Ibuprofen oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of ibuprofen.
Drugs List
Therapeutic Indications
Uses
Ankylosing spondylitis
Fever
Juvenile idiopathic arthritis
Musculo-skeletal conditions
Osteoarthritis
Pain - mild to moderate
Post immunisation pyrexia
Rheumatoid arthritis
Dosage
Dose recommendations and maximum doses may vary according to brand.
Adults
Immediate release products and oral liquid formulations
900mg to 1800mg daily in three to four divided doses. Increase if necessary.
Maintenance dose: 600mg to 1200mg daily may be adequate.
Maximum dose: 2400mg daily.
Modified-release products
Two 800mg modified-release tablets as a single dose, preferably in the early evening. The dose may be increased in severe cases to three tablets in two divided doses.
OR
One or two 300mg modified-release capsules twice a day.
Orodispersible tablets and effervescent tablets
200mg to 400mg every four hours up to a maximum of 1200mg in 24 hours.
Elderly
(See Dosage; Adult).
If considered necessary, use lowest possible dose as the elderly are at high risk of adverse effects. The patients should be monitored regularly during NSAID therapy, for gastrointestinal bleeding.
Children
Dose regimens vary according to brand.
Some brands are not recommended for use in children under 12 years of age.
Some brands are not suitable for children weighing under 20kg.
Effervescent granules are not suitable for children.
Oral solution is more suitable for dosing in infants and younger children.
Not licensed for use in children under 3 months or bodyweight under 5kg.
Mild to moderate pain; Pain and inflammation of soft-tissue injuries; Pyrexia with discomfort
Immediate-release and oral liquid preparations
Children aged 12 to 18 years: Initially 300mg to 400mg three to four times daily. Maintenance dose: 200mg to 400mg three times daily may be adequate. Maximum dose: 600mg four times daily.
Children aged 10 to 12 years: 300mg three times daily. Maximum dose: 30mg/kg or 2.4g daily in three to four divided doses.
Children aged 7 to 10 years: 200mg three times daily. Maximum dose: 30mg/kg or 2.4g daily in three to four divided doses.
Children aged 4 to 7 years: 150mg three times daily. Maximum dose: 30mg/kg daily in three to four divided doses.
Children aged 1 to 4 years: 100mg three times daily. Maximum dose: 30mg/kg daily in three to four divided doses.
Children aged 6 months to 1 year: 50mg three or four times daily. Maximum dose: 30mg/kg daily in three to four divided doses.
Children aged 3 to 6 months: 50mg three times daily. Maximum dose: 30mg/kg daily in three to four divided doses.
Children aged 1 to 3 months: 5mg/kg three to four times daily.
Pain and inflammation in rheumatic diseases, including idiopathic juvenile arthritis
Immediate-release and oral liquid preparations
Children aged 3 months to 18 years: 30mg/kg to 40mg/kg (maximum 2.4g) daily in three to four divided doses. In systemic juvenile idiopathic arthritis, up to 60mg/kg (maximum 2.4g) daily in four to six divided doses may be used.
Pyrexia after immunisation
Immediate-release and oral liquid preparations
Children aged 2 to 3 months: 50mg as a single dose. Repeat once after 6 hours if necessary.
Pain and Inflammation
Modified-release tablets
Children aged 12 to 18 years: 1.6g once daily, preferably early evening. In severe cases the dose can be increased to 2.4g daily in 2 divided doses.
Modified-release capsules
Children aged 12 to 18 years: 300mg to 600mg twice a day.
Patients with Renal Impairment
Monitor renal function and sodium and water retention in patients with renal impairment.
The Renal Drug Handbook suggests the following dose adjustments:
Glomerular Filtration Rate (GFR)
GFR 10 to 50ml/minute: Dose as in normal renal function, but avoid if possible.
GFR less than 10ml/minute: Dose as in normal renal function but only use if patient is on dialysis.
