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The following is a brief summary only. Before prescribing, see comglste prescribing information in Pedla-Proferl [abegng.
INDICATIONS AND USAGE: Pedla-Prolen 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 nlde~ CLINICAL PHARMACOLOGY: Controlled clinical trials comparing doses of 5 and 10 mg/kg ibuprofen and 10-15 mg/kg of aoetaminophe.a have been conducted in children O months to 12 years of age with fever primarily due to viral illnesses. In these studies there were no differences between treatments ~n fever reduction for the first hour and maximum fever reduction occurred between 2 and 4 hnu rs. Response after 1 hour was dependent on both the level of temperature elevation as well as the treatment. In child ran with baseline temperatures at or below 102.5ยฐF, both ibuprofen 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 Oy O hours children treated with ibuprofen 5 mg/kg tended to have recurrence of fever, whereas children treated with ibuprcten 10 mg/kg sRII bad significant fever reduction at S hours. In control groups treated with 10 mg/kg acctaminoghen, fever reduction resem bled that seen in children treated with S m gag of ibuprofen, with the exception that temperers re elevation tended to returd 1-2 hours earlie~ CONTRAINDICATIONS: Pedia-Prefen should not he used in patients who have previously exhibited hypersensitivity to ibugrofen, or in individuals with all or part of the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory agents. Anaphyiactoid reactions have occurred in such patients.
WARNINGS: Risk of GI Ulceration, Rleeding and Perforation with NSAID Therapy. Serious gastrointestinal toxicity such as bleeding, u[cerstion, and perforation, can gee ur at any time, with or without warning symptoms, in patients treated ehronically with NBAID therapy, Although minor upper gastrointestinal problems, such as dyspepsia, are common, usually develoding early in theragy, physicians should remain alert thr ulceration and bleeding in patients treated chronically with N SAIDs even in the absence o1 previous GI 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 yean Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Except for a 0dor history of serious G I events and other risk factors known to be associated with peptic ulcer disease, such as alcoholism, smoking, etc., 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 NSAIOs in causing such reactions. High doses of any NSNO probably carry a greater risk of these reactions, although controlled clinical trials showing this do not exist in most eases. In considering the use of relatively large doses (within the recommended dosage range), sufficient benctg should be anticipated 1o offset the potential increased risk of GI toxicity.
PRECAUTIONS: General: B$urred and/or diminished vision, scotomsta, and/or changes in color vision have been reported, If a patient develops such complaints while receiving Padia-Prolen, th e drug should be discontinued and the patient should h ave an oghthalmologic examination which includes central visual fields and color vision testing.
Fluid retention and edema have been reported in association with ibugrothn; therefore, the drug should be used with caution in patients with a history of cardiac decompensation or hypertension.
Pedia-Prafen, like other nonstero~dal anti-inflammstory agents, can inhibit plstelct aggregation, but the elfect is quantitatively less and of shorter d oration th an 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 he exaggerated in patients with underlying hemnstatic defects, Peaia-Prafen should be used with caution in persons with intrinsic coagulation defects and those on anticoagulant therapy.
PctJects on Pegia-Prefen sho u M report to their physicians signs or symptoms of g actrointestinal 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 eorticosteroid therapy should have their therapy tapered stowly rather than discontinued abruptly when ibuprofen is added to the treatment program.
The antipyratie and anti-inflammstory activity of Pedia-Prefen may reduce fever and inflammation, thus diminishing their utility as diagnostic signs In detecting complications of presumed noninfectious, noninflammatory painful conditions,
As with other nonsteroidal anti-inflammatory drugs, long-term ad ministration of ibuproten to animals has resulted in renal papillary necrosis and other abnormal renal pathology In humans, there have been reports of acute interstitial nephritis with hemsturia, prote[nuria, and occasionally neghrotic syndrome A second form of renal toxicity has been seen in patients with prerenal conditions leading to a reduction in renal blood Row or blood volume, where the renal drostaglandins have a supportive role in the maintenance of renal perfusion. In these patients administration of a non steroidal anti-inflammatory drug may cause a dose dependent reduction in prostaglandin formation and may precipitate overt renal deeomdensation. 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 nonstsraidal antidnflarnmatory drug therapy Is typically followed by recovery to the pre-treatraent state.
Those patients at high risk who chronically take ibuprofen should have renal function monitored if they have signs or symptoms which may be consistent with mbd azctemla, such as malaise, fatigue, loss of appetite, ets, Occasional patients may develop some elevstion of serum crestinine and BUN levels without signs or symptoms.
Since ibeprafen 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 gl controlled clinical trials in less than 1% of patients. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an ab n urinal liver test has occurred, should be evaluated for evidence of the develo pmect o1 more severe hepatic reaction s while on therapy with Pe0ia-Prolen. If abnormal liver tests persist or worsen, if olin ical sign s and symptoms consistent with liver disease develop, or if systemic manlfestagons occur (e.g. eosinopbiga, rash, etc.), Pedia-Ptofen should be discontinued, Safety and efficacy of Pedia-Profen in children below the age of 6 months has not been established, Ptegnanef. Reproductive ctudLes 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 adeguste and well-controlled studies in pregnant women, this drug should be used during pregnancy only if clearly needed. Because of the known effects of nonsteroidal antiinflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use durtsg late pregnancy should be avoided, As with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystecia and delayed parturition occurred in rats. Administration of Pedia-Profen is not recommended during pregnancy.
The most frequent type of adverse reaction occurring with ibuprofen is gastrointestinal. In controlled clinical trials, the percentage of 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 I% to 3% of patients; diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of Gltract, headache, nervousness, pruritus, tinnitus, decreased appetite, edern a, fluid retsntion (gee crafty respond s promptly to drug discontinuation). Still Other reactions (less than 1 in 100) have been reported, and are detailed in tha full summary of prescribing information DOSAGE AND ADMINISTRATION: Shake well prior to administration. Fever Reduction in Children 6 months to "12 years o1 age: Dosage should be adjusthd on the basis of the initial temperature level (See OLIN~CAL PHARMACOLOGY for a description of the controlled clinical trial results), The recommended dose is 5 rng/kg if the baseline temperature is less than 102.5 ยฐF or 10 mg/kg if the baseline temperature is greater than 102 5ยฐE The duration of fever reduction is generalry 6-8 hours and is longer with the higher dose. The recommended maximum daily dose is 40 mg/kg, ' Mild to moderale pain: 400 mg every 4 to S hours as necessary for the relief of pain in adults.
In controlled analgesic clinical trials, doses of ibuthcten greater than 400 mg were no more effective than 400 mg dose.
HOW SUPPLIED: Pedia-Profen Ibuprofen Suspension 100 rag/5 ml (tsaspoon)-orange, berry-vanilla flavored Bottles of 4 oz (120 ml) .
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The following is a brief summary only. Before prescribing, consult complete prescribing information in product labeling or PDR. LORI 7.5/SO0 ,C 7.5 mg hydmcodone bitartrate [Warning: May be habit forming) and 500 mg acetaminaphen INDICATIONS: For the relief of moderate to moderately severe pain, CON