IBU

Main information

  • Trade name:
  • IBU- ibu tablet
  • Composition:
  • IBUPROFEN 800 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IBU- ibu tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 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 WARNINGS). 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. 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 WARNINGS, ANAPHYLACTOID REACTIONS, and PRECAUTIONS, PREEXISTING ASTHMA

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 61919-621-71
  • Last update:
  • 25-05-2019

Summary of Product characteristics: dosage, interactions, side effects

IBU- ibu tablet

DIRECT RX

----------

IBUPROFEN

BOXED WARNING

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascularthrombotic events, myocardial

infarction, and stroke,which can be fatal. This risk may increase with duration ofuse. Patients with

cardiovascular disease or risk factors forcardiovascular disease may be at greater risk (See

WARNINGS).

IBU tablets are contraindicated for treatment of peri-operativepain in the setting of coronary

artery bypass graft (CABG)surgery (See WARNINGS).

Gastrointestinal Risk

NSAIDS cause an increased risk of serious gastrointestinaladverse events including bleeding,

ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur

at any time during use and without warning symptoms.Elderly patients are at greater risk for

serious gastrointestinalevents. (See WARNINGS).

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:

strucuture

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.

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 ADVERSE

REACTIONS). 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 ADVERSE REACTIONS) 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.

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 WARNINGS).

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.

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 WARNINGS, ANAPHYLACTOID REACTIONS,

and PRECAUTIONS, PREEXISTING ASTHMA).

IBU tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery

bypass graft (CABG) surgery(see WARNINGS).

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

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

IBU tablets like other NSAIDs, may cause serious CV side effects,such as MI or stroke, which may

result in hospitalization and evendeath. Although serious CV events can occur without

warningsymptoms, patients should be alert for the signs and symptoms ofchest pain, shortness of breath,

weakness, slurring of speech, andshould ask for medical advice when observing any indicative sign

orsymptoms. Patients should be apprised of the importance of thisfollow-up (see

WARNINGS,CARDIOVASCULAR EFFECTS).

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 WARNINGS,GASTROINTESTINAL

EFFECTS-RISK OF ULCERATION, BLEEDING AND PERFORATION).

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.

Patients should promptly report signs or symptoms of unexplainedweight gain or edema to their

physicians.

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 WARNINGS).

In late pregnancy, as with other NSAIDs, IBU tablets should beavoided because it may cause

premature closure of the ductus arteriosus.

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:Reports suggest that NSAIDs may diminish the antihypertensiveeffect of ACE-

inhibitors. This interaction should be given considerationin patients taking NSAIDs concomitantly with

ACE-inhibitors.

AspirinWhen IBU tablets are administered with aspirin, its protein bindingis reduced, although the

clearance of free IBU tablets is notaltered. The clinical significance of this interaction is not known;

however,as with other NSAIDs, concomitant administration of ibuprofenand aspirin is not generally

recommended because of the potential forincreased adverse effects.

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

IBUtablets 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 IBUtablets, 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).

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 stillwithin

the ranges reported in the table.

table

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.

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.

Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease:

Suggested Dosage: 1200 mg-3200 mg daily (400 mg, 600 mg or800 mg tid or qid). Individual patients

may show a better responseto 3200 mg daily, as compared with 2400 mg, although in well-

controlledclinical trials patients on 3200 mg did not show a better meanresponse in terms of efficacy.

Therefore, when treating patients with3200 mg/day, the physician should observe sufficient increased

clinicalbenefits to offset potential increased risk.The dose should be tailored to each patient, and may

be loweredor raised depending on the severity of symptoms either at time of initiatingdrug therapy or as

the patient responds or fails to respond.In general, patients with rheumatoid arthritis seem to require

higherdoses of IBU tablets than do patients with osteoarthritis.

The smallest dose of IBU tablets that yields acceptable controlshould be employed. A linear blood

level dose-response relationshipexists with single doses up to 800 mg (See CLINICAL

PHARMACOLOGYfor effects of food on rate of absorption).

