Brands of Ibuprofen Lysine In Kenya
Nurofen®, Reckitt Benckiser Healthcare international Limited
MODE OF ACTION
Ibuprofen lysine is the lysine salt of ibuprofen, a propionic acid derivative, having analgesic, antiinflammatory and antipyretic activity. The therapeutic effects of ibuprofen lysine as a non steroidal anti-inflammatory drug are thought to result from inhibitory activity on prostaglandin synthesis.
INDICATIONS :
For the relief of headache and migraine pain.
DOSAGE
For oral administration and short-term use only.
Adults, the elderly and children over 12 years:
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
Take 1 or 2 caplets with water, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 6 caplets in any 24 hour period.
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Severe heart failure, renal failure or hepatic failure .
Last trimester of pregnancy .
DRUG INTERACTIONS
The following drug interactions have been identified for ibuprofen acid:
Ibuprofen (like other NSAIDs) should be avoided in combination with:
Aspirin: unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions .
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects .
Ibuprofen should be used with caution in combination with:
Corticosteroids: as these may increase the risk of gastrointestinal ulceration or bleeding.
Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Anticoagulants. NSAIDs may enhance the effects of anti-coagulants, 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 evidence for the potential increase in 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 increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk haemarthroses and haematoma in HIV (+) 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 EFFECTS
Hypersensitivity reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritis
Very rare: severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dysponoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal:
The most commonly observed adverse events are gastrointestinal in nature.
Uncommon: abdominal pain, nausea, dyspepsia
Rare: Diarrhoea, flatulence, constipation and vomiting
Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.
Exacerbation of colitis and Crohn’s disease (section 4.4).
Nervous System:
Uncommon: Headache
Very rare: Aseptic meningitis – single cases have been reported very rarely.
Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum and oedema.
Hepatic:
Very rare: liver disorders.
Haematological:
Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Dermatological:
Uncommon: Various skin rashes
Very rare: Severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System:
In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed .
Cardiovascular and Cerebrovascular
Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that the use of NSAIDS (particularly at high doses 2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
Ibuprofen Lysine In Kenya
Ibuprofen Lysine In Kenya
Ibuprofen Lysine In Kenya
Ibuprofen Lysine In Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: C (Risk not ruled out)[1] D (US) at ≥30 weeks of gestation, due to the potential for premature closure of the ductus arteriosus
Routes of Administration: Oral
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
Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
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Drug Images
References/ Citation:
- Martin, W., et al. “Pharmacokinetics and absolute bioavailability of ibuprofen after oral administration of ibuprofen lysine in man.” Biopharmaceutics & drug disposition 11.3 (1990): 265-278.
- Poon, Grace. “Ibuprofen lysine (NeoProfen) for the treatment of patent ductus arteriosus.” Baylor University Medical Center Proceedings. Vol. 20. No. 1. Taylor & Francis, 2007.
- Nelson, S. L., et al. “Comparison of single-dose ibuprofen lysine, acetylsalicylic acid, and placebo for moderate-to-severe postoperative dental pain.” Clinical therapeutics 16.3 (1994): 458-465.