Hypersensitivity to aceclofenac, rabeprazole, and substituted benzimidazole or to any constituents of Naclo-R; asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see Warnings and Precautions); history of active or suspected peptic ulcer or gastrointestinal bleeding (see Warnings); moderate to severe renal impairment (see Warnings); treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Use in pregnancy & lactation: Pregnancy and lactation, unless there are compelling reasons for doing so. The lowest effective dosage of NSAIDs should be used.
Aceclofenac: In late pregnancy, as with other NSAIDs, aceclofenac should be avoided because it may cause premature closure of the ductus arteriosus.
Rabeprazole: Teratology studies have been performed in rats at IV doses up to 50 mg/kg/day (plasma AUC of 11.8 mcg·hr/mL, about 13 times the human exposure at the recommended dose of GERD) and rabbits at IV doses up to 30 mg/kg/day (plasma AUC of 7.3 mcg·hr/mL, about 8 times the human exposure at the recommended dose for GERD) and have revealed no evidence of impaired fertility or harm to the fetus due to rabeprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Naclo-R should be used during pregnancy only if clearly needed.