most beautiful [1%):<1%) Wound hemorrhage 4 (3%) 4 (1%) 4 (1%) Abdominal discomfort 4 (3%) 2 (> <1%) 0 Cough 4 (3%) 2 (> <1%) 1 (> <1%) Hypokalemia 5 (4%) 3 (> <1%) 8 (3%) Fever Studies Fever studies were conducted in febrile hospitalized patients with malaria and febrile hospitalized patients with varying causes of fever. In hospitalized febrile patients with malaria, the adverse reactions observed in at least two Caldolor-treated patients included abdominal pain and nasal congestion. In hospitalized febrile patients (all causes), adverse reactions observed in more than two patients in any given treatment group are presented in the table below. Table 2: Patients with Adverse Reactions Observed in 3% of Patients in any Caldolor Treatment Group in All-Cause Fever Study Event Caldolor Placebo N=28 100 mg N=30 200 mg N=30 400 mg N=31 Any Reaction 27 (87%) 25 (83%) 23 (74%) 25 (89%) Anemia 5 (17%) 6 (20%) 11 (36%) 4 (14%) Eosinophilia 7 (23%) 7 (23%) 8 (26%) 7 (25%) Hypokalemia 4 (13%) 4 (13%) 6 (19%) 5 (18%) Hypoproteinemia 3 (10%) 0 4 (13%) 2 (7%) Neutropenia 2 (7%) 2 (7%) 4 (13%) 2 (7%) Blood urea increased 0 0 3 (10%) 0 Hypernatremia 2 (7%) 0 3 (10%) 0 Hypertension 0 0 3 (10%) 0 Hypoalbuminemia 3 (10%) 1 (3%) 3 (10%) 1 (4%) Hypotension 0 2 (7%) 3 (10%) 1 (4%) Diarrhea 3 (10%) 3 (10%) 2 (7%) 2 (7%) Pneumonia bacterial 3 (10%) 1 (3%) 2 (7%) 0 Blood LDH increased 3 (10%) 2 (7%) 1 (3%) 1 (4%) Thrombocythemia 3 (10%) 2 (7%) 1 (3%) 0 Bacteremia 4 (13%) 0 0 0 Pediatric Population A total of 143 pediatric patients ages 6 months and older have received Caldolor in controlled clinical trials. The most common adverse reactions (incidence greater than or equal to 2%) in pediatric patients treated with Caldolor were infusion site pain, vomiting, nausea, anemia and headache. Drug Interactions See Table 3 for clinically significant drug interactions with ibuprofen. Table 3: Clinically Significant Drug Interactions with Ibuprofen Drugs That Interfere with Hemostasis Clinical Impact: Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of Caldolor with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions ( 5.11 ) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and Precautions ( 5.2 ) ]. Intervention: Concomitant use of Caldolor and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions ( 5.11 ) ]. Caldolor is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of Caldolor and ACE-inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of Caldolor and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see Warnings and Precautions ( 5.6 ) ]. When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of Caldolor with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Warnings and Precautions ( 5.6 ) ]. Digoxin Clinical Impact: The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of CADOLOR and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of Caldolor and lithium, monitor patients for signs of lithium toxicity. Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of Caldolor and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine Clinical Impact: Concomitant use of Caldolor and cyclosporine may increase cyclosporine's nephrotoxicity. Intervention: During concomitant use of Caldolor and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates Clinical Impact: Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) ]. Intervention: The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended. Pemetrexed Clinical Impact: Concomitant use of Caldolor and pemetrexed, may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). Intervention: During concomitant use of Caldolor and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Use of NSAIDs, including Caldolor, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Caldolor, in pregnant women starting at 30 weeks gestation (third trimester). There are no adequate and well-controlled studies of Caldolor in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In published animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation. In contrast, an increase in membranous ventricular septal defects was reported in rats treated on Gestation Days 9 & 10 with 0.8-times the MRHD. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre- and post-implantation loss. Advise a pregnant woman of the potential risk to a fetus. Clinical Considerations Labor or Delivery There are no studies on the effects of Caldolor during labor or delivery. In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Animal Data In a published study, female rabbits given 7.5, 20, or 60 mg/kg ibuprofen (0.04, 0.12, or 0.36-times the maximum recommended human daily dose of 3200 mg of ibuprofen based on body surface area) from Gestation Days 1 to 29, no clear treatment-related adverse developmental effects were noted. This dose was associated with significant maternal toxicity (stomach ulcers, gastric lesions). In the same publication, female rats were administered 7.5, 20, 60, 180 mg/kg ibuprofen (0.02, 0.06, 0.18, 0.54-times