Buy Naprelan Online

Naprelan (naproxen sodium)

BOXED WARNING

NSAIDs may increase risk of serious cardiovascular (CV) thrombotic events, MI, and stroke; increased risk w/ duration of use and w/ CV disease (CVD) or risk factors for CVD. Contraindicated for the treatment of perioperative pain in the setting of CABG surgery. May increase risk of serious GI adverse events (eg, bleeding, ulceration, and stomach/intestinal perforation), which can be fatal and can occur at any time during use and w/o warning symptoms; elderly patients are at greater risk.

THERAPEUTIC CLASS

NSAID

DEA CLASS

RX

INDICATIONS

Treatment of rheumatoid arthritis (RA), osteoarthritis (OA), ankylosing spondylitis (AS), tendinitis, bursitis, acute gout, and primary dysmenorrhea. Relief of mild to moderate pain.

ADULT DOSAGE

Rheumatoid Arthritis

Initial: 750mg or 1000mg qd
Titrate:
Adjust dose/frequency depending on clinical response
In patients who tolerate lower doses well, may increase to two 750mg tabs or three 500mg tabs once daily for limited periods, as needed

Osteoarthritis

Initial: 750mg or 1000mg qd
Titrate:
Adjust dose/frequency depending on clinical response
In patients who tolerate lower doses well, may increase to two 750mg tabs or three 500mg tabs once daily for limited periods, as needed

Ankylosing Spondylitis

Initial: 750mg or 1000mg qd
Titrate:
Adjust dose/frequency depending on clinical response
In patients who tolerate lower doses well, may increase to two 750mg tabs or three 500mg tabs once daily for limited periods, as needed

Mild to Moderate Pain

Initial: 1000mg qd; may give 1500mg qd for a limited period in patients requiring greater analgesia
Max: 1000mg/day after limited period of 1500mg qd

Primary Dysmenorrhea

Initial: 1000mg qd; may give 1500mg qd for a limited period in patients requiring greater analgesia
Max: 1000mg/day after limited period of 1500mg qd

Bursitis/Tendinitis

Acute:
Initial: 1000mg qd; may give 1500mg qd for a limited period in patients requiring greater analgesia
Max: 1000mg/day after limited period of 1500mg qd

Gout

Acute:
Day 1: 1000-1500mg qd
Succeeding Days: 1000mg qd until attack subsides

DOSING CONSIDERATIONS

Renal Impairment
Start at lower end of dosing range

Hepatic Impairment
Start at lower end of dosing range

Elderly
Start at lower end of dosing range

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab, Controlled-Release: 375mg, 500mg, 750mg

CONTRAINDICATIONS

History of asthma, urticaria, or allergic-type reactions w/ aspirin (ASA) or other NSAIDs. Treatment of perioperative pain in the setting of CABG surgery.

WARNINGS/PRECAUTIONS

Use lowest effective dose for the shortest duration possible. May cause HTN or worsen preexisting HTN; monitor BP closely. Fluid retention and edema reported; caution w/ fluid retention or heart failure (HF). Caution w/ history of ulcer disease, GI bleeding, or risk factors for GI bleeding; monitor for GI ulceration/bleeding and d/c if serious GI event occurs. Renal injury reported w/ long-term use; increased risk w/ renal/hepatic impairment, HF, and elderly. Not recommended w/ advanced renal disease or moderate to severe or severe renal impairment (CrCl <30mL/min); monitor renal function closely if therapy is initiated. Anaphylactoid reactions may occur. Caution w/ asthma and avoid w/ ASA-sensitive asthma and the ASA triad. May cause serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis); d/c at 1st appearance of skin rash/hypersensitivity. Avoid in late pregnancy; may cause premature closure of ductus arteriosus. Not a substitute for corticosteroids nor treatment for corticosteroid insufficiency. May mask signs of inflammation and fever. May cause elevated LFTs or severe hepatic reactions; d/c if liver disease or systemic manifestations occur, and if abnormal LFTs persist/worsen. Anemia reported; monitor Hgb/Hct if anemia develops. May inhibit platelet aggregation and prolong bleeding time; monitor patients w/ coagulation disorders.

ADVERSE REACTIONS

CV thrombotic events, MI, stroke, GI events, headache, dyspepsia, flu syndrome, pain, infection, nausea, diarrhea, constipation, rhinitis, sinusitis, UTI.

DRUG INTERACTIONS

Increased risk of GI bleeding w/ oral corticosteroids, anticoagulants, alcohol use, and smoking. Risk of renal toxicity w/ diuretics and ACE inhibitors. Monitor patients receiving anticoagulants. May diminish antihypertensive effect of ACE inhibitors. Not recommended w/ ASA. May reduce natriuretic effect of loop (eg, furosemide) or thiazide diuretics; monitor for signs of renal failure and diuretic efficacy. May increase lithium levels; monitor for lithium toxicity. May enhance methotrexate toxicity; caution w/ concomitant use. Synergistic effect on GI bleeding w/ warfarin.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

NSAID; not established. Inhibition of prostaglandin synthesis thought to be involved in anti-inflammatory effect.

PHARMACOKINETICS

Absorption: Rapid and complete. Bioavailability (95%); (1000mg qd multiple dose) Cmax=94mcg/mL, Tmax=5 hrs, AUC=1448mcg•hr/mL. Distribution: Vd=0.16L/kg; plasma protein binding (>99%); found in breast milk. Metabolism: Extensive; 6-0-desmethyl naproxen metabolite. Elimination: Urine (<1% unchanged, <1% 6-0-desmethyl naproxen, 66-92% conjugates), feces (<5%); T1/2=15 hrs.

ASSESSMENT

Assess for history of asthma, urticaria, or allergic-type reactions w/ ASA or other NSAIDs, ASA triad, CVD, risk factors for CVD, HTN, fluid retention, HF, history of ulcer disease, history of/risk factors for GI bleeding, general health status, renal/hepatic function, coagulation disorders, pregnancy/nursing status, and possible drug interactions. Obtain baseline CBC and BP.

MONITORING

Monitor BP, CBC, bleeding time, LFTs, renal function, and chemistry profile periodically. Monitor for GI bleeding/ulceration/perforation, CV thrombotic events, MI, stroke, HTN, fluid retention, edema, and skin/allergic reactions.

PATIENT COUNSELING

Inform to seek medical advice if symptoms of CV events, GI ulceration/bleeding, skin/hypersensitivity reactions, unexplained weight gain or edema, hepatotoxicity, or anaphylactoid reactions occur. Instruct to avoid in late pregnancy.

STORAGE

20-25°C (68-77°F).

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