Uses of Silysan

Silysan is a combination product between 2 active ingredients, Ceftriaxone Sodium and Sulbactam Sodium with the respective content of 1g and 0.5g. Silysan is manufactured by Prayash Healthcare Pvt., Ltd (India) and registered for circulation in Vietnam by Ambalal Sarabhai Enterprises., Ltd (India) with registration number VN-12835-11.
Silysan is prepared in powder form for injection, packed in 1 vial in each box with 1 tube of 10ml distilled water.

The ingredient Ceftriaxone in Silysan is a 3rd generation Cephalosporin antibiotic with a broad spectrum of action and is used only as an infusion. The bactericidal action of Ceftriaxone is due to inhibition of bacterial cell wall synthesis through binding to one or more penicillin-binding proteins (PBPs). Similar to other 3rd generation cephalosporin antibiotics (such as cefotaxime, ceftazidime...), ceftriaxone is generally less active against staphylococci (staphylococci) strains than 1st generation cephalosporins but has a spectrum of susceptibility to microorganisms Gram-negative bacteria are wider than the 1st and 2nd generation Cephalosporins.
The remaining ingredient in Silysan is Sulbactam, which is essentially a sulfon penicillanic acid, which is able to irreversibly inhibit bacterial beta-lactamases. secrete. Although it has antibacterial ability, when used alone, the effect of Sulbactam is very weak. Sulbactam is a good inhibitor of both plasmid and chromosomal-mediated beta-lactamases. Because Sulbactam has high affinity and binds to some beta-lactamases (enzymes that inactivate Ceftriaxone by hydrolysis of the beta-lactam ring), the combination of Sulbactam with Ceftriaxone in Silysan will create a synergistic and broad spectrum bactericidal effect. antibacterial activity of Ceftriaxone against strains resistant to Ceftriaxone used alone.

Patients only take Silysan as prescribed by the doctor after the diagnosis of infectious diseases caused by susceptible bacteria, including endocarditis, gastrointestinal infections, meningitis (including including prevention of meningococcal infections), Lyme disease, urinary tract infections (including pyelonephritis), pneumonia, gonorrhea, typhoid, syphilis, bacteremia, bone and joint infections and skin infections.
Besides, Silysan is also used for the purpose of preventing infection during surgery or endoscopic intervention.
Contraindications of Silysan:
Hypersensitivity to Ceftriaxone, Sulbactam or other Cephalosporin antibiotics; History of anaphylactic reaction to penicillin; Neonates with hyperbilirubinemia, especially at preterm birth, because ceftriaxone may increase the release of bilirubin from serum albumin; Contraindications to concomitant use of Silysan with calcium-containing preparations in children; History of cholestatic jaundice or liver dysfunction when using Sulbactam.

4.1. How to use Silysan Silysan can be used intravenously or intramuscularly; Time for intravenous injection is about 2 - 4 minutes and intravenous infusion needs at least 30 minutes; For doses greater than 1g of Ceftriaxone, it is recommended that only intravenous infusion rather than slow intravenous injection be given; Intramuscular doses greater than 1g of Ceftriaxone require multiple injection sites. 4.2. Dosage of Silysan for adults Usual dose: 1-2g per day (equivalent to 1-2 bottles of Silysan), can be injected once or divided into three times; In severe cases, a dose of 4g Ceftriaxone can be used (corresponding to 4 vials of Silysan). 4.3. Dosage of Silysan for children Children weighing less than 50kg: The recommended dose is 20-50mg/kg/day for a single dose. If the infection is severe, a dose of 80mg/kg/day can be used. Note that with doses of 50mg/kg or more, only intravenous infusion is recommended; Children weighing 50kg or more: The same dose as adults; Neonates: Only use intravenous infusion over 60 minutes at a dose of 20-50mg/kg/day; In case of meningitis caused by susceptible bacteria in children or infants up to 12 years old: A high dose of 100mg/kg/day (maximum 4g, corresponding to 4 vials of Silysan per day) is recommended. or divided into 2 equal doses every 12 hours, treatment duration 7-21 days. 4.4. Dosage of Silysan for some special indications Gonorrhea: Single intravenous dose of 250mg Ceftriaxone; Preoperative prophylaxis: 1-2g of Ceftriaxone by slow intravenous injection 30-90 minutes before surgery. 4.5. Silysan dosage for some special subjects Elderly: No need to adjust the dose of Silysan when liver and kidney function is normal; Patients with renal impairment: No dose adjustment of Silysan is necessary. When the creatinine clearance is less than 10 ml/min, the dose of ceftriaxone should not exceed 2 g/24 hours; Hemodialysis patients: The dose of 2g Ceftriaxone (corresponding to 2 vials of Silysan) is injected at the end of the dialysis session. In general, no additional dose of Silysan is required during and after hemodialysis because Ceftriaxone is not removed by dialysis; Patients with hepatic impairment: No dose adjustment of Silysan is necessary.

