Ketospray 10%

/ Megapharm

Paediatric population: Ketospray 10% – Spray should not be used in children below 12 years of age because of safety and efficacy concerns.
Method of administration
Adults and children over 12 years of age: A sufficient amount of solution should be applied on the skin in order to cover the affected area with Ketospray
10% – Spray. The number of spray puffs depends on the size of the area to be treated: 2 spray puffs for small joints (fingers, toes), 4 spray puffs for medium-sized joints (wrist, ankle) and up to 6 spray puffs for larger joints (shoulder, knee) or larger areas (f.i. on the back). Therefore 0.4 – 1.2 g spray are applied per application, which equals 40 – 120 mg ketoprofen. Treatment should be carried out 3 times per day. The maximum daily dose should not exceed 18 spray puffs (equals 3.6 g spray, or 360 mg ketoprofen).
The solution is gently spread over the affected area after 1 – 2 spray puffs each and let dry.
Do not apply occlusive dreesing to the treated area.
Hands should be washed subsequently, unless they are also included in the treatment. The treatment may be stopped after the symptoms (pain and swellings) have eased. 7 days duration of treatment is sufficient in most cases.
Elderly: The same dosage as for adults may be applied.

Topical treatment for the symptomatic relief of soft tissue pain and inflammation due to strains, sprains, distortions and contusions.

Children under 12 years of age.
Ketospray 10% – Spray must not be used in the following cases:
known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs;
history of hypersensitivity to any of the excipients;
history of any photosensitivity reaction;
history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blocker or perfumes;
sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and for 2 weeks after its discontinuation;
on pathological skin changes such as eczema or acne; or in infected skin or open wounds;
third trimester of pregnancy.

Ketospray 10% – Spray should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions consisting of renal affections have been reported.
Ketospray 10% – Spray must not be used with occlusive dressings.
Ketospray 10% – Spray must not come into contact with mucous membranes (in the oral, genital, or anal area) or the eyes.
Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene containing products.
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 photosensitization.
Hands should be washed thoroughly after each application of Ketospray 10% – Spray.
The recommended length of treatment should not be exceeded because the risk of developing contact dermatitis and photosensitivity reactions increases over time.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy (e.g. asthma, Quincke edema, urticaria) to aspirin and/or NSAIDs than the rest of the population.
Paedriatic population: The safety and efficacy of Ketospray 10% – Spray in children have not been established.

Uncommon: (1/100 – 1/1000), Rare (1/1000 – 1/10000), Very rare (< 1/10000). 
Immune System disorders: Not known: Anaphylactic shock, angioedema
(Quincke-oedema), hypersensitivity reactions.
Skin and subcutaneous tissue disorders: Uncommon: Local skin reactions such as erythema, eczema, pruritus and burning sensations.
Rare: Dermatological: Photosensitisation, urticaria. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
Renal and urinary disorders: Very rare: Cases of aggravation of previous renal insufficiency.
When Ketospray is applied on a large area over a prolonged period of time, adverse events affecting the whole body (mainly gastrointestinal disorders) cannot be excluded with certainty.

Interactions are unlikely as serum concentrations following topical administration are low. Serious interactions have been recorded after use of high dose methotrexate with non-steroidal anti-inflammatory agents, including
ketoprofen, when administered by the systemic route. It is advisable to monitor patients under treatment with anticoagulants such as coumarinic substances.

Pregnancy: During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketospray 10% – Spray during the first and second trimester of pregnancy should be avoided.
During the third trimester: During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged bleeding time in both mother and child may occur. Therefore, Ketospray 10% – Spray should not be used during the last trimester of pregnancy.
Lactation: No data is available on the excretion of ketoprofen in human milk. Ketospray 10% – Spray is not recommended in nursing mothers.

Due to the low systemic burden after topical administration no symptoms of overdose are to be expected.
If accidentally ingested, the spray may cause systemic adverse effects depending on the amount ingested.
However, if they occur, treatment should be supportive and symptomatic in accordance with overdose of oral antiphlogistics.

Shelf life: 48 months. 1 year after first opening.