the maximum daily dose) did not result in clear adverse developmental effects. Maternal toxicity (gastrointestinal lesions) was noted at 20 mg/kg and above. In a published study, rats were orally dosed with 300 mg/kg ibuprofen (0.912-times the maximum human daily dose of 3200 mg based on body surface area) during Gestation Days 9 and 10 (critical time points for heart development in rats). Ibuprofen treatment resulted in an increase in the incidence of membranous ventricular septal defects. This dose was associated with significant maternal toxicity including gastrointestinal toxicity. One incidence each of a membranous ventricular septal defect and gastroschisis was noted in fetuses from rabbits treated with 500 mg/kg (3-times the maximum human daily dose) from Gestation Day 9-11. Lactation Risk Summary No lactation studies have been conducted with Caldolor; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06% to 0.6% of the maternal weight-adjusted daily dose. There are no reports of adverse effects on the breastfed infant and no effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Caldolor and any potential adverse effects on the breastfed infant from the Caldolor or from the underlying maternal condition. Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including Caldolor, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin- mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including Caldolor in women who have difficulties conceiving or who are undergoing investigation of infertility. Pediatric Use The safety and effectiveness of Caldolor for the treatment of pain and fever in pediatric patients ages 6 months and older is supported by evidence of fever reduction from a multi-center, open-label study of hospitalized febrile pediatric patients along with safety data from exposure to Caldolor in 143 pediatric patients ages 6 months and older in two pediatric fever studies and one pediatric pain study, supportive data from other ibuprofen products approved in pediatric patients, and evidence from adequate and well controlled studies in adults. The effectiveness of Caldolor for the treatment of pain and fever has not been studied in pediatric patients less than 6 months of age. [ see DOSAGE AND ADMINISTRATION ( 2 ), Clinical Study Experience ( 6.1 ), Pharmacokinetics ( 12.3 ), CLINICAL STUDIES ( 14 ) ]. Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.6 , 5.13 ) ]. Clinical studies of Caldolor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients are at increased risk for serious GI adverse events. Overdosage Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.6 ) ]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center at 1-800-222-1222. Caldolor Description Caldolor (ibuprofen) Injection is a nonsteroidal anti-inflammatory drug, available as an 800 mg/8 mL single-dose vial (100 mg/mL) for intravenous administration. The chemical name is ibuprofen, which is ( )-2-( p -isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74 C to 77 C. It has a molecular weight of 206.28. It is very slightly soluble in water (> <1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is represented below: Each 1 mL of solution contains 100 mg of ibuprofen in Water for Injection, USP. The inactive ingredients in Caldolor include: 78 mg/mL arginine at a molar ratio of 0.92:1 arginine:ibuprofen. The solution pH is about 7.4. Caldolor is sterile and is intended for intravenous administration only. Caldolor - Clinical Pharmacology Mechanism of Action Ibuprofen has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Caldolor, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro. Ibuprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because ibuprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. Pharmacokinetics Ibuprofen is a racemic mixture of [-]R- and [+]S-isomers. In vivo and in vitro studies indicate that the [+]S-isomer is responsible for clinical activity. The [-]R-form, while thought to be pharmacologically inactive, is slowly and incompletely (~60%) interconverted into the active [+]S species in adults. The [-]R-isomer serves as a circulating reservoir to maintain levels of active drug. The pharmacokinetic parameters of Caldolor determined in a study with volunteers are presented below. Table 4: Pharmacokinetic Parameters of Intravenous Ibuprofen AUC = Area-under-the-curve Cmax = Peak plasma concentration CV = Coefficient of Variation KEL = First-order elimination rate constant T 1/2 = Elimination half-life * = 60 minute infusion time 400 mg* Caldolor Mean (CV%) 800 mg* Caldolor Mean (CV%) Number of Patients 12 12 AUC (mcg h/mL) 109.3 (26.4) 192.8 (18.5) C max (mcg/mL) 39.2 (15.5) 72.6 (13.2) KEL (1/h) 0.32 (17.9) 0.29 (12.8) T 1/2 (h) 2.22 (20.1) 2.44 (12.9) The pharmacokinetic parameters of Caldolor determined in a study with febrile pediatric patients are presented in Table 5 . It was observed that the median T max was at the end of the infusion and that Caldolor had a shorter elimination half-life