Ibu J
IBU-J CAPSULE
Ibuprofen, Paracetamol and Caffeine Capsules
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Ibuprofen BP: 200mg
Paracetamol BP: 325mg
Caffeine Anhydrous BP: 30mg
Excipients: Q.S
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PHARMACEUTICAL FORM
Capsule.
For oral administration. -
CLINICAL PARTICULARS
Therapeutic Indications
lBU-J capsules are indicated for the relief of headache from musculoskeletal origin. feverishness, muscular, menstrual and dental pain.
Posology and method of administration
Not recommended for children under twelve years.
Adults and children over 12 years: Two capsules every four hours, but not more than six capsules in twenty-four hours. Capsules are to be taken with food or after meals with sufficient water. Consult your doctor if no relief is obtained with the recommended dosage.
Contraindications
lBU-J is not recommended for use by pregnant or breast-feeding women. It should not be given to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration, renal failure and in those who are receiving coumarin anti-coagulants Severe liver function impairment.
Patients who are sensitive to any of the ingredients or aspirin should not be given IBU-J.
Special warnings and precautions for use
Patients suffering from liver or kidney disease should only take paracetamol under medical supervision.
Dosages in excess of those recommended may cause severe liver damage. Do not use continuously for more than ten days without consulting your doctor. Consult a doctor if no relief is obtained from the recommended dosage.
Interaction with other medicinal products and other forms of Interaction
NSAIDS may enhance the effect of anti-coagulants and diminish the effect of anti-hypertensives or thiazide diuretics. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.
The speed of absorption of paracetamol maybe increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Opioid analgesics should be given with care to patients receiving monoamine oxidase inhibitors.
Pregnancy and lactation
lBU-J is not recommended for use by pregnant or breastfeeding women.
Undesirable effects
Ibuprofen:
The most frequent adverse effects are gastrointestinal disturbances. Peptic ulceration and gastro-intestinal bleeding have been reported. Other Side effects include headache, dizziness, nervousness, skin rash, prurities, tinnitus, oedema, depression, drowsiness, insomnia, blurred vision and other ocular reactions.Sensitivity reactions, abnormalities of liver function tests, impairment of renal function. agranulocytosis and thrombocytopenia have been observed. Acute reversible renal failure has been reported.
In view of the products inherent potential to cause oedema, heart failure may be precipitated in some compromised patients.
Paracetamol:
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Sensitive reactions resulting in reversible skin rash or blood disorders eg. neutropenia, leucopenia and pancytopenia may occur. The skin rash is usually erythematous or urticarial, but sometimes more serious and may be accompanied by fever and mucosal lesions.Caffeine:
Nausea, headache, palpitations and insomnia. Caffeine should be given with care to patients with a history of peptic ulcers.Overdose
Ibuprofen - The most likely symptoms of over dosage are epigastric pains and nausea. Treatment is symptomatic and supportive.
Paracetamol - Symptoms of paracetamol over dosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.
Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the over dosage. Nausea, vomiting, enemas and abdominal pain may persist for a week or more. Liver injury may be manifested on the second day. (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death.
Cerebral oedema and nonspecific myocardial depression have also occurred. In the event of over dosage consult a doctor or take patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible. Prompt treatment is essential.
Any patient who has ingested about 7.5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered as soon as possible.
Acetylcysteine - Acetylcysteine should be administered as soon as possible, preferably within 8 hours of over dosage.
IV - An initial dose of 150 mg/kg in 200 mL glucose ingestion, given intravenously over 15 minutes followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally - 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17doses. Acetylcysteine is effective if administered within 8 hours of over dosage.
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PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Paracetamol has analgesic and antipyretic effects. Ibuprofen has analgesic, antipyretic and anti-inflammatory activities.
Ibuprofen exerts its anti-inflammatory action peripherally in inflamed tissue by reducing prostaglandin activity and by inhibiting synthesis and/or actions of other local mediators of the inflammatory response.
Caffeine is a potent stimulator of the CNS.
Phamacokinetic properties
Paracetamol - Absorption following oral administration is rapid and almost complete.
Paracetamol is metabolised in the liver primarily by conjugation.
Paracetamol has a half-life of 1 to 4 hours, time to peak concentration of 0.5 to 2 hours, time to peak effect of 1 to 3 hours and a duration of action of 3 to 4 hours. Paracetamol is renally excreted primarily as metabolites and 3% of a dose man be excreted unchanged.
Ibuprofen - Rapidly absorbed after oral administration. Onset of action for pain relief is 30 minutes and the time for peak effect for fever is 2 to 4 hours.
The half-life of ibuprofen is about 2 hours and the duration of action for fever is 6 to 8 hours or more and is 4 to 6 hours for pain. More than 90% of an ingested dose is excreted in the urine as metabolites or their conjugates.
Caffeine - is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methglunc acid 1-methytxanthine.
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PHARMACEUTICAL PARTICULARS
Special precaution for storage
Store in a dry place below 25?C.
Protect from light.
KEEP OUT REACH OF CHILDREN