A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rocephin Indications, Dosage, Storage, Stability - Ceftriaxone
Rocephin Indications, Dosage, Storage, Stability - Ceftriaxone
INDICATIONS
Rocephin is indicated for the treatment
of the following infections when caused by susceptible
organisms:
Lower Respiratory Tract Infections caused
by Streptococcus pneumoniae, Staphylococcus
aureus, Haemophilus
influenzae, Haemophilus parainfluenzae, Klebsiella
pneumoniae, Escherichia
coli, Enterobacter
aerogenes, Proteus mirabilis or Serratia marcescens.
Acute Bacterial Ottitis Media caused by Streptococcus
pneumoniae, Haemophilus influenzae (including beta-lactamase
producing strains) or Moraxella catarrhalis (including beta-lactamase
producing strains).
NOTE: In one study
lower clinical cure
rates were observed with a single dose
of Rocephin compared to 10 days of oral
therapy. In a second study
comparable cure rates were
observed between single dose
Rocephin and the comparator. The potentially lower clinical
cure rate
of Rocephin should be balanced against the potential
advantages of parenteral
therapy (see CLINICAL PHARMACOLOGY: CLINICAL
STUDIES).
Skin and Skin Structure Infections caused by Staphylococcus
aureus, Staphylococcus
epidermidis, Streptococcus
pyogenes, Viridans group streptococci, Escherichia coli,
Enterobacter cloacae,
Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus
mirabilis, Morganella morganii*, Pseudomonas aeruginosa, Serratia
marcescens, Acinetobacter
calcoaceticus, Bacteroides fragilis * or Peptostreptococcus
species.
Urinary Tract Infections (complicated and uncomplicated)
caused by Escherichia coli, Proteus
mirabilis, Proteus vulgaris,
Morganella morganii or Klebsiella pneumoniae.
Uncomplicated Gonorrhea (cervical/urethral and rectal) caused
by Neisseria gonorrhoeae, including both penicillinase- and
nonpenicillinase-producing strains, and pharyngeal
gonorrhea caused by
nonpenicillinase-producing strains of Neisseria gonorrhoeae.
Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae.
Rocephin, like other cephalosporins, has no
activity against Chlamydia
trachomatis. Therefore, when cephalosporins are used in the
treatment of patients with pelvic
inflammatory disease
and C. trachomatis is one of the suspected pathogens, appropriate
antichlamydial coverage should be added.
Bacterial Septicemia caused by Staphylococcus aureus,
Streptococcus pneumoniae, Escherichia
coli, Haemophilus
influenzae or Klebsiella pneumoniae.
Bone and Joint Infections caused by Staphylococcus aureus,
Streptococcus pneumoniae, Escherichia
coli, Proteus mirabilis,
Klebsiella pneumoniae or Enterobacter species.
Intra-Abdominal Infections caused by Escherichia coli,
Klebsiella pneumoniae, Bacteroides
fragilis, Clostridium species
(Note: most strains of C. difficile are resistant) or Peptostreptococcus
species.
Meningitis caused by Haemophilus influenzae, Neisseria
meningitidis or Streptococcus pneumoniae. Rocephin has
also been used successfully in a limited number
of cases of meningitis
and shunt infection
caused by Staphylococcus epidermidis* and Escherichia
coli.*
* Efficacy for this organism
in this organ system
was studied in fewer than ten infections.
Surgical Prophylaxis
The preoperative administration
of a single 1 gm dose of
Rocephin may reduce the incidence
of postoperative infections in patients undergoing surgical procedures
classified as contaminated or potentially contaminated (eg, vaginal
or abdominal hysterectomy
or cholecystectomy
for chronic calculous
cholecystitis in high-risk patients such
as those over 70 years of age, with acute
cholecystitis
not requiring therapeutic
antimicrobials, obstructive jaundice or common duct
bile stones) and in surgical
patients for whom infection at the operative
site would present
serious risk (e.g., during
coronary artery bypass
surgery). Although Rocephin has been shown to have been as effective
as cefazolin in the prevention
of infection following
coronary artery bypass
surgery, no
placebo-controlled trials have been conducted to evaluate any cephalosporin
antibiotic in the
prevention of infection
following coronary
artery bypass
surgery.
