product Characteristics: Ibuleve Speed Relief Gel. Diomed Developments Ltd. Revised October 2010.
    Summary of Product Characteristics: Ibuleve Speed Relief 5% spray. Diomed Developments Ltd. Revised November 2010.
    Summary of Product Characteristics: Ibuleve Speed Relief Max Strength Gel. Diomed Developments Ltd. Revised June 2010.
    Summary of Product Characteristics: Ibuleve Maximum Strength Gel. Diomed Developments Ltd. Revised October 2007.

    Summary of Product Characteristics: Ibuspray. Dermal Laboratories Ltd. Revised November 2010.

    Summary of Product Characteristics: Nurofen Joint & Back Pain Relief 5% Gel. Reckitt Benckiser Healthcare (UK) Ltd. Revised December 2015.
    Summary of Product Characteristics: Nurofen Joint & Back Pain Relief Max Strength 10% Gel. Reckitt Benckiser Healthcare (UK) Ltd. Revised October 2015.

    Summary of Product Characteristics: Nurofen Maximum Strength 10% Gel. Reckitt Benckiser Healthcare (UK) Ltd. Revised February 2013.

    Summary of Product Characteristics: Phorpain Gel 5%. Amdipharm Mercury Company Ltd. Revised September 2012.
    Summary of Product Characteristics: Phorpain Gel Maximum Strength. Amdipharm Mercury Company Ltd. Revised September 2012.

    Summary of Product Characteristics: Radian B Ibuprofen 5% Gel. Thornton & Ross Ltd. Revised August 2013.

    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
    Ibuprofen. Last revised: September 7, 2013
    Last accessed: September 12, 2013

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