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Drug Details

IBUGEL

• Drug Class Description
  Non-steroidal anti-inflammatory drugs (topical NSAIDs).
• Generic Name
  Ibuprofen
• Presentation
  Non -greasy, fragrance-free, clear, aqueous-alcoholic gel.
• Description
  Ibuprofen 5.0% w/w.
• Indications
  

  For the topical treatment of backache, rheumatic and muscular pain, sprains, strains and neuralgia. Ibugel is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.

• Adult Dosage
  

  Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Do not use excessively. Hands should be washed immediately after use (unless treating them). Treatment should not normally continue for more than a few weeks, unless recommended to do so by a doctor.

  The same dosage and dosage schedule applies to all age groups, although Ibugel is not normally recommended for use on children under the age of 12 years, unless instructed by their doctor.

• Child Dosage
  Not recommended.
• Contra Indications
  

  Not to be used in cases of sensitivity to any of the ingredients, particularly if asthmatic or suffer from allergic disease, and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers. Not to be used on broken skin.

• Special Precautions
  

  Seek medical advice if symptoms worsen or persist. Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with an active peptic ulcer, a history of kidney problems, asthma or intolerance to aspirin or ibuprofen taken orally should seek medical advice before using Ibugel. Keep Ibugel away from the eyes and mucous membranes. For external use only.

  The label will include statements to the following effect:

  If symptoms persist, consult your doctor or pharmacist. Do not use if sensitive to any of the ingredients, particularly if asthmatic, suffer from rhinitis or urticaria and have previously shown hypersensitivity to aspirin, ibuprofen or related painkillers. Consult your doctor before use if you are taking aspirin or other pain-killers.

• Interactions
  

  Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.

• Adverse Drug Reactions
  

  Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be discontinued:-

  Hypersensitivity: hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of:

  (a) non-specific allergic reactions and anaphylaxis

  (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or

  (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

  Renal: renal impairment can occur in patients with a history of kidney problems.

  Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported.