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IBUPROFEN is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ibuprofen is indicated in adolescents and children from 20 kg bodyweight and 6 years of age and above for the short-term symptomatic treatment of acute moderate pain and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified, when other routes of…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Use should be limited to situations where oral administration is inappropriate. Patients must switch to oral treatment as soon as this is possible. This medicinal product is indicated for the shortest period needed. Treatment should not exceed 3 days.
Adequate hydration of the patient should be maintained to minimize the risk of possible adverse reactions at renal level. The recommended ibuprofen dose in children and adolescents is based on the bodyweight or age. As a general rule, the recommended daily dose is 20 to 30 mg/ kg of bodyweight divided into three to four single doses (5-10 mg/kg): Children weighing 20 kg – 29 kg (6-9 years old): 200 mg of ibuprofen up to 3 times a day not exceeding a maximum daily dose of 600 mg.
Children weighing 30 kg – 39 kg (10-11 years old): 200 mg of ibuprofen up to 4 times a day not exceeding a maximum daily dose of 800 mg. Adolescents weighing 40 kg or more (12-17 years old): 200 mg to 400 mg of ibuprofen up to 3 times a day not exceeding a maximum daily dose of 1200 mg.
Not recommended for children under 20 kg or below 6 years of age. The respective dosing interval should be chosen in line with the symptomatology and the maximum daily dose. The interval between doses should not be below 6 hours. The recommended maximum daily dose should not be exceeded.
Renal insufficiency Precautions should be taken when NSAIDs are used in patients with renal insufficiency. In patients with mild or moderate renal impairment, the initial dose should be reduced and be kept as low as possible for the shortest duration necessary to control symptoms and renal function monitored.
3). Hepatic insufficiency Precautions should be taken when NSAIDs are used in this population although differences in the pharmacokinetic profile have not been observed. Patients with mild or moderate hepatic insufficiency should start the treatment with reduced doses, the dose should be kept as low as possible for the shortest duration necessary and they should be carefully monitored.
3).
Method of administration:
For intravenous use. This medicinal product should only be administered by qualified healthcare professionals in an environment where appropriate equipment is available (during treatment). The solution should be administered as an intravenous infusion over 30 minutes.
The following frequencies are taken as a basis when evaluating undesirable effects: Very common: ≥ 1/10 Common: ≥1/100 to< 1/10 Uncommon: ≥1/1,000 to< 1/100 Rare: ≥1/10,000 to< 1/1,000 Very rare: <1/10,000 Not known: frequency cannot be estimated from the available data The most commonly observed adverse events are gastrointestinal in nature.
Peptic ulcers, perforation or GI bleeding, sometimes fatal. 4) have been reported following administration. Less frequently, gastritis has been observed. Particularly the risk of gastrointestinal bleeding occurring is dependent on the dose range and the duration of use.
Very rarely have been reported severe hypersensitivity reactions (including infusion site reactions, anaphylactic shock) and serious cutaneous adverse reactions such as bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme and alopecia.
g. development of necrotising fasciitis) coinciding with the use of non-steroidal anti- inflammatory drugs has been described. This is possibly associated with the mechanism of action of the non-steroidal anti-inflammatory drugs. 4). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
4). g. development of necrotising fasciitis) coinciding with the use of non-steroidal anti- inflammatory drugs has been described. This is possibly associated with the mechanism of action of the non-steroidal anti-inflammatory drugs. Blood and lymphatic system disorders Very rare Disturbances to blood formation (anaemia, agranulocytosis, leukopenia, thrombocytopenia, and pancytopenia).
First symptoms are: fever, sore throat, superficial mouth wounds, influenza- like complaints, severe lassitude, nosebleeds and skin bleeding. Uncommon Hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with drop in blood pressure) Immune system disorders Very rare Systemic lupus erythematosus, severe hypersensitivity reactions, face oedema, swelling of the tongue, swelling of the internal larynx with constriction of the airways, difficulty breathing, palpitations, hypotension and life- threatening (shock).
8). Concomitant use of ibuprofen with other NSAIDs, including cyclooxygenase-2 selective inhibitors (Coxib), should be avoided.
Gastrointestinal risks:
GI bleeding, ulceration or perforation, which can be fatal, have been reported during treatment with all NSAIDs with or without warning symptoms or a previous history of serious GI events. 3). These patients should commence treatment on the lowest dose available.
g. 5). Patients with a history of GI toxicity should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. 5). 3). 8).
