IBUPROFEN- ibuprofen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ibuprofen (UNII: WK2XYI10QM) (ibuprofen - UNII:WK2XYI10QM)
Available from:
RxChange Co.
INN (International Name):
ibuprofen
Composition:
ibuprofen 600 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaph
Product summary:
Ibuprofen tablets are available in the following strengths : 400 mg (White to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side) Bottles of 100     (NDC 67877-294-01) Bottles of 500     (NDC 67877-294-05) 600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side) Bottles of 30       (NDC 67877-295-30) Bottles of 50       (NDC 67877-295-50) Bottles of 100     (NDC 67877-295-01) Bottles of 500     (NDC 67877-295-05) 800 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side) Bottles of 30       (NDC 67877-296-30) Bottles of 50       (NDC 67877-296-50) Bottles of 100     (NDC 67877-296-01) Bottles of 500     (NDC 67877-296-05) Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature] Rx only Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India Rev. 07/13
Authorization status:
Abbreviated New Drug Application
Authorization number:
33358-187-15, 33358-187-30, 33358-187-60

RxChange Co.

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

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

What is 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” and “anticoagulants”

longer use

smoking

drinking alcohol

older age

having poor health

NSAID medicines should only be used:

exactly as prescribed

at the lowest dose possible for your treatment

for the shortest time needed

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 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 effects include:

Other side effects include:

heart attack

stroke

high blood pressure

heart failure from body swelling (fluid retention)

kidney problems including kidney failure

stomach pain

constipation

diarrhea

gas

heartburn

bleeding and ulcers in the stomach and intestine

low red blood cells (anemia)

life-threatening skin reactions

life-threatening allergic reactions

liver problems including liver failure

asthma attacks in people who have asthma

nausea

vomiting

dizziness

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

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

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

symptoms:

nausea

more tired or weaker than usual

itching

your skin or eyes look yellow

stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms and legs, hands and feet

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

for more information about NSAID medicines.

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

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.

Generic Name

Tradename

Celecoxib

Celebrex

Diclofenac

Cataflam, Voltaren, Arthrotec (combined with

misoprostol)

Diflunisal

Dolobid

Etodolac

Lodine, Lodine XL

Fenoprofen

Nalfon, Nalfon 200

Flurbirofen

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-Naproxyn,

Naprelan, Naprapac (copackaged with lansoprazole)

Oxaprozin

Daypro

Piroxicam

Feldene

Sulindac

Clinoril

Tolmetin

Tolectin, Tolectin DS, Tolectin 600

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 and/or to Ascend Laaboratories at 1-877-272-

7901.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revision: R306/09

Manufactured for:

Ascend Laboratories, LLC

Montvale, NJ 07645

Manufactured by:

Marksans Pharma Ltd.

Verna, Goa-403 722, India

Revised: 11/2014

Document Id: 13171729-20a2-4569-928f-dd38b8eb89dc

Set id: 373aad4c-45a6-4e69-8791-d4f93c2f645c

Version: 2

Effective Time: 20141114

RxChange Co.

IBUPROFEN- ibuprofen tablet

RxChange Co.

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Ibuprofen Tablets, USP

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial

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

with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

(See WARNINGS).

Ibuprofen tablets are contraindicated for treatment of peri-operative pain in the setting of

coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

NSAIDS cause an increased risk of serious gastrointestinal adverse events including

bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These

events can occur at any time during use and without warning symptoms. Elderly patients are at

greater risk for serious gastrointestinal events (see WARNINGS).

DESCRIPTION

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl)

propionic acid. Ibuprofen is a white powder with 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:

Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and

800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose

sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,

pregelatinized starch, talc and titanium dioxide.

CLINICAL PHARMACOLOGY

Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of

action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin

synthetase inhibition.

In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets have been

shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a

statistically significant reduction in the milder gastrointestinal side effects (see ADVERSE

REACTIONS). Ibuprofen tablets may be well tolerated in some patients who have had gastrointestinal

side effects with aspirin, but these patients when treated with ibuprofen tablets should be carefully

followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not

definitely known whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study

involving 885 patients with rheumatoid arthritis treated for up to one year, there were no reports of

gastric ulceration with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the

aspirin group (statistically significant p< .001).

