| Ceftazim
Ceftazidime USP
Description:
Ceftazidime is
a semi-synthetic broad-spectrum, beta-lactam antibiotic for
parenteral administration. Ceftazidime for injection is a sterile,
powdered mixture of Ceftazidime pentahydrate and sodium carbonate
(118mg/gm of Ceftazidime). Ceftazidime is bactericidal in action,
exerting its effect by inhibition of the enzymes responsible
for cell-wall biosynthesis. A board spectrum of gram-negative
organisms is susceptible to Ceftazidime in vitro including strains
resistant to gentamicin and other aminoglycosides. It is also
effective against gram-positive organisms. It is highly stable
to most clinically important beta-lactamases, plasmid or chromosomal,
which are produced by both gram-positive and gram-negative bacteria
and consequently many strains resistant to ampicillin and other
cephalosporins.
Composition:
Ceftazim 250 mg
IV/IM Injection: White to faintly yellow powder in vials containing
250 mg of Ceftazidime (as pentahydrate), with sodium carbonate.
Ceftazim 500 mg
IV/IM Injection: White to faintly yellow powder in vials containing
500 mg of Ceftazidime (as pentahydrate), with sodium carbonate.
Ceftazim 1 g
IV/IM Injection: White to faintly yellow powder in vials containing
1 g of Ceftazidime (as pentahydrate), with sodium carbonate.
Indications:
Ceftazim is indicated
for the treatment of patients with infections caused by susceptible
strains of the designated organisms in the following diseases-
·
Severe infections in general: Septicaemia, bacteraemia, peritonitis,
meningitis, infection in immuno-suppressed patients with hematological
or solid malignancies, and in patients with cystic fibrosis.
·
Respiratory tract infections: Pneumonia, bronchopneumonia, infected
pleurisy, emphysema, lung abscess, infected bronchiectasis and
bronchitis and in lung infection in patients with cystic fibrosis.
·
Ear, nose and throat infections: Otitis media, malignant otitis
extrema, mastoiditis, sinusitis and severe car and throat infections.
·
Skin and skin structure infections: Erysipelas abscesses, cellulitis,
infected burns and wounds, mastitis, skin ulcers.
·
Bone and joint infections: Osteitis, osteomyelitis, septic arthritis,
infected bursitis.
·
Urinary tract infections: Acute and chronic pyelonephritis,
pyelitis, prostatitis, cystitis. Urethritis (bacterial only),
renal abscess and infections associated with bladder or renal
stones.
·
Gynecologic infections: Endometritis, pelvic cellulitis and
other infections of the female genital tract caused by Escherichia
coli.
·
Gastrointestinal, billary and abdominal infections: Cholangitis,
cholecystitis, emphysema of gall bladder, intra-abdominal abscesses,
peritonitis, diverticulitis, ceterocolitis, post-partum pelvic
inflammatory conditions.
·
Dialysis: Infections associated with haemo and peritoneal dialysis
and with continuous ambulatory peritoneal dialysis(CAPD)
Dosage and Administration:
The dose of Ceftazim
depends upon the severity, sensitivity and the type of infection.
Adults: 1 g every
8 hours or 2 g every 12 hours. In severe infections, 2g every
8-12 hours. In the elderly usual max. dose is 3 g daily.
Child (Up to 2
months): 25-60 mg/kg daily in 2 divided doses.
Child (Over 2 months):
30-100mg/kg daily in 2-3 divided doses, up to 150mg/kg daily
(max. 6g daily) in 3 divided doses. In case of meningitis or
immunocompromised patients, IV route is recommended for children.
Urinary-tract and
less serious infections: 0.5-1 g every 12 hours.
Pseudomonal lung
infection in cystic fibrosis: Adult with normal renal function
100-150 mg/kg daily in 3 divided doses. Child: Up to 150 mg/kg
daily (max 6 g daily) in 3 divided doses.
Surgical prophylaxis:
1 g at induction of anaesthesia in prostatic surgery, repeated
if necessary when cather is removed.
Contraindications:
Ceftazim is contraindicated
in patients with known hypersensitivity to cephalosporin antibiotics.
Preparation of
solution for intramuscular/intravenous injections:
For IM injection:
Add 1 ml & 1.5 ml water for injection BP with Ceftazim 250
mg & 500 mg receptively. Then shake gently to disperse.
For IV injection: Add 2.5 ml & 5 ml water for injection
BP with Ceftazim 250 mg & 500 mg receptively to make solution.
The injection should be administered by deep intramuscular or
by show intravenous injection over 3-5 minutes. The use of freshly
reconstituted solution is recommended. However, it maintain
potency for at least 18 hours if keep below 25°c & 7 days
if kept in a refrigerator.
All sizes of
vials as supplied are under reduced pressure. As the products
dissolves, carbon dioxide is released and a positive pressure
develops. For ease of use, it is recommended that the following
techniques of reconstitution are adopted.
Adverse reactions:
GI upsets, CNS
effect, phlebitis or thrombophlebitis at IV injection site,
very rarely hypersensitivity reaction. Transient hematological
changes may occur.
Warnings:
Like other beta-lactam
antibiotics before therapy with Ceftazim is instituted, careful
inquiry should be made for a history of hypersensitivity reactions
to Ceftazim, cephalosporins, penicillin, or other drugs. Special
precaution should be maintenance of type 1 or immediate hypersensitivity
reaction to penicillin. Discontinue Ceftazidime if an allergic
reaction is occurred.
Precautions:
Cephalosporin antibiotics at high dose should
be given with caution to patients receiving concurrent treatment
with nephrotoxic drugs e.g. aminoglycoside antibiotics or potent
diuretics such as furosemide.
Use in pregnancy
and lactation:
There is no experimental evidence of embryopathic
or teratogenic effect attributable to Ceftazim but like other
drugs is should be administered with caution during the early
month of pregnancy. Ceftazim is excreted in milk in less concentration.
There would appear to be little risk to breast feed infant.
Incompatibilities:
The admixture of beta-lactam antibacterials
(Penicillins and Cephalosporins) and aminoglycosides may result
in substantial mutual inactivation. If they are administered
concurrently, they should be administered in separate sites.
Do not mix them in the same intravenous bag or bottle.
Storage:
Store between 15° to 30° C. Protect from
light. Keep out of the reach of Children.
Packing:
Ceftazim 250 mg IV/IM Injection: Combipack
of 1 vial of 250 mg of Ceftazidime USP and 1 ampoule of 5 ml
Water for injection.
Ceftazim 500 mg IV/IM Injection: Combipack
of 1 vial of 500 mg of Ceftazidime USP and 1 ampoule of 5 ml
Water for injection.
Ceftazim 1 g IV/IM Injection: Combipack of
1 vial of 1 g of Ceftazidime USP and 1 ampoule of 10 ml Water
for injection. |
