PediaProfenยฎ
Ibuprofen Suspension 100 rag/5 ml
The following is a brief summary only Before prescribing, see complete prescribing information in PediaProfen labeling.
INOICATIONS AND USAGE: PediaProfea is indicated for the reduction of fever in patients aged 6 months and older, and for the relief of mild-to-moderate pain in patients aged 12 years and older.
CLINICAL PHARMACOLOGY: Controlled clinicaltrials comparing doses of 5 and 10 mg/kg ibuprofen and 10-15 mg/kg of acetaminophen have been conducted in children B months to 12 years of age with fever primarily due to viral illnesses. In these studies there were no differences between treatments in fever reduction for the first hour and maximum fever reduction occurred between 2 and 4 hours. Response after 1 hour was dependent on both the level of temperature elevation as well as the treatment. In children with baseline temperatures at or below 102.5ยฐE both ibaprolen doses and acetaminophen were equally effective in their maximum effect, in those children with temperatures above 102.5ยฐE the ibuprofen 10 mg/kg dose was more effective. By 6 hours children treated with ibuprofen 5 mg/kg tended to have recurrence of fever, whereas children treated with ibuprofen 10 mg/kg still had significant fever reduction at S hours. In control groups treated with 10 mg/kg acetaminophen, fever reduction resembled that seen in children treated with 5 mg/kg of ibuprofen, with the exception that temperature elevation tended to return 1-2 hours earlier CGNTRAINDICATIONS: PediaProlen should not be used in patients who have previously exhibited hypersensitivity to ibuprofen, or in individuals with all or part of the syndrome of nasal polyps, angioedema and broncbospastic reactivity to aspirin or other nonsteroidal anti-inflammatory agents Anaphylactatd reactions have occurred in such patients.
WARNINGS: Risk of GI Ulceration, Bleeding and Perforation with NSAID Therapy. Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAID therapy. Although minor upper gastrointestinal problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain atert for ulceration and bleeding in patients treated chronically with NSNOs even in the absence of previous G I tract symptoms. In patients observed in clinical trials of several months to two years duration, symptomatic upper GI ulcers, gross bleeding or perforation appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. Physicians ehould inform patients about the signs and/or symptoms of serious BI toxicity and what steps to take if they occul:
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Except for a prier history of serious GI events and other risk factors known to be associated with peptic ulcer disease, such as alcoholism, smoking, ~o., no risk factors {e.g., age, sex) have been associated with increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less well than other individuals and most spontaneous reports of fatal GI events are in this population. Studies to date are inconclusive concerning the relative risk of various NSNDs in causing such reactions. High doses of any NSAID probably carry a greater risk o1 these reactions, although controlled clinical trials showing this do not exist in most cases. In considering the use o1 relatively large doses (within the recommended dosage range), sufficient benefit should be anticipated to offset the potential increased risk of GI toxicity.
PRECAUTIONS: Generah Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving PediaPreten, the drug should be discontinued and the patient should have an ophthalmologic examination which includes central visual fields and color vision testing.
Fluid retention and edema have been reported in association with ibuprofen; therefore, the drug should be used with caution in patients with a history of cardiac decompensation or hypertension, PediePrefoo, like other nonsteroidal anti-inflammatory agents, can inhibit platelet aggregation, but the effect is quantitatively less and of shorter duration than that seen with aspirin. Ibuprofen has been shown to prolong bleeding time (but within the normal range) in normal subjects. Because this prolonged bleeding effect may be exaggerated in patients with underlying hemostatie defects, PediaProfen should be used with caution in persons with intrinsic coagulation detects and those on anticoagulant the rapy.
Patients on PediaPrefen should report to their physicians signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain, or edema.
In order to avoid exacerbation of disease of adrenal insufficiency, patients who have been on prolonged corticosteroid therapy should have their therapy tapered slowly rather than discontinued abruptly when ibuprofen is added to the treatment program.
