Brand Name : FLAMOL FORTE
Generic Name : Ibuprofen 400 mg + Paracetamol 500 mg
Preparation : Tablet
Pharmacological Category : NSAID (Non-Steroidal Anti-inflammatory Drug)
Mechanism of Action (MOA)
- Ibuprofen inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase isoenzymes COX-1 and COX-2. Recent research has found that Ibuprofen has additional anti-inflammatory properties that are due to modulation of leucocyte activity, reduced cytokine production, inhibition of free radicals and signaling transduction.
- Paracetamol inhibits synthesis of prostaglandin in the central nervous system by inhibiting cyclooxygenase (COX) with a predominant effect on COX-2. Thus, reduction in concentration of prostaglandin lowers the hypothalamic set-point to reduce fever and activates descending inhibitory serotonergic pathways to produce analgesia.
- Absorption :
Ibuprofen : Rapidly absorbed from the gastrointestinal tract
Paracetamol : Rapidly absorbed from the gastrointestinal tract
- Onset of Action :
Ibuprofen : 0.5 to 1 hour
Paracetamol : 1 hour
- Time to peak, Serum :
Ibuprofen : 1 to 2 hours
Paracetamol : 10 minutes to 1 hour
- Distribution :
Ibuprofen : Distributed into synovial fluid, the CNS, placenta and low concentration in breast milk
Paracetamol : Distributed into most body tissues, crosses placenta and present in breast milk
- Protein Binding :
Ibuprofen : 90 to 99%
Paracetamol : 10 to 25%
- Metabolism :
Ibuprofen : Liver
Paracetamol : Liver
- Elimination Half-life :
Ibuprofen : 2 to 4 hours
Paracetamol : 1 to 3 hours
- Excretion :
Ibuprofen : Urine (mostly), faeces
Paracetamol : Urine principally
Indications and Dosage
Fever, Mild to Moderate Pain and Inflammation in conditions such as Dysmenorrhoea, Headache, Migraine, Postoperative Pain, Dental Pain, Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Bursitis and Tenosynovitis, Sprains and Strains: one tablet every 4 to 6 hours; Maximum 6 tablets per day
COMMON : Gastrointestinal disturbances, peptic ulcer, headache, vertigo, dizziness, nervousness, tinnitus, depression, drowsiness, insomnia
OVERDOSE : Nausea, vomiting, tinnitus
Side effect of paracetamol is rare.
OCCASIONAL : Skin rashes and other hypersensitivity reactions
REPORTED : Thrombocytopenia, leucopenia, pancytopenia, neutropenia, agranulocytosis
OVERDOSE : Hepatotoxicity, renal tubular necrosis
Ibuprofen : Aspirin allergy, perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
Paracetamol : Hypersensitivity to paracetamol, severe active liver disease
Warnings / Precautions
- Caution in patients with peptic ulcer, history of peptic ulcer, asthma, cardiac disease, congestive heart failure, hepatic / renal impairment, hypertension, bleeding disorder, stomatitis, systemic lupus erythematosus, ulcerative colitis, upper gastrointestinal disease and late pregnancy (may cause premature closure of ductus arteriosus).
- If symptoms of blurred vision, scotomate and changes in color vision are seen, discontinue the therapy.
- Caution while operating heavy machines or driving as ibuprofen may cause drowsiness and dizziness.
Paracetamol : Caution in patients with impaired renal / hepatic function and alcohol dependence.
- Baclofen toxicity may develop after starting ibuprofen.
- Ibuprofen enhances the effect of anticoagulant.
- Ibuprofen increases the concentration of lithium, methotrexate, and cardiac glycoside.
- Ibuprofen increases the risk of nephrotoxicity if given with ACE inhibitors, ciclosporin, tacrolimus, or diuretics.
- Ibuprofen reduces the antihypertensive effects of ACE inhibitors, beta blockers and diuretics.
- Convulsion may occur due to an interaction of ibuprofen with quinolones.
- The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes.
- The absorption of paracetamol may be accelerated by drugs such as metoclopramide.
- Excretion may be affected and plasma concentrations altered when given with probenecid.
- Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
- Severe hepatotoxicity at therapeutic doses or moderate overdoses of paracetamol has been reported in patients receiving isoniazide alone or with other drugs for tuberculosis.
- Paracetamol may increase the risk of bleeding if taken with warfarin.
Pregnancy Category : C
FLAMOL FORTE : A box of 20 blisters, each blister of 10 tablets