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Maxbac®
Rx only
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxbac®
(Ceftazidime) injection and other antibacterial drugs, Maxbac® injection should be used only to
treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Description
Maxbac® injection (Ceftazidime) is a sterile, semisynthetic, broad-spectrum, cephalosporin
antibiotic for intravenous or intramuscular administration. It is the pentahydrate of pyridinium,1[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1 methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-,hydroxide,innersalt,[6R-[6a,7b(Z)]].
The
empirical formula of Ceftazidime is C22H32N6O12S2, representing a molecular weight of
636.60 and it has the following structural formula:
Maxbac® is a sterile, dry-powdered mixture of Ceftazidime Pentahydrate and Sodium
Carbonate. The Sodium Carbonate at a concentration of 118 mg/g of Ceftazidime activity has
been admixed to facilitate dissolution. The total Sodium content of the mixture is approximately
54 mg (2.3 mEq) per gram of Ceftazidime activity. The pH of freshly constituted solutions
usually ranges from 5 to 8. The color of Ceftazidime solutions ranges from light yellow to
amber, depending on the length of storage, concentration and diluent used.
Composition
Maxbac® 250 mg IM/IV Injection: Each vial contains dry substance equivalent to 250 mg
Ceftazidime USP (as sterile Ceftazidime Pentahydrate) with Sodium Carbonate buffer
accompanied by a solvent ampoule of 5 ml Water for Injection.
Maxbac® 500 mg IM/IV Injection: Each vial contains dry substance equivalent to 500 mg
Ceftazidime USP (as sterile Ceftazidime Pentahydrate) with Sodium Carbonate buffer
accompanied by a solvent ampoule of 5 ml Water for Injection.
Maxbac® 1 g IM/IV Injection: Each vial contains dry substance equivalent to 1 g Ceftazidime
USP (as sterile Ceftazidime Pentahydrate) with Sodium Carbonate buffer accompanied by a
solvent ampoule of 10 ml Water for Injection.
Microbiology
Ceftazidime is bactericidal in action, exerting its effect by inhibition of enzymes responsible for
cell-wall synthesis. 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 is usually active against the
following organisms, both in vitro and in clinical infections. Aerobic gram - positive
microorganisms: Staphylococcus aureus (including penicillinase and non-penicillinase
producing strains), Streptococcus agalactiae (group B streptococci), Streptococcus pneumoniae
and Streptococcus pyogenes (group A beta-hemolytic streptococci). Aerobic gram - negative
microorganisms: Citrobacter spp. (including Citrobacter freundii and Citrobacter diversus),
Enterobacter spp. (including Enterobacter cloacae and Enterobacter aerogenes), Escherichia
coli, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp. (including
klebsiella pneumoniae), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris,
Pseudomonas spp. (including Pseudomonas aeruginosa) and Serratia spp. Anaerobic
microorganisms: Bacteroides spp. (many strains of Bacteroides fragilis are resistant). Note:
Ceftazidime and aminoglycosides have been shown to be synergistic in vitro against
Pseudomonas aeruginosa and enterobacteriaceae. Ceftazidime and carbenicillin have also been
shown to be synergistic in vitro against Pseudomonas aeruginosa. Ceftazidime is not active in
vitro against methicillin-resistant staphylococci, Streptococcus faecalis and many other
enterococci, Listeria monocytogenes, Campylobacter spp., or Clostridium difficile.
Pharmacokinetic
Absorption: Ceftazidime is not absorbed following oral administration. After IV administration
of 500 mg and 1 g doses of Ceftazidime, the mean peak serum concentrations are 45 and 90
mg/L respectively. Following IM administration of 500 mg and 1 g doses, the mean peak serum
concentrations of 17 and 39 mg/L respectively are achieved at approximately 1 hour.
