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ibuprofen
Overview
What is PharmapureRx IBU 600-EZS?
IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:
IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.
What does PharmapureRx IBU 600-EZS look like?
What are the available doses of PharmapureRx IBU 600-EZS?
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What should I talk to my health care provider before I take PharmapureRx IBU 600-EZS?
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How should I use PharmapureRx IBU 600-EZS?
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see ).
IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
IBU tablets are indicated for relief of mild to moderate pain.
IBU tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.
Carefully consider the potential benefits and risks of IBU tabletsand other treatment options before deciding to use IBU tablets. Usethe lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with IBU tablets, thedose and frequency should be adjusted to suit an individual patient’sneeds.Do not exceed 3200 mg total daily dose. If gastrointestinal complaintsoccur, administer IBU tablets with meals or milk.
What interacts with PharmapureRx IBU 600-EZS?
IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen.
IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see ).
IBU tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
What are the warnings of PharmapureRx IBU 600-EZS?
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What are the precautions of PharmapureRx IBU 600-EZS?
General
IBU tablets cannot be expected to substitute for corticosteroids orto treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroidsmay lead to disease exacerbation. Patients on prolongedcorticosteroid therapy should have their therapy tapered slowly if adecision is made to discontinue corticosteroids.
The pharmacological activity of IBU tablets in reducing fever andinflammation may diminish the utility of these diagnostic signs indetecting complications of presumed noninfectious, painful conditions.
Hepatic effects
Borderline elevations of one or more liver tests may occur in upto 15% of patients taking NSAIDs, including IBU tablets. These laboratoryabnormalities may progress, may remain unchanged, or maybe transient with continuing therapy. Notable elevations of ALT orAST (approximately three or more times the upper limit of normal)have been reported in approximately 1% of patients in clinical trialswith NSAIDs. In addition, rare cases of severe hepatic reactions,including jaundice, fulminant hepatitis, liver necrosis, and hepaticfailure, some of them with fatal outcomes have been reported. Apatient with symptoms and/or signs suggesting liver dysfunction, orwith abnormal liver test values, should be evaluated for evidence ofthe development of a more severe hepatic reaction while on therapywith IBU tablets. If clinical signs and symptoms consistent with liverdisease develop, or if systemic manifestations occur (e.g.,eosinophilia, rash, etc.), IBU tablets should be discontinued.
Hematological effects
Anemia is sometimes seen in patients receiving NSAIDs, includingIBU tablets. This may be due to fluid retention, occult or gross GIblood loss, or an incompletely described effect upon erythropoiesis.Patients on long-term treatment with NSAIDs, including IBU tablets,should have their hemoglobin or hematocrit checked if they exhibitany signs or symptoms of anemia.
In two postmarketing clinical studies the incidence of a decreasedhemoglobin level was greater than previously reported. Decrease inhemoglobin of 1 gram or more was observed in 17.1% of 193patients on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of189 patients taking 2400 mg of ibuprofen daily (rheumatoid arthritis).Positive stool occult blood tests and elevated serum creatinine levelswere also observed in these studies.
NSAIDs inhibit platelet aggregation and have been shown to prolongbleeding time in some patients. Unlike aspirin, their effect onplatelet function is quantitatively less, of shorter duration, and reversible.
Patients receiving IBU tablets who may be adversely affected byalterations in platelet function, such as those with coagulation disordersor patients receiving anticoagulants should be carefully monitored.
Preexisting asthma
Patients with asthma may have aspirin-sensitive asthma. The useof aspirin in patients with aspirin-sensitive asthma has been associatedwith severe bronchospasm, which can be fatal. Since cross reactivity,including bronchospasm, between aspirin and NSAIDs hasbeen reported in such aspirin-sensitive patients, IBU tablets shouldnot be administered to patients with this form of aspirin sensitivityand should be used with caution in patients with preexisting asthma.
Ophthalmological effects.
Blurred and/or diminished vision, scotomata, and/or changes incolor vision have been reported. If a patient develops such complaintswhile receiving IBU tablets, the drug should be discontinued, and thepatient should have an ophthalmologic examination which includescentral visual fields and color vision testing.
Aseptic Meningitis
Aseptic meningitis with fever and coma has been observed on rareoccasions in patients on ibuprofen therapy. Although it is probablymore likely to occur in patients with systemic lupus erythematosusand related connective tissue diseases, it has been reported inpatients who do not have an underlying chronic disease. If signs orsymptoms of meningitis develop in a patient on IBU tablets, the possibilityof its being related to IBU tablets should be considered.
Information for Patients
- Cardiovascular Thrombotic Events: Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see ].