Cardiovascular and cerebrovascular effects:
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses should be avoided.
Cases of Kounis syndrome have been reported in patients treated with Ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction- associated with constriction of coronary arteries and potentially leading to myocardial infarction.
g. hypertension, hyperlipidaemia, diabetes mellitus). 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).
6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Metabolism and nutrition disorders Not known Hypokalaemia1 Uncommon Anxiety, restlessness Psychiatric disorders Rare Psychotic reactions, nervousness, irritability, confusion or disorientation and depression Very common Fatigue or sleeplessness, headache, dizziness Uncommon Insomnia, agitation, irritability or tiredness Nervous System disorders Very rare Aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or confusion).
Patients with autoimmune disorders (SLE, mixed connective-tissue disease) appear to be predisposed. Uncommon Visual disturbances Eye disorders Rare Reversible toxic amblyopia Ear and Common Vertigo Uncommon Tinnituslabyrinth disorders Rare Hearing disorders Cardiac disorders Very rare Palpitations, heart failure, myocardial infarction Not known Kounis syndrome Vascular disorders Very rare Arterial hypertension Respiratory, thoracic and mediastinal disorders Very rare Asthma, bronchospasm, dyspnoea and wheezing Very common Pyrosis, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood losses that may cause anaemia in exceptional cases Common Gastrointestinal ulcers, potentially with bleeding and perforation.
Ulcerative stomatitis, exacerbation of colitis and Crohn´s disease Uncommon Gastritis Rare Oesophageal stenosis, exacerbation of diverticular disease, unspecific haemorrhagic colitis. If gastrointestinal bleeding occurs could cause anaemia and haematemesis Gastrointestinal disorders Very rare Oesophagitis, pancreatitis, formation of intestinal, diaphragm-like strictures Rare Jaundice, hepatic dysfunction, hepatic damage, particularly in long-term therapy, acute hepatitis Hepatobiliary disorders Not known Hepatic insufficiency Common Skin eruption Uncommon Urticaria, pruritus, purpura (including allergic purpura), skin rash Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis), alopecia.
Photosensitivity reactions and allergic vasculitis. In exceptional cases, severe skin infections and soft-tissue complications in varicella infection (see also “Infections and infestations”). Skin and subcutaneous tissue disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Rare Stiff neck Uncommon Reduced urinary excretion and formation of oedemas, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal insufficiency.
Renal and urinary disorders Rare Renal tissue damage (papillary necrosis), particularly in long-term therapy, increased serum uric acid concentration in the blood Not known Renal tubular acidosis1 Common Pain and burning sensation in the administration site General disorders and administration site conditions Not known Injection site reaction such as swelling, haematoma or bleeding.
1 Renal tubular […]
Hepatic or renal insufficiency or dehydration:
Ibuprofen should be used with caution in patients with a history of liver or kidney disease and especially during simultaneous treatment with diuretics, as the inhibition of prostaglandins can cause fluid retention and renal function impairment.
Ibuprofen should be administered in these patients, at the lowest dose possible, and patient´s renal function should be regularly monitored. There is a risk of renal impairment in dehydrated children and adolescents. In case of dehydration, ensure sufficient fluid intake.
Use special caution in dehydrated patients, for example due to diarrhoea, such as dehydration could be a trigger factor for the development of kidney failure. Regular use of analgesics, especially when combining of different analgesic substances, can lead to kidney damage, with the risk of renal insufficiency (analgesic nephropathy).
This risk is higher in patients with renal insufficiency, heart failure, liver dysfunction, and those taking diuretics or ACE inhibitors. After discontinuing NSAID therapy, patient´s pre-treatment condition is usually restored. As with other NSAIDs, ibuprofen can cause mild transient increases in some liver function parameters, as well as significant increases in transaminases.
3).
Anaphylactoid Reactions:
As standard practice during intravenous infusion, close patient monitoring is recommended, especially at the beginning of the infusion to detect any anaphylactic reaction caused by the active substance or the excipients. g. anaphylactic shock) are very rarely observed.
At the first signs of a hypersensitivity reaction following the administration of Ibuprofen, therapy must be stopped and symptomatic treatment must be established. Medically required measures, in line with the symptoms, must be initiated by specialist personnel.
Respiratory disorders:
Caution is required if this medicinal product is administered to patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic diseases since NSAIDs have been reported to cause bronchospasm, urticaria or angioedema in such patients.
Haematological […]