IBU Tablets

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.

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.

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.

IBU Tablets are available in the following strengths, colors and sizes:

400 mg (white, oval, debossed 4I)

Bottles of 90 NDC 55111-682-09

Bottles of 100 NDC 55111-682-01

Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT)

600 mg (white, caplet, debossed 6I)

Bottles of 30 NDC 55111-683-30

Bottles of 50 NDC 55111-683-50

Bottles of 90 NDC 55111-683-09

Bottles of 100 NDC 55111-683-01

Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT)

800 mg (white, caplet, debossed 8I)

Bottles of 30 NDC 55111-684-30

Bottles of 50 NDC 55111-684-50

Bottles of 60 NDC 55111-684-60

Bottles of 90 NDC 55111-684-09

Bottles of 100 NDC 55111-684-01

Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT)

Store at room temperature. Avoid excessive heat 40°C (104°F).

Manufactured by:

Dr. Reddy’s Laboratories Louisiana, LLC

Shreveport, LA 71106 USA

Revised, July 2016

Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)

What it the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including: 

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

° with increasing doses of NSAIDs

° with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)."  

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. 

•Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:

° anytime during use

° without warning symptoms

° that may cause death

The risk of getting an ulcer or bleeding increases with: 

° past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

° taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs"

° increasing use of NSAIDs

° longer use of NSAIDs

° smoking

° drinking alcohol

° older age

° poor health

° advanced liver disease

° bleeding problems

NSAIDs should only be used:

° exactly as prescribed

° at the lowest dose possible for your treatment

° for the shortest time needed

What are NSAIDs? 

NSAIDs 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 NSAIDs?  

Do not take NSAIDs:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs

• right before or after heart bypass surgery

Before taking NSAIDs, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems

• have high blood pressure

• have asthma

• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks or pregnancy.

• are breastfeeding or plan to breast feed

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See "What is the most important information I should know about medicines called Nonsterodial Anti-Inflammatory Drugs (NSAIDs)?"

• new or worse high blood pressure • low red blood cells (anemia)

• heart failure • life-threatening skin reactions

• liver problems including liver failure • life-threatening allergic reactions

• kidney problems including kidney failure

• Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

 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 it is black and sticky like tar

• diarrhea • unusual weight gain

• itching • skin rash or blisters with fever

• your skin or eyes look yellow • swelling of the arms, legs, hands and feet

• indigestion or stomach pain • flu-like symptoms

If you take too much of your NSAIDs, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

•Aspirin is an NSAID 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 NSAIDs 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.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not us NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for professionals.

IBU™ Ibuprofen Tablets USP 400 mg, 600 mg, and 800 mg Rx - ANDA# 075682

Manufacturing facility: Dr. Reddy's Laboratories Louisiana, LLC - Shreveport, LA 71106 USA

Distributed by: Dr. Reddy's Laboratories, Inc.

For more info, call/contact: 1-888-375-3784

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

Revised May 2016