Ibuprofen


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Mild to moderate pain; Dysmenorrhoea As conventional tab or cap: 200-400 mg 4-6 hourly as needed. Max: 1.2 (OTC) or 3.2 g/day. Max duration: 10 days (OTC). As modified-release tab or cap: Up to 1.6 g once daily (evening). If needed, may further increase to 2.4 g/day in 2 divided doses. Fever 200-400 mg 4-6 hourly. Max: 1.2 (OTC) or 3.2 g/day. Max duration: 3 days (OTC). Osteoarthritis; Rheumatoid arthritis As conventional tab or cap: 400-800 mg 3-4 times/day. Max: 3.2 g/day. As modified-release tab or cap: Up to 1.6 g/day (evening). If needed, may further increase to 2.4 g/day in 2 divided doses. IV Mild to moderate pain 400-800 mg 6 hourly, as needed. Max: 3.2 g/day. Fever Initial: 400 mg then, 400 mg 4-6 hourly or 100-200 mg 4 hourly, as needed. Max: 3.2 g/day. Topical/Cutaneous Pain and inflammation associated with musculoskeletal and joint disorders As 5% gel, foam, spray solution or 10% gel: Apply onto affected area as directed. As 200 mg plaster: 1 plaster/day.
Dosage Details
Intravenous
Fever
Adult: Initially, 400 mg then, 400 mg 4-6 hourly or 100-200 mg 4 hourly, as needed. Max: 3.2 g daily.
Child: 6 months to <12 years 10 mg/kg over 10 minutes 4-6 hourly, as needed; 12-17 years 400 mg over 10 minutes 4-6 hourly. Max: 2.4 g daily (Max 400 mg/dose).

Intravenous
Mild to moderate pain
Adult: 400-800 mg 6 hourly, as needed. Max: 3.2 g daily.
Child: 6 months to <12 years 10 mg/kg over 10 minutes 4-6 hourly, as needed. 12-17 years 400 mg over 10 minutes 4-6 hourly. Max: 2.4 g daily (Max 400 mg/dose).

Intravenous
Closure of patent ductus arteriosus
Child: Initially, 10 mg/kg infused over 15 minutes then, 2 doses of 5 mg/kg after 24 and 48 hours. Dosage should be based on birth weight.

Oral
Juvenile rheumatoid arthritis
Child: As conventional tab or cap: 30-40 mg/kg daily in 3-4 divided doses. Max: 2.4 g daily. As modified-release tab or cap: ≥12 years Same as adult dosage.

Oral
Dysmenorrhoea
Adult: As conventional tab or cap: 200-400 mg 4-6 hourly. Max: 3.2 g daily. As modified-release tab or cap: Up to 1.6 g once daily (evening). If needed, may further increase to 2.4 g daily in 2 divided doses.

Oral
Fever
Adult: 200-400 mg 4-6 hourly. Max: 1.2 (OTC) or 3.2 g daily. Max duration: 3 days (OTC).
Child: ≥6 months 5-10 mg/kg 6-8 hourly. Max: 40 mg/kg daily (Max 400 mg/dose).

Oral
Osteoarthritis, Rheumatoid arthritis
Adult: As conventional tab or cap: 400-800 mg 3-4 times daily. Max: 3.2 g daily. As modified-release tab or cap: Up to 1.6 g once daily (evening). If needed, may further increase to 2.4 g daily in 2 divided doses.

Oral
Mild to moderate pain
Adult: As conventional tab or cap: 200-400 mg 4-6 hourly as needed. Max: 1.2 (OTC) or 3.2 g daily. Max duration: 10 days (OTC). As modified-release tab or cap: Up to 1.6 g once daily (evening). If needed, may further increase to 2.4 g daily in 2 divided doses.
Child: As conventional tab or cap: ≥6 months 4-10 mg/kg daily 6-8 hourly. Max: 400 mg/dose, 40 mg/kg daily. As modified-release tab or cap: ≥12 years Same as adult dosage.

Rectal
Fever, Mild to moderate pain
Child: As 60 or 125 mg suppository: ≥3-9 months weighing 6-8 kg: 60 mg 6-8 hourly up to 3 doses daily; >9 months to 2 years weighing 8-12.5 kg: 60 mg 6 hourly up to 4 doses daily; >2-4 years weighing 12.5-17 kg: 125 mg 6-8 hourly up to 3 doses daily; >4-6 years weighing 17-20.5 kg: 125 mg 6 hourly up to 4 doses daily. As 75 mg suppository: ≥8-12 months weighing 7.5-10 kg: 75 mg up to 3 times daily; >12 months to 3 years weighing 10-15 kg: 75 mg up to 4 times daily.

