IBUPROFEN TABLET 400MG

IBUPROFEN TABLET

  • Documents: GMP,COPP,CTD

IBUPROFEN TABLET 400MG

COMPOSITION:
Each sugar- coated tablet contains: Ibuprofen ВР 400 mg
INDICATIONS:
Ibuprofen provides relief from mild to moderate pain in conditions such as dysmenorrhoea,migraine, post operative pain, rheumatic disorders such as ankylosing spondylitis,osfeoarthril's and rheumatoid arhrilis including juvenile rheumatoid arthritis and in other musculo-skeletal and joint disorders such as sprains and strains.
CONTRAINDICATIONS:
Ibuprofen is contraindicated in the following condilions:
1.Bronchospasm
2.Known sensilivity to aspirin
3.Peptic ulcer
4.Recent gastrointestinal bleeding
5.Renal failure
6.Hypertension on treatment
PHARMAC OLOGICAL ACTIONS:
The propionic acid derivatives are all effective inhibitors of cyclo- oxygenase responsible for the biosynthesis of prostaglandins,All of these agents alter plalelet function and prolong bleeding time.
Ibuprofen is well absorbedafler oral administration. lbuprofen is rapidly melabolised and eliminated in the urine. The excretion of Ibuprofen is virtually complete with in 24 hours after the last dose. The serum half life is1.8 to 2.0 hours.
WARNING:
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma.Ibuprofen should not be given lo patienls in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symploms of asthma, rhinitis orurticaria.
PRECAUTIONS:
Blurred or diminished vision have been reported. If a patient develops such comolaints while receiving Ibuprofen lablels.the drug should be disconlinued and the patienl should have an ophthalmologic examination. Fluid retention and oedoma have been reported in association with lbuprofen: therefore, the drugshould be used with caution in patients with a history of cardiac decompensation or hypertension. Ibuprofen should be used with caution in persons with intrinsic coagulation defects and those on anticoagulant therapy.
ADVERSE EFFECTS:
The frequent adverse effects with Ibuprofen are gastrointestinal disturbances Peptic ulceration and gastro-intestinalblee ding have been reported Other side effecls include dizziness. nervousness. skin rash,tinnifus, oodema.depression, blurred vision. drowsiness and other reactions are also comm on.
DOSAGE AND ADMINISTRATION:
Adults: Recommended initial dose 1200-1800mg daily in divided doses. Some patients can be maintained on 600-1200mg daily.In severe or acute conditions It can be advantageous to increase the dosage until thE acute phase is brouaht under control,provided that the total daily dosage does not exceed 2400 mg in divided doses.
Children: Daily dose: 20 mg/kg body weight in divided doses. In juvenile rheumatoidarthritis up to 40m g/kg body weight in divided doses maybe taken.In children weighing<30 kg the lotal dose given in 24 hrs should not exceed 500mg.
Elderly: No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually.

STORAGE CONDITION:
Store in a cool, dry place. Protect from light. Keep all medicines away from reach of children.
PRESENTATION:
2 strips of in a carton. 10 strips of 10 tablets in a carton, 100strips of 10 tablets in a carton & HDPE container of 100/500/ 1000 tablets.