Oxaprozin (Oxaprozin)

Trade Name : Oxaprozin

Teva Pharmaceuticals USA, 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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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 (Oxaprozin) which is also known as Oxaprozin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 600 mg/1 per ml. Read more

Oxaprozin (Oxaprozin) 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

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Warnings and Precautions,Gastrointestinal Bleeding, Ulceration, and Perforation () 5/2019

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 ()
Oxaprozin 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 ()

Oxaprozin tablets are indicated:
Oxaprozin tablets are 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 tablets) given orally once a day (, , )
RA: 1200 mg (two 600 mg tablets) given orally once a day (, , )
JRA: 600 mg once daily in patients 22 to 31 kg. 900 mg once daily in patients 32 to 54 kg. 1200 mg once daily in patients u2265 55 kg (, )

Oxaprozin Tablets USP: 600 mg tablets, white to off-white, capsule-shaped, film-coated tablets. On one side scored and debossed with the numbers u201c9u201d and u201c3u201d on each side of the score. On the other side unscored and debossed u201c0924u201d.
Oxaprozin tablets: 600 mg ()

Oxaprozin tablets are 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 ()

See Table 2 for clinically significant drug interactions with oxaprozin [].
Laboratory Test Interactions
False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking oxaprozin. This is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of oxaprozin therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish oxaprozin from benzodiazepines.

Drugs that Interfere with Hemostasis :
Arrayn- Angiotensin Converting Enzyme (ACE) Inhibitors
ACE Inhibitors and ARBs:
Diuretics:
Digoxin:

Pregnancy:
Infertility:
5.10
8.1
8.3

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 [n ].
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 (1-800-222u20111222).

Oxaprozin Tablets USP are a non-steroidal anti-inflammatory drug, available as tablets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid, and has the following chemical structure:
CHNO M.W. 293
Oxaprozin, USP 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 Oxaprozin Tablets USP include: carnauba wax, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, pregelatinized corn starch, and titanium dioxide. Oxaprozin Tablets USP, 600 mg are white to off-white, capsule-shaped, film-coated tablets. On one side scored and debossed with the numbers u201c9u201d and u201c3u201d on each side of the score. On the other side unscored and debossed u201c0924u201d.

No data

Carcinogenesis
In carcinogenicity studies in rats and mice, oxaprozin administration for 2 years was associated with the exacerbation of liver neoplasms (hepatic adenomas and carcinomas) in male CD mice, but not in female CD mice or male or female rats treated with up to 216 mg/kg via the diet (1.2-times the maximum daily human dose of 1800 mg based on body surface area). The significance of this species-specific finding to man is unknown.
Mutagenesis
Oxaprozin was not genotoxic in the Ames test, forward mutation in yeast and Chinese hamster ovary (CHO) cells, DNA repair testing in CHO cells, micronucleus testing in mouse bone marrow, chromosomal aberration testing in human lymphocytes, or cell transformation testing in mouse fibroblast.
Impairment of Fertility
Oxaprozin administration was not associated with impairment of fertility in male and female rats at oral doses up to 200 mg/kg/day (1.1-times the maximum recommended human daily dose [MRHD] of 1800 mg based on a body surface area comparison). However, testicular degeneration was observed in beagle dogs treated with 37.5 mg/kg/day (0.7-times the MRHD based on body surface area) of oxaprozin for 42 days or 6 months, a finding not confirmed in other species. The clinical relevance of this finding is not known.

No data

Oxaprozin Tablets USP, 600 mg are white to off-white, capsule-shaped, film-coated tablets. On one side scored and debossed with the numbers u201c9u201d and u201c3u201d on each side of the score. On the other side unscored and debossed u201c0924u201d.
Supplied in bottles of 100 (NDC 0093-0924-01) and 500 (NDC 0093-0924-05).
Storage
Keep bottles tightly closed. 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).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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 oxaprozin and periodically during the course of ongoing therapy.
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [].
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [].
Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and u201cflu-likeu201d symptoms). If these occur, instruct patients to stop oxaprozin and seek immediate medical therapy [].
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [].
Anaphylactic Reactions
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [].
Serious Skin Reactions
Advise patients to stop oxaprozin immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [].
Female Fertility
Advise females of reproductive potential who desire pregnancy that NSAIDs, including oxaprozin, may be associated with a reversible delay in ovulation [].
Fetal Toxicity
Inform pregnant women to avoid use of oxaprozin and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [].
Avoid Concomitant Use of NSAIDs
Inform patients that the concomitant use of oxaprozin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy []. Alert patients that NSAIDs may be present in u201cover the counteru201d medications for treatment of colds, fever, or insomnia.
Use of NSAIDS and Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with oxaprozin until they talk to their healthcare provider [].
Manufactured In Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
Rev. I 5/2019

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No data

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Oxaprozin (Oxaprozin)

Trade Name : Oxaprozin

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Oxaprozin (Oxaprozin)

Trade Name : Oxaprozin

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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