Ziftum 750mg/1G Inj
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Ziftum
Each vial contains:
Sterile Cefuroxime sodium USP
equivalent to Cefuroxime …………… 750 mg/1.5 g
Indications / Uses
Tablet: Upper and lower respiratory tract infections; skin and soft tissue infections; urinary tract infection, gonococcal infection, septicaemia, meningitis and surgical prophylaxis.
Injection: Treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower respiratory tract infections eg, bacterial pneumonia, acute and chronic bronchitis, infected bronchiectasis, lung abscess and postoperative chest infections caused by Streptococcus pneumonia, Haemophilus influenza (including ampicillin-resistant strains), Klebsiella spp, Staphylococcus aureus (penicillinase-and non-penicillinase-producing strains), Streptococcus pyogenes and Escherichia coli.
Urinary tract infections eg, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria caused by Escherichia coli and Klebsiella spp.
Skin and skin-structure infections eg, cellulitis, erysipelas, peritonitis and wound infections caused by Staphylococcus aureus (penicillinase-and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp and Enterobacter spp.
Septicaemia caused by Staphylococcus aureus (penicillinase-and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenza (including ampicillin-resistant strains), Klebsiella spp.
Meningitis caused by Streptococcus pneumoniae, Haemophilus influenza (including ampicillin-resistant strains), Neisseria meningitides and Staphylococcus aureus (penicillinase-and non-penicillinase-producing strains).
Gonorrhoea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing strains) in both males and females.
Bone and joint infections eg, osteomyelitis and septic arthritis caused by Staphylococcus aureus ( penicillinase-and non-penicillinase-producing strains).
Prophylaxis against infection in abdominal, pelvic, orthopedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.
Dosage / Direction for Use
Tablet: Usual Dose: 250-500 mg twice daily for 10 days. Uncomplicated UTI: 125-250 mg twice daily for 10 days. Uncomplicated Gonorrhoea: 1 g as a single dose.
Injection: Adults: Many infections respond to 750 mg 3 times daily by IM or IV injection. For more severe infections, the dose should be increased to 1.5 g 3 times daily IV. The frequency of administration may be increased to 6 hrs if necessary giving total daily doses of 3-6 g.
Infants and Children: 30-100mg/kg/day given as 3 or 4 divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
Neonates: 30-100mg /kg/day given as 2 or 3 divided doses.
Administration: Reconstitute Ziftum 750 mg injection with water for injection 8.3 mL for IV administration or in 3 mL for IM administration. Reconstitute Ziftum 1.5 g injection with water for injection 15 mL for IV administration.
Overdosage
Tablet: Excessively large doses of all cephalosporins can cause cerebral irritation and may cause convulsions.
Injection: Overdosage of cephalosporin can lead to cerebral irritation and seizures. With seizure, cefuroxime should be discontinued and appropriate anticonvulsive therapy administered. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
Contraindications
Hypersensitivity to cephalosporins.
Special Precautions
Tablet: As with other broad-spectrum antibiotics, prolonged administration of cefuroxime axetil may result in overgrowth of nonsusceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.
Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.
Injection: Hypersensitivity to cephalosporins and/or penicillin should be looked before starting cefuroxime, if the former is known, Cefuroxime should not be given. Cefuroxime should be given cautiously to penicillin sensitive patients keeping ready emergency resuscitative measures.
Use in pregnancy & lactation: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Cefuroxime axetil should be used during pregnancy only if clearly needed.
Because cefuroxime is excreted in human milk in low concentration, consideration should be given to discontinue nursing temporarily during treatment with cefuroxime axetil.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Cefuroxime axetil should be used during pregnancy only if clearly needed.
Because cefuroxime is excreted in human milk in low concentration, consideration should be given to discontinue nursing temporarily during treatment with cefuroxime axetil.
Adverse Reactions
Tablet: As with all cephalosporins, anaphylaxis is possible particularly in patients with history of allergic reactions to cephalosporins or penicillin, but is rare. A small proportion of patients receiving cefuroxime axetil have experienced gastrointestinal disturbances, including diarrhea, nausea and vomiting.
Injection: Cefuroxime for injection is generally well-tolerated. Adverse reactions are mild and transient. The common adverse effects reported are gastrointestinal disturbances, hypersensitivity reactions including skin rashes, urticaria, pruritus, interstitial nephritis, pruritus, interstitial nephritis, drug fever and very rarely anaphylaxis. Transient pain may be experienced at the site of IM injection and occasionally, thrombophebitis may follow at the site of IV injection.
Click to View ADR Monitoring Form
Interactions
Injection: Concurrent administration of probenacid prolongs the excretion of cefuroxime and produces an elevated peak serum level. Concurrent administration of potent diuretics, aminoglycisides may adversely affect renal functions.
Interference with Laboratory Tests: Slight Interference may occur with the copper reduction methods (Fehling’s, Benedict’s) but this should not lead to false-positive results. Cefuroxime does not interfere with the enzyme-based tests for glycosuria, or with the alkaline picrate method for creatinine. It is recommended that either the hexokinase or glucose oxidase methods are used for determination of blood/plasma glucose levels.
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Storage
Store in a cool, dark place. Protect from light.
Description
Ziftum tablet contain cefuroxime as axetil while the Ziftum injection contains cefuroxime as sodium.
Cefuroxime injection is a 2nd generation cephalosporin, to reduce the development of drug resistance bacteria. It is steriline crystalline form and its solution range in colour from light yellow to amber. The pH of the freshly prepared solution ranges from 6-8.5.
Mechanism of Action
Pharmacology: Tablet: Cefuroxime is the 1-acetoxyethyl ester of cefuroxime. Cefuroxime is a semi-synthetic analogs of cephalosporin C. Cefuroxime has in vitro activity against a wide range of gram-positive and gram-negative organisms and it is highly stable in the presence of β-lactamases of certain gram-negative bacteria. The bactericidal action of cefuroxime results from inhibition of cell wall synthesis. Cefuroxime is active against Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae and Streptococcus pyogenes (and other streptococci), Citrobacter spp, Enterobacter spp, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp, Moraxella catarrhalis and other gram-negative bacteria.
Injection: Cefuroxime is a cephalosporin antibiotic. All caphalosporins (β-lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis. The initial step in drug action consists of binding of the drug to cell receptors, called penicillin-binding proteins. After a β-lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.
Pharmacokinetics: Tablet: Absorption and Metabolism: After oral administration, cefuroxime axetil is well-absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Absorption of the tablet is greater when taken after food (absolute bioavailability of cefuroxime axetil tablets increases from 37-52%). Peak serum concentrations are achieved 2-3 hrs after an oral dose. Serum levels of 2.1 and 4.1 mcg/mL are obtained from oral administration of 125 and 250 mg of cefuroxime axetil. About 50% of the drug is protein-bound. It is widely distributed in the body, including pleural fluid, sputum, bone, synovial fluid, aqueous humor and cerebrospinal fluid when meninges are inflamed. The axetil moiety is metabolized to acetaldehyde and acetic acid. Cefuroxime is excreted unchanged in the urine and approximately 50% of the administered dose is recovered in the urine within 12 hrs. Mean elimination half-life (t½) is 1.2 hrs.
Injection: The serum t½ after either IM or IV administration is approximately 70 min. After IM injection the peak serum level occurs after about 45 min.
The blood-brain barrier can be passed by cefuroxime when the meninges are inflamed. Cefuroxime is excreated approximately 50% by glomerular filtration and 50% through the renal tubules. Cefuroxime is almost completely recovered unchanged in the urine within 24 hrs, most being excretedwithin 6 hrs.
ATC Classification
J01DC02 – cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
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