Gastroscopic studies at varying doses show an increased tendency toward gastric irritation at higher

doses. However, at comparable doses, gastric irritation is approximately half that seen with aspirin.

Studies using 51Cr-tagged red cells indicate that fecal blood loss associated with ibuprofen tablets in

doses up to 2400 mg daily did not exceed the normal range, and was significantly less than that seen in

aspirin-treated patients.

In clinical studies in patients with rheumatoid arthritis, ibuprofen tablets have been shown to be

comparable to indomethacin in controlling the signs and symptoms of disease activity and to be

associated with a statistically significant reduction of the milder gastrointestinal (see ADVERSE

REACTIONS) and CNS side effects.

Ibuprofen tablets may be used in combination with gold salts and/or corticosteroids.

Controlled studies have demonstrated that ibuprofen tablets are a more effective analgesic than

propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for

the relief of the symptoms of primary dysmenorrhea.

In patients with primary dysmenorrhea, ibuprofen tablets have been shown to reduce elevated levels of

prostaglandin activity in the menstrual fluid and to reduce resting and active intrauterine pressure, as

well as the frequency of uterine contractions. The probable mechanism of action is to inhibit

prostaglandin synthesis rather than simply to provide analgesia.

The ibuprofen in ibuprofen 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 under the 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 tablets are

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

ibuprofen tablets were given in conjunction with an antacid 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% to 79% 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.

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options

before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration

consistent with individual patient treatment goals (see WARNINGS).

Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and

osteoarthritis.

Ibuprofen tablets are indicated for relief of mild to moderate pain.

Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have

not been conducted.

CONTRAINDICATIONS

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen.

Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-

type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to

NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and

PRECAUTIONS, Preexisting Asthma).

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

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

WARNINGS

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have

shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and

stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar

risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize

the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose

should be used for the shortest duration possible. Physicians and patients should remain alert for the

development of such events, even in the absence of previous CV symptoms. Patients should be informed

about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious

CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does

increase the risk of serious GI events (see WARNINGS, Gastrointestinal Effects-Risk of

Ulceration, Bleeding, and Perforation).

Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first

10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke

(see CONTRAINDICATIONS).

Hypertension

NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of pre-

existing hypertension, either of which may contribute to the increased incidence of CV events. Patients

taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.

NSAIDs, including ibuprofen tablets, should be used with caution in patients with hypertension. Blood

pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the

course of therapy.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen tablets should

be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including

inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine,

which can be fatal. These serious adverse events can occur at any time, with or without warning

symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI

adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation

caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of

patients treated for one year. These trends continue with longer duration of use, increasing the

likelihood of developing a serious GI event at some time during the course of therapy. However, even

short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with

a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer

disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for

developing a GI bleed compared to patients treated with neither of these risk factors. Other factors that

increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral

corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older

age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or

debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest

effective dose should be used for the shortest possible duration. Patients and physicians should remain

alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate

additional evaluation and treatment if a serious GI event is suspected. This should include

discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients,

alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in

the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-

dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which 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 ACE inhibitors, and the

elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of ibuprofen tablets in

patients with advanced renal disease. Therefore, treatment with ibuprofen tablets is not recommended in

these patients with advanced renal disease. If ibuprofen tablet therapy must be initiated, close monitoring

of the patients renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to

ibuprofen tablets. Ibuprofen tablets should not be given to patients with the aspirin triad. This symptom

complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or

who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see

CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma). Emergency help should be

sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including ibuprofen tablets, can cause serious skin adverse events such as exfoliative

dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

These serious events may occur without warning. Patients should be informed about the signs and

symptoms of serious skin manifestations and use of the drug should be discontinued at the first

appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, ibuprofen tablets should be avoided because it may cause

premature closure of the ductus arteriosus.

PRECAUTIONS

General

Ibuprofen tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid

insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on

prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to

discontinue corticosteroids.

The pharmacological activity of ibuprofen tablets in reducing fever and inflammation may diminish the

utility of these diagnostic signs in detecting complications of presumed noninfectious, painful

conditions.

Hepatic effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs,

including ibuprofen tablets. These laboratory abnormalities may progress, may remain unchanged, or

may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or

more times the upper limit of normal) have been reported in approximately 1% of patients in clinical

trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant

hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported.