Contraindications
Neonates under 1 month
Predisposition to haemorrhage
Asthma, urticaria or acute rhinitis associated with NSAIDS
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of gastrointestinal bleeding
History of peptic ulcer
New York Heart Association class IV failure
Peptic ulcer
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy
Precautions and Warnings
Allergic disposition
Children aged 1 to 3 months
Elderly
Females attempting to conceive
Restricted sodium intake
Risk factors for cardiovascular disorder
Varicella
Acute porphyria
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Chronic inflammatory bowel disease
Coagulopathy
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Galactosaemia
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of asthma
History of cardiac disorder
History of cardiac failure
History of colitis
History of gastrointestinal disorder
Hypertension
Ischaemic heart disease
Lactose intolerance
New York Heart Association class II failure
Peripheral arterial circulatory disorder
Phenylketonuria
Renal impairment
Second trimester of pregnancy
Severe dehydration
Systemic lupus erythematosus
May mask symptoms or signs of infections
NSAIDs may provoke or exacerbate asthma
Sodium content of formulation may be significant
Some formulations contain aspartame - caution in phenylketonuria
Some formulations contain more than 1mmol (23mg) sodium per dose
Consider other first line treatment options in the elderly
Consider the need for combination therapy with gastroprotective agents
High dose increases cardiovascular risk
Not all available brands are licensed for all age groups
Not all available brands are licensed for all body weights
Not all available brands are licensed for all indications
Contains potassium; caution in low potassium diets
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain glucose
Some formulations contain lactose
Some formulations contain propylene glycol
Some formulations contain sucrose
Some formulations contain wheat starch
Some presentations may contain benzyl alcohol
Some products may contain soya or soya derivative
Discontinue if signs of gastro-intestinal bleeding occur
Elderly - monitor for gastro-intestinal bleeding over initial 4 weeks
Monitor renal function in elderly patients
Advise patients to report signs or symptoms of gastro-intestinal ulcer
May cause bronchospasm
Discontinue if patient is attempting to conceive
Discontinue if symptoms of peptic ulcer occur
Discontinue treatment if skin rash or other allergic reaction occurs
Dose varies with brand
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Reduce dose in elderly
Start treatment at lowest recommended dose
Female: Reduced fertility (reversible) possible with long term use
Advise patient to consult physician if condition worsens / does not improve
The inhibition of renal prostaglandin synthesis by NSAIDs may interfere with renal function, especially in the presence of renal disease. A deterioration in renal function could possible lead to renal failure. Avoid NSAID therapy if possible. If not, check serum creatinine 48-72 hours after initiating treatment and discontinue if levels are raised.
Patients with mixed connective tissue disorders such as systemic lupus erythematosus may be especially susceptible to aseptic meningitis. This has also been reported in patients with no underlying chronic disease.
Use with caution in patients with coagulopathies as NSAIDs including ibuprofen can interfere with platelet aggregation and can prolong bleeding time.
There is limited evidence that drugs which inhibit cyclooxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of ibuprofen is therefore not recommended in women attempting to conceive (Briggs, 2015).
Avoid high dose ibuprofen (2400mg per day or more) in patients with cardiovascular disorders or risk factors for cardiovascular events.
Risk of renal impairment in dehydrated children and adolescents.
Pregnancy and Lactation
Pregnancy
Ibuprofen is contraindicated in the third trimester of pregnancy.
Use of any NSAID is considered contraindicated during the third trimester of pregnancy.
First trimester exposure to NSAIDs has been associated with an increased risk spontaneous abortions and of birth defects (notably cardiac septal defects). There is conflicting evidence, however, from various studies and the risk appears to be low (Briggs, 2015).
Ibuprofen should be used with caution in the first and second trimesters. Schaefer (2015) considers that use of NSAIDs in early pregnancy does not require termination of pregnancy or invasive diagnostic procedures.
Ibuprofen is a prostaglandin synthetase inhibitor and may have effects during the second and third trimesters, including pulmonary and cardiac toxicity in the foetus/newborn from the beginning of the sixth month and increases in risk if administration is close to full term. Other effects also include, functional renal injury in the foetus, inhibition of uterine contractions with delayed onset and prolongation of labour, increased possibility of bleeding in mother and child, and increased risk of maternal oedema formation. When used in the perinatal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.
Lactation
Use ibuprofen with caution during breastfeeding.
Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breastfed infant adversely (Lactmed, 2018).
Due to ibuprofens extremely low levels in breast milk and short half-life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers (Schaefer, 2015).
Counselling
Advise patient, especially the elderly to report any unusual abdominal symptoms.
Advise patient to seek medical advise if symptoms worsen or do not improve.
Advise patient modified-release preparations should be swallowed whole with plenty of water.
Advise patient not to chew liquid capsules.
Advise patient orodispersible tablets should be placed on the tongue and allowed to dissolve before swallowing.
Advise patient effervescent tablets should be dissolved in a glass of water and the solution drunk immediately after dissolution. Do not swallow effervescent tablets whole.
Advise patient that they ensure the granules are dissolved in plenty of water as a transient sensation of burning in the mouth or throat may occur.
Advise patient to take with or after food.
Side Effects
Abdominal pain
Abnormal liver function
Acute generalised exanthematous pustulosis
Acute renal failure (reversible)
Anaphylactic reaction
Angioedema
Anxiety
Aseptic meningitis
Asthma
Blood disorders
Bronchospasm
Bullous reactions
Cardiac failure
Colitis
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Duodenal ulcer
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exacerbation of pre-existing asthma
Exfoliative dermatitis
Flatulence
Fluid retention
Gastric ulceration
Gastritis
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Gastro-intestinal symptoms
Gastro-intestinal ulceration with occult bleeding
Haematemesis
Haematuria
Headache
Hearing disturbances
Hepatic failure
Hepatic impairment
Hepatitis
Hypersensitivity reactions
Hypertension
Interstitial fibrosis
Interstitial nephritis
Jaundice
Laryngeal oedema
Melaena
Mouth ulcers
Myocardial infarction
Nausea
Nephrotic syndrome
Oedema
Optic neuritis
Pancreatitis
Papillary necrosis
Paraesthesia
Peptic ulceration
Photosensitivity
Pruritus
Purpura
Rash
Rhinitis
Somnolence
Stevens-Johnson syndrome
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Urticaria
Vertigo
Visual disturbances
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2015
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Anadin Liquifast 200mg effervescent tablets. Pfizer Consumer Healthcare. Revised September 2012.
