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Celecoxib (Celebrex)

Trade Name : CELEBREX

G.D. Searle LLC Division of Pfizer Inc

CAPSULE

Strength 50 mg/1

CELECOXIB 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 Celecoxib (Celebrex) which is also known as CELEBREX and Manufactured by G.D. Searle LLC Division of Pfizer Inc. It is available in strength of 50 mg/1 per ml. Read more

Celecoxib (Celebrex) 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
  • 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 the treatment and may increase with duration of use. ()
  • CELEBREX is 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. ()
  • No data
  • CELEBREX is indicated
  • CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:
  • Osteoarthritis (OA) ()
  • Rheumatoid Arthritis (RA) ()
  • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ()
  • Ankylosing Spondylitis (AS) ()
  • Acute Pain (AP) ()
  • Primary Dysmenorrhea (PD) ()
  • Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). (, , )
  • Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, (, , ).
  • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ()
  • OA: 200 mg once daily or 100 mg twice daily (, )
  • RA: 100 mg to 200 mg twice daily (, )
  • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg (, )
  • AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit (, )
  • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed (, )
  • CELEBREX (celecoxib) capsules:
  • 50 mg white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body.
  • 100 mg white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body.
  • 200 mg white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body.
  • 400 mg white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body.
  • CELEBREX (celecoxib) capsules: 50 mg, 100 mg, 200 mg and 400 mg ()
  • CELEBREX is contraindicated in the following patients:
  • Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides ()
  • 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 in arthritis trials (>2% and >placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • See for clinically significant drug interactions with celecoxib.
  • Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs])
  • Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers
  • ACE Inhibitors and ARBs
  • Diuretics
  • Digoxin
  • No data
  • Pregnancy
  • Infertility
  • Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [].
  • No overdoses of CELEBREX were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose.
  • 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).
  • CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is CHFNOS, and it has the following chemical structure:
  • Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.
  • The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
  • No data
  • No data
  • No data
  • CELEBREX (celecoxib) 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:
  • CELEBREX (celecoxib) 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:
  • CELEBREX (celecoxib) 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:
  • CELEBREX (celecoxib) 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as:
  • Storage
  • Store at room temperature 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]
  • 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 CELEBREX and periodically during the course of ongoing therapy.
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0036-19.0
  • No data
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • NDC 0025-1515-01
  • Pfizer
  • Celebrex
  • 50 mg
  • 60 Capsulesn n
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • NDC 0025-1520-31
  • Pfizer
  • Celebrex
  • 100 mg
  • 100 Capsulesn n
  • PRINCIPAL DISPLAY PANEL - 100 mg Blister Pack
  • Celebrexn
  • 100 mg
  • Distributed byn n- G.D. Searle LLCn
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0025-1520-34n n
  • Celebrexn
  • 100 mg
  • For in-institution use only
  • 100 CapsulesUNIT DOSE
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • NDC 0025-1525-31
  • Pfizer
  • Celebrex
  • 200 mg
  • 100 Capsulesn n
  • PRINCIPAL DISPLAY PANEL - 200 mg Blister Pack
  • Celebrexn
  • 200 mg
  • Distributed byn n- G.D. Searle LLCn
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0025-1525-34n n
  • Celebrexn
  • 200 mg
  • For in-institution use only
  • 100 CapsulesUNIT DOSE
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • CELEBREX
  • 200 mg
  • 1-800-249-2692www.celebrex.com
  • 200 mg200 mg200 mg
  • NDC 0025-1525-99Rx only
  • PROFESSIONAL SAMPLE u2013 NOT FOR SALE
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Contains: 1 blister x 3 capsules
  • CELEBREX
  • 200 mg
  • For patient information, please call 1-800-249-2692or visit our web site at www.celebrex.com
  • PROFESSIONAL SAMPLE u2013 NOT FOR SALE
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Contains: 4 blisters x 3 capsules each
  • NDC 0025-1525-96Contains 4 of NDC 0025-1525-99
  • CELEBREX
  • 200 mg
  • For patient information, please call 1-800-249-2692or visit our web site at www.celebrex.com
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • NDC 0025-1530-02
  • Pfizer
  • Celebrex
  • 400 mg
  • 60 Capsulesn n
  • PRINCIPAL DISPLAY PANEL - 400 mg Blister Pack
  • Celebrexn
  • 400 mg
  • Distributed byn n- G.D. Searle LLCn
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0025-1530-01n n
  • Celebrexn
  • 400 mg
  • For in-institution use only
  • 100 CapsulesUNIT DOSE

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