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Flurbiprofen (Flurbiprofen)

Trade Name : Flurbiprofen

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 50 mg/1

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

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Mylan Pharmaceuticals Inc.. It is available in strength of 50 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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  • No data
  • Boxed Warning
  • Warnings and Precautions, Cardiovascular Thrombotic Events ()u00a0u00a0u00a0u00a0u00a05/2016
  • Warnings and Precautions, Heart Failure and Edema ()u00a0u00a0u00a0u00a0u00a05/2016
  • Arrayn- Array
  • Arrayn- Array
  • 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:
  • 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 [].
  • After observing the response to initial therapy with flurbiprofen tablets, the dose and frequency should be adjusted to suit an individual patientu2019s needs.
  • For relief of the signs and symptoms of rheumatoid arthritis or osteoarthritis, the dosage is 200 mg 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 are available containing 50 mg or 100 mg of flurbiprofen, USP.
  • Fluriprofen tablets: 50 mg and 100 mg ()
  • Flurbiprofen tablets are contraindicated in the following patients:
  • 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 ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or n
  • 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, available as 50 mg beige, film-coated, round, debossed with over on one side of the tablet and blank on the other side and 100 mg beige, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side, for oral administration. Flurbiprofen 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-alpha-methyl-, (u00b1)-. The molecular weight is 244.26. Its molecular formula is CHFO and it has the following structural formula:
  • The inactive ingredients in flurbiprofen tablets (both strengths) include: black iron oxide, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polydextrose, propylene glycol, sodium lauryl sulfate, titanium dioxide, triacetin, and yellow iron oxide.
  • No data
  • No data
  • Flurbiprofen Tablets, USP are available containing 50 mg or 100 mg of flurbiprofen, USP.
  • The 50 mg tablets are beige, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:
  • 0378-0076-01bottles of 100 tablets
  • The 100 mg tablets are beige, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:
  • 0378-0093-01bottles of 100 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from light.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PHARMACIST:
  • Advise the patient to read the FDA-approved patient labeling () that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with flurbiprofen tablets and periodically during the course of ongoing therapy.
  • Cardiovascular Thrombotic Events:u00a0n- see n
  • Gastrointestinal Bleeding, Ulceration, and Perforation:n- see n
  • Hepatotoxicity:n- see n
  • Heart Failure and Edema:n- see n
  • Anaphylactic Reactions:n- see and n
  • Serious Skin Reactions:u00a0n- see n
  • Female Fertility:n- see n
  • Fetal Toxicity:n- see and n
  • Avoid Concomitant Use of NSAIDs:n- see n n- Array
  • Use of NSAIDs and Low-Dose Aspirin:u00a0n- see n
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Mylan Pharmaceuticals Inc.
  • Revised: 5/2016FRB:R11m
  • NDC 0378-0076-01
  • Flurbiprofenn- Tablets, USPn- 50 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each film-coated tablet contains:Flurbiprofen, USP 50 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM0076A8
  • NDC 0378-0093-01
  • Flurbiprofenn- Tablets, USPn- 100 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each film-coated tablet contains:Flurbiprofen, USP 100 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM0093A8

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