Ketoprofen

Registered South African indications:

• Pain - mild to moderate
• Inflammation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients  
• Pregnancy >30 weeks
• History of any photosensitivity reaction
• Known hypersensitivity reactions to aspirin and other non-steroidal anti-inflammatory drugs
• History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or ultraviolet 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
• Open or infected wounds or lesions of the skin
• Topical should not be applied to mucous membranes, anal or genital areas, eyes or used without occlusive dressings

Cautions

• Pregnancy <30 weeks
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Impaired cardiac function
• Asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis
• Open or infected wounds or lesions of the skin
• Sun exposure
• Prolonged use
• Occlusive dressings
• Mucous membranes

Forms avail. in SA and covered in this monograph: gel

Pain and inflammation - musculoskeletal and joint

• Topical (gel): Apply 5-15cm (equiv. to 100 - 300mg) to the affected area, once or twice dly

Treatment should not exceed 7 days 

Not approved for use in South Africa for children below 12 years

Pregnancy

• Caution; not recommended: First-trimester
• Contraindicated: Third-trimester
• No embryopathic effects have been demonstrated in animals and there is epidemiological evidence of the safety of ketoprofen in human pregnancy
• Nevertheless, it is recommended that ketoprofen should be avoided during the first and second trimester of pregnancy
• 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 mother and child may occur
• Non-steroidal anti-inflammatory drugs may also delay labour. Therefore, ketoprofen is contraindicated during the last trimester of pregnancy

Breastfeeding

• Caution; not recommended
• Trace amounts of ketoprofen are excreted in breastmilk; therefore ketoprofen gel should not be used during breastfeeding

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Caution; dose adjustment recommended

Elderly

• Caution; dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Cardiovascular Disorders

• Vasculitis

Gastrointestinal Disorders

• Peptic ulcer
• Gastrointestinal bleeding
• Diarrhoea
• Lip oedema

Genitounrinary Disorders

• Acute renal failure and insufficiency aggravated

Skin and Subcutaneous Tissue Disorders

• Rash
• Eczema
• Pruritus
• Burning sensation
• Application site burn
• Dermatitis
• Urticaria
• Blister
• Photosensitivity reaction
• Photosensitivity allergic reaction
• Skin exfoliation
• Skin oedema

Immune, Blood and Lymphatic System Disorders

• Secondary impetigo
• Eosinophilia
• Anaphylactic reaction
• Angioedema
• Hypersensitivity
• Pyrexia

Sensory Organs

• Eyelid oedema

Others

• Wound complication

Coumarin derivatives

None routine

Inhibits cyclooxygenase resulting in decrease in prostaglandin synthesis.

Gel (per 100g) 2.5g

• Fastum Gel (Adcock) originator
• Fastum Gel Dispenser (Adcock) orginator

Also available in the following form: Capsule.