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Indications/Uses
Indicated for the treatment of infections caused by pathogens sensitive to Ceftriaxone (KEPTRIX), namely: Lower respiratory tract infections, Skin and skin structure infections, Bone and joint infections, Intra-abdominal infections, Urinary tract infections, Meningitis and septicemia caused by susceptible organisms.
Dosage/Direction for Use
Intravenous Injection: Ceftriaxone (KEPTRIX) 1 g is dissolved in 10 mL of Sterile Water for Injection. Administered by intravenous injection lasting two to four minutes.
Intramuscular Injection: Ceftriaxone (KEPTRIX) 1 g is dissolved in 3.5 mL of 1% Lidocaine solution and administered by deep intramuscular injection. If more than 1 g is to be injected intramuscularly then the dose should be divided between more than one site.
Standard Dosage: Adults and children over 12 years: Administer 1 to 2 g once daily (every 24 hours) in severe cases the dosage may be raised to a maximum dose of 4 g administered once daily.
Infants and children: 20 to 50 mg/Kg once daily; for severe infections up to 80 mg/Kg once daily may be given.
Neonates: The maximum dose should not exceed 50 mg/Kg once daily; intravenous doses in neonates should be given over 60 minutes. Doses above 50 mg/Kg should be administered by intravenous infusion only.
Special Dosage: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/Kg body weight (not to exceed 4 g) once daily. The duration of therapy is as follows: Neisseria meningitis, 4 days; Streptococcus pneumoniae, 7 days; Haemophilus influenzae, 6 days; Susceptible Enterobacteriaceae, 10-14 days.
A reduction in dosage may be necessary in patients with severe renal impairment and in those with both impaired renal and hepatic function; plasma concentrations should be monitored in such patients.
Intramuscular Injection: Ceftriaxone (KEPTRIX) 1 g is dissolved in 3.5 mL of 1% Lidocaine solution and administered by deep intramuscular injection. If more than 1 g is to be injected intramuscularly then the dose should be divided between more than one site.
Standard Dosage: Adults and children over 12 years: Administer 1 to 2 g once daily (every 24 hours) in severe cases the dosage may be raised to a maximum dose of 4 g administered once daily.
Infants and children: 20 to 50 mg/Kg once daily; for severe infections up to 80 mg/Kg once daily may be given.
Neonates: The maximum dose should not exceed 50 mg/Kg once daily; intravenous doses in neonates should be given over 60 minutes. Doses above 50 mg/Kg should be administered by intravenous infusion only.
Special Dosage: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/Kg body weight (not to exceed 4 g) once daily. The duration of therapy is as follows: Neisseria meningitis, 4 days; Streptococcus pneumoniae, 7 days; Haemophilus influenzae, 6 days; Susceptible Enterobacteriaceae, 10-14 days.
A reduction in dosage may be necessary in patients with severe renal impairment and in those with both impaired renal and hepatic function; plasma concentrations should be monitored in such patients.
Overdosage
In appropriately large doses, Ceftriaxone (KEPTRIX) may cause seizures, particularly in patients with renal impairment. If seizure occurs, promptly discontinue the drug, administer anticonvulsant therapy if clinically indicated.
Contraindications
Contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.
Special Precautions
As with other cephalosporin, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare case, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation of Ceftriaxone (KEPTRIX) therapy. In-vitro studies have shown that Ceftriaxone (KEPTRIX) can displace bilirubin from serum albumin. Caution should be exercised when considering Ceftriaxone (KEPTRIX) for neonates, especially prematures.
Use in Pregnancy: Although there is no experimental evidence of mutagenic or teratogenic effects.
Ceftriaxone (KEPTRIX) should not be used in pregnancy (particularly in the first trimester) unless absolutely indicated.
Use in Lactation: Ceftriaxone (KEPTRIX) is excreted in human milk, usually in low concentrations. Caution should be exercised if Ceftriaxone (KEPTRIX) is given to nursing mother.
Use in Pregnancy: Although there is no experimental evidence of mutagenic or teratogenic effects.
Ceftriaxone (KEPTRIX) should not be used in pregnancy (particularly in the first trimester) unless absolutely indicated.
Use in Lactation: Ceftriaxone (KEPTRIX) is excreted in human milk, usually in low concentrations. Caution should be exercised if Ceftriaxone (KEPTRIX) is given to nursing mother.
Use In Pregnancy & Lactation
Use in Pregnancy: Although there is no experimental evidence of mutagenic or teratogenic effects.
Ceftriaxone (KEPTRIX) should not be used in pregnancy (particularly in the first trimester) unless absolutely indicated.
Use in Lactation: Ceftriaxone (KEPTRIX) is excreted in human milk, usually in low concentrations. Caution should be exercised if Ceftriaxone (KEPTRIX) is given to nursing mother.
Ceftriaxone (KEPTRIX) should not be used in pregnancy (particularly in the first trimester) unless absolutely indicated.
