Ibuprofen + paracetamol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Mild to moderate pain; Fever; Inflammation Each tab contains ibuprofen 150 mg and paracetamol 500 mg: 1-2 tab either 4 hourly, 6 hourly or 8 hourly. Max: 6-8 tab per 24 hours (ibuprofen 900-1,200 mg and paracetamol 3,000-4,000 mg). Max duration: 3 days (72 hours). Refer to individual product and local guidelines as dosing recommendations may vary. Each tab contains ibuprofen 200 mg and paracetamol 500 mg: 1-2 tab up to tid, with intervals of at least 6 hours. Max: 6 tab per 24 hours (ibuprofen 1,200 mg and paracetamol 3,000 mg). Each tab or cap contains ibuprofen 200 mg and paracetamol 325: 1 tab or cap 6 hourly as needed. Max duration: 10 days. IV Mild to moderate pain; Fever Each 100 mL vial contains ibuprofen (as Na dihydrate) 300 mg and paracetamol 1000 mg: 100 mL infused over 15 minutes 6 hourly, as needed. Max: Paracetamol 4,000 mg.
Contraindications
Hypersensitivity to ibuprofen, paracetamol or other NSAIDs. Active or history of peptic ulceration or haemorrhage (including history of gastrointestinal bleeding related to previous NSAID therapy); severe heart failure (NYHA Class IV), cerebrovascular or other active bleeding, coagulation disorders, history of ulcerative colitis or Crohn's disease, bronchial asthma, urticaria or allergic-type reactions to aspirin or other NSAIDs, active alcoholism. Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, spinal cord injury (IV). Children <18 years of age. Severe hepatic and renal failure. 3rd trimester of pregnancy (oral). Pregnancy and lactation (IV). Concomitant use with paracetamol- or NSAID-containing drugs (e.g. cyclo-oxygenase-2 inhibitors, aspirin (doses >75 mg daily).
Special Precautions
Patient with existing or history of bronchial asthma or allergic disease, history of hypertension, mild to moderate CHF, mixed connective tissue disorder, SLE, non-cirrhotic alcoholic liver disease. G6PD deficiency, chronic malnutrition, anorexia, bulimia, cachexia, dehydration, hypovolaemia (IV). Elderly. Renal and hepatic impairment. 1st and 2nd trimester of pregnancy. Lactation (PO). Patient Counselling This drug may cause drowsiness, dizziness, fatigue and visual disturbance if affected, do not drive or operate machinery. Monitoring Parameters Monitor hepatic, renal and cardiac function; symptoms of gastrointestinal bleeding.
Adverse Reactions
Significant: Fluid retention, impaired female fertility. Rarely, blood dyscrasias (e.g. anaemia). Ear and labyrinth disorders: Tinnitus. Gastrointestinal disorders: Nausea, vomiting, heartburn, abdominal pain or discomfort, diarrhoea, dyspepsia, constipation, flatulence. Investigations: Increased ALT, gamma-glutamyltransferase, blood creatinine and urea, abnormal LFT. Nervous system disorders: Dizziness, headache, nervousness. Psychiatric disorders: Insomnia. Surgical and medical procedures: Rash, pruritus. Vascular disorders: Hypertension.
Potentially Fatal: Gastrointestinal bleeding, ulceration or perforation; Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, hepatotoxicity.
Drug Interactions
May enhance the effect of anticoagulants (e.g. warfarin). Paracetamol: May increase the plasma concentration of chloramphenicol. Increased absorption by domperidone and metoclopramide. Decreased absorption by cholestyramine and other drugs that reduce gastric emptying time (e.g. narcotic analgesics, propantheline, antidepressants with anticholinergic properties). Altered plasma concentration with probenecid. Concomitant use with zidovudine, co-trimoxazole or isoniazid (alone or with other anti-TB drugs) may result in severe hepatotoxicity. Ibuprofen: May reduce the effects of ACE inhibitors, angiotensin II antagonists, diuretics and mifepristone. Increased risk of gastrointestinal bleeding with corticosteroids, antiplatelet agents and selective SSRIs. May increase the plasma levels of cardiac glycosides. May increase the risk of nephrotoxicity when given with ciclosporin and tacrolimus. May decrease the elimination of lithium and methotrexate. May increase the risk of convulsions associated with quinolone antibiotics. Increased risk of haematological toxicity with zidovudine.
ATC Classification
G02CC01 - ibuprofen ; Belongs to the class of antiinflammatory products for vaginal administration used in the treatment and prevention of inflammation.
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
M02AA13 - ibuprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
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.
R02AX02 - ibuprofen ; Belongs to the class of other throat preparations.
Disclaimer: This information is independently developed by CIMS based on ibuprofen + paracetamol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by CIMSAsia.com
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