Drugs List

Therapeutic Indications

Uses

Non-serious arthritic pain
Relief of pain and inflammation due to trauma

Contraindications

Allergic disposition
Children under 12 years
History of serious hypersensitivity reactions
Open wounds
Photosensitivity
Asthma
Eczema
History of asthma
Skin infection
Third trimester of pregnancy

Precautions and Warnings

Children aged 12 to 18 years
Breastfeeding
Exudative dermatosis
First trimester of pregnancy
Second trimester of pregnancy
Severe renal impairment

NSAIDs may provoke or exacerbate asthma
Not all available brands are licensed for all age groups
Advise patient to wash hands after use
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Do not apply to ano-genital areas
Do not apply to broken skin or open pressure sores
NSAIDs may provoke bronchospasm/urticaria in susceptible patients
Prolonged topical application may cause sensitisation reactions
Discontinue treatment if skin rash or other allergic reaction occurs
Treatment should be for a maximum period of 7 days
Advise patient on appropriate sun protection methods
Advise patient that photosensitivity possible
Advise patient to avoid sun/UV rays during and for 2 weeks after treatment
Advise patients to report skin rash

Pregnancy and Lactation

Pregnancy

Ketoprofen is contraindicated in the third trimester.

Ketoprofen crosses the human placenta. Ketoprofen has been associated with spontaneous abortion, although the risk appears to be small. If ketoprofen is used in the third trimester it is known to; interfere with the closure of the ductus arteriosus, inhibit labour and prolong pregnancy, and suppress the foetal renal function. Persistent pulmonary hypertension of the newborn may occur if ketoprofen is used late in pregnancy (Briggs, 2011).

The manufacturer recommends that ketoprofen should be avoided during 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

Ketoprofen should be used with caution during breastfeeding. At the time of writing, there is no published experience concerning the use of ketoprofen during breastfeeding.

Ketoprofen is known to be excreted into breast milk in trace amounts.

The infant should be monitored for gastro-intestinal symptoms, including diarrhoea and cramping, if ketoprofen is used by the mother.

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

Acute renal failure
Anaphylactic reaction
Angioedema
Blistering
Bullous dermatoses
Burning sensation (local)
Dermatitis
Diarrhoea
Eczema
Eosinophilia
Erythema at application site
Eyelid oedema
Gastro-intestinal symptoms
Gastrointestinal bleeding
Hypersensitivity reactions
Impetigo
Oedema
Oedema of the lips
Peptic ulceration
Pruritus
Pyrexia
Rash
Renal impairment
Skin exfoliation
Skin photosensitivity
Skin reactions
Urticaria
Vasculitis

Presentation

Gel formulation of ketoprofen.

Drugs List

Therapeutic Indications

Uses

Non-serious arthritic pain
Relief of pain and inflammation due to trauma

Dosage

Dose varies according to brand

Adults

Elderly

Children

Contraindications

Allergic disposition
Children under 12 years
History of serious hypersensitivity reactions
Open wounds
Photosensitivity
Asthma
Eczema
History of asthma
Skin infection
Third trimester of pregnancy

Precautions and Warnings

Children aged 12 to 18 years
Breastfeeding
Exudative dermatosis
First trimester of pregnancy
Second trimester of pregnancy
Severe renal impairment

NSAIDs may provoke or exacerbate asthma
Not all available brands are licensed for all age groups
Advise patient to wash hands after use
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Do not apply to ano-genital areas
Do not apply to broken skin or open pressure sores
NSAIDs may provoke bronchospasm/urticaria in susceptible patients
Prolonged topical application may cause sensitisation reactions
Discontinue treatment if skin rash or other allergic reaction occurs
Treatment should be for a maximum period of 7 days
Advise patient on appropriate sun protection methods
Advise patient that photosensitivity possible
Advise patient to avoid sun/UV rays during and for 2 weeks after treatment
Advise patients to report skin rash

Pregnancy and Lactation

Pregnancy

Ketoprofen is contraindicated in the third trimester.

Ketoprofen crosses the human placenta. Ketoprofen has been associated with spontaneous abortion, although the risk appears to be small. If ketoprofen is used in the third trimester it is known to; interfere with the closure of the ductus arteriosus, inhibit labour and prolong pregnancy, and suppress the foetal renal function. Persistent pulmonary hypertension of the newborn may occur if ketoprofen is used late in pregnancy (Briggs, 2011).

The manufacturer recommends that ketoprofen should be avoided during 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

Ketoprofen should be used with caution during breastfeeding. At the time of writing, there is no published experience concerning the use of ketoprofen during breastfeeding.

Ketoprofen is known to be excreted into breast milk in trace amounts.

The infant should be monitored for gastro-intestinal symptoms, including diarrhoea and cramping, if ketoprofen is used by the mother.

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

Acute renal failure
Anaphylactic reaction
Angioedema
Blistering
Bullous dermatoses
Burning sensation (local)
Dermatitis
Diarrhoea
Eczema
Eosinophilia
Erythema at application site
Eyelid oedema
Gastro-intestinal symptoms
Gastrointestinal bleeding
Hypersensitivity reactions
Impetigo
Oedema
Oedema of the lips
Peptic ulceration
Pruritus
Pyrexia
Rash
Renal impairment
Skin exfoliation
Skin photosensitivity
Skin reactions
Urticaria
Vasculitis

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: July 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) 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.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Oruvail Gel 2.5%. Sanofi. Revised July 2014.
Summary of Product Characteristics: Powergel 2.5% gel. A.Menarini Farmaceutica Internazionale SRL. Revised February 2013.
Summary of Product Characteristics: Tiloket Gel 2.5%. Tillomed Laboratories Ltd. Revised May 2015.

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
Ketoprofen Last revised: June 16, 2008
Last accessed: July 9, 2013