Sultrex

Sultrex

Manufacturer:

Cosmas

Distributor:

Endure Medical
Full Prescribing Info
Description
Each vial contains Ceftriaxone 1 g, Sulbactam 500 mg.
Action
Pharmacology: Ceftriaxone is a third-generation cephalosporin antibiotic with an extended spectrum of activity and increased potency against Gram-negative bacteria including the Enterobacteriaceae, Haemophilus influenza, Moraxella (Branhamella) catarrhalis, and Neisseria spp., but only moderate activity against Pseudomonas spp. It has a relatively long half-life and is given by injection as the sodium salt once or twice daily. Adverse effects are similar to those for all cephalosporins, including hypersensitivity reactions. Its high biliary excretion has sometimes resulted in reversible biliary sludge or pseudolithiasis and may also contribute to change in bowel flora. Because of high plasma protein binding Ceftriaxone can displace bilirubin to cause hyperbilirubinaemia; it should be avoided in jaundiced neonates.
The 1.18 g of monograph substance is approximately equivalent to 1 g of Ceftriaxone. Each g of monograph substance represents about 3.0 mmol of sodium. Freely soluble in water; very slightly soluble in alcohol; sparingly soluble in methyl alcohol.
Sulbactam is a penicillinic acid sulfone with beta-lactamase inhibitory properties. It is active against Neisseriaceae and Acinetobacter baumanii, but generally has only weak antibacterial activity against other organisms. It is an irreversible inhibitor of many plasmid-mediated and some chromosomal beta-lactamases and has a similar spectrum of beta-lactamase inhibition to clavulanic acid (p250). Although it is regarded as less potent. Sulbactam can therefore enhance the activity of penicillins and cephalosporins against many resistant strains of bacteria.
Pharmacokinetics: Ceftriaxone demonstrates nonlinear dose-dependent pharmacokinetics because of its protein binding; about 85 to 95% is bound to plasma proteins depending on the concentration of ceftriaxone. Mean peak plasma concentrations of about 40 to 80 micrograms/mL have been reported 2 hours after intramuscular injection of 0.5 and 1g of ceftriaxone respectively. The plasma half-life of ceftriaxone is not dependent on the dose and varies between 6 and 9 hours; it may be prolonged in neonates. The half-life does not change appreciably in patients with moderate renal impairment, but it may be prolonged in severe impairment especially when there is also hepatic impairment. Ceftriaxone 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 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.
Indications/Uses
Ceftriaxone-Sulbactam is used in the treatment of infections caused by susceptible organisms including sepsis, meningitis, abdominal infections (e.g. peritonitis, infections of the biliary tract), infections of the bones, joints, soft tissue, skin and of wounds, renal and urinary tract infections, respiratory tract infections, particularly pneumonia, and ear, nose, and throat infections and uncomplicated gonorrhea.
Ceftriaxone-Sulbactam may also be used for pre-operative prophylaxis of infections. A single dose given pre-operatively may reduce chances of postoperative infection.
Dosage/Direction for Use
Adult: The recommended adult dosage is 1.5 g (1 g Ceftriaxone as sodium salt and 0.5 g Sulbactam as sodium salt) to 3 g (2 g Ceftriaxone as sodium salt and 1 g Sulbactam as sodium salt) every 6 hours. The total dose of Sulbactam should not exceed 4 g per day.
Neonates, Infants, and Children up to 12 years: Neonates: 20 mg to 50 mg/kg body weight once daily, up to 14 days. The daily dose should not exceed 50 mg/kg.
Infants and Children (15 days to 12 years old): 20 mg to 80 mg/kg once daily.
Or as prescribed by the physician.
Overdosage
The treatment of Ceftriaxone-sulbactam overdose is essentially supportive and symptomatic.
Contraindications
Ceftriaxone-Sulbactam is contraindicated in patients with history of allergy to cephalosporins, penicillins and other components of the drug.
Special Precautions
Super-infections with non-susceptible microorganisms may occur. Since pseudomembranous colitis has been reported to occur with ceftriaxone, it is important to consider this diagnosis in patients who present with diarrhea prior to the administration of Ceftriaxone-Sulbactam. Ceftriaxone, if given at higher than standard doses, may get precipitated as its calcium salt in the gall bladder, the shadows of which seen under sonography, could be mistaken for gallstones. However, it is largely asymptomatic and shadows disappears on discontinuation of therapy or in due completion of therapy. Like other cephalosporins, Ceftriaxone is known to displace bilirubin from serum albumin. Hence caution needs to be exercised when considering Ceftriaxone and Sulbactam for the treatment of neonates with hyper-bilirubinemia.
Use in Pregnancy & Lactation: Reproductive studies on Ceftriaxone have been performed in mice and rats at very high doses. No evidence of embryotoxicity, fetotoxicity or teratogenicity was observed. However, in the absence of adequate and well-controlled studies in pregnant women, caution should be taken when using this drug in pregnant women and should only be used if the benefits outweigh the risks.
As Ceftriaxone is secreted in breast milk, caution should be exercised in nursing mothers.
Use In Pregnancy & Lactation
Reproductive studies on Ceftriaxone have been performed in mice and rats at very high doses. No evidence of embryotoxicity, fetotoxicity or teratogenicity was observed. However, in the absence of adequate and well-controlled studies in pregnant women, caution should be taken when using this drug in pregnant women and should only be used if the benefits outweigh the risks.
As Ceftriaxone is secreted in breast milk, caution should be exercised in nursing mothers.
Adverse Reactions
Gastrointestinal disorders such as diarrhea, nausea, vomiting, stomatitis and glossitis has been observed. Elevations of SGOT/SGPT has occurred. Hemolytic anemia is observed less frequently as well as eosinophilia, thrombocytopenia, leucopenia, granulocytopenia, hematoma, and bleeding.
Agranulocytosis (<500/mm3) has been reported occasionally at a total of cumulative dose exceeding 20 g. Exanthemia, allergic dermatitis, pruritus, urticarial, edema, erythema multiforme also occurred. Other side effects such as headaches, dizziness, increase in serum creatinine, mycosis of genital tract, oliguria, fever, and shivering have been observed. Anaphylactic shock may occur which requires immediate counter-measures. On the site of administration, pain, induration, and tenderness may be encountered. Inflammatory reactions in the vein wall may also occur after IV administration. These may be minimized by slow injection, given over 2 to 5 minutes.
Drug Interactions
Aminoglycosides: No evidence of renal toxicity with concomitant use of aminoglycoside.
Diuretics: No impairment of renal function has been observed after concurrent administration of large doses of Ceftriaxone and potent diuretics.
Chloramphenicol: Ceftriaxone and chloramphenicol have been shown to be antagonistic in-vitro studies.
Probenecid: Elimination of Ceftriaxone is not altered by probenecid.
Laboratory Test: False-positive direct Coombs' test results in certain patients (eg, those with azolemia). Non-enzymatic urinary glucose estimation methods may give false positive results.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DD63 - ceftriaxone and beta-lactamase inhibitor ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1's, 20's.
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