KINGLION CEFTRIAXONE SODIUM INJECTION
Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 250mg, 500mg or 1.0g.
PHARMACOLOGY AND TOXICOLOGY
Ceftriaxone is a third-generation cephalosporin antibiotic. It has good activity against Enterobactenaceae. MIC90 of ceftriaxone for the following susceptible organisms ranges from 0.12 to 0.25mg/L, including Escherichia coli, Klebsiella pneumonile, Enterobacter aerogens, Citrobacter freundii, indole-positive proteus, providencia and serratia. Enterobacter cloacae, Acinetobacter and Pseudomonas aeruginosa are less susceptible to ceftriaxone. Ceftriaxone is active against Hemophilus influenza, Neisseria gonorrhoeae and N. meningitides, as well as hemolytic streptococcus and pneumococci, Staphylococcus aureus is sensitive with an MIC90 of about 2 to 4mg/L. Methicillin-resistant Staphylococcus spp., Enterococci and most of Bacteoides fragilis are resistant to ceftriaxone.
Ceftriaxone is indicated for the treatment of infections due to susceptible organisms, including lower respiratory tract infections, urinary tract and biliary tract infections, abdominal infections, pelvic infections, infections of the skin, soft tissue, bone and joints, sepsis, meningitis and preoperative prophylaxis of infections. Single administration of ceftriaxone can be used in the treatment of uncomplicated gonorrhoea.
DOSAGE AND ADMINISTRATION
Adult and Children over twelve dosage: The usual dosage is 1 to 2g of ceftriaxone once daily (every 24 hours), or 0.5 to 1g (every 12 hours) by IM or IV administration. Maintenance therapy should last for 1 to 14 days. The daily dosage may be raised to 4g.
Infants and children below twelve dosage: The daily dosage will be 20 to 80mg/2ml/kg body weight once daily by IV route.
For the treatment of gonorrhea a single IM dose of 0.25g ceftriaxone is recommended. The Injection should be freshly prepared. Do not refrigerate the reconstituted solution. Discard any unused portion.
For IV use: Should be reconstituted with sterile water for injection BP 9.5ml.
For IM use: Should be reconstituted with 1% Lidocaine Injection BP 3.5m1.
The adverse reactions are considered to be related to ceftriaxone dosage and course of treatment. Local reactions include philbitis (1.86%), skin rahes, pruritis, fever, bronchospasm, serum sickness and allergic reactions (2.77%), headache and dizziness (0.27%), diarrhea, nausea, vomiting, stomatitis, colitis, jaundice, abdominal distension, dysgeusia and digestive tract reactions (3.45%). Other observed abnormal reactions in the laboratories amounted to 19% relating to haematological changes (14%), such as oesinophilia, thrombocytosis and leucopenia, hepatic dysfunction (5%) and impairment of renal function (1.4%).
Ceftriaxone is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
1. Ceftriaxone should not be given to patients who are hypersensitive to it, to cephamycin, to other cephalosporins, to penicillins, to penicillin derivants or to penicillamine. About 5% to 10% of penicillin-sensitive patients may also be allergic to cephalosporins. If an assay of immune response is made in patients, the above-mentioned reaction rate comes up to 20%.
2. Ceftriaxone should be used with caution in patients with gastrointestinal diseases, particularly those with a history ulcerative colitis, local or antibiotic-associated enteritis (cephalosporins may cause pseudomembranous colitis on rare cases).
3. Since cephalosporins toxicity is relatively lower, patients with chronic hepatic diseases require no adjustment in dosage, however, in patients with severe hepatorenal impairment or cirrhosis, ceftriaxone dosage should be adjusted.
4. Dosage adjustment should not be necessary in patients with renal dysfunction when serum creatinine clearance is more that 5mL/min and administration of ceftriaxone in less than 2g daily. Only a small part of ceftriaxone is removed by haemodialysis, therefore, the dosage is not necessary to be increased in patients after haemolialysis.
5. Ceftriaxone may interfere with some diagnoses, including a false-positive result for glycosuria, using copper-reduction, but glycose enzymatic methods have no influence on determining glycosuria. Temporary rises in serum creatinine and urea may occur in rare instances. Elevations of serum bilirubin, alkaline phospatase, ALT and AST may occur in the clinical use.
Before using Ceftriaxone, the intradermic allergic test should be taken with 0.1 ml of test solution via intradermic injection. Test solution: dilute ceftriaxone with sterile physiological saline to the concentration of 250ug/ml.
The positive Patient is a contraindication.
Pregnancy and Lactation
Although administration of ceftriaxone in pregnancy and lactation does not reveal any malformation on the foetues, ceftriaxone should be used during pregnancy and lactation only if clearly needed.
1. Turbidity will occur when the following drugs are mixed with intravenous infusion of cephalosporins: erythromycin, tetracycline, amphotericin B, vasoactive drugs (metaraminol, norephinephrine), phenytoin sodium, chlorphromazine, isopropanol, vitamin B group and vitamin C. Ceftriazone sodium should be used alone since it is incompatible with a lot of drugs
2. Because disulfiram-like reactions may occur in rare occasions after administration of alcohol or drugs containing alcohol with ceftriaxone during the treatment, alcohol or drugs containing alcohol should be avoided during the period of treatment with ceftriaxone and some days after withdrawal of ceftriaxone.
Store in a cool dry place. Keep in tight container and avoid lighting.
Three years when stored as prescribed.
NAFDAC REG. NO: B4-3458
SOOTHE HEALTHCARE & INVESTMENT LTD.
385, IKORODU ROAD, OJOTA, LAGOS, NIGERIA
North China Pharmaceutical Co., Ltd
108, Haihe Road, High & New Technology
Development Zone, Shijiazhuang City, China