Ib
COMPOSITION
Each 5ml of the syrup contains 100mg of Ibuprofen.
CLINICAL PHARMACOLOGY
Pharmacodynamic Properties:
Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and anti-pyretic activities. The drug’s therapeutic effects as a Non-Steroidal Anti-inflammatory Drug (NSAID) are thought to result from its inhibitory effects on the enzyme cyclo-oxygenase which result in a marked reduction in prostaglandin synthesis.
Pharmacokinetic Properties:
Ibuprofen is rapidly absorbed from the gastro-intestinal tract. Peak serum concentrations occurring 1 – 2 hours after administration. The elimination half life is approximately 2 hours. Ibuprofen is metabolized in the liver to two inactive metabolites and these together with unchanged ibuprofen are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete. Ibuprofen is extensively bound to plasma proteins.
INDICATIONS
Ibuprofen Suspension is indicated:
- In short term use for the treatment of pyrexia in children over six months of age.
- For mild to moderate muscular pain.
- In soft tissues injuries such as sprains and strains.
- For its analgesic and anti-inflammatory effects in the treatment of juvenile rheumatism, arthritis or Still’s disease.
- Headache, earache, toothache, backache, post-immunization fever.
- Fever and symptoms of colds and influenza.
CONTRAINDICATIONS
Patients with a history of active peptic ulceration. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, or urticaria) in response to Ibuprofen, aspirin or other NSAIDs.
INTERACTIONS
Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients.
- Corticosteroids increased risk of gastro-intestinal bleeding.
- Anticoagulants: Ibuprofen enhances anticoagulant effects.
- Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics.
- Concomitant use of Aspirin with Ibuprofen can increase the chances of having stomach ulcers and bleeding.
- Diuretics: Diuretics can increase the risk of nephrotoxicity of NSAIDs.
- Antihypertensives: Reduced antihypertensive effect.
- Lithium (Used for treatment of mental illnesses): Decreased elimination of lithium.
WARNINGS / PRECAUTIONS
Caution is required if Ibuprofen is administered to patients suffering from or with a previous history of bronchial asthma since Ibuprofen has been reported to cause bronchospasm in such patients.
Ibuprofen should only be given with care to patients with a history of gastrointestinal disease.
Ibuprofen should be given with care to patients with history of heart failure or hypertension since oedema has been reportedly associated with Ibuprofen administration.
Caution is required in patients with renal, hepatic or cardiac impairment, since the use of NSAIDs may result in deterioration of renal function.
The dose should be kept as low as possible and renal function should be monitored in these patients.
PREGNANCY AND LACTATION
Congenital abnormalities have been reported in association with Ibuprofen administration in man, however these are low in frequency and do not appear to follow any discernable pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (closure of ductus arteriosus) use in late pregnancy should be avoided.
In the limited studies so far available, Ibuprofen appears in the breast milk in very low concentrations and is unlikely to adversely affect the breast-fed infant.
KEEP OUT OF THE REACH OF CHILDREN!
ADVERSE REACTIONS / SIDE EFFECT
- Gastrointestinal disturbances including nausea, diarrhoea, dyspepsia, ulceration and hemorrhage.
SYMPTOMS OF OVERDOSAGE AND ANTIDOTE
Symptoms include nausea, vomiting, dizziness and rarely, loss of consciousness. Large overdoses are generally well tolerated when no other drugs are involved.
Treatment consists of gastric lavage and if necessary correction of serum electrolytes and appropriate supportive measures.
There is no specific antidote to Ibuprofen.
DOSAGE AND ADMINISTRATION
CHILDREN:
Pain and fever: The usual dose for pain and fever is 20mg per kg of body weight each day in divided doses.
This can be given as follows:
6 – 12 months: 2.5 ml three times daily.
Children 1 – 2 years: 2.5ml three to four times daily.
Children 3 – 7 years: One 5ml spoonful three to four times daily.
Children 8 – 12 years: Two 5ml spoonfuls three to four times daily.
Post-immunization fever: 2.5ml (50mg) followed by one further dose of 2.5ml (50mg) six hours later if necessary. Not more than 2 doses in 24 hours; if fever persists, please consult your doctor.
Up to 40mg/kg may be given daily in juvenile idiopathic arthritis.
PRESENTATION
Ibuprofen Suspensionis presented in amber bottle with a total content of 100ml.
STORAGE CONDITION
Store below 30oC. Protect from light.