- IBU tablets, like other NSAIDs, can cause GI discomfort and, rarely,serious GI side effects, such as ulcers and bleeding, which mayresult in hospitalization and even death. Although serious GI tractulcerations and bleeding can occur without warning symptoms,patients should be alert for the signs and symptoms of ulcerationsand bleeding, and should ask for medical advice when observingany indicative signs or symptoms including epigastric pain, dyspepsia,melena, and hematemesis. Patients should be apprised of theimportance of this follow-up (see ).
- IBU tablets, like other NSAIDs, can cause serious skin side effectssuch as exfoliative dermatitis, SJS and TEN, which may result inhospitalization and even death. Although serious skin reactions mayoccur without warning, patients should be alert for the signs andsymptoms of skin rash and blisters, fever, or other signs of hypersensitivitysuch as itching, and should ask for medical advice whenobserving any indicative sign or symptoms. Patients should beadvised to stop the drug immediately if they develop any type ofrash and contact their physicians as soon as possible.
- Heart Failure and Edema: Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see ].
- Patients should be informed of the warning signs and symptoms ofhepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice,right upper quadrant tenderness and “flu-like” symptoms). If theseoccur, patients should be instructed to stop therapy and seek immediatemedical therapy.
- Patients should be informed of the signs of an anaphylactoid reaction(e.g. difficulty breathing, swelling of the face or throat). If theseoccur, patients should be instructed to seek immediate emergencyhelp (see ).
- In late pregnancy, as with other NSAIDs, IBU tablets should beavoided because it may cause premature closure of the ductus arteriosus.
Patients should be informed of the following information beforeinitiating therapy with an NSAID and periodically during the course ofongoing therapy. Patients should also be encouraged to read theNSAID Medication Guide that accompanies each prescription dispensed
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Laboratory Tests
Because serious GI tract ulcerations and bleeding can occur withoutwarning symptoms, physicians should monitor for signs orsymptoms of GI bleeding. Patients on long-term treatment withNSAIDs should have their CBC and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renaldisease develop, systemic manifestations occur (e.g., eosinophilia,rash etc.), or abnormal liver tests persist or worsen, IBU tabletsshould be discontinued.
Drug Interactions
ACE-inhibitors:
Aspirin
Diuretics
Clinical studies, as well as post marketing observations, haveshown that Ibuprofen tablets can reduce the natriuretic effect-offurosemide and thiazides in some patients. This response has beenattributed to inhibition of renal prostaglandin synthesis. During concomitanttherapy with NSAIDs, the patient should be observed closelyfor signs of renal failure (see PRECAUTIONS, Renal Effects), aswell as to assure diuretic efficacy.
Lithium
Ibuprofen produced an elevation of plasma lithium levels and areduction in renal lithium clearance in a study of eleven normal volunteers.The mean minimum lithium concentration increased 15%and the renal clearance of lithium was decreased by 19% during thisperiod of concomitant drug administration.This effect has been attributed to inhibition of renal prostaglandinsynthesis by ibuprofen. Thus, when ibuprofen and lithium are administeredconcurrently, subjects should be observed carefully for signsof lithium toxicity. (Read circulars for lithium preparation before useof such concurrent therapy.)
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexateaccumulation in rabbit kidney slices. This may indicate that they couldenhance the toxicity of methotrexate. Caution should be used whenNSAIDs are administered concomitantly with methotrexate.
Warfarin-type anticoagulants
Several short-term controlled studies failed to show that Ibuprofentablets significantly affected prothrombin times or a variety of otherclotting factors when administered to individuals on coumarin-typeanticoagulants. However, because bleeding has been reported whenIBU tablets and other NSAIDs have been administered to patients oncoumarin-type anticoagulants, the physician should be cautiouswhen administering IBU tablets to patients on anticoagulants. Theeffects of warfarin and NSAIDs on GI bleeding are synergistic, suchthat the users of both drugs together have a risk of serious GI bleedinghigher than users of either drug alone.
H-2 Antagonists
In studies with human volunteers, co-administration of cimetidineor ranitidine with ibuprofen had no substantive effect on ibuprofenserum concentrations.
Pregnancy
Teratogenic effects: Pregnancy Category C
Reproductive studies conducted in rats and rabbits have notdemonstrated evidence of developmental abnormalities. However,animal reproduction studies are not always predictive of humanresponse. There are no adequate and well-controlled studies in pregnantwomen. Ibuprofen should be used in pregnancy only if thepotential benefit justifies the potential risk to the fetus.
Nonteratogenic effects
Because of the known effects of NSAIDs on the fetal cardiovascularsystem (closure of ductus arteriosus), use during late pregnancyshould be avoided.
Labor and Delivery
In rat studies with NSAIDs, as with other drugs known to inhibitprostaglandin synthesis, an increased incidence of dystocia, delayedparturition, and decreased pup survival occurred. The effects of IBU tablets on labor and delivery in pregnant women are unknown.
