Nurofen for Children

Nurofen for Children

ibuprofen

Manufacturer:

RB (Health)

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Ibuprofen.
Action
Ibuprofen is a nonsteroidal analgesic, antipyretic and anti-inflammatory agent and is effective in the relief of inflammation, pain and fever.
Indications/Uses
For the relief of fever eg, fever associated with cold and flu and pain eg, pain from teething and toothache, earache, sore throats, headache and minor aches and sprains. Also for the relief of inflammation of muscles and joints.
Dosage/Direction for Use
Nurofen for Children is a special formulation for babies and children from 6 months, to be given orally.
The daily dosage of Nurofen for Children is 20-40 mg/kg body weight in divided doses. It is recommended that children weighing <30 kg should not take >5-level tsp (500 mg) within 24 hrs.
Post-Immunization: Children 10-12 years: 15 mL; 7-9 years: 10 mL; 4-6 years: 7.5 mL; 1-3 years: 5 mL. All doses to be taken 3 times daily. Babies 6-12 months: 2.5 mL 3-4 times daily.
Nurofen for Children may be given to a baby 3 to <6 months weighing more than 5 kg on the advice of a doctor. Initial dose of 2.5 mL followed by a further 2.5 mL 6 hrs later, if necessary. No more than 5 mL in 24 hrs.
Overdosage
There is no specific antidote to overdose with ibuprofen. Gastric lavage may be performed and if necessary, blood electrolytes corrected.
Contraindications
Patients who are sensitive to aspirin, ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs) or hypersensitivity reactions related to previous NSAID therapy. Patients in whom aspirin and other NSAIDs induce the symptom of asthma, rhinitis and urticaria. Patients with active or history of peptic ulceration, recurrent peptic ulcer/haemorrhage, varicella infection. History of gastrointestinal bleeding or perforation. Severe heart failure, renal failure or hepatic failure. Last trimester of pregnancy.
Special Precautions
Nurofen for Children should be given with care to the elderly, to patients with cardiovascular disease, and in liver or renal failure. Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion, and therefore these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
Nurofen for Children should be discontinued in patients who experience blurred or diminished vision, or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.
Nurofen for Children should be given with care to patients who have asthma or have ever suffered from asthma.
If the child's symptoms (eg, earache) persist for >3 days, consult the doctor.
Nurofen for Children should be given with care to patients with systemic lupus erythematosus and mixed connective tissue disease, history of gastrointestinal disease (ulcerative colitis, Crohn’s disease). Use in pregnancy & lactation: Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during pregnancy should, if possible, be avoided. In the limited studies so far available, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.
Use In Pregnancy & Lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during pregnancy should, if possible, be avoided. In the limited studies so far available, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.
Adverse Reactions
Nurofen for Children is generally well tolerated by the majority of people. However, the following adverse effects observed are usually of a mild and transient nature: Stomach discomfort or pain, nausea, gastrointestinal intolerance and bleeding, stomach ulcer, activation of peptic ulcer, black tarry stools, rashes or worsening of asthma, liver and kidney problems (cystitis, haematuria, acute renal failure, interstitial nephritis and nephrotic syndrome), headache, dizziness and hearing disturbance and very rarely skin peeling and easy bruising. Serious skin reaction are also observed, some of them fatal (such as exfoliative dermatitis, Stevens-Johnson Syndrom, toxic epidermal necrolysis), severe hypersensitivity reactions, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exacerbation of infections in varicella infection, cardiac failure & oedema. Haematopoietic disorders also occur.
Drug Interactions
In therapeutic doses, no evidence of clinically significant interactions with other commonly used drugs has so far been observed.
However, as with other NSAIDs, caution should be exercised in patients receiving: Oral anticoagulants (eg, coumarins); antihypertensive treatment with thiazide diuretics, ACE inhibitors and β-blockers; methotrexate and lithium and; other pain relievers containing aspirin, ibuprofen or other NSAIDs; oral corticosteroids, SSRI, anti-platelet agents, cardiac glycosides, ciclosporin, mifepristone, tacrolimus, zidovudine, quinolone antibiotics.
Storage
Store below 30°C. Protect from light.
Shelf-Life: 3 years.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Nurofen for Children syr 100 mg/5 mL
Packing/Price
60 mL x 1's;60 mL x 48 × 1's
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