Ibuprofen

Registered South African indications:

• Acute painful musculoskeletal conditions

Contraindications

South African recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs
  - In asthmatic patients in whom aspirin or non-steroidal anti-inflammatories are known to precipitate asthmatic attacks, rhinitis or urticaria
• Pregnancy (last trimester)
• Broken or denuded skin
• Presence of local infection
• Heart failure
• Active ulcer, haemorrhage or perforation
• History of recurrent ulcer, haemorrhage or perforation
• History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory drugs
• Children <14 years
• Coadministration with any other topical agent at the same site

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to aspirin, ibuprofen or related painkillers (including when taken by mouth)
  - Especially where associated with a history of asthma, rhinitis or urticaria
• Broken or damaged skin

Cautions

• Pregnancy (first six months)
• Breastfeeding
• Renal impairment
• Hepatic impairment
• History of renal disease
• Active peptic ulcer
• Asthma
• Use with occlusive dressings
• Contact with eyes, mucous membranes and inflamed skin
• Excessive exposure of treated area to sunlight
• Exposure of the treated area or fabric that has been in contact with the product to naked flames

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

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Acute painful musculoskeletal conditions
- As a topical anti-inflammatory and analgesic intended for symptomatic relief of conditions caused by trauma such as sports injuries, sprains, strains and contusions

• Topical (jel): Apply 50-125mg (1-4cm of gel) to the affected area; Repeat dose after ≥4hrs if needed; Max: 3 doses/24hrs

Gently massage the affected area until absorbed using the lowest effective dose for the shortest possible duration of treatment. Do not cover the skin with bandages, plaster or any other dressings. Wash hands after every application. If no improvement is seen after two weeks, patient should be advised to consult healthcare professional 

Indications and dosages registered in other jurisdictions

Pain and Inflammation
- Backache, rheumatic pain, and muscular aches
- Pains or swellings, such as strains, sprains and sports injuries

• Topical (jel): Apply 1-2.5g of gel (quantified by appropriate means) to the affected area, up to 3 times dly; Admin. ≥4hrs apart; Max: 7.5g of gel/24hrs

Apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Wash hands after use unless treating them. Not to be used with occlusive dressings. Unless recommended by a doctor, advice should be sought about continued treatment if symptoms persist for more than 2 weeks

Paed. forms avail. in SA and covered in this monograph: jel

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Acute painful musculoskeletal conditions
- As a topical anti-inflammatory and analgesic intended for symptomatic relief of conditions caused by trauma such as sports injuries, sprains, strains and contusions

Younger than 14 years

• Not recommended for use

Older than 14 years

• See adult dosage

Indications and dosages registered in other jurisdictions

Pain and Inflammation
- Backache, rheumatic pain, and muscular aches
- Pains or swellings, such as strains, sprains and sports injuries

Younger than 12 years

• Not recommended for use

Older than 12 years

• See adult dosage

Pregnancy

South African recommendations

• First six months: Caution; not recommended
• Last trimester: Contraindicated
• The safety of this preparation in pregnancy has not been established
• In the case of sufficient systemic concentrations, inhibition of spontaneous labour, premature closure of the ductus arteriosus botalli, increased bleeding complications in the mother and neonate and increased risk of oedema in the mother can be expected
• Regular use of non-steroidal anti-inflammatory agents during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased

Recommendations in other jurisdictions

• Caution; not recommended
• Not to be used during pregnancy. Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased

Breastfeeding

• Caution; not recommended 
• Ibuprofen appears in breast milk in very low concentrations but is unlikely to affect breastfed infants adversely

Fertility

• No observed effects at this level of exposure

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders

• Abdominal pain
• Dyspepsia

Genitourinary Disorders

• Renal Impairment (patients with history of kidney disease)

Skin and Subcutaneous Tissue Disorders

• Application-site reactions

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
  - Non-specific reactions and anaphylaxis
  - Asthma
  - Bronchospasm
  - Dyspnoea
  - Pruritus
  - Urticaria
  - Purpura
  - Angioedema
  - Exfoliative and bullous dermatoses
  - Toxic epidermal necrolysis
  - Erythema multiforme

• Antihypertensives
• Anticoagulants
• Other non-steroidal anti-inflammatory drugs

None routine

Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and anti-pyretic activity.The therapeutic effect, as a non-steroidal anti-inflammatory drug (NSAID), is thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in prostaglandin synthesis. When formulated in a gel, ibuprofen exerts its anti-inflammatory and analgesic effects directly in inflamed tissues underlying the site of application. Because it is formulated in an aqueous/ alcoholic gel, the preparation also exerts a soothing and cooling effect when applied to the affected area. 

Gel (per g) 50mg 

• Deep Relief (Mentholatum)

Also available in the following forms: Suspension, tablet, capsule and injection.