CEFAZOLIN SOD
DESCRIPTION:
AZOLIN (sterile cefazolin sodium) is a semi- synthetic cephalosporin for
parenteral administration. It is the sodium salt of 3-(((5-methyl-1,3,4-
thiadiazol- 2-yl)thio)-methyl)-8-oxo-7-(2-(1H-tetrazol-1-yl) acetamido)-5-thia-
1-azabicyclo (4.2.0) oct-2-ene- 2-carboxylic acid.
The sodium content is 46 mg per gram of cefazolin.
AZOLIN in lyophilized form is supplied in vials equivalent to 500 mg or 1 gram of
AZOLIN is also supplied as a frozen, sterile, nonpyrogenic solution of cefazolin
sodium in an iso-osmotic diluent in plastic containers. After thawing, the
solution is intended for intravenous use.
ACTIONS/CLINICAL PHARMACOLOGY:
HUMAN PHARMACOLOGY: After intramuscular administration of AZOLIN to normal
volunteers, the mean serum concentrations were 37 mcgm/mL at 1 hour and 3
mcgm/mL at 8 hours following a 500 mg dose, and 64 mcgm/mL at 1 hour and 7
mcgm/mL at 8 hours following a 1 gram dose.
Studies have shown that following intravenous administration of AZOLIN to normal
volunteers, mean serum concentrations peaked at approximately 185 mcgm/mL and
were approximately 4 mcgm/mL at 8 hours for a 1 gram dose.
The serum half-life for AZOLIN is approximately 1.8 hours following I.V.
administration and approximately 2.0 hours following I.M. administration.
In a study (using normal volunteers) of constant intravenous infusion with
dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2
hours (approximately 100 mg), AZOLIN produced a steady serum level at the third
hour of approximately 28 mcgm/mL.
Studies in patients hospitalized with infections indicate that AZOLIN (sterile
cefazolin sodium) produces mean peak serum levels approximately equivalent to
those seen in normal volunteers.
Bile levels in patients without obstructive biliary disease can reach or exceed
serum levels by up to five times; however, in patients with obstructive biliary
disease, bile levels of AZOLIN are considerably lower than serum levels (< 1.0
mcgm/mL).
In synovial fluid, the AZOLIN level becomes comparable to that reached in serum
at about 4 hours after drug administration.
Studies of cord blood show prompt transfer of AZOLIN across the placenta. AZOLIN
is present in very low concentrations in the milk of nursing mothers.
AZOLIN is excreted unchanged in the urine. In the first 6 hours approximately 60%
of the drug is excreted in the urine and this increases to 70% to 80% within 24
hours. AZOLIN achieves peak urine concentrations of approximately 2400 mcgm/mL
and 4000 mcgm/mL respectively following 500 mg and 1 gram intramuscular doses.
In patients undergoing peritoneal dialysis (2 l/hr.), AZOLIN produced mean serum
levels of approximately 10 and 30 mcgm/mL after 24 hours' instillation of a
dialyzing solution containing 50 mg/l and 150 mg/l, respectively. Mean peak
levels were 29 mcgm/mL (range 13-44 mcgm/mL) with 50 mg/l (three patients), and
72 mcgm/mL (range 26-142 mcgm/mL) with 150 mg/l (six patients). Intraperitoneal
administration of AZOLIN is usually well tolerated.
Controlled studies on adult normal volunteers, receiving 1 gram 4 times a day
for 10 days, monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase, BUN,
creatinine and urinalysis, indicated no clinically significant changes
attributed to AZOLIN.
MICROBIOLOGY: In Vitro tests demonstrate that the bactericidal action of
cephalosporins results from inhibition of cell wall synthesis. AZOLIN (sterile
cefazolin sodium) is active against the following organisms In Vitro and in
clinical infections:
Staphylococcus Aureus (including penicillinase- producing strains)
Staphylococcus Epidermidis
Methicillin-resistant staphylococci are uniformly resistant to cefazolin
Group A beta-hemolytic streptococci and other strains of streptococci (many
strains of enterococci are resistant)
Streptococcus Pneumoniae
Escherichia Coli
Proteus Mirabilis
Klebsiella species
Enterobacter Aerogenes
Haemophilus Influenzae
Most strains of indole positive Proteus (Proteus Vulgaris), Enterobacter
Cloacae, Morganella Morganii and Providencia Rettgeri are resistant. Serratia,
Pseudomonas, Mima, Herellea species are almost uniformly resistant to cefazolin.
