100MG / 5ML 100ML Oral Suspension Drugs Ibuprofen Dry Suspension
Each 5 mL of suspension contains 100 mg of ibuprofen.
Preservatives: Methyl Hydroxybenzoate 0,1% m/v, Propyl
Hydroxybenzoate 0,05% m/v, Sodium Benzoate 0,25% m/v.
A/3.1/Antirheumatics (anti-inflammatory agents).
Ibuprofen ((RS)-2-(4-isobutylphenyl) propionic acid) is a
nonsteroidal anti-inflammatory compound used to relieve mild to
moderate pain, fever and inflammation. Ibuprofen is rapidly
absorbed after oral administration and peak plasma concentrations
occur about one to two hours after ingestion. Ibuprofen is 90 to
99% bound to plasma proteins and has a plasma half life of about 2
hours.It is rapidly excreted in the urine mainly as metabolites and
their conjugates. About 1% is excreted in urine as unchanged
ibuprofen and about 14% as conjugated ibuprofen. There appears to
be little if any excretion in breast milk. Ibuprofen is
stereoselective and there is some metabolic coversion of the
inactive R(-)-enantiomer to the active S(+)-enantiomer.
Ibuprofen is indicated for the management of mild to moderate pain
and inflammation. Ibuprofen is also used to reduce fever.
Ibuprofen is used in the management of mild to moderate pain and
inflammation, musculoskeletal and joint disorders such as juvenile
rheumatoid arthritis, peri-articular disorders such as bursitis,
and tensosynovitis, and soft tissue disorders such as pains and
Ibuprofen should not be given to patients with peptic ulceration
and should be used with caution in patients with a history of such
disorders. Ibuprofen should not be administered during the third
trimester of pregnancy. Hypersensitivity to ibuprofen. There is
considerable cross reactivity between aspirin and other
non-steroidal anti-inflammatory medicines and it is generally
recommended that patients who have had a hypersensitivity reaction
to one particular non-steroidal anti-inflammatory medicine should
avoid all non-steroidal anti-inflammatory medicines.
DOSAGE AND DIRECTIONS FOR USE:
Juvenile Rheumatoid Arthritis - 20 mg/kg of body mass daily in divided doses with up to 40 mg/kg
being given daily if necessary.
Ibuprofen is not recommended for children under 1 year of age or in
those weighing less than 7 kg.
5 mg/kg of body mass. A second dose of 5 mg/kg may be given after 2
hours if pain is not controlled, thereafter 5 mg/kg every 4-6
hours. If pain persists for more than 7 days, consult your
5 mg/kg of body mass every 4-6 hours. If fever persists more than
three days consult your doctor.
|Age||Daily Dosage||Body Mass|
|1-2 years||2.5 mL 3-4 times daily||7-12 kg|
|3-7 years||2.5-5 mL 3-4 times daily||14-23 kg|
|8-12 years||10 mL 3-4 times daily||25-40 kg|
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side effects with Ibuprofe are gastro-intestinal
disturbances; these are usually mild and reversible but in some
patients peptic ulcer and gastro-intestinal bleeding have been
reported. CNS - related side effects include headache, dizziness,
nervousness, tinnitus, depression, drowsiness and insomnia.
Hypersensitivity reactions may occur and include fever, asthma and
rashes. Hepatotoxicity and aseptic meningitis which occur less
frequently may also be hypersensitivity reactions.
Some patients may experience visual disturbances, such as blurred
vision, changes in visual colour perception and toxic amblyopia.
Haematological adverse effects include anaemias, thrombocytopaenia,
neutropaenia, eosinophilia, and agranulocytosis. They may cause
nephrotoxicity such as interstitial nephritis, nephrotic syndrome
and renal failure. Ibuprofe can provoke bronchospasm in patients
with asthma. Ibuprofen may cause cystitis and haematuria.
Ibuprofen should be used with caution in patients with a history of
peptic ulceration. Other precautions to be observed include
patients with haemorrhagic disorders, asthma, a history of
hypersensitivity reactions to aspirin or other NSAID's,
hypertension, and impaired renal, hepatic or cardiac function.
Patients should be monitored for the development of blood, kidney,
liver or eye disorders. Ibuprofen should be used with caution in
Care is required in those receiving oral anti-coagulants, lithium,
methotrexate and cardiac glycosides. Patients with collagen disease
may be at increased risk of developing aseptic meningitis.
Ibuprofen should be discontinued in patients who experience blurred
or diminished vision, or changes in colour vision.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Epigastric pain and nausea. Gastric lavage will remove any
unabsorbed Ibuprofen, if recently taken and electrolytes may be
corrected by intravenous infusions, if necessary.
An orange flavoured, orange coloured syrupy suspension.
Store in a well closed container. Store below 25°C.
KEEP OUT OF THE REACH OF CHILDREN.