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Quadrant Ceftriaxone 250

Quadrant Healthcare Ltd
71, Jebba Street, Ebute-Metta (East), Lagos
Email: quaint998@hotmail.com
Tel: 08066122428, 07028090227, 08026044280

Brand Name

Quadrant Ceftriaxone 250

Manufacturer

North China Pharmaceutical Co., Ltd,
No. 388 East Heping Road, Shijiazhuang, China

Therapeutic Class

Antibacterial, Cefalosporins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection(NRN:-): Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 250 mg Excipient: none

Pack Size:

Pharmacology

PHARMACOLOGY AND TOXICOLOGY:

Ceftriaxone is a third-generation cephalosporin antibiotic. It has good activity against Enterobacteriaceae. MIC90 of ceftriaxone for the following susceptible organisms ranges from 0.12 to 0.25 mg/L, including Escherichia coli, Klebsiella pneumonite, Enterobacter aerogenes, Citrobacter freundii, indole-positive Proteus, Providencia and serretia.

Enterobacter cloacae. Acinetobacter and Pseudomonas aeruginosa are less susceptible to ceftriaxone. Ceftriaxone is active against Hemophilus influenzae, Neisseria gonorrhoeae and N. meningitides, as well hemolytic streptococcus and pneumococci.

Staphylococcus aureus is sensitive with an MIC90 of about 2 to 4 mg/L. Methicillin-resistant Staphylococcus spp., Enterococci and most of Bacteoides fragilis are resistant to ceftriaxone.

Indications

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 ghorrhoea.

Contra-indications

Ceftriaxone is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

Precautions/Warnings

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 than 5 mL/min and administration of ceftriaxone is 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 haemodialysis.

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 phosphatase, 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 250 ug/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 foetus, ceftriaxone should be used during pregnancy and lactation only if clearly needed.

Interactions

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. Ceftriaxone 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.

Adverse Effects

The adverse reactions are considered to be related to ceftriaxone dosage and course of treatment:

Local reactions include phlebitis (1.86%), skin rashes, pruritis, fever, bronchospasm, serum sickness and allergic reactions (2.77%), headache and dizziness (0.27%), diarrhea, nausea, vomiting, stomatitis, colitis, jaundice, abdominal distension, dysgeusia, dyspepsia and digestive tract reactions (3.45%).

Other observed abnormal reactions in the laboratories amounted to 19%, relating to haematological changes (14%), such as eosinophilia, thrombocytosis and leukopenia, hepatic dysfunction (5%) and impairment of renal function (1.4%).

Dosage & 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 lM or IV administration. Maintain therapy will be lasted for 7 to 14 days. The daily dosage may be raised to 4g.

Infants and children below twelve dosage:

The daily dosage will be 20 to 80 mg/kg bodyweight once daily by IV route.

For the treatment of gonorrhoea, 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.

Storage/Handling Recommendations

Store in a cool and dry place. Kept in a light container and avoid lighting.

SHELF LIFE: Three years when stored as prescribed.

Review Date

2017-02-06 01:58:47