Medical Description
Antibiotic; belongs to the third generation of cephalosporins used in the treatment of bacterial meningitis, acute otitis media, pneumonia, sexually transmitted infections, urinary tract infection and diabetic foot infection.
Indication & Usage
Warning: the doses below are the general doses for ceftriaxone and are not product specific. Use the intravenous vials for intravenous injections and the intramuscular vials for intramuscular injections.
-Acute Otitis media: IM, IV: 1 to 2 g once daily for 3 days.
-Pneumonia: Inpatients without risk factors for P. aeruginosa: IV: 1 to 2 g once daily in combination with other appropriate agent(s). Total duration (which may include oral step-down therapy) is for a minimum of 5 days; patients should be clinically stable with normal vital signs prior to discontinuation.
-Salmonella infection: Enteric fever: IV: 2 g every 12 to 24 hours for 10 to 14 days.
-Chronic obstructive pulmonary disease: IV: 1 g once daily for 5 to 7 days.
-Diabetic foot infection: IV: 1 to 2 g once daily in combination with other appropriate agents. Duration (which may include oral step-down therapy) is usually 2 to 4 weeks.
-Bacterial Meningitis: IV: 2 g every 12 hours. Treatment duration is 7 to 21 days, depending on causative pathogen(s) and clinical response.
-Sexually transmitted infections:
1-Gonococcal infection: In case of uncomplicated gonorrhea: IM: 500 mg as a single dose; 1 g is recommended for patients weighing ≥150 kg. While in case of disseminated gonococcal infection: IV (preferred), IM: 1 g once daily.
2- Neurosyphilis: IM, IV: 1 to 2 g once daily for 10 to 14 days.
-Complicated Urinary tract infection: Inpatients: IV: 1 g once daily. Switch to an appropriate oral regimen once symptoms improve. Total duration of therapy ranges from 5 to 14 days and depends on clinical response and the antimicrobial chosen to complete the regimen. While in case of outpatients: IV, IM: 1 g once, followed by 5 to 14 days of appropriate oral therapy.
-Skin and soft tissue infection: IV: 1 to 2 g once daily, usually as part of an appropriate combination regimen. Duration varies by extent of infection, clinical response.
-Pediatric dosing: See dosage and administration.
Active Ingredients
Ceftriaxone
Dosage & Administration
-For intravenous injection only.
-Intravenous: Do not coadminister with calcium-containing solutions. Infuse as an intermittent infusion over 30 minutes. In case of neonates: Administer over 60 minutes to decrease risk of bilirubin encephalopathy.
-Pediatric dosing:
-General dosing: Infants, children, and adolescents: IM, IV: 50 to 75 mg/kg/dose every 24 hours; maximum dose: 1,000 mg/dose; higher doses are recommended in certain infections (eg, endocarditis, meningitis).-Acute Otitis media: Infants, children, and adolescents: In case of acute bacterial infections: IM, IV: 50 mg/kg/dose every 24 hours for 1 or 3 days; maximum dose: 1,000 mg/dose.
-Pneumonia: Infants >3 months, children, and adolescents: IV: 50 to 100 mg/kg/day divided every 12 to 24 hours; maximum daily dose: 2,000 mg/day.-Acute bacterial rhinosinusitis: Outpatients: Children and adolescents: IM, IV: 50 mg/kg as a single dose; maximum dose: 2,000 mg/dose. While in case of severe infection requiring hospitalization: Infants, children, and adolescents: IV: 25 mg/kg/dose every 12 hours for 10 to 14 days; maximum dose: 2,000 mg/dose.
-Salmonella infection: Infants, children, and adolescents: IM, IV: 75 to 100 mg/kg/day divided every 12 to 24 hours; for 5 to 14 days; maximum dose: 2,000 mg/dose.-Shigellosis: Infants, children, and adolescents: IM, IV: 50 to 100 mg/kg/dose every 24 hours for 2 to 5 days; maximum dose: 2,000 mg/dose.
-Urinary tract infection: Infants, children, and adolescents: IM, IV: 50 mg/kg/dose every 24 hours; maximum dose: 2,000 mg/dose. Treatment duration dependent on age of patient, response to therapy, and extent of involvement.
-Skin and soft tissue infection: Infants, children, and adolescents: IM, IV: 50 to 75 mg/kg/day in divided doses every 12 to 24 hours; maximum daily dose: 2,000 mg/day.
-Bacterial meningitis: Infants, children, and adolescents: IV: 80 to 100 mg/kg/day divided every 12 to 24 hours; maximum daily dose: 4,000 mg/day.
Side Effects
-Clostridioides difficile associated diarrhea, hemolytic anemia, anaphylaxis and Kernicterus has been reported in neonates.
-Skin tightness, warm sensation at injection site, flushing, diaphoresis, pruritus, skin rash, nausea, vomiting, casts in urine, vaginitis, anemia, eosinophilia, hemolytic anemia, leukopenia, lymphocytopenia, neutropenia, prolonged prothrombin time, thrombocythemia, thrombocytopenia, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin, candidiasis, tenderness at injection site, chills, dizziness, headache, increased blood urea nitrogen, increased serum creatinine, palpitations, glycosuria, abdominal pain, choledocholithiasis, cholelithiasis, dyspepsia, flatulence, gallbladder sludge, pancreatitis, hematuria, agranulocytosis, basophilia, decreased prothrombin time, granulocytopenia, lymphocytosis, monocytosis, Jaundice, seizure, bronchospasm, epistaxis and hypersensitivity pneumonitis.
-Ceftriaxone-calcium precipitation occurs when co-administered with calcium intravenously , leading to fatal lung and kidney damage in premature and term neonates. Urinary sludge (hypercalciuria), nephrolithiasis, urolithiasis, and acute renal failure have been reported. Gallbladder sludge, cholelithiasis, and pseudolithiasis (choledocholithiasis), as well as subsequent pancreatitis, have also occurred. Most reports have occurred in pediatric patients; however, there are reports in adults.
Safety Advice
-For intravenous injection only.
-Should not be given to patients suffering from hypersensitivity to ceftriaxone.
-Rapid intravenous push injection over 5 minutes of a 2,000 mg dose resulted in tachycardia, restlessness, diaphoresis, and palpitations in an adult patient.
-Should not be given to premature hyperbilirubinemic neonates.
-May cause an increase in INR, especially in case of nutritionally deficient patients, prolonged treatment, hepatic or renal disease.
-Prolonged use may result in fungal or bacterial superinfection.
-Use with caution in patients with concurrent hepatic dysfunction and severe kidney disease.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
Store at room temperature.
Drug Interactions
-Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides.
-BCG Vaccine: Antibiotics may diminish the therapeutic effect of BCG Vaccine.
-Calcium Salts (Intravenous): May enhance the adverse/toxic effect of Ceftriaxone.
-Probenecid: May increase the serum concentration of Cephalosporins.
-Ringer's Injection (Lactated): May enhance the adverse/toxic effect of Ceftriaxone.
-Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate.
-Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists.
Pregnancy & Lactation
-Ceftriaxone crosses the placenta. Based on available data, cephalosporin antibiotics are generally considered compatible for use during pregnancy. Ceftriaxone is recommended for use in pregnant patients for the treatment of gonococcal infections and may be used in certain situations prior to vaginal delivery in patients at high risk for endocarditis.
-Ceftriaxone is present in breast milk. In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Ceftriaxone is considered compatible with breastfeeding when used in usual recommended doses, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
-Ask your physician before taking any medication during pregnancy or lacatation.