The antipyretio and anti-inflammatory activity of PediaPrefeo may reduce fever and inflammation, thus diminishing their utility as diagnostic signs in detecting compdcations 01 presumed noninfectious, noninflammatory painful conditions
As with other nonsteroidat anti-inflammatory drugs, long-term administration of ibuprofen to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports o1 acute interstitial nephritis with hematuria, proteinuria, and occasionally nephrotic syndrome.
A second form of renal toxicity has been seen in patients with prerenal conditions leading to a reduction in renal bleed flow or blood volume, where the renal prostaglandins have a supportive role in the maintenance of renal perfusion, in these patients administration of a nonsteratdat antiinflammatory drug may cause a dose dependent ,eduction in prostaglandin formation and may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly Discontinuation of nonsteratdat anti-inflammatory drug therapy is typically followed by recovery to the pro-treatment state.
Those patients at high risk who chronically take ibuproten should have renal function monitored if they have signs or symptoms which may be consistent with mild azotemia, such as malaise, fatigue, loss of appetite, etc. Occasional patients may develop some elevation o1 serum creatinine and BUN levels without signs or symptoms Since ibuprofen is eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored and a reduction in dosage should be anticipated to avoid drug accumulation. Prospective studies on the safety of ibuprofen in patients with chronic renal failure have not been conducted.
Meaningful (3 times the upper limit of normal), elevations of SGPT or SGOT (AST) occurred in controlled conical trials in less than 1% of patients. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development o1 more severe hepatic reactions while on therapy with PodiaProfen. If abnormal liver tests persist or worsen, if clinicM signs and symptoms consistent with liver disease develop, or it systemic manifestations occur (e.g. eoeinophilia, rash, etc.), PediaPtofen should be discontinued.
Safety and efficacy of PediaProfen in children below the age of 6 months has not been established. Pregnancy: Reproductive studies conducted in rats and rabbits at doses somewhat less than the maximal clinical dose did not demonstrate evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. As there are no adequate and wellcontrolled studies in pregnant women, this drug should be used during pregnancy only if clearly needed. Because o1 the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure o1 ductus arteriosus), use during late pregnancy should be avoided. As with other drugs known to inhibit prostaglandin synthesis, an increased incidence o1 dystocia and delayed parturition occurred in rats. Administration of PedieProten is not recommended during pregnancy.
ADVERSE REACTIONS:
The most frequent type o1 adverse reaction occurring with ibuproten is gastrointestinal. In controlled clinical trials, the percentage o1 adult patients reporting one or more gastrointestinal complaints ranged from 4% to 16%.
Adverse reactions occurring in 3% to 9% of patients treated with ibuprofen: nausea, epigastric pain, heartburn, dizziness, rash. Adverse reactions occurring in 7 % to 3% of patients: diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract, headache, nervousness, pruritus, tin@us, decreased appetite, edema, fluid retention (generaLly responds promptly to drug discontinuation). Still other reactions (less than 1 in 100) have been reported, and are detailed in the full summary of prescribing information.
DOSAGE AND ADMINISTRATION: Shake well prior to administration. Fever RedncRon in Children 6 months to 12 years of age: Dosage should be adjusted on the basis o1 the initial temperature level (See CLINICAL PHARMACOLOGY for a description of the controlled clinical trial results). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5ยฐF or 10 mg/kg if the baseline temperature is greater than 102.5"E The duration of fever reduction is generally 6-8 hours and is longer with the higher dose. The recommended maximum daily dose is 40 mg/kg.
Mild In moderate pain: 400 mg every 4 to 6 hours as necessary for the relief of pain in adults.
In controlled analgesic clinical trials, doses of ibuprofen greater than 400 mg were no more effective than 400 mg dose.
NOW SUPPLIED: PediaProfen Ibuprofen Suspension 100 mg/5 ml (teaspoon)orange, berry-vanilla flavored Bottles of 4 oz (120 ml) .