FASTUM GEL ® Ketoprofen

FASTUM GEL © is a drug based on ketoprofen lysine salt

THERAPEUTIC GROUP: Non-steroidal anti-inflammatory drugs for topical use.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications FASTUM GEL "Retard" ® Ketoprofen

FASTUM GEL ® is indicated in the treatment of local pain of mild and modest osteo-articular and muscular entity, both of rheumatic and post-traumatic origin.

Mechanism of action FASTUM GEL "Retard" ® Ketoprofen

FASTUM GEL ® is a drug based on ketoprofen, an active ingredient derived from arylpropionic acid among the non-steroidal anti-inflammatory drugs used in the local treatment of phlogistic conditions.

The topical administration of this drug in fact significantly reduces the systemic absorption of the active principle, allowing ketoprofen to concentrate mainly in the site and more precisely at the level of the synovies.

Here it performs its therapeutic action, acting on inflamed structures and inhibiting the activity of cyclooxygenases, enzymes able to mediate the conversion of arachidonic acid into molecules with pro-inflammatory activity known as prostaglandins.

This inhibition, characterized by the reduction of vascular permeability and the recruitment of inflammatory cells, results in the reduction of the typical signs of inflammation, including edema, redness, pain and functional deterioration of the tissue.

Although the blood concentrations that are observed following the dermal intake of ketoprofen are minimal, in reality this active principle is able to easily pass the haemato-encephalic membrane, carrying out a sensitive non-opioid analgesic action at the level of the central nervous system.

Studies carried out and clinical efficacy

1. THE KETOPROPHENES IN GEL

Eur Rev Med Pharmacol Sci. 2011 Aug; 15 (8): 943-9.

Review that evaluates the results of the latest studies published in the literature, demonstrating how topical administration of ketoprofen can be effective and safe in the treatment of musculoskeletal disorders.

2. THE PHOTOSENSITIZATION INDUCED BY KETOPROPHENE

Prescrire Int. 2010 Oct; 19 (109): 216.

Case report showing one of the main side effects associated with topical administration of ketoprofen. The photosensitization induced by the drug should prompt patients to avoid exposure to sunlight, or at least to resort to appropriate protections.

3. KETOPROPHENES IN THE TREATMENT OF SEVER'S DISEASE

Phys Ther. 2006 Mar; 86 (3): 424-33.

Sever's disease is a very painful form of osteochondritis of the heel, which significantly limits athletic ability even in the youngest.

Treatment with gel ketoporphene has been shown to be effective in reducing pain, although the literature had never previously evaluated this activity.

Method of use and dosage

FASTUM GEL ®

Gel for cutaneous use at 2.5% ketoprofen (equal to 2.5 grams per 100 grams of product).

It is advisable to apply the sufficient amount of gel to cover the affected area twice a day, gently massaging it in order to improve absorption.

It is important to avoid the application of FASTUM GEL ® on evidently damaged or mucous tissues.

Warnings FASTUM GEL "Retard" ® Ketoprofen

Before applying FASTUM GEL ® on the affected skin region, it is necessary to ascertain the absence of obvious lesions.

Significant changes related to the degree of absorption of topically taken ketoprofen, could be observed following the use of occlusive bandages or prolonged administrations, thus increasing the risk of adverse reactions.

Face the risk of photosensitivity is recommended to avoid exposure to sunlight, following the application of the medicine.

Following the appearance of side effects, including skin, it would be advisable to contact your doctor and stop therapy immediately.

PREGNANCY AND BREASTFEEDING

Despite the low degree of systemic absorption that is observed following topical administration of ketoprofen, the use of FASTUM GEL ® is contraindicated during pregnancy given the potential side effects of the fetus.

Fetal malformations especially affecting the cardiovascular and respiratory tracts and unwanted abortions represent the greatest risks.

Interactions

Given the very low degree of absorption that occurs following topical administration of ketoprofen, no clinically relevant drug interactions have been observed at the time.

Contraindications FASTUM GEL "Retard" ® Ketoprofen

The use of FASTUM GEL ® is contraindicated in patients hypersensitive to the active ingredient, to its excipients and to structurally related molecules or with a history of previous photosensitivity reactions.

Undesirable effects - Side effects

The topical use of ketoprofen, like the one that is carried out in the treatment with FASTUM GEL ®, allows to significantly reduce some adverse reactions related to the oral intake of the active ingredient.

The use of FASTUM GEL ®, especially in some predisposed patients and when continued for a long time, could be associated with the appearance of gastro-intestinal and dermatological disorders such as eczema bullous, erythema, urticaria, pruritus and photosensitivity.

However, it is necessary to reiterate in clinical practice, such reactions assume little relevance, given the low incidence with which they occur.