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Celecoxib (Celecoxib)

Trade Name : Celecoxib

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 100 mg/1

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

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Product information is meant for

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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 Celecoxib (Celecoxib) which is also known as Celecoxib and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Celecoxib (Celecoxib) 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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  • 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 ()
  • Celecoxib capsules 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 ()
  • Celecoxib capsules are indicated
  • Celecoxib capsules are 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 to 200 mg twice daily (, )
  • JRA: 50 mg twice daily in patients 10 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 (, )
  • Capsules: 50 mg, 100 mg, 200 mg, and 400 mg
  • Celecoxib capsules: 50 mg, 100 mg, 200 mg, and 400 mg
  • Celecoxib 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 ().
  • See Table 3 for clinically significant drug interactions with celecoxib.
  • 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
  • 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 celecoxib 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).
  • Celecoxib capsules are 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)-1-pyrazol-1-yl]benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure:
  • CHFNOS M.W. 381.38
  • Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg, or 400 mg of celecoxib.
  • The inactive ingredients in celecoxib capsules include: black iron oxide, gelatin, mannitol, povidone, propylene glycol, shellac, sodium lauryl sulfate, sodium stearyl fumarate, and titanium dioxide. In addition, the 50 mg capsules contain D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #40, and potassium hydroxide; 100 mg capsules contain FD&C blue #1; 200 mg capsules contain D&C red #33 and D&C yellow #10; and 400 mg capsules contain D&C yellow #10 and FD&C green #3.
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  • Celecoxib capsules are available as follows:
  • 50 mg - hard gelatin capsules with a white body and medium orange-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting u201cTEVAu201d on the cap and u201c7306u201d on the body, in bottles of 60 (NDC 0093-7306-06).
  • 100 mg - hard gelatin capsules with an opaque-white body and blue-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting u201cTEVAu201d on the cap and u201c7165u201d on the body, in bottles of 100 (NDC 0093-7165-01) and 500 (0093-7165-05).
  • 200 mg - hard gelatin capsules with an opaque-white body and yellow-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting u201cTEVAu201d on the cap and u201c7166u201d on the body, in bottles of 100 (NDC 0093-7166-01) and 500 (NDC 0093-7166-05).
  • 400 mg - hard gelatin capsules with a dark green body and cap, filled with a white to off-white powder with small agglomerates, imprinting u201cTEVAu201d on the cap and u201c7170u201d on the body, in bottles of 60 (NDC 0093-7170-06).
  • Storage
  • 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 celecoxib and periodically during the course of ongoing therapy.
  • Arrayn- see Warnings and Precautions ()
  • Arrayn- see Warnings and Precautions ()
  • Arrayn- see Warnings and Precautions (), Use in Specific Populations ()
  • Arrayn- see Warnings and Precautions ()
  • Arrayn- see Contraindications () and Warnings and Precautions ()
  • Arrayn- see Warnings and Precautions ()
  • Arrayn- see Use in Specific Populations ()
  • Arrayn- see Warnings and Precautions () and Use in Specific Populations ()
  • Arrayn- see Warnings and Precautions () and Drug Interactions ()
  • Arrayn- see Drug Interactions ()
  • Manufactured In Israel By:n n Jerusalem, 9777402, IsraelManufactured For:n n North Wales, PA 19454Rev. D 5/2016
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