Nursing Mothers
It is not known whether this drug is excreted in human milk.Because many drugs are excreted in human-milk and because of thepotential for serious adverse reactions in nursing infants from IBU tablets, a decision should be made whether to discontinue nursing ordiscontinue the drug, taking into account the importance of the drugto the mother.
Pediatric Use
Safety and effectiveness of IBU tablets in pediatric patients havenot been established.
Geriatric Use
As with any NSAIDs, caution should be exercised in treating theelderly (65 years and older).
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What are the side effects of PharmapureRx IBU 600-EZS?
The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In controlled clinical trials thepercentage of patients reporting one or more gastrointestinal complaintsranged from 4% to 16%.
In controlled studies when Ibuprofen tablets were compared toaspirin and indomethacin in equally effective doses, the overall incidenceof gastrointestinal complaints was about half that seen in eitherthe aspirin- or indomethacin-treated patients.
Adverse reactions observed during controlled clinical trials at anincidence greater than 1% are listed in the table. Those reactions listedin Column one encompass observations in approximately 3,000patients. More than 500 of these patients were treated for periods ofat least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 werereported in controlled clinical trials and from marketing experience.These reactions have been divided into two categories: Column twoof the table lists reactions with therapy with Ibuprofen tablets wherethe probability of a causal relationship exists: for the reactions inColumn three, a causal relationship with Ibuprofen tablets has notbeen established.
Reported side effects were higher at doses of 3200 mg/day thanat doses of 2400 mg or less per day in clinical trials of patients withrheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table.
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What should I look out for while using PharmapureRx IBU 600-EZS?
IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen.
IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see ).
IBU tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
What might happen if I take too much PharmapureRx IBU 600-EZS?
Approximately 11⁄2 hours after the reported ingestion of from 7 to10 Ibuprofen tablets (400 mg), a 19-month old child weighing 12 kgwas seen in the hospital emergency room, apneic and cyanotic,responding only to painful stimuli. This type of stimulus, however,was sufficient to induce respiration. Oxygen and parenteral fluidswere given; a greenish-yellow fluid was aspirated from the stomachwith no evidence to indicate the presence of ibuprofen. Two hoursafter ingestion the child’s condition seemed stable; she still respondedonly to painful stimuli and continued to have periods of apnea lastingfrom 5 to 10 seconds. She was admitted to intensive care andsodium bicarbonate was administered as well as infusions of dextroseand normal saline. By four hours post-ingestion she could bearoused easily, sit by herself and respond to spoken commands.Blood level of ibuprofen was 102.9 μg/mL approximately 81⁄2 hoursafter accidental ingestion. At 12 hours she appeared to be completelyrecovered.
In two other reported cases where children (each weighingapproximately 10 kg) accidentally, acutely ingested approximately120 mg/kg, there were no signs of acute intoxication or late sequelae.Blood level in one child 90 minutes after ingestion was 700 μg/mL —about 10 times the peak levels seen in absorption-excretion studies.A 19-year old male who had taken 8,000 mg of ibuprofen over aperiod of a few hours complained of dizziness, and nystagmus wasnoted. After hospitalization, parenteral hydration and three days bedrest, he recovered with no reported sequelae.
In cases of acute overdosage, the stomach should be emptied byvomiting or lavage, though little drug will likely be recovered if morethan an hour has elapsed since ingestion. Because the drug is acidicand is excreted in the urine, it is theoretically beneficial to administeralkali and induce diuresis. In addition to supportive measures, the useof oral activated charcoal may help to reduce the absorption andreabsorption of Ibuprofen tablets.
How should I store and handle PharmapureRx IBU 600-EZS?
Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016IBU tablets are available in the following strengths, colors and sizes:400 mg (white, oval, debossed 4I)Bottles of 90 NDC 55111-682-09Bottles of 100 NDC 55111-682-01Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)600 mg (white, caplet, debossed 6I)Bottles of 30 NDC 55111-683-30Bottles of 50 NDC 55111-683-50Bottles of 90 NDC 55111-683-09Bottles of 100 NDC 55111-683-01Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)800 mg (white, caplet, debossed 8I)Bottles of 30 NDC 55111-684-30Bottles of 50 NDC 55111-684-50Bottles of 60 NDC 55111-684-60Bottles of 90 NDC 55111-684-09Bottles of 100 NDC 55111-684-01Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)Store at room temperature. Avoid excessive heat 40°C (104°F).Manufactured by: Shreveport, LA 71106 USARevised, July 2016
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
IBU tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin synthetaseinhibition.