Use in Lactation: Ceftriaxone (KEPTRIX) is excreted in human milk, usually in low concentrations. Caution should be exercised if Ceftriaxone (KEPTRIX) is given to nursing mother.
Adverse Reactions
Gastrointestinal disturbances: Loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis.
Hematological changes: Eosinophilia, leucopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.
Skin reactions: Exanthema, allergic dermatitis, pruritus, urticaria, edema, erythema multiforme.
Other rare adverse effects: Headache and dizziness, increase in liver enzymes, gallbladder sludge, oliguria, increase in serum creatinine, mycosis of the genital tract, shivering and anaphylactoid reactions.
Local adverse effects: In rare cases, phlebitic reaction occurred after IV administration. These may be prevented by slow injection (2 to 4 minutes).
Seek advice from a healthcare professional at the first sign of any adverse drug reaction.
Hematological changes: Eosinophilia, leucopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.
Skin reactions: Exanthema, allergic dermatitis, pruritus, urticaria, edema, erythema multiforme.
Other rare adverse effects: Headache and dizziness, increase in liver enzymes, gallbladder sludge, oliguria, increase in serum creatinine, mycosis of the genital tract, shivering and anaphylactoid reactions.
Local adverse effects: In rare cases, phlebitic reaction occurred after IV administration. These may be prevented by slow injection (2 to 4 minutes).
Seek advice from a healthcare professional at the first sign of any adverse drug reaction.
Drug Interactions
No impairment of renal function has been observed after concurrent administration of large doses of Ceftriaxone (KEPTRIX) and loop diuretics (e.g. furosemide). There is no evidence that Ceftriaxone (KEPTRIX) increases renal toxicity of Aminoglycosides. Ceftriaxone (KEPTRIX) has the potential to increase the effects of anticoagulants and to cause a disulfiram-like reaction with alcohol. Unlike many cephalosporins, probenecid does not affect the renal excretion of Ceftriaxone (KEPTRIX).
Caution For Usage
Stability of Reconstituted Solution: Reconstituted solution retains their physical and chemical stability to six hours at room temperature (or 24 hours at 5°C). However, it is generally recommended that the solutions be used immediately after reconstitution. The color of the solution ranges from pale yellow to amber depending on concentration and length of storage. This characteristic of the active ingredient has no significance in the efficacy or tolerance of the drug.
Incompatibilities: The admixture of Sterile Ceftriaxone Sodium with other antibacterials is not recommended. The admixture of Ceftriaxone (KEPTRIX) and Aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.
Incompatibilities: The admixture of Sterile Ceftriaxone Sodium with other antibacterials is not recommended. The admixture of Ceftriaxone (KEPTRIX) and Aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle.
Storage
Store below 25°C. Protect from light.
Action
Pharmacology: Pharmacodynamics: Ceftriaxone (KEPTRIX) is a third-generation cephalosporin. It inhibits mucopeptide synthesis in the bacterial cell wall, making it defective and osmotically unstable. Ceftriaxone (KEPTRIX) is highly stable to most beta-lactamases and therefore, it is active against a wider spectrum of gram-negative bacteria and most Enterobacteriaceae. It is not active against gram-positive cocci as compared to the first and second generation cephalosporins. In vitro the activities of Ceftriaxone (KEPTRIX) and Aminoglycosides are synergistic against certain susceptible and resistant strains of P. aeruginosa, S. marcescens and other Enterobacteriaceae, including Enterobacter cloacae, E. coli, K. pneumoniae and P. mirabilis.
Pharmacokinetics: Ceftriaxone (KEPTRIX) is widely distributed in body tissues and fluids. It crosses both inflamed and non-inflamed meninges, generally achieving therapeutic concentrations in the CSF. It crosses the placenta and low concentrations have been detected in breast milk.
High concentrations are achieved in bile.
About 40 to 65% of a dose of Ceftriaxone (KEPTRIX) is excreted unchanged in the urine, principally by glomerular filtration; the remainder is excreted in the bile and is ultimately found in the feces as unchanged drug and microbiologically inactive compounds.
Pharmacokinetics: Ceftriaxone (KEPTRIX) is widely distributed in body tissues and fluids. It crosses both inflamed and non-inflamed meninges, generally achieving therapeutic concentrations in the CSF. It crosses the placenta and low concentrations have been detected in breast milk.
High concentrations are achieved in bile.
About 40 to 65% of a dose of Ceftriaxone (KEPTRIX) is excreted unchanged in the urine, principally by glomerular filtration; the remainder is excreted in the bile and is ultimately found in the feces as unchanged drug and microbiologically inactive compounds.
MedsGo Class
Cephalosporins
Features
Brand
KEPTRIX
Full Details
Dosage Strength
1g
Drug Ingredients
- Ceftriaxone
Drug Packaging
Powder for Injection (I.M./I.V.) 1's
Generic Name
Ceftriaxone Sodium
Dosage Form
Powder For Injection (I.M./I.V.)
Registration Number
DR-XY27137
Drug Classification
Prescription Drug (RX)