DISK SUSCEPTIBILITY TESTS
DISK DIFFUSION TECHNIQUE--Quantitative methods that require measurement of zone
diameters give the most precise estimates of antibiotic susceptibility. One such
procedure (REF. 1) has been recommended for use with disks to test
susceptibility to cefazolin.
Reports from a laboratory using the standardized single-disk susceptibility
test(1) with a 30 mcgm cefazolin disk should be interpreted according to the
following criteria:
Susceptible organisms produce zones of 18 mm or greater, indicating that the
tested organism is likely to respond to therapy.
Organisms of intermediate susceptibility produce zones 15 to 17 mm, indicating
that the tested organism would be susceptible if high dosage is used or if the
infection is confined to tissues and fluids (e.g., urine), in which high
antibiotic levels are attained.
Resistant organisms produce zones of 14 mm or less, indicating that other
therapy should be selected.
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(1) Bauer, A.W.; Kirby, W.M.M.; Sherris, J.C.; and Turck, M.: Antibiotic Testing
by a Standardized Single Disc Method, Am. J. Clin. Path. 45:493, 1966.
Standardized Disc Susceptibility Test, Federal Register 39:19182-19184, 1974.
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For gram-positive isolates, a zone of 18 mm is indicative of a cefazolin-
susceptible organism when tested with either the cephalosporin-class disk (30
mcgm cephalothin) or the cefazolin disk (30 mcgm cefazolin).
Gram-negative organisms should be tested with the cefazolin disk (using the
above criteria), since cefazolin has been shown by In Vitro tests to have
activity against certain strains of Enterobacteriaceae found resistant when
tested with the cephalothin disk. Gram-negative organisms having zones of less
than 18 mm around the cephalothin disk may be susceptible to cefazolin.
Standardized procedures require use of control organisms. The 30 mcgm cefazolin
disk should give zone diameter between 23 and 29 mm for E. Coli ATCC 25922 and
between 29 and 35 mm for S. Aureus ATCC 25923.
The cefazolin disk should not be used for testing susceptibility to other
cephalosporins.
DILUTION TECHNIQUES--A bacterial isolate may be considered susceptible if the
minimal inhibitory concentration (MIC) for cefazolin is not more than 16 mcgm
per mL. Organisms are considered resistant if the MIC is equal to or greater
than 64 mcgm per mL.
The range of MIC's for the control strains are as follows:
S. Aureus ATCC 25923, 0.25 to 1.0 mcgm/mL
E. Coli ATCC 25922, 1.0 to 4.0 mcgm/mL
INDICATIONS AND USAGE:
AZOLIN (sterile cefazolin sodium) is indicated in the treatment of the following
serious infections due to susceptible organisms:
RESPIRATORY TRACT INFECTIONS due to Streptococcus Pneumoniae, Klebsiella
species, Haemophilus Influenzae, Staphylococcus Aureus (penicillin- sensitive
and penicillin-resistant) and group A beta-hemolytic streptococci.
Injectable benzathine penicillin is considered to be the drug of choice in
treatment and prevention of streptococcal infections, including the prophylaxis
of rheumatic fever.
AZOLIN is effective in the eradication of streptococci from the nasopharynx;
however, data establishing the efficacy of AZOLIN in the subsequent prevention of
rheumatic fever are not available at present.
URINARY TRACT INFECTIONS due to Escherichia Coli, Proteus Mirabilis, Klebsiella
species and some strains of enterobacter and enterococci.
SKIN AND SKIN STRUCTURE INFECTIONS due to Staphylococcus Aureus (penicillin-
sensitive and penicillin-resistant), group A beta-hemolytic streptococci and
other strains of streptococci.
BILIARY TRACT INFECTIONS due to Escherichia Coli, various strains of
streptococci, Proteus Mirabilis, Klebsiella species and Staphylococcus Aureus.
BONE AND JOINT INFECTIONS due to Staphylococcus Aureus.
GENITAL INFECTIONS (i.e., prostatitis, epididymitis) due to Escherichia Coli,
Proteus Mirabilis, Klebsiella species and some strains of enterococci.
SEPTICEMIA due to Streptococcus Pneumoniae, Staphylococcus Aureus (penicillin-
sensitive and penicillin-resistant), Proteus Mirabilis, Escherichia Coli and
Klebsiella species.
