CEFSURE
COMBIPACK OF CEFTAZIDIME FOR INJECTION USP 1 GM & STERILISED WATER FOR INJECTION BP 10 ML
COMPOSITION
(As Ceftazidime Pentahydrate USP)
(As Ceftazidime Pentahydrate USP)
CEFTAZIDIME Base | 1 gm |
A blend of Sterile Ceftazidime Pentahydrate & Sterile Sodium Carbonate One Ampoule of:
Sterilized Water for Injection BP | 10 ml |
INDICATIONS
- Treatment of single or multiple infections caused by susceptible organisms.
INDICATIONS INCLUDE
severe infections e.g. septicaemia, bacteraemia, peritonitis, meningitis; infections in immunosuppressed patients; infections in patients in intensive care, e.g. infected burns; respiratory tract infections including lung infections in cystic fibrosis; ear, nose and throat infections; urinary tract infections; skin and soft tissue infections; gastrointestinal, biliary and abdominal infections; bone and joint infections; infections associated with haemo – and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD).
PHARMACODYNAMICS
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis, primarily penicillin binding protein 3 (PBP3). A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins. Ceftazidime has activity against the gram-negative organisms Pseudomonas and Enterobacteriaceae. Its activity against Pseudomonas is a distinguishing feature of ceftazidime among the cephalosporins.
The bactericidal activity of ceftazidime results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs).
The bactericidal activity of ceftazidime results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs).
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METRONIDAZOLE POWDER FOR ORAL SUSPENSION
- Do not take Metronidazole and tell your doctor if:
- you are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients of this medicine(listed in section 6). Signs of an allergic reaction include a rash, itching or shortness of breath
- treating infections, including infections of your blood, brain, lungs, bones, lining of your abdomen, pelvis and infections following childbirth or around the area where you had an operation
- you are pregnant, think you are pregnant or breast feeding. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metronidazole.
PHARMACOKINETICS
- ABSORPTION : The absorption of ceftazidime is directly proportional to the size of the dose.
- DISTRIBUTION : <10% protein binding.
ELIMINATION
The elimination of ceftazidime by the kidneys resulted in high therapeutic concentrations in the urine.
Half-life, following IV administration, is approximately 1.9-hours. Since ceftazidime is eliminated almost solely by the kidneys, its serum half-life is significantly prolonged in patients with impaired renal function.
Half-life, following IV administration, is approximately 1.9-hours. Since ceftazidime is eliminated almost solely by the kidneys, its serum half-life is significantly prolonged in patients with impaired renal function.
DOSAGE AND ADMINISTRATION
Dosage depends upon the severity, sensitivity, site and type of infection and upon the age and renal function of the patient.
Use CEFSURE injection intravenously or by deep intramuscular injection. Recommended IM injection sites are the upper outer quadrant of the gluteus maximus or lateral part of the thigh.
Ceftazidime solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids.
Use CEFSURE injection intravenously or by deep intramuscular injection. Recommended IM injection sites are the upper outer quadrant of the gluteus maximus or lateral part of the thigh.
Ceftazidime solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids.
ADULTS
1 to 6 g daily in two or three divided doses by IV or IM injection.
INFANTS AND CHILDREN OLDER THAN 2 MONTHS
30 to 100 mg/kg daily in two or three divided doses. Doses up to 150 mg/kg daily (maximum 6 g daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.
NEONATES AGED 0 TO 2 MONTHS
- 25 to 60 mg/kg daily in two divided doses.
- OR As directed by physician.
CONTRAINDICATION
- Patients with known hypersensitivity to cephalosporin antibiotics, ceftazidimepentahydrate or to any of the excipients.
- History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
SIDE EFFECT
- Nausea, vomiting, diarrhea, stomach pain;
- Headache, dizziness
- Numbness or tingly feeling; or
- Vaginal itching or discharge.
DRUG INTERACTION : INTERACTIONS WITH OTHER MEDICINES
- Concurrent use of high doses with nephrotoxic medicines may adversely affect renal function.
- Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins.
USE IN PREGNANCY AND LACTATION USE IN PREGNANCY
Assigned Category B1 by the Australian Drug Evaluation Committee. Studies in animals have not shown evidence of an increased occurrence of foetal damage. There is no experimental evidence of embryopathic or teratogenic effects, but as with all medicines, ceftazidime should be administered with caution during the early months of pregnancy and early infancy.
USE IN LACTATION
Ceftazidime is excreted in human milk in small quantities and should be used with caution in nursing mothers.
STORAGE CONDITION
Store at or below 25°C. Protect from light and moisture. Store the reconstituted medicine between 2 to 8°C and use within 24 hours. Refrigerate, do not freeze.
PRESENTATION
Combipack of 1 vial of 1000 mg Ceftazidime for Injection USP + 10 ml Ampoule for SWFI in a Tray in a Mono pack.