BRANDS OF IBUPROFEN IN KENYA:
Asfen®, Astra Lifecare
Betafen®, Beta Healthcare
Brufen®, Abbott Laboratories S.A. (Ptv) Ltd
Brufol®, Careplus Ltd
Daprofen®, Dawa Limited
Fenpro®, Dinlas Pharma EPZ Ltd
Gofen®, Mega Lifesciences Ltd
Ibucos®, Cosmos Limited
Ibufen®, Elys Chemical Industries Ltd
Ibufil®, Fourrts (India) Laboratories Pvt. Limited.
Ibuflam®, Biodeal Laboratories Ltd
Ibulgan®, Lagap SA UAE
Ibulite®, Skylight Chemicals
Ibumex®, Regal Pharmaceuticals Limited
Ibun®, Lincoln Pharmaceuticals Ltd
Ibut®, Leben Laboratories Pvt Ltd
Ibuprofen Denk, Denk pharma
Ibuprofen, Orange Pharma Ltd
Iburin®, Mac’s (withdrawn)
Ibutab®, Universal Corporation Limited
Ifen®, Zest Pharma
Medifen®, Harleys Limited
Neoprofane®, Fredun Pharmaceuticals Ltd
Nurofen®, Reckitt Benckiser Healthcare International
Okagesic®, Dinlas Pharma EPZ Ltd
Orbifen®, Sai Pharmaceuticals Limited
Pedifen®, Dafra Pharma GmbH
Ponafen®, Sphinx Pharmaceuticals
Profen®, Laboratory & Allied Ltd
Triofen®, National Pharma Ltd
Ubimol®, Umedica Laboratories Pvt Ltd
MODE OF ACTION:
Ibuprofen blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower levels of prostaglandins. As a consequence, inflammation, pain and fever are reduced.
Ibuprofen is indicated for the relief of mild to moderate pain including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and for the relief of the symptoms of cold and influenza.
It is also used for pericarditis and patent ductus arteriosus.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Adults and children over 12 years of age:
The recommended dosage of Ibuprofen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. In severe or acute conditions, it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided doses.
The daily dosage of Ibuprofen is 20 mg/kg of body weight in divided doses.
For young children, more suitable formulations are available.
In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in divided doses may be taken.
Not recommended for children weighing less than 7 kg.
The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually.
For oral administration.
It is recommended that patients with sensitive stomachs take Ibuprofen with food. If taken shortly after eating, the onset of action of Ibuprofen may be delayed. To be taken preferably with or after food, with plenty of fluid. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation
Hypersensitivity to ibuprofen or any of the constituents in the product .
Ibuprofen is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
Active or previous peptic ulcer (two or more episodes of proven ulceration or bleeding).
History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
Patients with severe hepatic failure, renal failure or severe heart failure (NYHA Class IV) .
Use in last trimester of pregnancy
Ibuprofen should not be used in combination with:
Concomitant administration of ibuprofen and aspirin (acetylsalicylic acid) is not generally recommended (unless low-dose aspirin (not above 75mg daily) has been advised by a doctor), as this combination may increase the risk of adverse reactions.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose aspirin (acetylsalicylic acid) cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use
- Other NSAIDs including cyclooxygenase-2 selective inhibitors: as these may increase the risk of adverse effects
Ibuprofen should be used with caution in combination with:
- Corticosteroids: may increase the risk of adverse reactions, especially of the gastrointestinal tract .
- Antihypertensives and diuretics: NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
- Anticoagulants: NSAIDS may enhance the effects of anticoagulants, such as warfarin .
- Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
- Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
- Lithium: There is evidence for potential increase in plasma levels of lithium.
- Methotrexate: There is the potential for increased plasma levels of methotrexate.
- Ciclosporin: Increased risk of nephrotoxicity.
- Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
- Tacrolimus: Possible increase risk of nephrotoxicity when NSAIDs are given with tacrolimus.
- Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV positive haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
- Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
ADVERSE DRUG REACTIONS
Adverse effects include nausea, dyspepsia, diarrhea, constipation, gastrointestinal ulceration/bleeding, headache, dizziness, rash, salt and fluid retention, and high blood pressure.
Infrequent adverse effects include esophageal ulceration, heart failure, high blood levels of potassium, kidney impairment, confusion, and bronchospasm.Ibuprofen can exacerbate asthma, sometimes fatally
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: by mouth, rectal, topical, and intravenous
Bioavailability: 80–100% (by mouth), 87% (rectal)
Protein Binding: 98%
Metabolosim: Liver (CYP2C9)
Onset of Action: 30 min
Elimination Half life: 2–4 hours
Excretion: Urine (95%)
Legal Status | Dosage forms & Strengths
OTC / Rx-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This Drug is not Subject to DDA drugs Act
Dosage Forms | Strengths:
Tablets | Capsules : 200, 400,600 ,800mg Suspension: 100mg/5 ml
|CompTox Dashboard (EPA)|
- PPB Retention Register
- Davies, Neal M. “Clinical pharmacokinetics of ibuprofen.” Clinical pharmacokinetics 34.2 (1998): 101-154.
- Rainsford, K. D. “Ibuprofen: pharmacology, efficacy and safety.” Inflammopharmacology 17.6 (2009): 275-342.
- Mills, R. F. N., et al. “The metabolism of ibuprofen.” Xenobiotica 3.9 (1973): 589-598.
- MacDonald, T. M., and L. Wei. “Effect of ibuprofen on cardioprotective effect of aspirin.” the LANCET 361.9357 (2003): 573-574.
- Ohlsson, Arne, Rajneesh Walia, and Sachin S. Shah. “Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants.” Cochrane Database of Systematic Reviews 4 (2013).