in pediatric patients compared to adults. The volume of distribution and clearance increased with age. Table 5: Pharmacokinetic Parameters of 10 mg/kg Intravenous Ibuprofen, Pediatric Patients, by Age Group * Median (minimum-maximum) # WT: body weight (kg) 6 months to> <2 years Mean (CV%) 2 years to> <6 years Mean (CV%) 6 years to 16 years Mean (CV%) Number of Patients 5 12 25 AUC (mcg h/mL) 71.1 (37.1) 79.2 (37.0) 80.7 (36.9) C max (mcg/mL) 59.2 (34.8) 64.2 (34.3) 61.9 (26.6) T max (min)* 10 (10-30) 12 (10-46) 10 (10-40) T 1/2 (h) 1.8 (29.9) 1.5 (41.8) 1.55 (26.4) Cl (mL/h) 1172.5 (38.9) 1967.3 (56.0) 4878.5 (71.0) Vz (mL) 2805.7 (20.1) 3695.8 (30.0) 10314.2 (67.4) Cl/WT # (mL/hr/kg) 133.7 (58.6) 130.1 (82.4) 109.2 (41.6) Vz/WT # (mL/kg) 311.2 (35.4) 227.2 (41.7) 226.8 (30.4) Ibuprofen, like most NSAIDs, is highly protein bound (> 99% bound at 20 mcg/mL). Protein binding is saturable, and at concentrations >20 mcg/mL binding is nonlinear. Based on oral dosing data, there is an age- or fever-related change in volume of distribution for ibuprofen. Drug Interaction Studies Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered. The clinical significance of this interaction is not known. See Table 3 for clinically significant drug interactions of NSAIDs with aspirin [ see Drug Interactions ( 7 ) ]. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of ibuprofen have not been conducted. Mutagenesis In published studies, ibuprofen was not mutagenic in the in vitro bacterial reverse mutation assay (Ames assay). Impairment of Fertility In a published study, dietary administration of ibuprofen to male and female rats 8-weeks prior to and during mating at dose levels of 20 mg/kg (0.06-times the MRHD based on body surface area comparison) did not impact male or female fertility or litter size. In other studies, adult mice were administered ibuprofen intraperitoneally at a dose of 5.6 mg/kg/day (0.0085-times the MRHD based on body surface area comparison) for 35 or 60 days in males and 35 days in females. There was no effect on sperm motility or viability in males but decreased ovulation was reported in females. Clinical Studies Analgesia (Pain) The effect of Caldolor on acute pain was evaluated in two multi-center, randomized, double-blind, placebo-controlled studies. In a study of women who had undergone an elective abdominal hysterectomy, 319 patients were randomized and treated with Caldolor 800 mg or placebo administered every 6 hours (started intra-operatively) and morphine administered on an as needed basis. Efficacy was demonstrated as a statistically significant greater reduction in the mean morphine consumption through 24 hours in patients who received Caldolor as compared to those receiving placebo (47 mg and 56 mg, respectively). The clinical relevance of this finding is supported by a greater reduction in pain intensity over 24 hours for patients treated with Caldolor, even though morphine was available on an as needed basis. In a study of patients who had undergone an elective abdominal or orthopedic surgery, 406 patients (87 men, 319 women) were randomized to receive Caldolor 400 mg, Caldolor 800 mg, or placebo administered every 6 hours (started intra-operatively), and morphine on an as needed basis. This study failed to demonstrate a statistically significant difference in outcome between patients receiving Caldolor 800 mg or 400 mg and placebo, although there were trends favoring the active treatments. Antipyretic (Fever) The effect of Caldolor on fever was evaluated in two randomized, double-blind studies in adults and in one open-label study in pediatric patients. In a multi-center study, 120 hospitalized patients (88 men, 32 women) with temperatures of 101 F or greater were randomized to Caldolor 400 mg, 200 mg, 100 mg or placebo, administered every 4 hours for 24 hours. Each of the three Caldolor doses, 100 mg, 200 mg, and 400 mg, resulted in a statistically greater percentage of patients with a reduced temperature ( <101 F) after 4 hours, compared to placebo (65%, 73%, 77% and 32%, respectively). The dose response is shown in the figure below. Figure 1: Temperature Reduction by Treatment Group, Hospitalized Febrile Patients In a single-center study, 60 hospitalized patients (48 men, 12 women) with uncomplicated P. falciparum malaria having temperatures 100.4 F were randomized to Caldolor 400 mg or placebo, administered every 6 hours for 72 hours of treatment. There was a significant reduction in fever within the first 24 hours of treatment, measured as the area above the temperature 98.6 F vs . time curve for patients treated with Caldolor. In a multi-center, open-label study, 100 hospitalized pediatric patients 6 months of age and older with temperatures of 101.0ºF or greater were randomized and treated with 10 mg/kg of Caldolor or a low dose of an active comparator every 4 hours as needed for fever. Efficacy was demonstrated as a statistically significant greater reduction in temperature for the primary