Zeptri

Each vial contains: Ceftriaxone Sodium USP.

Antibacterial.

Susceptible strains: Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (Group A β-hemolysis), Streptococcus agalactiae (Group B), Streptococcus viridans, Streptococcus bovis, Aeromonas spp., Alcaligenes spp., Moraxella catarrhalis, Citrobacter spp., Enterobacter spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including Ampicillin resistant strains). Haemophilus parainfluenzae, Klebsiella spp. (K. pneumoniae), Moraxella spp., Moraxella morganii, Proteus mirabilis, Proteus vulgaris, Providencia spp., Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitidis, Plesiomonas shigelloides, Pseudomonas aeruginosa (some strains are resistant), Salmonella spp. (including S. typhi), Serratia spp. (including S. marcescens), Shigella spp., Yersinia spp. (including Y. enterocolitica), Treponema pallidum, Bacteroides spp. (including some strains of B. fragilis), Clostridium spp. (except C. difficile), Fusobacterium (except F. mortiferum and F. varium), Peptococcus, Peptostreptococcus.
Indications: Respiratory tract infections such as pneumonia, bronchitis, etc.; Ear, nose and throat infections; Renal and urinary tract infections, genital infection such as gonorrhea; Sepsis; Perioperative prophylaxis of infections; Infections of bones and joints; Infections of skin, wounds and soft tissue; Peritonitis, cholecystitis, cholangitis and infections of gastrointestinal tract; Infections in patients with immunodeficiency; Meningitis.

Adults and children over 12 years of age: 1-2 g (potency) of Ceftriaxone sodium administered once daily intravenously or intramuscularly. In severe cases or in infections caused by moderately sensitive organisms, the dosage may be increased to 4 g (potency) once daily.
Neonates (within 14 days): A daily dose of 20-50 mg (potency)/kg of body weight, not to exceed 50 mg (potency)/kg. It is not necessary to differentiate between premature and infants born at full term.
Infants and children (15 days to twelve years): 20-80 mg/kg (potency) is administered once daily. For children with bodyweight of 50 kg or more, the usual adult dosage should be used intravenous doses of 50 mg (potency) or more per kg bodyweight should be given by infusion over at least 30 minutes.
Elderly patients: The dosage recommended for adults is applied to geriatric patients.
Meningitis: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg (potency) per kg (not to exceed 4 g (potency)) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly.
The following duration of therapy has shown to be effective: (N. meningitidis: 4 days/H. influenzae: 6 days/S. pneumoniae: 7 days).
Gonorrhea: For the treatment of gonorrhea (penicillinase producing and nonpenicillinase-producing strains), a single IM dose of 250 mg (potency) is recommended.

In order to prevent appearance of the resistant microorganisms, susceptibility should be determined and treatment should be continued only for the minimum period of time required.
In order to predict side effects such as shock, etc., patient history should be taken in detail and skin reaction test should be performed.
Emergency measures have to be available in preparation for occurrence of shock (if anaphylactic shock occurs intravenous epinephrine has to be followed by a glucocorticoid injection), and even after measures taken the patient should be observed cautiously in stable condition.
It is desirable to perform laboratory test (hepatic function, renal function, blood etc.) at regular intervals during treatment.
Shadows which have been mistaken for gallstones have been detected on sonograms of the gallbladder, usually following doses higher than the standard recommended dose. These shadows are, however, precipitates of calcium ceftriaxone which disappear on completion or discontinuation of ceftriaxone therapy. Rarely, have these findings been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended. Discontinuation of ceftriaxone treatment in symptomatic cases should be at the discretion of clinician.
In the case of overdose, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.
Ceftriaxone is not reported to have side effects on a person ability to drive vehicles or operate machinery.
Cases of pancreatitis, possibly of biliary obstruction aetiology, have been rarely reported in patients treated with ceftriaxone. Most patients presented with risk factors for biliary stasis and biliary sludge, e.g. preceding major therapy, severe illness and total parenteral nutrition (TPN). A trigger or cofactor role of ceftriaxone-related biliary precipitation cannot be eliminated.
Safety and effectiveness of ceftriaxone in neonates, infants and children have been established for the dosages described in the Dosage & Administration. Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.
Ceftriaxone is contraindicated in hyperbilirubinemic neonates, especially prematures.

Cautious treatment is required as renal insufficiency may be worsened with combination of similar compounds (other cephem antibiotics) and diuretics such as furosemide, etc.
Synergy between ceftriaxone and aminoglycosides has been demonstrated with many gram-negative bacilli under experimental conditions and it is of special importance in severe life-threatening infections due to microorganisms such as Pseudomonas aeruginosa. Because of physical incompatibility the two drugs must be administered separately at the recommended dosages. There is no evidence that ceftriaxone increases renal toxicity of aminoglycosides.
The elimination of ceftriaxone is not altered by probenecid.
Ceftriaxone does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins. No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of ceftriaxone.
In vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone.
Bacteriostatic agent may weaken bactericidal action of this drug.

Store at temperature not exceeding 30°C.

Cephalosporins

J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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