ENDOCARDITIS due to Staphylococcus Aureus (penicillin-sensitive and penicillin-
resistant) and group A beta-hemolytic streptococci.
Appropriate culture and susceptibility studies should be performed to determine
susceptibility of the causative organism to AZOLIN.
PERIOPERATIVE PROPHYLAXIS: The prophylactic administration of AZOLIN
preoperatively, intraoperatively and postoperatively may reduce the incidence of
certain postoperative infections in patients undergoing surgical procedures
which are classified as contaminated or potentially contaminated (e.g., vaginal
hysterectomy, and cholecystectomy in high-risk patients such as those over 70
years of age, with acute cholecystitis, obstructive jaundice or common duct bile
stones).
The perioperative use of AZOLIN may also be effective in surgical patients in
whom infection at the operative site would present a serious risk (e.g., during
open-heart surgery and prosthetic arthroplasty).
The prophylactic administration of AZOLIN should usually be discontinued within a
24-hour period after the surgical procedure. In surgery where the occurrence of
infection may be particularly devastating (e.g., open-heart surgery and
prosthetic arthroplasty), the prophylactic administration of AZOLIN may be
continued for 3 to 5 days following the completion of surgery.
If there are signs of infection, specimens for cultures should be obtained for
the identification of the causative organism so that appropriate therapy may be
instituted.
(See DOSAGE AND ADMINISTRATION.)
CONTRAINDICATIONS:
AZOLIN (STERILE CEFAZOLIN SODIUM) IS CONTRAINDICATED IN PATIENTS WITH KNOWN
ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.
WARNINGS:
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE
BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY
TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A
HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF
INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED
SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY
WITH AZOLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC
REACTION OCCURS, AZOLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY SHOULD BE
INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT
WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING
INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH NEARLY ALL ANTIBACTERIAL AGENTS,
INCLUDING AZOLIN, AND MAY RANGE IN SEVERITY FROM MILD TO LIFE- THREATENING.
THEREFORE, IT IS IMPORTANT TO CONSIDER THIS DIAGNOSIS IN PATIENTS WHO PRESENT
WITH DIARRHEA 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."
After the diagnosis of pseudomembranous colitis has been established,
therapeutic measures should be initiated. Mild cases of pseudomembranous colitis
usually respond to drug discontinuation alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation and treatment with an antibacterial drug clinically
effective against C. Difficile colitis.
PRECAUTIONS:
GENERAL--Prolonged use of AZOLIN (sterile cefazolin sodium) may result in the
overgrowth of nonsusceptible organisms. Careful clinical observation of the
patient is essential.
When AZOLIN is administered to patients with low urinary output because of
impaired renal function, lower daily dosage is required (see DOSAGE AND
ADMINISTRATION).
As with other beta-lactam antibiotics, seizures may occur if inappropriately
high doses are administered to patients with impaired renal function (see DOSAGE
AND ADMINISTRATION).
AZOLIN, as with all cephalosporins, should be prescribed with caution in
individuals with a history of gastrointestinal disease, particularly colitis.
DRUG INTERACTIONS--Probenecid may decrease renal tubular secretion of
cephalosporins when used concurrently, resulting in increased and more prolonged
cephalosporin blood levels.
DRUG/LABORATORY TEST INTERACTIONS--A false- positive reaction for glucose in the
urine may occur with Benedict's solution, Fehling's solution or with
Clinitest(R) tablets, but not with enzyme-based tests such as Clinistix(R) and
Tes-Tape(R).
Positive direct and indirect antiglobulin (Coombs) tests have occurred; these
may also occur in neonates whose mothers received cephalosporins before
delivery.
CARCINOGENESIS/MUTAGENESIS -- Mutagenicity studies and long-term studies in
animals to determine the carcinogenic potential of AZOLIN (sterile cefazolin
sodium) have not been performed.
PREGNANCY--Teratogenic Effects--Pregnancy Category B. Reproduction studies have
been performed in rats, mice and rabbits at doses up to 25 times the human dose
and have revealed no evidence of impaired fertility or harm to the fetus due to
AZOLIN. There are, however, no adequate and well-controlled studies in pregnant
women. Because animal reproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if clearly needed.
LABOR AND DELIVERY--When cefazolin has been administered prior to caesarean
section, drug levels in cord blood have been approximately one quarter to one
third of maternal drug levels. The drug appears to have no adverse effect on the
fetus.