Summary of Product Characteristics: Anadin Joint Pain 200mg Tablets. Pfizer Consumer Healthcare. Revised June 2014.
Summary of Product Characteristics: Anadin Ibuprofen 200mg Tablets. Pfizer Consumer Healthcare. Revised January 2015.
Summary of Product Characteristics: Anadin Period Pain Relief 200mg Capsules. Pfizer Consumer Healthcare. Revised June 2014.
Summary of Product Characteristics: Anadin Ultra / Anadin Liquifast 200mg Capsules. Pfizer Consumer Healthcare. Revised June 2014.
Summary of Product Characteristics: Anadin Ultra Double Strength 400mg Capsules / Anadin Liquifast 400mg Capsules. Pfizer Consumer Healthcare. Revised October 2011.
Summary of Product Characteristics: Brufen 400mg Tablets. Abbott Laboratories Limited. Revised November 2019.
Summary of Product Characteristics: Brufen 600mg Tablets. Abbott Laboratories Limited. Revised November 2019.
Summary of Product Characteristics: Brufen Retard. Mylan. Revised November 2019.
Summary of Product Characteristics: Brufen Granules. Abbott Laboratories Limited. Revised November 2019.
Summary of Product Characteristics: Cuprofen Maximum Strength Tablets. SSL International plc. Revised July 2015.
Summary of Product Characteristics: Flarin 200mg soft capsules. Infirst Healthcare Limited. Revised December 2015.
Summary of Product Characteristics: Hedex Ibuprofen Tablets. GlaxoSmithKline Consumer Healthcare. Revised April 2014.
Summary of Product Characteristics: Ibular tablets 200mg. Ennogen Pharma Limited. Revised September 2018.
Summary of Product Characteristics: Ibular tablets 400mg. Ennogen Pharma Limited. Revised September 2018.
Summary of Product Characteristics: Ibuprofen Seven Plus Pain Relief 200mg/5ml oral suspension. Aspire Pharama Ltd. Revised July 2018.
Summary of Product Characteristics: Ibuprofen Twelve Plus Pain Relief 200mg/5ml oral suspension. Aspire Pharama Ltd. Revised July 2018.
Summary of Product Characteristics: Nurofen 200mg Caplets. Reckitt Benckiser Healthcare (UK) Ltd. Revised September 2014.
Summary of Product Characteristics: Nurofen 200mg Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised June 2018.
Summary of Product Characteristics: Nurofen 200mg Tablets (Pharmacy). Reckitt Benckiser Healthcare (UK) Ltd. Revised October 2015.
Summary of Product Characteristics: Nurofen 200mg Liquid capsules. Reckitt Benckiser Healthcare (UK) Ltd. Revised August 2014.
Summary of Product Characteristics: Nurofen 200mg Liquicaps Pharmacy Only / Nurofen Express 200mg liquid capsules. Reckitt Benckiser Healthcare (UK) Ltd. Revised March 2015.
Summary of Product Characteristics: Nurofen Express Period Pain 200mg soft capsules. Reckitt Benckiser Healthcare (UK) Ltd. Revised March 2015.
Summary of Product Characteristics: Nurofen Express 400mg Liquid Capsules. Reckitt Benckiser Healthcare (UK) Ltd. Revised March 2015.
Summary of Product Characteristics: Nurofen for Children 100mg chewable capsules, soft. Reckitt Benckiser Healthcare (UK) Ltd. Revised October 2015.
Summary of Product Characteristics: Nurofen for Children. Reckitt Benckiser Healthcare (UK) Ltd. Revised September 2014.
Summary of Product Characteristics: Nurofen for Children 200mg/5ml orange oral suspension. Reckitt Benckiser Healthcare (UK) Ltd. Revised March 2019.
Summary of Product Characteristics: Nurofen for Children 200mg/5ml strawberry oral suspension. Reckitt Benckiser Healthcare (UK) Ltd. Revised March 2019.
Summary of Product Characteristics: Nurofen Back Pain 300mg Sustained Release Capsules. Reckitt Benckiser Healthcare (UK) Ltd. Revised June 2018.
Summary of Product Characteristics: Nurofen Joint & Back Pain Relief 200mg soft Capsules. Reckitt Benckiser Healthcare (UK) Ltd. Revised December 2015.
Summary of Product Characteristics: Nurofen Meltlets Lemon. Reckitt Benckiser Healthcare (UK) Ltd. Revised October 2015.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
MHRA Drug Safety Update June 2015
Available at: https://www.mhra.gov.uk
Last accessed: 10 November 2015
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 June 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ibuprofen. Last revised: 31 October 2018
Last accessed: 07 March 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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