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Name of the medicinal product

Ceftizoxime for injection USP 2000mg TajPharma
Ceftizoxime for Injection USP 1000mg TajPharma
Ceftizoxime for Injection USP 500mg TajPharma
Ceftizoxime for Injection USP 250mgTajPharma

Qualitative and quantitative composition

a) Each vial contains:
Ceftizoxime Sodium USP
(equivalent to Ceftizoxime)                     2000mg

b) Each vial contains:
Ceftizoxime Sodium USP
(equivalent to Ceftizoxime)1000mg

c) Each vial contains:
Ceftizoxime Sodium USP
(equivalent to Ceftizoxime)                       500mg

d)Each vial contains:
Ceftizoxime Sodium USP
(equivalent to Ceftizoxime)                       250mg

Pharmaceutical form

Powder for solution for infusion.

Pharmacology

Ceftizoxime is a semisynthetic, broad spectrum, Beta-lactamase resistant cephalosporin antibiotic for parenteral administration (IV, IM).

Indications

Ceftizoxime  is  effective  against  a  wide   range   of  the   following   bacteria:   Gram-positive    bacte- ria: Staphylococcus aureus (including  penicil-  linase and non-penicillinase producing strains); Staphylococcus epidermidis (including penicillin- ase and non-penicillinase producing strains), strep- tococcusagalactiae, Streptococcus

pneumoniae, Streptococcus pyogenes. Gram-negative  bacte-  ria: acinetobacter, Enterobacter, Escherichia coli, Haemophilusinfluenzae (including ampicillin-resis- tant strains); Klebsiellapneumoniae, Morganellamorganii; Neisseria gonorrhoeae; Proteus mirabilis, Proteus vulgaris, Providenciarettgeri, Serratia marc- escens. Anaerobic bacteria Bacteroides species, Peptococcus, Peptostreptococcus,  Eubacterium and clostridium species. Ceftizoxime is usually active against the following organisms in vitro but the clinical significance is unknown: Corynobacteriumdiphtheriae, Aermonoushydrophela, Citrobacter species, Moragsilla species, Neisseria menin- gitides, Pasteurellamultucida,  Providenciastu- artii, Salmonella species,  Shigella  species,  Yersinia enterocoliteca, Actenomycis species, Bifidobacterium species, Clostridium Species, Eubacterium species, Fusobacterium species, Propionibacterium species, Veillonella species. Thus, Ceftizoxime is indicated for the treatmentof:

  • Lower respiratory tractinfections
  • Skin and soft tissueinfections
  • Urinary tractinfections
  • Bone and jointinfections
  • Gonorrhea
  • Gynaecologicalinfections
  • Septicaemia
  • Intra-abdominal infections including biliary infec- tions
  • Perioperative prophylaxis ofinfections
  • Pelvic inflammatoryinfections

Dosage and administration

Usual adult dose: 1-2 g of Ceftizoxime every 8-12 hours IM or IV.

Gonorrhea (uncomplicated): Single 1 g IM dose. Urinary tract infections: 0.5-1 g every 12 hours IM or IV. Septicaemia: 6-12 g/day may be given IV divided into 3 doses.

The maximum daily dose should not exceed 12 g. Usual pediatric dose: (6 months of age and older): 50 mg/kg/body weight every 6-8 hours IM or IV.

Dosage may be increased to 200 mg/kg/day (not to exceed the maximum adult dose for serious infections).

Dosage in renal impairment: Modification of dosage is necessary in patients with impaired renal function. For an adult, following an initial loading dose of 0.5-1 g IM or IV, the maintenance dosing schedule should be as follows:

 

Creatinine clearance (ml/min) Moderate infections Severe or life threatening infections
50-79 0.5 g

every 8 hours

 

 0.75-1.5gevery8hours
5-49 0.25-0.5 g

every 12 hour

 

 0.5-1 g every 12 hours
0-4

(dialysis patients)

 0.25 g

every 24 hour

 0.5 g every 24 hours

Reconstitution

Intravenous injection: Reconstitute with sterile water for injection in volumes shown below and shake well. For direct intravenous use, inject slowly over 3-5minutes.

Vial size Sterile water for injection

0.5 g      5 ml

1 g         10ml

2 g         20ml

For intravenous drip infusion: Dilute Ceftizoxime recon- stituted with water for injection in 50-100 ml of one the following solutions:

  • Sodium Chloride Injection
  • Ringer’sInjection
  • 5% or 10% Dextroseinjection
  • 5% Dextrose and 0.9%, 0.45%, 0.2% Sodium Chloride Injection
  • Lactate Ringer’sInjection
  • Invert sugar 10% in sterile water forinjection
  • 5% Sodium Bicarbonate in sterile water for injection

Intramuscular injection:

Reconstitute with the provided ampoules of lido- caine or with sterile water for injection and shake well.

Do not use lidocaine in patients hypersensitive to it. Do not inject intravenously when reconstituted with lidocaineHCl.

Vialsize0.5%lidocaineorsterilewaterforinjection

500 mg 2 ml 2ml

1 g         4 ml        3ml

  • Inject into large musclemass.

Note: Ceftizoxime should be used within 24 hours after reconstitution when stored at room temperature and within 96 hours if refrigerated. Solutions may vary   in color from yellow to amber. This does not affect their potency. Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.

Precautions

Prolonged use of broad spectrum antibiotics may result in overgrowth of resistant bacteria. There are no adequate and well-controlled studies in preg- nant women, therefore this drug should beusedin pregnancy only  if  clearly  needed.  Ceftizoxime  is excreted unchanged in breast milk, usually in low concentrations. However, problems in humans have not been documented todate.

Side effects

Ceftizoxime is generally well tolerated. The fol- lowing side effects have been rarely reported: Hypersensitivity, transient elevation in SGOT, SGPT and alkaline phosphatase, diarrhea, nausea and vomiting.

Overdose

Serious acute hypersensitivity reactions may require adrenaline and other emergency measures.

Presentation

CEFTIZOXIME 500 IV: Sterile Ceftizoxime (as sodium) USP 500mg
CEFTIZOXIME 1000 IV: Sterile Ceftizoxime (as sodium) USP 1000mg
CEFTIZOXIME 2000 IV: Sterile Ceftizoxime (as sodium) USP 2000mg
CEFTIZOXIME 500 IM: Sterile Ceftizoxime (as sodium) USP500mgwith diluentampoule (2mlof 0.5%lido- caineHCl)
CEFTIZOXIME 1000 IM: Sterile Ceftizoxime (as sodium) USP 1000 mg with diluent ampoule (4 ml of 0.5% lidocaineHCl)

Warnings

Ceftizoxime should be given cautiously to penicillin- sensitive patients and patients with impaired renal function.

Contraindications

Ceftizoxime is contraindicated in patients with known allergy to cephalosporinantibiotics.

Manufactured in India by:


TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com