Description:
Properties
Ketoprofen is a non-steroidal anti-inflammatory agent of the propionic group, a derivative of aryl-carboxylic acid. It has anti-inflammatory and analgesic properties.
Pharmacokinetic properties
Applied locally in the form of a gel, ketoprofen is absorbed very gradually and is not accumulated in the body. e systemic passage of the gel compared to that of the oral formulations of ketoprofen is around 5 %, which enables a local eect to be obtained without systemic incidence.
Indications:
Symptomatic relief of pain soft tissue injuries, including sport injuries, sprains, strains, musculo tendonitis, swelling, backache and rheumatic pain.
Contraindications:
• Known allergy to Ketoprofen, or substances of similar activity to aspirin or any of the excipients
• History of any photosensitivity reactions
• Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen,
fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs (including when taken orally)
• History of skin allergy to ketoprofen, tiaprofenic acid, fenobrate or UV blocker or perfumes
• Sun exposure, even in the case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation
• Dermatosis, eczema, infected skin lesion, wounds.
• Not to be applied on mucous membranes or on the eyes.
Posology and method of administration:
For cutaneous use. Penetration of the gel by gentle and prolonged massage on the painful
or inamed surface for up to seven days.
Two to four daily applications of approximately 2 to 4g gel, representing
approximately 5 to 10cm. e usual maximum dose is 15g per day.
Children (under 15 years): Not recommended, as safety in children has not been established
Warnings and precautions:
For topical use only. e appearance of cutaneous eruption following application of the gel requires interruption of treatment.
Hands should be washed thoroughly before use and immediately after each application of product (unless they are being treated).
It is recommended to protect treated areas by wearing clothing during all the application of the product and two weeks following its discontinuation to avoid the risk of
photosensitisation.
Not for use with an occlusive dressing. Topical application of large amounts may result in
systemic effects including hypersensitivity and asthma (the renal disease has also been reported).
If symptoms persist consult the doctor or the pharmacist.
Drug Interaction:
Interactions are unlikely, as serum concentrations following topical application are low.
However concurrent aspirin or other NSAIDs may result in increased incidence of adverse reaction.
Pregnancy and lactation:
It is recommended that ketoprofen should be avoided during pregnancy. Non-steroidal anti-inammatory drugs may also delay labour.
Trace amounts of ketoprofen are excreted in breast milk following oral administration, therefore the gel should not be used during breast feeding.
Undesirable effects:
• Local skin reactions such as erythematous, pruritis and burning sensations.
• Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
• Hypersensivity reactions, photosensitisation
Overdose:
Overdosage is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse eects depending on the amount ingested. However, if they occur, treatment should be supportive and symptomatic.
Storage conditions: Store in a dry place below 25° C
How supplied: 20- 40 g