Concise Prescribing Info
Aceclofenac SR 200 mg, rabeprazole Na EC 20 mg
Pain & inflammation relief in OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
Adult 1 cap once daily at bedtime.
Should be taken with food: Take preferably at bedtime. Swallow whole w/ water.
Hypersensitivity to aceclofenac, rabeprazole & substituted benzimidazole. Aspirin- or NSAID-induced asthma, urticaria or allergic-type reactions. History of active or suspended peptic ulcer or GI bleeding. Moderate to severe renal impairment. Peri-operative pain treatment of CABG. Pregnancy & lactation.
Special Precautions
Hematological effects eg, blood dyscrasias (thrombocytopenia & neutropenia), anemia. Not as substitute for corticosteroids or as treatment for corticosteroids insufficiency. Discontinue w/ occurrence of consistent hepatic dysfunction signs & symptoms, or systemic manifestations (eg, eosinophilia, rash). Do not use in patients w/ aspirin-sensitive asthma. Preexisting asthma. May impair fertility. Monitor for signs & symptoms of GI bleeding. May impair ability to drive & operate machinery. Long-term therapy; risk of cross-reactivity w/ proton pump inhibitor or substituted benzimidazoles. Monitor for potential increase in INR & prothrombin time in concomitant use w/ warfarin. Co-administration w/ atazanavir is not recommended. Aceclofenac: Potentially fatal increased risk of serious CV thrombotic events, MI & stroke. May lead to onset of new or worsening preexisting HTN. Patients w/ CHF or fluid retention. History of ulcer disease or GI bleeding. Risk of renal papillary necrosis & other renal injury w/ long-term use in patients w/ renal impairment, heart failure, liver dysfunction, concurrently using diuretics & ACE-inhibitors, & in the elderly. Not recommended in patients w/ advanced renal disease. Severe hepatic impairment. Do not use in patients w/ aspirin triad. Potentially fatal skin reactions eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Rabeprazole: Not recommended in childn.
Adverse Reactions
Aceclofenac: Dyspepsia, abdominal pain, nausea, diarrhoea & occasional dizziness. Increased hepatic enzyme. Rabeprazole: Headache, diarrhoea & nausea. Infection, insomnia, dizziness, cough, pharyngitis, rhinitis, vomiting, abdominal pain, constipation, flatulence, non-specific pain/back pain, asthenia & flu-like syndrome.
Drug Interactions
Aceclofenac: Elevates lithium plasma levels; potential lithium toxicity if used concurrently. Concomitant use w/ cardiac glycosides may increase plasma glycoside (including digoxin) levels, exacerbate cardiac failure & reduce the GFR. Monitor serum K levels when used concomitantly w/ K-sparing diuretics. Diuretics can increase risk of nephrotoxicity of NSAIDs. Risk of serious GI bleeding when used concomitantly w/ anticoagulants eg, warfarin. May cause hypoglycaemic & hyperglycaemic effects w/ antidiabetic agents. May result in increased toxicity w/ methotrexate if administered w/in 24 hr. May reduce effect of mifepristone if used 8-12 days after administration. Concomitant therapy w/ aspirin, other NSAIDs & steroids may increase frequency of adverse reactions including GI bleeding. Concomitant use w/ cyclosporine may increase cyclosporine nephrotoxicity. Convulsions may occur in concomitant use w/ quinolone antimicrobials. NSAIDs may diminish the anti-HTN effect of ACE inhibitors. Rabeprazole: Concomitant use w/ warfarin may increase INR & prothrombin time. Coadministration w/ ketoconazole or itraconazole may decrease antifungal plasma levels. Coadministration w/ atazanavir decreases atazanavir plasma conc.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Naclo-R cap
3 × 10's
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