The availability of three tablet strengths facilitates dosage adjustment.In chronic conditions, a

therapeutic response to therapy with IBU tablets is sometimes seen in a few days to a week but most

often isobserved by two weeks. After a satisfactory response has beenachieved, the patient’s dose

should be reviewed and adjusted asrequired.

Mild to moderate pain:

400 mg every 4 to 6 hours as necessaryfor relief of pain.In controlled analgesic clinical trials, doses

of Ibuprofen tabletsgreater than 400 mg were no more effective than the 400 mg dose.

Dysmenorrhea:

For the treatment of dysmenorrhea, beginningwith the earliest onset of such pain, IBU tablets should be

given in adose of 400 mg every 4 hours as necessary for the relief of pain.

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What it the most important information I should know about medicines called Non-Steroidal Anti-

Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

with longer use of NSAID medicines in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery

bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during

treatment. Ulcers and bleeding:

can happen without warning symptoms may cause death

The chance of a person getting an ulcer or bleeding increases with:

taking medicines called “corticosteroids” drinking alcohol and “anticoagulants”

older age

longer use having poor health

smoking

NSAID medicines should only be used:

exactly as prescribed

for the shortest time needed

at the lowest dose possible for your treatment

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) ?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical

conditions such as:

different types of arthritis

menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID) ? Do not take an NSAID

medicine:

if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine

for pain right before or after heart bypass surgery

Tell your healthcare provider:

about all of your medical conditions

about all of the medicines you take. NSAIDs and some other medicines can interact with each other

and cause serious side effects.

Keep a list of your medicines to show to your healthcare provider and pharmacist.

if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.

if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effect Other side effect include

heart attack stomach pain

stroke constipation

high blood pressure diarrhea

heart failure from body swelling (fluid retention) gas

kidney problems including kidney failure heartburn

bleeding and ulcers in the stomach and intestine nausea

low red blood cells (anemia) vomiting

life-threatening skin reactions dizziness

life-threatening allergic reactions

liver problems including liver failure

asthma attacks in people who have asthma

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing slurred speech

chest pain swelling of the face or throat

weakness in one part or side of your body

Stop your NSAID medicine and call your healthcare provider right away if you have any of the

following symptoms:

nausea vomit blood

more tired or weaker than usual there is blood in your bowel movement or sticky it is black and

sticky like tar

itching skin rash or blister with fever

your skin or eyes look yellow unusual weight gain

stomach pain swelling of the arms and legs, hands and feet

flu-like symptoms

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or

pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-

FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause

bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter)

Talk to your healthcare provider before using over- the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Trade Name

Celecoxib Celebrex

Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)

Diflunisal Dolobid

Etodolac Lodine, Lodine XL

Fenoprofen Nalfon, Nalfon 200

Flurbiprofen Ansaid

Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with

oxycodone)

Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan

Ketoprofen Oruvail

Ketorolac Toradol

Mefenamic Acid Ponstel

Meloxicam Mobic

Nabumetone Relafen

Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with

lansoprazole)

Oxaprozin Daypro

Piroxicam Feldene

Sulindac Clinoril

Tolmetin Tolectin, Tolectin DS, Tolectin 600

*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDS, and is usually

used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may

increase the risk of heart attack or stroke

IBU

ibu tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -6 21(NDC:55111-6 8 4)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

8 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYDEXTRO SE (UNII: VH2XOU12IE)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DIRECT RX

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

Product Characteristics

Color

white

S core

sco re with uneven pieces

S hap e

CAPSULE

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -6 21-71

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /30 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 756 8 2

0 8 /30 /20 16

Labeler -

DIRECT RX (079254320)

Registrant -

DIRECT RX (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

DIRECT RX

0 79 254320

re pa c k(6 19 19 -6 21)

Revised: 8/2016