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Oxaprozin (Daypro)

Trade Name : Daypro

G.D. Searle LLC Division of Pfizer Inc

TABLET, FILM COATED

Strength 600 mg/1

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

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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 Oxaprozin (Daypro) which is also known as Daypro and Manufactured by G.D. Searle LLC Division of Pfizer Inc. It is available in strength of 600 mg/1 per ml. Read more

Oxaprozin (Daypro) 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 treatment and may increase with duration of use ()
  • DAYPRO 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
  • DAYPRO is indicated:
  • DAYPRO is a non-steroidal anti-inflammatory drug indicated for:
  • Relief of signs and symptoms of Osteoarthritis (OA) ()
  • Relief of signs and symptoms of Rheumatoid Arthritis (RA) ()
  • Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) ()
  • No data
  • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ()
  • OA: 1200 mg (two 600 mg caplets) given orally once a day (, , )
  • RA: 1200 mg (two 600 mg caplets) given orally once a day (, , )
  • JRA: 600 mg once daily in patients 22u201331 kg. 900 mg once daily in patients 32u201354 kg. 1200 mg once daily in patients u2265 55 kg (, )
  • DAYPRO (oxaprozin) caplets: 600 mg caplets, white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side.
  • DAYPRO (oxaprozin) caplets: 600 mg ()
  • DAYPRO is contraindicated in the following patients:
  • Known hypersensitivity to oxaprozin 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 (>3 %) are: constipation, diarrhea, dyspepsia, nausea, 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 oxaprozin [].
  • Laboratory Test Interactions
  • False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking DAYPRO. This is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of DAYPRO therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish DAYPRO from benzodiazepines.
  • 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 [].
  • Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 grams to 100 grams in adults, 1 gram 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).
  • DAYPRO (oxaprozin) caplet is a nonsteroidal anti-inflammatory drug, available as caplets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293. Its molecular formula is CHNO, and it has the following chemical structure.
  • Oxaprozin is a white to off-white powder with a slight odor and a melting point of 162u00b0C to 163u00b0C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4). The pK in water is 4.3.
  • The inactive ingredients in DAYPRO include: microcrystalline cellulose, hypromellose, methylcellulose, magnesium stearate, polacrilin potassium, starch, polyethylene glycol and titanium dioxide. DAYPRO 600-mg caplets are white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side.
  • No data
  • No data
  • No data
  • DAYPRO (oxaprozin) 600 mg caplets are white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side, supplied as:
  • Storage
  • Keep bottles tightly closed. Store at room temperature 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect the unit dose from light.
  • 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 DAYPRO 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-0189-11.0
  • No data
  • ALWAYS DISPENSE WITH MEDICATION GUIDEPfizerNDC 0025-1381-31
  • Daypron oxaprozin caplets
  • 600 mg
  • 100 CapletsRx only

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