Therapeutically effective concentrations are still found in the serum 8 to 12 hours after both IV
and IM administration. Distribution: The volume of distribution after a 1 g dose of Ceftazidime
given by IV or IM route is 16 L. Ceftazidime is widely distributed into body tissues and fluids
including the gallbladder, bone, bile, skeletal muscle, prostatic tissue, endometrium,
myometrium, heart, skin, adipose tissue, aqueous humor, and sputum, and pleural, peritoneal,
synovial, ascitic, lymphatic, and blister fluids. Generally, Ceftazidime diffuses into CSF
following IV administration. CSF concentrations are higher in patients with inflamed meninges
than in those with uninflamed meninges. Ceftazidime is distributed into bile, but biliary
concentrations following IM or IV administration may be lower than concurrent serum
concentrations. It Crosses the placenta and is distributed into milk. Protein binding: The degree
of protein binding is independent of concentration. The serum protein binding of Ceftazidime is
low at about 10%. Metabolism: Ceftazidime is not metabolized. Elimination: Total plasma
clearance is 115 ml/min. Mean renal clearance is 100 ml/min. Approximately 80-90% of an IM
or IV dose of Ceftazidime is excreted unchanged in the urine within 24 hours. Less than 1% is
excreted via the bile. The elimination half-life in adults is about 1.4 to 2 hours.
Indication and Use
Maxbac® is indicated for the treatment of patients with infections caused by susceptible
organisms in the following diseases: Single infections, Mixed infections, Severe and lifethreatening infections like septicemia, bacteremia, Respiratory tract infections, Ear, nose and
throat infections, Urinary tract infections, Skin and skin-structure infections, Gastrointestinal,
biliary and abdominal infections, Gynaecological infections, Bone and joint infections,
Meningitis and other CNS infections, Dialysis - infections associated with haemo- and peritoneal
dialysis and with continuous ambulatory peritoneal dialysis (CAPD).
Dosage and Administration
Maxbac® may be administered either intravenously or intramuscularly. The dosage and route
should be determined by the susceptibility of the causative organisms, the severity of infection
and the condition and renal function of the patient. Adults: The usual dosage is 1 to 6 g per day
8 or 12 hourly (IM/IV). In the majority of infections, 1 g 8 hourly or 2 g 12 hourly should be
given. In urinary tract infections and many less serious infections, 500 mg or 1 g 12 hourly is
usually adequate. In very severe infections, especially immunocompromised patients, including
those with neutropenia, 2 g 8 or 12 hourly should be administered. When used as a prophylactic
agent in prostatic surgery, 1 g should be given at the induction of anesthesia. A second dose
should be considered at the time of catheter removal. Elderly: Considering the reduced clearance
in elderly, the daily dosage should not exceed 3 g, especially in those over 80 years of age.
Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung
infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used. In adults
with normal renal function 9 g/day has been used. Infants and Children: The usual dosage
range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided
doses. Doses up to 150 mg/kg/day (maximum 6 g daily) in three divided doses may be given to
infected immunocompromised or fibrocystic children or children with meningitis. Neonates and
Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day given as two
divided doses. Impaired renal function: Ceftazidime is excreted by the kidneys almost
exclusively by glomerular filtration. Therefore, in patients with impaired renal function it is
recommended that the dosage of Ceftazidime should be reduced to compensate for its slower
excretion except in mild impairment, i.e. glomerular filtration rate (GFR) greater than 50 ml/min.
Peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous
ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be
incorporated into the dialysis fluid (usually 125 to 250 mg for 2 L of dialysis fluid).
Direction for use
Intramuscular Injection: For IM injection, Maxbac 250 mg is dissolved in 1 ml, Maxbac 500
mg in 1.5 ml and Maxbac 1 g in 3 ml of Water for Injection and administered by deep IM
injection. Intravenous Injection: For IV injection, Maxbac 250 mg is dissolved in 2.5 ml,
Maxbac 500 mg in 5 ml and Maxbac 1 g in 10 ml of Water for Injection. The injection should be
administered directly into the vein over a period of 3 to 5 minutes.
Contraindication
Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or
cephalosporin group of antibiotics.