In clinical studies in patients with rheumatoid arthritis andosteoarthritis, Ibuprofen tablets have been shown to be comparableto aspirin in controlling pain and inflammation and to be associatedwith a statistically significant reduction in the milder gastrointestinalside effects (see ). Ibuprofen may be well toleratedin some patients who have had gastrointestinal side effectswith aspirin, but these patients when treated with IBU tablets shouldbe carefully followed for signs and symptoms of gastrointestinalulceration and bleeding. Although it is not definitely known whetheribuprofen causes less peptic ulceration than aspirin, in one studyinvolving 885 patients with rheumatoid arthritis treated for up to oneyear, there were no reports of gastric ulceration with ibuprofenwhereas frank ulceration was reported in 13 patients in the aspiringroup (statistically significant p<.001).
Gastroscopic studies at varying doses show an increased tendencytoward gastric irritation at higher doses. However, at comparabledoses, gastric irritation is approximately half that seen with aspirin.Studies using 51Cr-tagged red cells indicate that fecal blood lossassociated with Ibuprofen tablets in doses up to 2400 mg daily didnot exceed the normal range, and was significantly less than thatseen in aspirin-treated patients.
In clinical studies in patients with rheumatoid arthritis, Ibuprofenhas been shown to be comparable to indomethacin in controlling thesigns and symptoms of disease activity and to be associated with astatistically significant reduction of the milder gastrointestinal (see ) and CNS side effects.
Ibuprofen may be used in combination with gold salts and/or corticosteroids.
Controlled studies have demonstrated that Ibuprofen is a more effective analgesic than propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief ofthe symptoms of primary dysmenorrhea.
In patients with primary dysmenorrhea, Ibuprofen has been shown to reduce elevated levels of prostaglandin activity in the menstrualfluid and to reduce resting and active intrauterine pressure, as well asthe frequency of uterine contractions. The probable mechanism ofaction is to inhibit prostaglandin synthesis rather than simply to provide analgesia.
The ibuprofen in IBU tablets is rapidly absorbed. Peak serum ibuprofen levels are generally attained one to two hours after administration.With single doses up to 800 mg, a linear relationship exists between amount of drug administered and the integrated area underthe serum drug concentration vs time curve. Above 800 mg, however,the area under the curve increases less than proportional to increases in dose. There is no evidence of drug accumulation or enzyme induction.
The administration of Ibuprofen tablets either under fasting conditions or immediately before meals yields quite similar serum ibuprofen concentration-time profiles. When Ibuprofen is administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption.The bioavailability of the drug is minimally altered by the presence of food.
A bioavailability study has shown that there was no interference with the absorption of ibuprofen when given in conjunction with anantacid containing both aluminum hydroxide and magnesium hydroxide.
Ibuprofen is rapidly metabolized and eliminated in the urine. The excretion of ibuprofen is virtually complete 24 hours after the last dose. The serum half-life is 1.8 to 2.0 hours.
Studies have shown that following ingestion of the drug, 45% to79% of the dose was recovered in the urine within 24 hours as metabolite A (25%), (+)-2-[p-(2hydroxymethyl-propyl) phenyl] propionic acid and metabolite B (37%), (+)-2-[p-(2carboxypropyl)phenyl]propionic acid; the percentages of free and conjugated ibuprofen were approximately 1% and 14%, respectively.
Non-Clinical Toxicology
IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen.IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see ).
IBU tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
ACE-inhibitors:
Aspirin
IBU tablets cannot be expected to substitute for corticosteroids orto treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroidsmay lead to disease exacerbation. Patients on prolongedcorticosteroid therapy should have their therapy tapered slowly if adecision is made to discontinue corticosteroids.
The pharmacological activity of IBU tablets in reducing fever andinflammation may diminish the utility of these diagnostic signs indetecting complications of presumed noninfectious, painful conditions.
The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In controlled clinical trials thepercentage of patients reporting one or more gastrointestinal complaintsranged from 4% to 16%.
In controlled studies when Ibuprofen tablets were compared toaspirin and indomethacin in equally effective doses, the overall incidenceof gastrointestinal complaints was about half that seen in eitherthe aspirin- or indomethacin-treated patients.
Adverse reactions observed during controlled clinical trials at anincidence greater than 1% are listed in the table. Those reactions listedin Column one encompass observations in approximately 3,000patients. More than 500 of these patients were treated for periods ofat least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 werereported in controlled clinical trials and from marketing experience.These reactions have been divided into two categories: Column twoof the table lists reactions with therapy with Ibuprofen tablets wherethe probability of a causal relationship exists: for the reactions inColumn three, a causal relationship with Ibuprofen tablets has notbeen established.
Reported side effects were higher at doses of 3200 mg/day thanat doses of 2400 mg or less per day in clinical trials of patients withrheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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