A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values,

should be evaluated for evidence of the development of a more severe hepatic reaction while on

therapy with ibuprofen tablets. If clinical signs and symptoms consistent with liver disease develop, or

if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen tablets should be

discontinued.

Hematological effects

Anemia is sometimes seen in patients receiving NSAIDs, including ibuprofen tablets. This may be due

to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon

erythropoiesis. Patients on long-term treatment with NSAIDs, including ibuprofen tablets, should have

their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than

previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients

on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of ibuprofen

daily (rheumatoid arthritis). Positive stool occult blood tests and elevated serum creatinine levels were

also observed in these studies.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.

Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible.

Patients receiving ibuprofen tablets who may be adversely affected by alterations in platelet function,

such as those with coagulation disorders or patients receiving anticoagulants should be carefully

monitored.

Preexisting asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-

sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross

reactivity, including bronchospasm, between aspirin and NSAIDs has been reported in such aspirin-

sensitive patients, ibuprofen tablets should not be administered to patients with this form of aspirin

sensitivity and should be used with caution in patients with preexisting asthma.

Ophthalmological effects

Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a

patient develops such complaints while receiving ibuprofen tablets, the drug should be discontinued,

and the patient should have an ophthalmologic examination which includes central visual fields and

color vision testing.

Aseptic Meningitis

Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen

therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and

related connective tissue diseases, it has been reported in patients who do not have an underlying

chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen tablets, the

possibility of its being related to ibuprofen tablets should be considered.

Information for Patients

Patients should be informed of the following information before initiating therapy with an NSAID

and periodically during the course of ongoing therapy. Patients should also be encouraged to

read the NSAID Medication Guide that accompanies each prescription dispensed.

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

which may result in hospitalization and even death. Although serious CV events can occur without

warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of

breath, weakness, slurring of speech, and should ask for medical advice when observing any

indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see

WARNINGS, Cardiovascular Effects).

Ibuprofen tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects,

such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI

tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the

signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing

any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.

Patients should be apprised of the importance of this follow-up (see WARNINGS,

Gastrointestinal Effects- Risk of Ulceration, Bleeding and Perforation).

Ibuprofen tablets, like other NSAIDs, can cause serious skin side effects such as exfoliative

dermatitis, SJS and TEN, which may result in hospitalization and even death. Although serious skin

reactions may occur without warning, patients should be alert for the signs and symptoms of skin

rash and blisters, fever, or other signs hypersensitivity such as itching, and should ask for medical

advice when observing any indicative sign or symptoms. Patients should be advised to stop the drug

immediately if they develop any type of rash and contact their physicians as soon as possible.

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

physicians.

Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea,

fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and “flu-like” symptoms). If

these occur, patients should be instructed to stop therapy and seek immediate medical therapy.

Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing,

swelling of the face or throat). If these occur, patients should be instructed to seek immediate

emergency help (see WARNINGS).

In late pregnancy, as with other NSAIDs, ibuprofen tablets should be avoided because it may cause

premature closure of the ductus arteriosus.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians

should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs

should have their CBC and chemistry profile checked periodically. If clinical signs and symptoms

consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash

etc.), or abnormal liver tests persist or worsen, ibuprofen tablets should be discontinued.

Drug Interactions

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This

interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin

When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the

clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not

known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not

generally recommended because of the potential for increased adverse effects.

Diuretics

Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce

the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to

inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should

be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure

diuretic efficacy.

Lithium

Ibuprofen produced an elevation of plasma lithium levels and a reduction 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 this period of concomitant drug administration. This

effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when

ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of

lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.

This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when

NSAIDs are administered concomitantly with methotrexate.

Warfarin-type anticoagulants

Several short-term controlled studies failed to show that ibuprofen tablets significantly affected

prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-

type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other

NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be

cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and

NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of

serious GI bleeding higher than users of either drug alone.

H-2 Antagonists

In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no

substantive effect on ibuprofen serum concentrations.

Pregnancy

Teratogenic effects-Pregnancy Category C

Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental

abnormalities. However, animal reproduction studies are not always predictive of human response.

There are no adequate and well-controlled studies in pregnant women. Ibuprofen tablets should be used

in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic effects

Because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus

arteriosus), use during late pregnancy should be avoided.