NURSING MOTHERS--AZOLIN (sterile cefazolin sodium) is present in very low
concentrations in the milk of nursing mothers. Caution should be exercised when
AZOLIN is administered to a nursing woman.
PEDIATRIC USE--Safety and effectiveness for use in prematures and infants under
1 month of age have not been established. See DOSAGE AND ADMINISTRATION for
recommended dosage in children over 1 month.
The potential for the toxic effect in children from chemicals that may leach
from the single- dose I.V. preparation in plastic has not been determined.
DRUG INTERACTIONS:
Probenecid may decrease renal tubular secretion of cephalosporins when used
concurrently, resulting in increased and more prolonged cephalosporin blood
levels.
(See Also PRECAUTIONS)
ADVERSE REACTIONS:
The following reactions have been reported:
GASTROINTESTINAL: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea,
stomach cramps, anorexia and pseudomembranous colitis. Onset of pseudomembranous
colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).
Nausea and vomiting have been reported rarely.
ALLERGIC: Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-
Johnson syndrome.
HEMATOLOGIC: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.
HEPATIC AND RENAL: Transient rise in SGOT, SGPT, BUN and alkaline phosphatase
levels has been observed without clinical evidence of renal or hepatic
impairment.
LOCAL REACTIONS: Rare instances of phlebitis have been reported at site of
injection. Pain at the site of injection after intramuscular administration has
occurred infrequently. Some induration has occurred.
OTHER REACTIONS: Genital and anal pruritus (including vulvar pruritus, genital
moniliasis and vaginitis).
DOSAGE AND ADMINISTRATION:
USUAL ADULT DOSAGE
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TYPE OF INFECTION DOSE FREQUENCY
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Moderate to severe 500 mg every 6
infections to to 8 hrs.
1 gram
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Mild infections caused 250 mg every
by susceptible gram + to 8 hours
cocci 500 mg
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Acute, uncomplicated 1 gram every
urinary tract infections 12 hours
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Pneumococcal 500 mg every
pneumonia 12 hours
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Severe, life-threatening 1 gram every
infections (e.g., endo- to 6 hours
carditis, septicemia)* 1.5 grams
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*In rare instances, doses of up to 12 grams of AZOLIN per day have been used.
PERIOPERATIVE PROPHYLACTIC USE
To prevent postoperative infection in contaminated or potentially contaminated
surgery, recommended doses are:
a. 1 gram I.V. or I.M. administered 1/2 hour to 1 hour prior to the start of
surgery.
b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram
I.V. or I.M. during surgery (administration modified depending on the duration
of the operative procedure).
c. 500 mg to 1 gram I.V. or I.M. every 6 to 8 hours for 24 hours
postoperatively.
It is important that (1) the preoperative dose be given just (1/2 to 1 hour)
prior to the start of surgery so that adequate antibiotic levels are present in
the serum and tissues at the time of initial surgical incision; and (2) AZOLIN be
administered, if necessary, at appropriate intervals during surgery to provide
sufficient levels of the antibiotic at the anticipated moments of greatest
exposure to infective organisms.
In surgery where the occurrence of infection may be particularly devastating
(e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic
administration of AZOLIN (sterile cefazolin sodium) may be continued for 3 to 5
days following the completion of surgery.
DOSAGE ADJUSTMENT FOR PATIENTS WITH REDUCED RENAL FUNCTION
AZOLIN may be used in patients with reduced renal function with the following
dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or
greater or a serum creatinine of 1.5 mg % or less can be given full doses.
Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine
of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted
to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to
34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual
dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or
less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual
dose every 18 to 24 hours. All reduced dosage recommendations apply after an
initial loading dose appropriate to the severity of the infection. Patients
undergoing peritoneal dialysis: See Human Pharmacology.
PEDIATRIC DOSAGE
In children, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20
mg per pound) of body weight, divided into three or four equal doses, is
effective for most mild to moderately severe infections. Total daily dosage may
be increased to 100 mg per kg (45 mg per pound) of body weight for severe
infections. Since safety for use in premature infants and in infants under 1
month has not been established, the use of AZOLIN (sterile cefazolin sodium) in
these patients is not recommended.
