Cumberland Pharmaceuticals Inc. announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants, published in the journal Pediatric Drugs. Caldolor (ibuprofen) injection, is an intravenous non-steroidal anti-inflammatory drug (NSAID) approved by the FDA for the treatment of pain and fever in adults and children. The results of this published study supported the recent FDA approval of Caldolor in infants 3 to 6 months of age.

A multicenter, randomized,pen-label, active-comparator trial to determine the eFCacy, safety, and pharmacokinetics of ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb.

1;17(1):42.bout Caldldolor(R) Caldolor is indicated in adults and pediatric patien for the management of mild toto moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever. It was the first FDA- approved intravenous therapy for fever. It was the firstF FDA- approved intravenous therapy For fever.

Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic-type reactions after taking aspirin or other NSAIDs. Caldolor is contrainDicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors.

Blood pressure should be monitored during product treatment.