ACTION AND MECHANISM

Dexketoprofen is a non-steroidal anti-inflammatory drug (ANSI) and analgesic that works by preventing the synthesis of prostaglandins and other prostanoids through the inhibition of cyclooxygenase, which is involved in inflammatory processes.

SPECIAL WARNINGS

Before prescribing this medication, it is especially important to verify the absence of contraindications related to phototoxicity and photoallergy. Sun exposure of the treated area may cause photosensitivity (see Precautions and Adverse Reactions). If symptoms persist for more than 7 days, or if irritation or worsening occurs, the patient's clinical condition should be evaluated. Informative materials on recommendations for preventing photosensitivity reactions associated with topical ketoprofen and dexketoprofen are available for both healthcare professionals and patients (see Additional Information: Additional Drug Information).

PATIENT ADVICE

- Do not use this medication if you have or have had any allergy to topical ketoprofen or dexketoprofen, or to other ingredients such as tiaprofenic acid, fenofibrate, UV protectants (sunscreens, specifically those containing octocrylene), or perfumes. - Avoid contact with the eyes and mucous membranes. - Do not use with occlusive dressings or tight clothing over the application area. - Do not apply simultaneously to the same area as other topical preparations. - Do not use for prolonged periods (no more than 7 days) or on large areas. - Use only on intact skin, not on open wounds, mucous membranes, or eczematous skin. - Avoid exposure to direct sunlight or ultraviolet rays during treatment and for up to 2 weeks after its completion, even when using sunscreen. The treated area should be covered with appropriate clothing, even on cloudy days. - Wash your hands after each application (to avoid spreading the product to other areas that come into contact with your hands). - Discontinue treatment if any skin rash appears in the application area, including reactions after co-application of products containing octocrylene (an excipient used in cosmetic and hygiene products such as sunscreens, shampoos, aftershave massages, bath and shower gels, skin creams, lipsticks, anti-aging creams, makeup removers and hairsprays). - A document titled "Specific Information for the Patient on Photoallergic Reactions" is available (see Additional Information: Additional Information on Medicines) which outlines the precautions to be taken during the use of the medicine.

CONTRAINDICATIONS

- Hypersensitivity to dexketoprofen or any of the components of this medicine. - [NSAID ALLERGY] [SALICYLATE ALLERGY]: Although local administration minimizes the risks associated with systemic use, prolonged topical application to large areas of skin, open wounds, mucous membranes, or eczematous skin, with the use of occlusive dressings, can cause systemic effects. Therefore, it is important to remember that its use is not recommended in patients who have experienced allergic reactions (rhinitis, asthma, pruritus, angioedema, urticaria, shock, or others) caused by acetylsalicylic acid, tiaprofenic acid, or other NSAIDs due to the possibility of cross-hypersensitivity. - History of photosensitivity. - History of skin allergy to topical ketoprofen or dexketoprofen, tiaprofenic acid, fenofibrate, or UV protectants (particularly those containing octocrylene) or perfumes.

ADVANCED AGE

There is no recommendation for use in these patients.

PREGNANCY

Animal safety: no data available.

Safety in humans: There are no adequate and well-controlled studies in humans. As a precautionary measure, its use is not recommended.

Effects on fertility: no specific studies have been conducted in humans.

PHARMACOKINETICS

Topical application of dexketoprofen has been shown to achieve significant local levels of the drug with very low plasma concentrations. Pharmacokinetic studies in humans demonstrate that after application, percutaneous absorption leads to peak plasma concentrations 4 hours after administration, followed by an elimination phase lasting up to 24 hours. Therapeutically active concentrations are maintained in synovial fluid. Drug levels in synovial fluid following administration of 1.25% dexketoprofen have been found to be equivalent to or higher than those obtained with 2.5% racemic ketoprofen gel. The complete absence of inversion from the active S-(+) enantiomer to the inactive R-(-) enantiomer has been confirmed.

INDICATIONS

Local symptomatic relief of painful or inflammatory conditions of traumatic or degenerative origin of the joints, tendons, ligaments and muscles ([ARTHRITIS], periarthritis, [CAPSULITIS], arthrosynovitis, [TENDINITIS], [TENOSYNOVITIS], [BURSITIS], [CONTUSION], sprains, [DISLOCATION], meniscal injuries of the knee, [TORTICOLLIS], [LUMBALGIA], [SPRAIN], [MUSCLE CONTRACTURE]).

INTERACTIONS

They have not been described in cutaneous use, since very low systemic concentrations of the drug are reached, but it will be assessed whether it should be used in conjunction with other topical analgesics.

LACTATION

Animal safety: no data available.

Safety in humans: It is unknown whether it is excreted in breast milk, and the potential consequences for the infant. It is recommended to discontinue breastfeeding or avoid its administration.

CHILDREN

Safety and efficacy have not been evaluated in children under 6 years of age, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

Apply with a gentle massage to promote absorption. Wash your hands after each application.

POSOLOGY

- Adults and children 6 years and over: Apply a thin layer to the affected area 2-3 times a day.

PRECAUTIONS

[PHOTOSENSITIVITY REACTIONS]. Dexketoprofen has caused photoallergic reactions, due to an immunological mechanism and therefore independent of the administered dose and unpredictable. These generally present as vesicular-bullous eczema at the application site, although some cases of spread to other areas have been reported. Cross-reactions may occur with some sunscreens, fenofibrate, and other products containing benzophenone in their structure. Additionally, cross-photoallergic reactions may occur between dexketoprofen and other arylpropionic NSAIDs administered topically. Patients with a history of photosensitivity reactions, especially to dexketoprofen, should avoid using this medication (see Contraindications). For all other patients, it is recommended to avoid exposure to ultraviolet light (both sunlight and artificial light) during treatment and for 14 days afterward, even when using sunscreen. It is recommended that the application area be protected with appropriate clothing, even on cloudy days, avoiding occlusive clothing or dressings. It is also recommended to wash your hands after applying the medication to avoid contaminating other areas. If, despite these measures, a skin rash develops, it is recommended to discontinue the medication and consult your doctor and/or pharmacist.

ADVERSE REACTIONS

- Moderate local [ERYTHEMA] (0.1%-1%), [DERMATITIS], local [SKIN IRRITATION], [PRURITUS] (0.1%-1%) and a sensation of [SKIN IRRITATION] may occur in the application area, which disappear upon discontinuation of treatment. - [PHOTOSENSITIVITY REACTIONS] may occur (0.01%-0.1%). Post-marketing experience indicates that photoallergic reactions constitute a significant proportion of reported adverse reactions and appear to be more frequent than with other topical NSAIDs (see Precautions and Warnings/Advice). - If symptoms occur for which no explanation can be found, treatment should be discontinued and the patient's clinical condition reassessed. - Prolonged topical administration, over large areas of skin, on open wounds, mucous membranes, or eczematous skin, as well as the use of occlusive dressings, may lead to the appearance of systemic adverse reactions typical of NSAIDs.

OVERDOSE

- Symptoms: Due to its external use, poisoning is unlikely. In case of accidental ingestion, overdose symptoms will be systemic adverse reactions that will depend on the dose ingested and the time elapsed since ingestion. - Treatment: If accidental ingestion occurs, gastric lavage and symptomatic therapy will be administered.