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PEDIATRIC DOSAGE GUIDE
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25 MG/KG/DAY 25 MG/KG/DAY
DIVIDED INTO DIVIDED INTO
WEIGHT 3 DOSES 4 DOSES
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Vol. (mL) Vol. (mL)
Approxi- needed Approxi- needed
mate with mate with
Single dilution Single dilution
Dose of 125 Dose of 125
Lbs Kg mg/q8h mg/mL mg/q6h mg/mL
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10 4.5 40 mg 0.35 mL 30 mg 0.25 mL
20 9.0 75 mg 0.60 mL 55 mg 0.45 mL
30 13.6 115 mg 0.90 mL 85 mg 0.70 mL
40 18.1 150 mg 1.20 mL 115 mg 0.90 mL
50 22.7 190 mg 1.50 mL 140 mg 1.10 mL
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50 MG/KG/DAY 50 MG/KG/DAY
DIVIDED INTO DIVIDED INTO
WEIGHT 3 DOSES 4 DOSES
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Vol. (mL) Vol. (mL)
Approxi- needed Approxi- needed
mate with mate with
Single dilution Single dilution
Dose of 225 Dose of 225
Lbs Kg mg/q8h mg/mL mg/q6h mg/mL
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10 4.5 75 mg 0.35 mL 55 mg 0.25 mL
20 9.0 150 mg 0.70 mL 110 mg 0.50 mL
30 13.6 225 mg 1.00 mL 170 mg 0.75 mL
40 18.1 300 mg 1.35 mL 225 mg 1.00 mL
50 22.7 375 mg 1.70 mL 285 mg 1.25 mL
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In children with mild to moderate renal impairment (creatinine clearance of 70
to 40 mL/min.), 60 percent of the normal daily dose given in equally divided
doses every 12 hours should be sufficient. In patients with moderate impairment
(creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose
given in equally divided doses every 12 hours should be adequate. Children with
severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given
10 percent of the normal daily dose every 24 hours. All dosage recommendations
apply after an initial loading dose.
RECONSTITUTION
PREPARATION OF PARENTERAL SOLUTION
Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected
visually for particulate matter prior to administration. If particulate matter
is evident in reconstituted fluids, the drug solutions should be discarded.
When reconstituted or diluted according to the instructions below, AZOLIN
(sterile cefazolin sodium) is stable for 24 hours at room temperature or for 10
days if stored under refrigeration (5 deg C or 41 deg F). Reconstituted
solutions may range in color from pale yellow to yellow without a change in
potency.
SINGLE-DOSE VIALS
For I.M. injection, I.V. direct (bolus) injection or I.V. infusion, reconstitute
with Sterile Water for Injection according to the following table. SHAKE WELL.
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Approximate
Vial Amount of Approximate Available
Size Diluent Concentration Volume
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500 mg 2.0 mL 225 mg/mL 2.2 mL
1 gram 2.5 mL 330 mg/mL 3.0 mL
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PHARMACY BULK VIALS
Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium
Chloride Injection according to the table below. SHAKE WELL.
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Approximate
Vial Amount of Approximate Available
Size Diluent Concentration Volume
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5 grams 23 mL 1 gram/5 mL 26 mL
48 mL 1 gram/10 mL 51 mL
10 grams 45 mL 1 gram/5 mL 51 mL
96 mL 1 gram/10 mL 102 mL
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"PIGGYBACK" VIALS
Reconstitute with 50 to 100 mL of Sodium Chloride Injection or other I.V.
solution listed under ADMINISTRATION. When adding diluent to vial, allow air to
escape by using a small vent needle or by pumping the syringe. SHAKE WELL.
Administer with primary I.V. fluids, as a single dose.
ADMINISTRATION
INTRAMUSCULAR ADMINISTRATION--Reconstitute vials with Sterile Water for
Injection according to the dilution table above. Shake well until dissolved.
AZOLIN should be injected into a large muscle mass. Pain on injection is
infrequent with AZOLIN.
INTRAVENOUS ADMINISTRATION--Direct (bolus) injection: Following reconstitution
according to the above table, further dilute vials with approximately 5 mL
Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes,
directly or through tubing for patients receiving parenteral fluids (see list
below).
Intermittent or continuous infusion: Dilute reconstituted AZOLIN in 50 to 100 mL
of one of the following solutions:
Sodium Chloride Injection, USP
5% or 10% Dextrose Injection, USP
5% Dextrose in Lactated Ringer's Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.2% Sodium Chloride Injection, USP
Lactated Ringer's Injection, USP
Invert Sugar 5% or 10% in Sterile Water for Injection
Ringer's Injection, USP
5% Sodium Bicarbonate Injection, USP
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