Topact gel contains Ketoprofen B.P 2.5%w/w
It belongs to a class of medicines known as Non-steroidal Anti-inflammatory Drugs (NSAIDs) for topical use. It has anti-inflammatory and analgesic actions.Pharmacokinetics:
By cutaneous route, absorption is very low. In fact, the percutaneous application of 50-150 mg of Ketoprofen produces plasma levels of the active ingredient of 0.08-0.15 μg/mL approximately 5-8 hours after application.
For local relief of pain and inflammation associated with rheumatic and muscular disorders and soft tissue injuries such as acute strains and sprains.
Dosage and administration:
Adults: Apply a length of gel 5-10cm long to the skin of the affected area two or three times a day.
Children under 12 years of age: Not recommended.
Topact gel is contraindicated in patients who:
- have previously had any photosensitivity reactions -an abnormal reaction of the skin to sunlight which may resemble severe sunburn.
- are hypersensitive(allergic) to the active substance Ketoprofen, UV blockers (sun creams) or perfumes.
- are hypersensitive to Aspirin, other NSAIDs (eg. Ibuprofen) or any medicine for pain relief or inflammation including tiaprofenic acid.
- are sensitive to fenofibrate (a medicine used to lower blood cholesterol)
- have had wheezing (asthma), runny nose( rhinitis) or any itchy rash(hives)after taking Aspirin or other NSAIDs .
- intend to use it on skin conditions such as eczema, acne or infected skin, an open wound or skin lesion(eg. abscess, ulcer or tumor).
- are pregnant.
- Like most medicines, Topact gel can cause mild side effects , although not everybody gets them. They include:•
- Localized allergic skin reactions such as redness, swelling, itching and blisters.
- Burning sensation.
- Increased sensitivity of your skin to sunlight.
- Severe skin reactions (similar to severe sunburn) during exposure to sunlight.
- Cases of more severe forms of eczema which may spread or become generalized.
- Inflamed skin causing skin changes resembling eczema may develop as a delayed reaction to sunlight.
- Blisters on the lips, eyes or tongue which may swell rapidly causing swallowing or breathing problems.
- Kidney problems (worsening of a pre-existing kidney problem).
- Allergic reactions, which may lead to difficulty breathing and/or may be very severe (anaphylaxis).
- Use in pregnancy and lactation
- No teratogenic or embryopathic effects have been demonstrated in animals. As the safety of Ketoprofen in pregnant and nursing women has not been establised, the use of Ketoprofen during pregnancy and nursing should be avoided.
– 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 risk of developing contact dermatitis and photosensitivity reactions
increasing over time.
– Protect treated areas by wearing clothing during treatment for two weeks following its discontinuation to avoid any risk of photosensitisation.
– Hands should be washed thoroughly after each application of Topact Gel.
– If gel comes into contact with mucous membranes or eyes, wash thoroughly with warm water.
– Treatment should be discontinued immediately upon development of any skin reaction after application of Topact Gel.
Topact Gel is available in the following pack sizes – 30 g, 50g and 100g in collapsible Aluminium tubes packed in unit boxes.
Store below 30°C. Keep out of the reach of children. Replace the cap after use.