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Coxanto
oxaprozin
Black Box Warnings .
Cardiovascular Thrombotic Event
NSAIDs incr. risk of serious and potentially fatal cardiovascular thrombotic events, including MI and stroke; risk may occur early in tx and may incr. with duration of use; contraindicated in CABG periop setting
GI Bleeding, Ulceration, and Perforation
NSAIDs incr. risk of serious and potentially fatal GI adverse events including bleeding, ulcer, and stomach or intestine perforation; GI events may occur at any time during use and without warning symptoms; elderly patients and patients with history of PUD or GI bleeding at greater risk for serious GI events
Adult Dosing .
Dosage forms: CAP: 300 mg
osteoarthritis
- [1200 mg PO qd]
- Max: 1200 mg/day; Info: start 600 mg PO qd if low body wt; use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
rheumatoid arthritis
- [1200 mg PO qd]
- Max: 1200 mg/day; Info: start 600 mg PO qd if low body wt; use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
for anti-inflammatory uses (off-label)
- [1200 mg PO qd]
- Max: 1200 mg/day; Info: start 600 mg PO qd if low body wt; use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
pain, mild-moderate (off-label)
- [1200 mg PO qd]
- Max: 1200 mg/day; Info: start 600 mg PO qd if low body wt; use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
renal dosing
- [see below]
- mild-moderate impairment: consider decr. usual dose; severe impairment: avoid use; Alt: start 600 mg qd, max 1200 mg qd; advanced renal disease: avoid use
- HD: avoid use; Alt: start 600 mg qd, max 1200 mg qd; no supplement after dialysis; PD: avoid use; Alt: start 600 mg qd, max 1200 mg qd; no supplement
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: CAP: 300 mg
juvenile idiopathic arthritis
- [6-16 yo, 22-31 kg]
- Dose: 600 mg PO qd; Max: 1200 mg/day; Info: use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
- [6-16 yo, 32-54 kg]
- Dose: 900 mg PO qd; Max: 1200 mg/day; Info: use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
- [6-16 yo, >55 kg]
- Dose: 1200 mg PO qd; Max: 1200 mg/day; Info: use lowest effective dose, shortest effective tx duration; may divide dose bid; give with food if GI upset occurs
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to ASA
- hypersensitivity to NSAIDs
- asthma, ASA-induced
- asthma, NSAID-induced
- urticaria, ASA-induced
- urticaria, NSAID-induced
- aspirin triad
- renal impairment, severe
- renal disease, advanced
- pregnancy starting at 30 wk gestation
- CABG surgery periop use
- CHF, severe
- MI, recent
- GI bleeding
- GI bleeding history
- PUD history
- dehydration
- hypovolemia
- avoid: sun exposure
- avoid: UV light exposure, artificial
- caution: pregnancy at <30 wk gestation
- caution: elderly patients
- caution: debilitated patients
- caution: renal impairment
- caution: hepatic impairment
- caution: asthma
- caution: cardiovascular disease
- caution: cardiac disease risk
- caution: HTN
- caution: CHF
- caution: fluid retention
- caution: coagulation disorder
- caution: smokers
- caution: alcohol use, concurrent
- caution: prolonged use
- caution: patients of childbearing potential trying to conceive
Drug Interactions .
Overview
oxaprozin
NSAID
- affects growth hormone diagnostic test results
- alters gallbladder contraction/motility
- antiplatelet effects
- decreases renal perfusion/fxn
- GI mucosal injury/bleeding risk
- hyperkalemia
- hypertensive effects
- hyponatremia
- lowers seizure threshold
- photosensitivity
- thrombogenic effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- GI bleeding
- GI perforation
- GI ulcer
- MI
- stroke
- thromboembolism
- HTN
- CHF
- CHF exacerbation
- renal papillary necrosis
- nephrotoxicity
- hepatotoxicity
- anaphylactoid reaction
- bronchospasm
- exfoliative dermatitis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug reaction with eosinophilia and systemic symptoms
- generalized bullous fixed drug eruption
- anemia
- blood dyscrasia
- prolonged bleeding time
- hyperkalemia
Common Reactions
- dyspepsia
- nausea
- vomiting
- abdominal pain
- constipation
- anorexia
- flatulence
- diarrhea
- headache
- dizziness
- somnolence
- sleep disturbance
- pruritus
- rash
- ALT or AST elevated
- edema
- fluid retention
- tinnitus
- dysuria
- renal impairment
- anemia
- prolonged bleeding time
- photosensitivity
- delayed ovulation
Safety/Monitoring .
Monitoring Parameters
Cr at baseline, then if renal or hepatic impairment, CHF, dehydration, or hypovolemia continue periodically; BP during tx start, then periodically; CBC, chemistry profile if long-term tx
Look/Sound-Alike Drug Names
oxaprozin confused with: OXcarbazepine; oxyBUTYnin
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit if <30 wk gestation, especially at 20-29 wk gestation, avoid use starting at 30 wk gestation; if must use at 20-29 wk gestation, limit dose and duration, and consider monitoring amniotic fluid if use >48h; risk of embryo-fetal toxicity and death low in 1st trimester based on conflicting human data; risk of fetal harm, including renal dysfunction and oligohydramnios, starting at 20 wk gestation and premature ductus arteriosus closure, starting at 30 wk gestation, based on human data with NSAID class and drug's mechanism of action
Individuals of Reproductive Potential
weigh risk/benefit in patients of childbearing potential trying to conceive, especially if long-term use; NSAIDs may reversibly delay ovulation during tx based on limited human or animal data and drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding, consider short-acting NSAID; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for oxaprozin: liver; CYP450: unknown
Excretion: for oxaprozin: urine 65% (5% unchanged), feces 35%; Half-life: 41-55h
Subclass: Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Mechanism of Action
for oxaprozin: exact mechanism of action unknown; inhibits cyclooxygenase, reducing prostaglandin and thromboxane synthesis
Formulary .
No Formulary Selected
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