Labor and Delivery

In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased

incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of

ibuprofen 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 the potential for serious adverse reactions in nursing infants from ibuprofen tablets,

a decision should be made whether to discontinue nursing or discontinue the drug, taking into account

the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established.

Geriatric Use

As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

ADVERSE REACTIONS

The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In

controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints

ranged from 4% to 16%.

In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally

effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either

the aspirin- or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in

the table. Those reactions listed in Column one encompass observations in approximately 3,000

patients. More than 500 of these patients were treated for periods of at least 54 weeks.

Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials

and from marketing experience. These reactions have been divided into two categories: Column two of

the table lists reactions with therapy with ibuprofen tablets where the probability of a causal

relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has

not been established.

Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in

clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still

within the ranges reported in the table.

Incidence Greater than 1%

(but less than 3%)

Probable Causal Relationship

Unknown*

Precise Incidence Unknown

(but less than 1%)

Probable Causal Relationship*

Precise Incidence

Unknown (but less than 1%)

Causal Relationship

GASTROINTESTINAL

Nausea†, epigastric pain†,

heartburn†, diarrhea, abdominal

distress, nausea and vomiting,

indigestion, constipation,

abdominal cramps or Pain,

fullness of GI tract (bloating and

flatulence)

Gastric or duodenal ulcer with

bleeding and/or perforation,

gastrointestinal hemorrhage, melena,

gastritis, hepatitis, jaundice,

abnormal liver function tests;

pancreatitis

CENTRAL NERVOUS

SYSTEM

Dizziness†, headache,

nervousness

Depression, insomnia, confusion,

emotional lability, somnolence,

aseptic meningitis with fever and

coma (see

PRECAUTIONS)

Paresthesias, hallucinations,

dream abnormalities, pseudo-

tumor cerebri

DERMATOLOGIC

Rash† (including maculopapular

type), pruritus

Vesiculobullous eruptions,

urticaria, erythema multiforme,

Stevens-Johnson syndrome, alopecia

Toxic epidermal necrolysis,

photoallergic skin reactions

SPECIAL SENSES

Tinnitus

Hearing loss, amblyopia (blurred

and/or diminished vision, scotomata

and/or changes in color vision) (see

PRECAUTIONS)

Conjunctivitis, diplopia, optic

neuritis, cataracts

HEMATOLOGIC

Neutropenia, agranulocytosis,

aplastic anemia, hemolytic anemia

(sometimes Coombs positive),

thrombocytopenia with or without

purpura, eosinophilia, decreases in

hemoglobin and hematocrit

(see PRECAUTIONS)

Bleeding episodes (eg

epistaxis, menorrhagia)

METABOLIC/ENDOCRINE

Decreased appetite

Gynecomastia, hypoglycemic

reaction, acidosis

CARDIOVASCULAR

Edema, fluid retention (generally

responds promptly to drug

discontinuation)

(see PRECAUTIONS)

Congestive heart failure in patients

with marginal cardiac function,

elevated blood pressure, palpitations

Arrhythmias (sinus tachycardia,

sinus bradycardia)

ALLERGIC

Syndrome of abdominal pain, fever,

chills, nausea and vomiting;

anaphylaxis; bronchospasm

(see CONTRAINDICATIONS)

Serum sickness,

lupuserythematosus syndrome.

Henoch-Schonlein vasculitis,

angioedema

RENAL

Acute renal failure

(see PRECAUTIONS), decreased

creatinine clearance, polyuria,

azotemia, cystitis, Hematuria

Renal papillary necrosis

MISCELLANEOUS

Dry eyes and mouth,

gingival ulcer, rhinitis

Reactions are classified under “Probable Causal Relationship (PCR)” if there has been one positive rechallenge or

if three or more cases occur which might be causally related. Reactions are classified under “Causal Relationship

Unknown” if seven or more events have been reported but the criteria for PCR have not been met.

Reactions occurring in 3% to 9% of patients treated with ibuprofen tablets. (Those reactions occurring in less than

3% of the patients are unmarked).

OVERDOSAGE

Approximately 1½ hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-

month old child weighing 12 kg was 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 fluids were given; a greenish-yellow fluid was aspirated from the stomach with

no evidence to indicate the presence of ibuprofen. Two hours after ingestion the child’s condition

seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting

from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as

well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused

easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 μg/mL

approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely

recovered.