endpoint, an area under the curve analyses of temperature versus time for the first 2 hours, as well as over the entire dosing interval. Seventy-four percent of Caldolor treated patients became afebrile (temperature> <99.5ºF) by the end of first dosing interval. How Supplied/Storage and Handling Caldolor (ibuprofen) Injection is a clear, colorless, non-pyrogenic, aqueous solution intended for intravenous use available in an 800 mg/8 mL (100 mg/mL) single-dose vial. Carton of 25 vials, NDC 66220-287-08 Storage Store at controlled room temperature 20 C to 25 C (68 F to 77 F); excursions permitted between 15 C to 30 C (59 F to 86 F) [see USP Controlled Room Temperature]. The stopper in the Caldolor vial does not contain natural rubber latex, dry natural rubber, or blends of natural rubber. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with Caldolor and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions ( 5.2 ) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and flu-like symptoms). If these occur, instruct patients to stop Caldolor and seek immediate medical therapy [ see Warnings and Precautions ( 5.3 )]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions ( 5.5 ) ]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.7 )]. Serious Skin Reactions Advise patients to stop Caldolor immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [ see Warnings and Precautions ( 5.9 ) ]. Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including Caldolor, may be associated with a reversible delay in ovulation [ see Use in Specific Populations ( 8.3 ) ] Fetal Toxicity Inform pregnant women to avoid use of Caldolor and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [ see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.1 ) ]. Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of Caldolor with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 ) ]. Alert patients that NSAIDs may be present in over the counter medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with Caldolor until they talk to their healthcare provider [ see Drug Interactions ( 7 ) ]. Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN 37203 US Patent Number 6,727,286, 8,871,810, 8,735,452, 9,012,508, 9,114,068 and 9,138,404 Caldolor is a registered trademark of Cumberland Pharmaceuticals Inc. Principal Display Panel - 8 mL Vial Label NDC 66220-287-08 Rx Only Caldolor (ibuprofen) Injection 800 mg/8 mL (100 mg/mL) FOR INTRAVENOUS USE. MUST DILUTE BEFORE USE. Store at controlled room temperature, 20 C - 25 C (68 - 77 F). Single dose vial, discard unused portion. DOSAGE: See package insert for dosage, dilution, and administration information. Principal Display Panel - 8 mL Carton Label NDC 66220-287-08 25 x 8 mL Vials 800 mg/8 mL For Intravenous Use Must Dilute Before Use Caldolor (ibuprofen) Injection 800 mg/8 mL (100 mg/mL) Caldolor ibuprofen injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66220-247 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ibuprofen (ibuprofen) ibuprofen 400 mg in 4 mL Inactive Ingredients Ingredient Name Strength water arginine hydrochloric acid nitrogen Packaging # Item Code Package Description 1 NDC:66220-247-04 25 VIAL in 1 CARTON 1 4 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022348 06/11/2009 12/01/2011 Caldolor ibuprofen injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66220-287 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ibuprofen (ibuprofen) ibuprofen 800 mg in 8 mL Inactive Ingredients Ingredient Name Strength water arginine hydrochloric acid nitrogen Packaging # Item Code Package Description 1 NDC:66220-287-08 25 VIAL in 1 CARTON 1 8 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022348 06/11/2009 Labeler - Cumberland Pharmaceuticals Inc. (069532880) Revised: 04/2016 Cumberland Pharmaceuticals Inc. Next Interactions Print this page Add to My Med List More about Caldolor (ibuprofen) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: nonsteroidal anti-inflammatory agents Consumer resources Caldolor Caldolor (Advanced Reading) Professional resources Ibuprofen (AHFS Monograph) Ibuprofen Tablets (FDA) Other brands: Advil , Motrin , IBU , Motrin IB , ... +5 more Related treatment guides Fever Juvenile Rheumatoid Arthritis Pain> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC Pregnancy Category Risk depends on usage N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Nonsteroidal anti-inflammatory agents Related Drugs nonsteroidal anti-inflammatory agents ibuprofen , meloxicam , naproxen , diclofenac , Voltaren , Aleve Pain tramadol , acetaminophen , Tylenol , naproxen , oxycodone , aspirin , ibuprofen , More... Fever acetaminophen , Tylenol , naproxen , aspirin , ibuprofen , Aleve , Advil , Ecotrin , More... Juvenile Rheumatoid Arthritis prednisone , naproxen , aspirin , ibuprofen , meloxicam , Aleve , Celebrex , Mobic , More... Caldolor Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } the sort of
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