COMPOSITION :
Ibuprofen Suspension 100 mg/5 ml, each 5 ml (a measurement spoonful) contains : Ibuprofen 100 mg.
DESCRIPTIONS :
Ibuprofen containing Ibuprofen as active ingredient available in suspension 100 mg/5 ml.
INDICATIONS :
Relief fever in children.
Relief mild to moderate pain : Toothache, headache, pain due to tooth extraction, pain after surgery and sprained.
DOSAGE AND ADMINISTRATIONS :
Adult : For relief mild to moderate pain : 200 mg, 3 – 4 times daily.
Children : For reduce fever and pain, recommended dose is 20 mg/kgBW/day in divided doses :
1 – 2 years : 50 mg (½ measurement spoonful), 3 – 4 times daily.
3 – 7 years : 100 mg (1 measurement spoonful), 3 – 4 times daily.
8 – 12 years : 200 mg (2 measurement spoonfuls), 3 – 4 times daily.
Not recommended for children under 1 year old.
Should be taken after meal.
CONTRAINDICATIONS :
Patients with hypersensitive history to Ibuprofen and other non steroid anti-inflammatory drugs.
Patients with severe and active peptic ulcer (gastric and duodenal ulcer).
Patients experiencing asthma, rhinitis or urticaria when treated with Acetosal or other non steroid anti-inflammatory drugs.
Pregnancy in last trimester.
WARNINGS AND PRECAUTIONS :
CARDIOVASCULAR EFFECTS
- Cardiovascular thrombotic events :
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the sign and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Acetyl salicylic acid mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of Acetyl salicylic acid and an NSAID does increase the risk of serious GI events (see WARNINGS, Gastrointestinal (GI) effect-risk of GI ulceration, bleeding and perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
- Hypertension :
NSAIDs, including Ibuprofen can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Ibuprofen, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with Ibuprofen and throughout the course of therapy.
- Congestive heart failure and edema :
Fluid retention and edema have been observed in some patients taking NSAIDs, including Ibuprofen. Ibuprofen should be used with caution in patients with fluid retention or heart failure.
GASTROINTESTINAL (GI) EFFECTS
- Risk of GI ulceration, bleeding and perforation
NSAIDs, including Ibuprofen, can cause serious gastrointestinal events, including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms. In patients treated with NSAIDs. Only one in five patients, who develop serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months and in about 2 – 4% of patients treated for one year. These trends with longer duration of use, increasing the likelihood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should prescribed with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy. If serious GI adverse event is suspected, immediate additional evaluation and treatment, including discontinuation of the use of NSAIDs.
OTHERS
Ibuprofen is not recommended for children under age of 1 year.
Do not use over recommended dosage.
Before using this drug, consult to physician when suffer from any diseases or disorders such as :
Upper gastrointestinal tract disease history (peptic ulcer).
Impaired renal function because primer elimination via kidney.
Heart failure, hypertension and other diseases causing body liquid retention.
Blood coagulation disorders.
Asthma because may cause bronchospasm.
Systemic lupus erythematosus.
During use this drug don’t take Acetosal or other drugs containing Ibuprofen, also anticoagulation agents such as Warfarin.
Contact doctor if adverse effects occur during use this drug.
If pain does not relief within 5 days, call doctor or Health Service Unit immediately.
Not recommended for pregnant and lactating woman.
ADVERSE REACTIONS :
Although rarely occur, but side effect of gastrointestinal disturbance such as nausea, vomiting, diarrhea, constipation, abdominal pain, burning sensation in upper stomach, gastric hemorrhage may occur.
Skin rash, bronchospasm, thrombocytopenia, lymphopenia had ever reported to occur.
Reduce vision sharpness and difficulty in distinguish color may occur, but very rare and will recover with discontinuation of the drug.
PRESENTATION :
Ibuprofen Suspension 100 mg/5 ml Box, 10 bottles @ 60 ml Reg. No. GTL1702356033A1
STORAGE :
STORE BELOW 30ºC
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
