Fastum Gel

Ketoprofen.

Each 100 g of gel contains ketoprofen 2.50 g.
Excipients/Inactive Ingredients: carbomer 940, ethyl alcohol, neroli oil, lavender oil, triethanolamine, purified water.

Pharmacology: Ketoprofen, in a suitable vehicle, reaches by transcutaneous route the inflammation site, allowing local treatment of pain of joints, tendons, ligaments and muscles.
Following oral administration of a single dose within 2 hours maximum blood concentrations are reached.
Plasma half-life of ketoprofen varies from 1 hour to 3 hours: binding to plasma proteins is 60-90%. Elimination occurs mainly by urinary route, in glucuronoconjugated form: approximately 90% of the administrated dose is excreted within 24 hours.
Conversely the absorption by cutaneous route is very low. In fact the application of 50-150 mg of ketoprofen by percutaneous route determines plasma levels of the active ingredient equal to 0.08-0.15 μg/ml about 5-8 hours after the application.

Local treatment of painful disorders of the osteo-articular and muscular system of rheumatic or traumatic origin: contusions, distortions, muscle strains, stiff neck, lumbago.

Apply a thin layer of gel 1 to 3 times daily onto the area of affected skin, gently massaging to help absorption.

Overdose is unlikely to be caused by topical administration. If accidentally ingested, contact a doctor: the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be symptomatic and supportive in accordance with overdosage of oral antiphlogistics.

History of any photosensitivity reaction.
Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other Nonsteroidal Anti-inflammatory Drugs.
History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes.
Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation.
Hypersensitivity to any of the excipients of the product.
Ketoprofen gel should not be applied to pathological skin changes such as eczema or acne or on infected skin, open wounds, lesions of the skin, or near the eyes.
Third trimester of pregnancy (see Use in Pregnancy & Lactation).

Although systemic effects should be low, ketoprofen should be used with caution in patients with severe renal impairment, or reduced cardiac, hepatic or renal function, history of peptic ulceration or inflammatory bowel disease or bleeding diathesis. Isolated cases of systemic adverse reactions consisting of renal dysfunction have been reported.
Topical application of large amounts may result in systemic effects, including hypersensitivity and asthma.
The treatment should be interrupted if rash appears.
The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increasing over time.
Duration of treatment should be kept to a minimum as the risk of developing contact dermatitis and photosensitivity reactions increases over time.
Hands should be washed thoroughly after each application of the product.
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 treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation.
Not for use with occlusive dressing.
The gel must not come into contact with mucous membranes or the eyes.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or Nonsteroidal Antiinflammatory Drugs than the rest of the population.
Keep out of the reach and sight of children.
Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. The total dose of product should not exceed 25 g of gel daily. If there is no improvement, or the condition is aggravated the doctor should be consulted. The safety and efficacy of ketoprofen gel in children have not been established.
Driving and Using Machines: Effects on ability to drive and use machines are not known.

As there has been no such experience with the topical formulation, the following is stated according to the systemic formulation.
Pregnancy: During the first and second trimester: In mice and rats, there is no evidence of teratogenic or embryotoxicity. In the rabbit, slight embryotoxicity likely related to maternal toxicity has been reported.
As the safety of ketoprofen in pregnant women has not been evaluated, the use of ketoprofen during the first and second trimester of pregnancy should be avoided.
During the third trimester of pregnancy: All prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy, prolonged bleeding time in both the mother and child may occur. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.
Lactation: No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

There have been reports of localised skin reactions which might subsequently spread beyond the area of application. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
Other systemic effects of anti-inflammatory drugs: these depend on the transdermic spreading of the active ingredient, hence on the amount of gel applied, on the surface involved, on the degree of the intactness of the skin, on the duration of the treatment and on the use of an occlusive bandage (hypersensitivity, gastrointestinal and renal disorders).
Since marketing, the following adverse reactions have been reported. They have been listed according to classes of organ and system and classified according to their frequency as follows: very common (equal to or above 10%); common (ranging between 1% and 10%), uncommon (ranging between 0.1% and 1%), rare (ranging between 0.01% and 0.1%); very rare (below 0.01%), including isolated reports. (See table.)

Click on icon to see table/diagram/image

Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs.

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 coumarinic substances.

Instructions for use: Opening of the soft tube: unscrew the cap and perforate the diaphragm of aluminium with the point of the inverted cap.
Pre-filling of the dispensing tube: push the dispenser cap several times or push the base of the tube until the gel appears; it is advisable to use it in a horizontal position.

Store in a cool and dry place, below 30°C.
Shelf-Life: 5 years.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA10 - ketoprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.

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