INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo IBUMAX PAEDIATRIC SUSPENSION

SCHEDULING STATUS:
Schedule 3: When intended for the treatment of inflammatory joint disease.
Schedule 2: When the recommended daily dose for children up to and including the age of 12 years does not exceed 20 mg/kg of body-weight.

PROPRIETARY NAME
(and dosage form):

IBUMAX PAEDIATRIC SUSPENSION

COMPOSITION:
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.

PHARMACOLOGICAL CLASSIFICATION:
A/3.1/Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
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. (dexibuprofen)

INDICATIONS:
Ibumax is indicated for the management of mild to moderate pain and inflammation. Ibumax is also used to reduce fever.
Ibumax 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 sprains.

CONTRA-INDICATIONS:
Ibumax should not be given to patients with peptic ulceration and should be used with caution in patients with a history of such disorders. Ibumax 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:
Children:
Juvenile Rheumatoid Arthritis - 20 mg/kg of body mass daily in divided doses with up to 40 mg/kg being given daily if necessary.
Ibumax is not recommended for children under 1 year of age or in those weighing less than 7 kg.
Pain:
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 physician.
Fever:
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 Ibumax 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. Ibumax can provoke bronchospasm in patients with asthma. Ibuprofen may cause cystitis and haematuria.
Precautions:
Ibumax 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. Ibumax should be used with caution in the elderly.
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. Ibumax 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 Ibumax, if recently taken and electrolytes may be corrected by intravenous infusions, if necessary.

IDENTIFICATION:
An orange flavoured, orange coloured syrupy suspension.

PRESENTATION:
100 mL or 200 mL amber glass bottles or 2,5 L white plastic bottle.

STORAGE INSTRUCTIONS:
Store in a well closed container. Store below 25°C.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER:
36/3.1/0436

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Xeragen Laboratories (Pty) Ltd.
P.O. Box 22544
Glenashley
4027

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
02/05/2003

New addition to this site: May 2004
Source: Pharmaceutical Industry

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