Use in Pregnancy and Lactation
Pregnancy: The safety of Ceftazidime in the treatment of infections during pregnancy has not
been established. Ceftazidime should only be used during pregnancy if the likely benefit
outweighs the potential risk to the fetus and/or the mother. Lactation: Ceftazidime is excreted in
breast milk in low concentrations, caution should be exercised when Ceftazidime is administered
to a nursing mother.
Side Effect
Ceftazidime is generally well tolerated. Adverse reactions are infrequent. They include - Local:
Phlebitis and inflammation at the site of injection. Hypersensitivity: Pruritus, rash, fever and very
rarely angioedema and anaphylaxis. Gastrointestinal: Diarrhea, nausea, vomiting, abdominal
pain and very rarely pseudomembranous colitis. Genitourinary: Candidiasis and vaginitis. CNS:
Headache, dizziness, paresthesia. Hematologic: Hemolytic anemia.
Precaution
As with other antibiotics, prolonged use of Ceftazidime may result in overgrowth of
nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs
during therapy, appropriate measures should be taken. Broad-spectrum antibiotics should be
prescribed with caution in individuals with a history of gastrointestinal disease, particularly
colitis. Nephrotoxicity has been reported following concomitant administration of
aminoglycoside antibiotics or potent diuretics such as furosemide. The total daily dose of
Ceftazidime should
be reduced in patients with transient or persistent renal insufficiency, because high and
prolonged serum antibiotic concentrations can occur in such individuals from usual doses.
Prothrombin time should be monitored in patients at risk.
Warning
Before therapy with Ceftazidime is instituted, careful inquiry should be made to determine
whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and
other drugs. This product should be given cautiously to penicillin hypersensitive patients. Serious
acute hypersensitivity reactions may require treatment with epinephrine and other emergency
measures. Pseudomembranous colitis has been reported with nearly all antibacterial agents,
including Ceftazidime and may range in severity from mild to life-threatening. Therefore, it is
important to consider this diagnosis in patients who develop diarrhoea subsequent to the
administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora
of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by
Clostridium difficile is one primary cause of antibiotic-associated colitis.
Drug Interaction
Nephrotoxicity has been reported following concomitant administration of cephalosporins with
aminoglycoside antibiotics or potent diuretics such as furosemide. Ceftazidime should not be
used in combination with Chloramphenicol for potential antagonistic action.
Overdosage
Overdosage can lead to neurological problem including encephalopathy, convulsions and coma.
Patients who receive an acute overdosage should be carefully observed and given supportive
treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in
the removal of Ceftazidime from the body.
Stability and Storage Recommendation
Ceftazidime sterile powder should be stored at room temperature (15°C to 30°C) and protected
from light. The color of Ceftazidime solutions ranges from light yellow to amber, depending on
the length of storage, concentration and diluent used. Reconstituted solutions retain their physical
and chemical stability for 24 hours at refrigerator (2°C - 8°C). Unused solutions should be
discarded after the time periods mentioned above.
Packaging Quantity
Maxbac® 250 mg IM/IV Injection: Pack of 1 vial containing 250 mg Ceftazidime USP (as
sterile Ceftazidime Pentahydrate) accompanied by one ampoule of 5 ml Water for Injection USP,
a sterile disposable syringe (5 ml) with a baby needle, an alcohol prep pad and a strip bandage.
Maxbac® 500 mg IM/IV Injection: Pack of 1 vial containing 500 mg Ceftazidime USP (as
sterile Ceftazidime Pentahydrate) accompanied by one ampoule of 5 ml Water for Injection USP,
a sterile disposable syringe (5 ml) with a baby needle, an alcohol prep pad and a strip bandage.
Maxbac® 1 g IM/IV Injection: Pack of 1 vial containing 1 g Ceftazidime USP (as sterile
Ceftazidime Pentahydrate) accompanied by one ampoule of 10 ml Water for Injection USP, a
sterile disposable syringe (10 ml) with an extra needle, an alcohol prep pad and a strip bandage.