Flurbiprofen (Flurbiprofen)

Trade Name : Flurbiprofen

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 100 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Flurbiprofen (Flurbiprofen) which is also known as Flurbiprofen and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Flurbiprofen (Flurbiprofen) 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.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Arrayn- Cardiovascular Thrombotic Events
  • Arrayn- Gastrointestinal Bleeding, Ulceration, and Perforation
  • WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
  • See full prescribing information for complete boxed warning.
  • 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 ()
  • Flurbiprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (, )
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ()
  • Flurbiprofen tablets are indicated:
  • Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for
  • Relief of the signs and symptoms of rheumatoid arthritis
  • Relief of the signs and symptoms of osteoarthritis
  • Carefully consider the potential benefits and risks of flurbiprofen tablets and other treatment options before deciding to use flurbiprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [n ].
  • After observing the response to initial therapy with flurbiprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
  • For relief of the signs and symptoms of rheumatoid arthritis or osteoarthritis, the dosage is 200 to 300 mg per day, divided for administration two, three, or four times a day. The largest recommended single dose in a multiple-dose daily regimen is 100 mg.
  • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ()
  • The recommended starting dose of flurbiprofen tablets is 200 to 300 mg per day, divided for administration two, three, or four times a day. The largest recommended single dose in a multiple-dose daily regimen is 100 mg ()
  • Flurbiprofen tablets USP: 100 mg round, blue, film-coated tablets debossed u201c93u201d-u201c711u201d
  • Flurbiprofen tablet USP, 100 mg ()
  • Flurbiprofen tablets are contraindicated in the following patients:
  • Known hypersensitivity to flurbiprofen or any components of the drug product (, )
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (, )
  • In the setting of CABG surgery ()
  • No data
  • Hepatotoxicity
  • Hypertension
  • Heart Failure and Edema
  • Renal Toxicity
  • Anaphylactic Reactions
  • Exacerbation of Asthma Related to Aspirin Sensitivity
  • Serious Skin Reactions
  • Premature Closure of Fetal Ductus Arteriosus
  • Hematologic Toxicity
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (incidence > 3% from clinical trials) are: abdominal pain, dyspepsia, nausea, diarrhea, constipation, headache, edema, signs and symptoms suggesting urinary tract infection ()
  • See Table 1 for clinically significant drug interactions with flurbiprofen.
  • Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs)
  • ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers
  • ACE Inhibitors and ARBs
  • Diuretics
  • Pregnancy
  • Infertility
  • Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare [].
  • Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
  • For additional information about overdosage treatment contact a poison control center (1-800-222-1222).
  • Flurbiprofen tablets USP are a member of the phenylalkanoic acid derivative group of nonsteroidal anti-inflammatory drug. Flurbiprofen tablets USP are round, blue, film-coated debossed u201c93u201d u2013 u201c711u201d tablets for oral administration. Flurbiprofen, USP is a racemic mixture of (+)S- and (-)R- enantiomers. Flurbiprofen, USP is a white or slightly yellow crystalline powder. It is slightly soluble in water at pH 7.0 and readily soluble in most polar solvents. The chemical name is [1,1u2019-biphenyl]-4-acetic acid,2-fluoro-u03b1-methyl-, (u00b1)-. It has the following structural formula:
  • Each tablet, for oral administration, contains 100 mg flurbiprofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and FD&C Blue #1 aluminum lake.
  • No data
  • Carcinogenesis
  • Mutagenesis
  • in vivo
  • Impairment of Fertility
  • Flurbiprofen tablets USP, 100 mg are round, blue, film-coated tablets debossed u201c93u201d-u201c711u201d available in bottles of 100 (NDC 0093-0711-01) and 500 (NDC 0093-0711-05).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with flurbiprofen and periodically during the course of ongoing therapy.
  • Cardiovascular Thrombotic Eventsn- see Warnings and Precautions ()
  • Gastrointestinal Bleeding, Ulceration, and Perforationn- see Warnings and Precautions ()
  • Hepatotoxicity n- see Warnings and Precautions ()
  • Heart Failure and Edeman- see Warnings and Precautions ()
  • Anaphylactic Reactionsn- see Contraindications () and Warnings and Precautions ()
  • Serious Skin Reactionsn- see Warnings and Precautions ()
  • Female Fertilityn- see Use in Specific Populations ()
  • Fetal Toxicityn- see Warnings and Precautions () and Use in Specific Populations ()
  • Avoid Concomitant Use of NSAIDsn- see Warnings and Precautions () and Drug Interactions ()
  • Use of NSAIDS and Low-Dose Aspirinn- see Drug Interactions ()
  • Manufactured In India By:n n Pithampur, Madhya Pradesh, IndiaManufactured For:n n n North Wales, PA 19454Rev. K 5/2016
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