Topical/Cutaneous
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: As 5% gel, foam, spray solution or 10% gel: Apply onto affected area as directed. As 200 mg plaster: 1 plaster daily.
Child: As 5% gel, foam, spray solution or 10% gel: ≥12 years Same as adult dosage. As 200 mg plaster: ≥16 years 1 plaster daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity (including asthma) to ibuprofen or other NSAIDs. History of gastrointestinal bleeding, perforation, or ulceration related to NSAID therapy. Gastrointestinal ulceration, perforation or haemorrhage. Severe cardiac failure or patients undergoing coronary artery bypass graft surgery. Severe renal or hepatic impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with CV disease or risk factors of (e.g. CHF, ischaemic heart disease, CVA, hypertension, hyperlipidaemia, diabetes mellitus), bleeding disorders, SLE, mixed connective tissue disorders, porphyria. Surgery. Hepatic and renal impairment. Elderly, children (especially premature neonates with risk factors for infection and infants with increased bilirubin levels). Pregnancy (1st-2nd trimester) and lactation. Concomitant use of other NSAIDs, antiplatelets, anticoagulants. Not for prolonged usage.
Adverse Reactions
Significant: Anaphylactoid reactions, risk of hyperkalaemia, oedema, HTN, liver function abnormalities, anaemia, blurred vision, scotomata, changes in colour vision. Rarely, severe blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia).
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, heartburn, abdominal pain; enterocolitis (IV).
General disorders and administration site conditions: Fluid retention.
Infections and infestations: Sepsis (IV).
Injury, poisoning and procedural complications: Injection site reactions.
Investigations: Increased BUN (IV).
Metabolism and nutrition disorders: Decreased appetite; hypoalbuminemia, hypoglycaemia, hypocalcaemia, hypokalaemia, hypernatraemia, adrenal insufficiency (IV).
Nervous system disorders: Headache, dizziness; intraventricular haemorrhage (IV).
Psychiatric disorders: Nervousness.
Renal and urinary disorders: Haematuria, UTI.
Respiratory, thoracic and mediastinal disorders: Apnoea, cough, respiratory infection.
Skin and subcutaneous tissue disorders: Rashes, pruritus; skin irritation (IV).
Potentially Fatal: CV thrombotic events (e.g. MI, stroke), gastrointestinal ulceration, perforation or haemorrhage; rarely, hepatotoxicity (e.g. fulminant hepatitis, hepatic necrosis or failure), Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.
Patient Counseling Information
This drug may cause dizziness, drowsiness or blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor CBC, occult blood loss, K levels, LFTs and renal function; signs and symptoms of ophthalmic-related reactions.
Overdosage
Symptoms: Headache, drowsiness, CNS depression, seizures, tinnitus, nausea, vomiting, abdominal pain, hypotension, bradycardia, tachycardia, atrial fibrillation, apnoea, respiratory failure, hyperkalaemia, acute renal failure, lethargy, metabolic acidosis, coma. Management: Supportive and symptomatic treatment. Induce emesis with syrup of ipecac or perform gastric lavage. Administer activated charcoal to reduce absorption and reabsorption. Forced alkaline diuresis might be beneficial. Management of hypotension, gastrointestinal bleeding and acidosis may also be necessary.
Drug Interactions
Increased risk of gastrointestinal ulceration, perforation or haemorrhage with other NSAIDs (e.g. aspirin), antiplatelets, anticoagulants (e.g. warfarin), corticosteroids, SSRIs. Increased risk of hyperkalaemia and renal toxicity with ciclosporin, tacrolimus. Increased levels and risk of toxicity with lithium, methotrexate. May decrease antihypertensive effect of ACE inhibitors, angiotensin II receptor antagonist; natriuretic effect of diuretics.
Food Interaction
Food intake decreases absorption rate. Avoid alcohol.
Action
Description: Ibuprofen, an NSAID, has analgesic, anti-inflammatory and antipyretic properties. It inhibits cyclooxygenase-1 and 2 thereby, also inhibiting prostaglandin synthesis.
Onset: Analgesic: 30-60 minutes. Anti-inflammatory: ≤7 days (oral).
Duration: 4-6 hours (oral).
Pharmacokinetics:
Absorption: Absorbed from the gastrointestinal tract, partially into the skin, and almost completely absorbed after rectal administration. Food intake decreases absorption rate. Time to peak plasma concentration: 1-2 hours (oral); 0.75 hours (rectal).
Distribution: Enters breast milk. Plasma protein binding: 90-99%.
Metabolism: Metabolised in the liver via oxidation.
Excretion: Mainly via urine (45-80% as metabolites, approx 1% as unchanged drug); faeces. Elimination half-life: Approx 2 hours.
Chemical Structure

Chemical Structure Image
Ibuprofen

Source: National Center for Biotechnology Information. PubChem Database. Ibuprofen, CID=3672, https://pubchem.ncbi.nlm.nih.gov/compound/Ibuprofen (accessed on Jan. 21, 2020)

Storage
Store between 20-25°C. Protect from light.
ATC Classification
R02AX02 - ibuprofen ; Belongs to the class of other throat preparations.
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
C01EB16 - ibuprofen ; Belongs to the class of other cardiac preparations.
M02AA13 - ibuprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
References
Anon. Ibuprofen. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com/. Accessed 12/07/2018.

Anon. Ibuprofen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/07/2018.

Buckingham R (ed). Ibuprofen. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/07/2018.

Caldolor Injection (Cumberland Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 13/07/2018.

Ibuprofen Drug Facts Label. U.S. FDA. https://www.fda.gov/. Accessed 28/05/2014.

Joint Formulary Committee. Ibuprofen. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/07/2018.

McEvoy GK, Snow EK, Miller J et al (eds). Ibuprofen. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 28/05/2014.

Wickersham RM. Ibuprofen. Facts and Comparisons [online]. St. Louis, MO. Wolters Kluwer Clinical Drug Information, Inc. https://www.wolterskluwercdi.com/facts-comparisons-online/. Accessed 29/05/2014.

Disclaimer: This information is independently developed by MIMS based on Ibuprofen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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