Ceftriaxone crosses the blood placenta barrier.The average values of maximum plasma concentration, elimination half-life, plasma clearance and volume of distribution after a 50 mg/kg IV dose and after a 75 mg/kg IV dose in pediatric patients suffering from bacterial meningitis are shown in Compared to that in healthy adult subjects, the pharmacokinetics of ceftriaxone were only minimally altered in elderly subjects and in patients with renal impairment or hepatic dysfunction (The elimination of ceftriaxone is not altered when ceftriaxone is co-administered with probenecid.In one study, total ceftriaxone concentrations (bound and unbound) were measured in middle ear fluid obtained during the insertion of tympanostomy tubes in 42 pediatric patients with otitis media. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.In rats, in the Segment I (fertility and general reproduction) and Segment III (perinatal and postnatal) studies with intravenously administered ceftriaxone, no adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior and reproductive ability of the offspring, at doses of 586 mg/kg/day or less.Low concentrations of ceftriaxone are excreted in human milk. After reconstitution, protection from normal light is not necessary. The probability of such precipitates appears to be greatest in pediatric patients. Less frequently reported (<1%) were pruritus, fever or chills.Eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Average Pharmacokinetic Parameters of Ceftriaxone in Humans Table 5. This product should be given cautiously to penicillin and other beta-lactam agent-sensitive patients. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL.Rash (1.7%). Multiple IV or IM doses ranging from 0.5 to 2 g at 12- to 24-hour intervals resulted in 15% to 36% accumulation of ceftriaxone above single dose values.Thirty-three percent to 67% of a ceftriaxone dose was excreted in the urine as unchanged drug and the remainder was secreted in the bile and ultimately found in the feces as microbiologically inactive compounds. The following packages are available:Vials containing 250 mg equivalent to ceftriaxone. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures.As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions (i.e., anaphylaxis) have been reported. Discontinue ceftriaxone sodium in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above.Ceftriaxone-calcium precipitates in the urinary tract have been observed in patients receiving ceftriaxone and may be detected as sonographic abnormalities. Refer to the prescribing information of lidocaine.Before therapy with ceftriaxone for injection is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam agents or other drugs. Sulbactam is a β-lactamase inhibitor. After a 1 g IV dose, average concentrations of ceftriaxone, determined from 1 to 3 hours after dosing, were 581 mcg/mL in the gallbladder bile, 788 mcg/mL in the common duct bile, 898 mcg/mL in the cystic duct bile, 78.2 mcg/g in the gallbladder wall and 62.1 mcg/mL in the concurrent plasma.Over a 0.15 to 3 g dose range in healthy adult subjects, the values of elimination half-life ranged from 5.8 to 8.7 hours; apparent volume of distribution from 5.78 to 13.5 L; plasma clearance from 0.58 to 1.45 L/hour; and renal clearance from 0.32 to 0.73 L/hour. Many strains of the above organisms that are resistant to other antibiotics, eg, penicillins, cephalosporins and aminoglycosides, are susceptible to Ceftriaxone. The condition appears to be reversible upon discontinuation of ceftriaxone sodium and institution of conservative management. Shown to be greatest in pediatric patients with Meningitis Table 4, severe illness, total parenteral nutrition via Y-site... 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