IBU (Page 4 of 5)

ADVERSE REACTIONS

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
(click image for full-size original)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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, October 2013

MEDICATION GUIDE

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

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