Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Rx Only
BOXED WARNING SECTION
BOXED WARNING SECTION
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see Warnings and Precautions ). Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see Contraindications and 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
DESCRIPTION SECTION
Ibuprofen Tablets, USP contain the active ingredient Ibuprofen, USP which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° C to 77° C and is very slightly soluble in water (
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
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 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 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 whereas frank ulceration was reported in 13 patients in the aspirin group (statistically significant p
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. 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
CONTRAINDICATIONS SECTION
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 ). In the setting of coronary artery bypass graft (CABG) surgery [see Warnings ].
WARNINGS
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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 3,200 mg/day than at doses of 2,400 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* Precise Incidence Unknown (but less than 1%) Probable Causal Relationship** Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown** GASTROINTESTINAL Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence) CENTRAL NERVOUS SYSTEM Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS ) Paresthesias, hallucinations, dream abnormalities, Dizziness*, headache, nervousness pseudotumor cerebri DERMATOLOGIC Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens- Johnson syndrome, alopecia Toxic epidermal necrolysis, photoallergic skin reactions Rash*, (including maculopapular type), pruritus SPECIAL SENSES Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and /or changes in color vision) (see PRECAUTIONS ) Conjunctivitis, diplopia, optic neuritis, cataracts Tinnitus 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 Gynecomastia, hypoglycemic reaction, acidosis Decreased appetite CARDIOVASCULAR Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations Arrhythmias (sinus tachycardia, sinus bradycardia) Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS ) ALLERGIC Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS ) Serum sickness, Iupus erythematosus syndrome. Henoch-Schonlein vasculitis, angioedema RENAL Acute renal failure (see PRECAUTIONS ), decreased creatinine clearance, poliuria, azotemia, cystitis, hematuria Renal papillary necrosis MISCELLANEOUS Dry eyes and mouth, gingival ulcer, rhinitis *Reactions occurring in 3% to 9% of patients treated with IBU (those reactions occurring in less than 3% of the patients are unmarked.) **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.
OVERDOSAGE
OVERDOSAGE SECTION
Approximately 1 1/2 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 8 1/2 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 bedrest, he recovered with no reported sequelae. In cases of acute over dosage, 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
DOSAGE & ADMINISTRATION SECTION
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 3,200 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 : 1,200 mg to 3,200 mg daily (400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3,200 mg daily, as compared with 2,400 mg, although in well-controlled clinical trials patients on 3,200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3,200 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 three 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
HOW SUPPLIED SECTION
Ibuprofen Tablets, USP are available in the following strengths: The 400 mg tablets are film-coated clear, round shaped, white tablets, debossed “C5” on one side and plain on the other side. They are available as follows: Bottles of 90 tablets – NDC 68071-2798-9 (PACKAGE NOT CHILD-RESISTANT) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 USA Distributed by: Florida Pharmaceutical Products, LLC 6111 Broken Sound Pkwy NW Suite 160 Boca Raton, FL 33487 Toll Free Number: 1-800-315-0985 14464-04-21 MEDICATION GUIDE Medication Guide for Non-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 take a 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. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of 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 Nonsteroidal 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 use 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. For more information, call/contact: 1-631-231-4610 This Medication Guide has been approved by the U.S. Food and Drug Administration Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 Distributed by: Florida Pharmaceutical Products, LLC 6111 Broken Sound Pkwy NW Suite 160 Boca Raton, FL 33487, Toll Free Number: 1-800-315-0985 14517-04-21
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
