CEFTIZOXIME 1g Powder for Injection

Ceftizoxime Sodium ~ Ceftizoxime 1 g

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COMPOSITION :

Ceftizoxime Sodium Powder for Injection 1 g, each vial contains : Ceftizoxime sodium equivalent to Ceftizoxime 1 g.

 

DESCRIPTIONS : 

Ceftizoxime Sodium are preparation of Ceftizoxime sodium (equivalent to Ceftizoxime), which is available in 1 g of sterile powder for injection in vial pack.

 

INDICATIONS : 

Infections caused by Ceftizoxime sodium susceptible bacteria :

  • Septicemia, bacterial endocarditis.
  • Secondary infections of burns.
  • Bronchitis, secondary infections of chronic respiratory tract diseases, infected bronchiectasis, pneumonia, pulmonary suppuration, pyothorax.
  • Cholangitis, cholecystitis.
  • Peritonitis.
  • Pyelonephritis, cystitis, prostatitis.
  • Meningitis caused by H. influenzae.

 

DOSAGE AND ADMINISTRATIONS : 

  • Intravenous injection (IV)

Adults : 0.5 – 2 g/day in 2 – 4 equally divided doses, increased to 4 g/day for severe or intractable infections, according to the age and condition of the patient.

Children ≥ 6 months : 40 – 80 mg/kg BW/day in 2 – 4 equally in divided doses, increased to 120 mg/kg BW/day for severe or intractable infections, according to the age and condition of the patient.

  • Intramuscular injection (IM)

Adults : 0.5 – 2 g/day in 2 – 4 equally divided doses, according to the age and condition of the patient.

Reconstitution :

  • Intravenous injection :

Reconstitute with 10 ml of Sterile Water for Injection, then inject slowly.

  • Intramuscular injection : 

Reconstitute with 2 ml of Sterile Water for Injection.

Reconstituted solution must be used within 7 hours below 30°C and 48 hours if refrigerated ± 5°C, to avoid possible precipitation which may happen with longer storage. 

 

CONTRAINDICATIONS : 

  • Patients with a history of shock caused by Ceftizoxime sodium.
  • Patients with a history of allergy to Lidocaine or other local anesthesia (if Lidocaine or other local anesthesia is used to reconstitution before IM injection).
  • Patients with a history of allergy to Penicillin/Cephem.
  • Patients with a history (in family disease) allergy eg asthma bronchial, rash or urticaria.
  • Serious renal disease if Ceftizoxime serum level remained high in a long time. Advisable the dosage should be decreased or extended the administration interval, adjusted by the severity of the renal disease.
  • Patients with poor oral nutrition, parenteral nutrition, elderly or debilitated states must be observed carefully because concerned there was a vitamin K deficiency.

 

WARNING AND PRECAUTIONS : 

  • Caution in patients with a history of allergy. So that, before administered advisable to do skin sensitivity test to avoid anaphylactic shock reaction.
  • Use in infants : Safety in newborns and children less than six months has not been established.
  • Use in pregnancy : Safety during pregnancy has not been established; therefore the drug should be administered to patients who are pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk.
  • Effect on the laboratory test : False-positive results with urine sugar tests using Benedicts test solution, Fehling test solution, and Clinitest® may occur. A false-positive direct Coombs’ test may occur.
  • Intravenous administration must be given slowly because it is possible that pain or thrombophlebitis after IV administration in high dose can occur.
  • IM administration must consider the following :
  1. The use of this IM injection should be avoided, except there is no other way, eg avoided conferring on the same place.
  2. Not to give IM in new born baby, premature, a nursing infant and pediatric.
  3. Avoid injected at the nerve.
  4. If patients complaining very painful at the injection site, the syringe must be pulled out immediately and find the other site.
  5. The used of Lidocaine as solvent for IM administration is should not be used in IV administration.
  6. IM administration can cause pain and hardening in the injection site.

 

ADVERSE REACTIONS : 

  • Shock : If any related signs or symptoms such as feeling unwell, oral cavity discomfort, stridor, dizziness, abnormal urge to defecate, tinnitus or diaphoresis occur, the drug must be discontinued immediately.
  • Hypersensitivity : If signs of hypersensitivity reactions such as rash, urticaria, erythema, pruritus, fever, lymph node enlargement, the drug should be discontinued.
  • Hematological : Granulocytopenia, eosinophilia, erythrocytopenia, haemolytic anemia or thrombocytopenia may occur. The drug should be discontinued if any these symptoms were found.
  • Hepatic : Increase in SGOT, SGPT, ALP, bilirubin and ikteric symptoms may occur. 
  • Renal : Increase in BUN or serum creatinine level, oliguria or proteinuria may occur. The drug should be discontinued if the symptoms were found.
  • Gastrointestinal : A serious colitis manifested by fever, abdominal pain, leucocytosis and severe diarrhea with mucus/blood in stools may occur. Upon endoscopy this may be diagnosed as pseudomembranous colitis.
  • Abdominal pain or frequent diarrhea requires appropriate measures, including prompt withdrawal of the drug. Nausea or vomiting may occur.
  • Because of the possibility alteration in bacterial flora, stomatitis or candidiasis may occur.
  • Vitamin deficiencies : Vitamin K deficiencies may occur (due to hypoprothrombinaemia or bleeding tendencies) or vitamin B group deficiencies which cause glossitis, stomatitis, anorexia or neuritis.
  • Others : Headache may occur. 

 

PRESENTATION :

Ceftizoxime Sodium Powder for Injection 1 g Box, 10 Vials @ 1 g

Reg. No. GKL1402349044A1

 

STORAGE :

STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT

 

Reconstituted solution must be used within 7 hours below 30°C and 48 hours if refrigerated ± 5°C, to avoid possible precipitation which may happen with longer storage. 

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by: 

BERNOFARM

Sidoarjo – Indonesia

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