Trade Name: IBU

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 600 mg/1

Storage and handling

IBUPROFEN Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Cardiovascular Risk
  • Gastrointestinal Risk
  • IBU tablets contain the active ingredient ibuprofen, which is (u00b1) -2 - (n n n - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77u00b0 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:n nn
  • IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.
  • IBU tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin synthetaseinhibition.
  • In clinical studies in patients with rheumatoid arthritis andosteoarthritis, Ibuprofen tablets have been shown to be comparableto aspirin in controlling pain and inflammation and to be associatedwith a statistically significant reduction in the milder gastrointestinalside effects (see n n n ). 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).n nn
  • 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 n n n ) and CNS side effects.n nn
  • 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-[n n n -(2hydroxymethyl-propyl) phenyl] propionic acid and metabolite B (37%), (+)-2-[n n n -(2carboxypropyl)phenyl]propionic acid; the percentages of free and conjugated ibuprofen were approximately 1% and 14%, respectively.n nn
  • 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 n n n ).n nn
  • IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
  • IBU tablets are indicated for relief of mild to moderate pain.
  • IBU tablets are also indicated for the treatment of primary dysmenorrhea.
  • Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.
  • IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen.
  • IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see n n n n n n n
  • IBU tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery(see n n n ).n n n n
  • No data
  • No data
  • 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 11u20442 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 childu2019s 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 u03bcg/mL approximately 81u20442 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 u03bcg/mL u2014about 10 times the peak levels seen in absorption-excretion studies.A 19-year old male who had taken 8,000 mg of ibuprofen over aperiod of a few hours complained of dizziness, and nystagmus wasnoted. After hospitalization, parenteral hydration and three days bedrest, he recovered with no reported sequelae.
  • In cases of acute overdosage, the stomach should be emptied byvomiting or lavage, though little drug will likely be recovered if morethan an hour has elapsed since ingestion. Because the drug is acidicand is excreted in the urine, it is theoretically beneficial to administeralkali and induce diuresis. In addition to supportive measures, the useof oral activated charcoal may help to reduce the absorption andreabsorption of Ibuprofen tablets.
  • Carefully consider the potential benefits and risks of IBU tabletsand other treatment options before deciding to use IBU tablets. Usethe lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS).
  • After observing the response to initial therapy with IBU tablets, thedose and frequency should be adjusted to suit an individual patientu2019sneeds.Do not exceed 3200 mg total daily dose. If gastrointestinal complaintsoccur, administer IBU tablets with meals or milk.
  • IBU tablets are available in the following strengths, colors and sizes:
  • 600 mg (white, caplet, debossed 6I)
  • Bottles of 15 NDC 66267-117-15
  • Bottles of 20 NDC 66267-117-20
  • Bottles of 21 NDC 66267-117-21
  • Bottles of 30 NDC 66267-117-30
  • Bottles of 40 NDC 66267-117-40
  • Bottles of 50 NDC 66267-117-50
  • Bottles of 60 NDC 66267-117-60
  • Bottles of 90 NDC 66267-117-90
  • Store at room temperature. Avoid excessive heat 40u00b0C (104u00b0F).
  • Manufactured by:
  • Dr. Reddyu2019s Laboratories Louisiana, LLC
  • Shreveport, LA 71106 USA
  • Revised, October 2013
  • Medication Guide forn- u00a0Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
  • Array
  • 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 ton- death.
  • This chance increases:
  • u2022 with longer use of NSAID medicines u00a0u2022 in people who have heart disease u00a0
  • NSAID medicines should never be used right before or after a heart surgery called a u201ccoronary artery bypass graft (CABG).u201d
  • NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
  • u2022 can happen without warning symptoms u00a0u2022 may cause death
  • The chance of a person getting an ulcer or bleeding increases with:
  • u2022 taking medicines called u201ccorticosteroidsu201d u2022 drinking alcohol and u201canticoagulantsu201d
  • u2022 older age
  • u2022 longer use u2022 having poor health
  • u2022 smoking
  • NSAID medicines should only be used
  • u2022 exactly as prescribed
  • u2022 for the shortest time needed
  • u2022 at the lowest dose possible for your treatmentu00a0
  • 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:
  • u2022 different types of arthritis
  • u2022 menstrual cramps and other types of short-term pain
  • Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID) ? n- Do not take an NSAID medicine:
  • u2022 if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • u2022 for pain right before or after heart bypass surgery
  • Tell your healthcare provider:
  • Array
  • u2022 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 ton- show to your healthcare provider and pharmacistn- .
  • Arrayn- u2022 n- NSAID medicines should not be used by pregnant women laten- in their pregnancy.
  • Arrayn- Talk to your doctor.
  • What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
  • Arrayn- Get emergency help right away if you have any of the following symptoms
  • u2022 shortness of breath or trouble breathing u2022 slurred speech
  • u2022 chest pain u2022 swelling of the face or throat
  • u2022 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 n- following symptoms:n- Array
  • 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-1088n- Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
  • u2022Aspirin 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.
  • u2022 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
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Ibuprofen (IBU) which is also known as IBU and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 600 mg/1.

Ibuprofen (IBU) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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