In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely

ingested approximately 120 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 a period of a few hours complained of

dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest,

he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug

will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic

and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In

addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption

and reabsorption of ibuprofen tablets.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options

before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration

consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be

adjusted to suit an individual patient’s needs.

Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen

tablets with meals or milk.

Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease

Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).

Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although

in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of

efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient

increased clinical benefits to offset potential increased risk.

The dose should be tailored to each patient, and may be lowered or raised depending on the severity of

symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do

patients with osteoarthritis.

The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear

blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL

PHARMACOLOGY for effects of food on rate of absorption).

The availability of four tablet strengths facilitates dosage adjustment.

In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few

days to a week but most often is observed by two weeks. After a satisfactory response has been

achieved, the patient’s dose should be reviewed and adjusted as required.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.

In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more

effective than the 400 mg dose.

Dysmenorrhea

For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets

should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

HOW SUPPLIED

Ibuprofen tablets are available in the following strengths :

400 mg (White to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side

and plain on other side)

Bottles of 100 (NDC 67877-294-01)

Bottles of 500 (NDC 67877-294-05)

600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on

one side and plain on other side)

Bottles of 30 (NDC 67877-295-30)

Bottles of 50 (NDC 67877-295-50)

Bottles of 100 (NDC 67877-295-01)

Bottles of 500 (NDC 67877-295-05)

800 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on

one side and plain on other side)

Bottles of 30 (NDC 67877-296-30)

Bottles of 50 (NDC 67877-296-50)

Bottles of 100 (NDC 67877-296-01)

Bottles of 500 (NDC 67877-296-05)

Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature]

Rx only

Manufactured for:

Ascend Laboratories, LLC

Montvale, NJ 07645

Manufactured by:

Marksans Pharma Ltd.

Verna, Goa-403 722, India

Rev. 07/13

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

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

What is 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” and “anticoagulants”

longer use

smoking

drinking alcohol

older age

having poor health

NSAID medicines should only be used:

exactly as prescribed

at the lowest dose possible for your treatment

for the shortest time needed

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 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 effects include:

Other side effects include:

heart attack

stroke

high blood pressure

heart failure from body swelling (fluid retention)

kidney problems including kidney failure

bleeding and ulcers in the stomach and intestine

low red blood cells (anemia)

life-threatening skin reactions

life-threatening allergic reactions

liver problems including liver failure

asthma attacks in people who have asthma

stomach pain

constipation

diarrhea

gas

heartburn

nausea

vomiting

dizziness

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

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

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

following symptoms:

nausea

more tired or weaker than usual

itching

your skin or eyes look yellow

stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms and legs, hands and feet

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

pharmacist for more information about NSAID medicines.

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 Name

Tradename

Celecoxib

Celebrex

Diclofenac

Cataflam, Voltaren, Arthrotec (combined with misoprostol)

Diflunisal

Dolobid

Etodolac

Lodine, Lodine XL

Fenoprofen

Nalfon, Nalfon 200

Flurbirofen

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-Naproxyn, Naprelan,

Naprapac (copackaged with lansoprazole)

Oxaprozin

Daypro

Piroxicam

Feldene

Sulindac

Clinoril

Tolmetin

Tolectin, Tolectin DS, Tolectin 600

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 and/or to Ascend Laaboratories

at 1-877-272-7901.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revision: R306/09

Manufactured for:

Ascend Laboratories, LLC

Montvale, NJ 07645

Manufactured by:

Marksans Pharma Ltd.

Verna, Goa-403 722, India

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.

IBUPROFEN

ibuprofen tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:33358 -18 7(NDC:6 78 77-29 5)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ibupro fen (UNII: WK2XYI10 QM) (ibupro fen - UNII:WK2XYI10 QM)

ibupro fe n

6 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white (White to o ff white)

S core

no sco re

S hap e

CAPSULE (capsule shaped, bico nvex)

S iz e

18 mm

RxChange Co.

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:33358 -18 7-30

30 in 1 BOTTLE

2

NDC:33358 -18 7-6 0

6 0 in 1 BOTTLE

3

NDC:33358 -18 7-15

15 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 79 6

11/0 9 /20 14

Labeler -

RxChange Co. (781126805)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RxChange Co .

78 1126 8 0 5

re pa c k(33358 -18 7)

Revised: 11/2014

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