Side effects of Ceftriaxone ingredients include:
Common: Diarrhea, skin reactions, itching, rash; Uncommon: Fever, phlebitis, edema, eosinophilia, thrombocytopenia, leukopenia, urticaria; Rare: Headache, dizziness, anaphylaxis, anemia, agranulocytosis, coagulopathy, pseudomembranous colitis, erythema multiforme, hematuria, serum creatinine or transient elevation of enzymes liver; Treatment with antibiotics (including Ceftriaxone) often affects the intestinal flora, thereby increasing the risk of developing non-susceptible fungal or bacterial infections. Side effects of Sulbactam ingredient in Silysan:
Common: Local reactions (such as injection site pain, thrombophlebitis), diarrhea, nausea, vomiting, rash, increased liver enzymes, anemia , thrombocytopenia, eosinophilia, hyperbilirubinemia; Uncommon: Pruritus rash, urticaria, erythema multiforme, anaphylaxis. neutropenia, decreased Hemoglobin and Hematocrit causing anemia; Rare: Glossitis.

Before starting treatment with Silysan, the patient should be thoroughly investigated for a history of allergy to Cephalosporin antibiotics, penicillin or Sulbactam and other ingredients contained in the drug. Cases of cross-allergic reactions to ceftriaxone have been reported in patients allergic to penicillin. In patients with significant impairment of both renal and hepatic function, the dose of Ceftriaxone should not exceed 2 g/day (not to exceed 2 vials of Silysan) if plasma concentrations cannot be monitored. Use caution when treatment with Silysan lasts longer than 14 days. The cause of anemia must be sought during treatment with cephalosporin antibiotics (including Ceftriaxone in Silysan) because this class of antibiotics has the potential to cause severe, even fatal, immune-mediated hemolytic anemia. Patients taking Silysan may develop symptoms of urolithiasis, ureteral obstruction, and post-renal acute renal failure, especially common in pediatric patients. Discontinue Silysan immediately if convulsions occur. Physicians should administer anticonvulsant therapy if clinically indicated. Patients who develop diarrhea during or after taking Silysan should be considered to discontinue therapy and institute specific therapies for Clostridium difficile pseudomembranous colitis. In patients treated with Ceftriaxone (such as Silysan), the Coombs test may give a false positive result. Clinical experience with the treatment of Silysan in pregnant women is limited. Therefore, Silysan should only be used during pregnancy when absolutely necessary. Ceftriaxone is excreted in low concentrations in milk; however, Silysan should be used with caution in nursing patients.

Chloramphenicol : When combined with Ceftriaxone in vitro was determined to be antagonistic; The nephrotoxic potential of cephalosporins may be increased when co-administered with Gentamicin, Colistin or Furosemide; Probenecid does not affect the renal clearance of Ceftriaxone, so it can be used concomitantly with Silysan; Avoid concomitant use of Silysan with calcium salts (infusion) and Ringer lactate solution; Silysan may increase the effect of vitamin K antagonist anticoagulants; The potency of Silysan may be increased when co-administered with agents that increase uric acid in urine; Ceftriaxone may reduce the effectiveness of typhoid vaccine, therefore patients should be vaccinated with caution during treatment with Silysan.