When administered prior to surgical
procedures for which it is indicated, a single 1 gm dose
of Rocephin provides protection from most infections due to susceptible
organisms throughout the course of the procedure.
Before instituting treatment
with Rocephin, appropriate
specimens should be obtained for isolation
of the causative organism
and for determination of its susceptibility
to the drug. Therapy may be instituted prior to obtaining results
of susceptibility
testing.
DOSAGE AND ADMINISTRATION
Rocephin may be administered intravenously or intramuscularly.
ADULTS
The usual adult daily
dose is 1 to 2 grams given
once a day (or in equally divided doses twice a day) depending on
the type and severity of
infection. The total daily dose
should not exceed 4 grams. If C. trachomatis is a suspected
pathogen, appropriate
antichlamydial coverage should be added, because ceftriaxone
sodium has no
activity against this
organism. For the treatment
of uncomplicated gonococcal
infections, a single intramuscular dose of 250 mg
is recommended. For preoperative use (surgical prophylaxis), a single
dose of 1 gram
administered intravenously ½ to 2 hours before surgery
is recommended.
PEDIATRIC PATIENTS
For the treatment
of skin and skin
structure infections,
the recommended total daily dose
is 50 to 75 mg/kg given once a day (or in equally divided doses
twice a day). The total daily doses should not exceed 2 grams. For
the treatment of acute
bacterial otitis media,
a single intramuscular
dose of 50 mg/kg (not to exceed 1 gram) is recommended
For the treatment
of serious miscellaneous infections other than meningitis, the recommended
total daily dose is 50
to 75 mg/kg, given in divided doses every 12 hours. The total daily
dose should not exceed
2 grams.
In the treatment
of meningitis, it
is recommended that the initial
therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter,
a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily)
is recommended. The daily dose may be administered once a day (or
in equally divided doses every 12 hours). The usual duration
of therapy is 7 to 14
days. Generally, Rocephin therapy should be continued for at least
2 days after the signs and symptoms of infection
have disappeared. The usual duration
of therapy is 4 to 14
days; in complicated infections, longer therapy
may be required.
When treating infections caused by Streptococcus pyogenes,
therapy should be continued for at least 10 days. No
dosage adjustment
is necessary for patients with impairment
of renal or hepatic
function, however, blood levels should be monitored in patients
with severe renal impairment
(eg, dialysis patients) and in patients with both renal
and hepatic dysfunctions.
DIRECTIONS FOR USE
Intramuscular Administration: Reconstitute Rocephin
powder with the appropriate
diluent (see COMPATIBILITY
AND STABILITY section, below). After reconstitution
each 1 mL of solution
contains approximately 250 mg
or 350 mg equivalent
of ceftriaxone according
to the amount of diluent indicated below. If required, more dilute
solutions could be utilized. A 350 mg/ mL concentration
is not recommended for the 250 mg
vial since it may not be
possible to withdraw the entire
contents. As with all intramuscular
preparations, Rocephin should be injected
well within the body of
a relatively large muscle; aspiration
helps to avoid unintentional injection
into a blood vessel.
|
Vial Dosage Size
|
Amount of Diluent to be Added
|
| |
250 mg/mL
|
350 mg/mL
|
|
250 mg
|
0.9 mL
|
—
|
|
500 mg
|
1.8 mL
|
1.0 mL
|
|
1 gm
|
3.6mL
|
2.1 mL
|
|
2gm
|
7.2 mL
|
4.2 mL
|
Intramuscular Convenience Kit: For the 500 mg
vial, withdraw 1 mL of
diluent, discard the remainder. Inject diluent
into vial, shake vial thoroughly
to form solution. Withdraw
entire contents of vial
into syringe to vial approximately
1.4 mL.
For 1 gm vial withdraw
entire contents of diluent
(2.1 mL). Inject diluent into vial,
shake vial thoroughly to
form solution. Withdraw
entire contents of vial
into syringe to equal
approximately 2.8 mL.
Intravenous Administration: Rocephin should be administered
intravenously by infusion
over a period of 30 minutes.
Concentrations between 10 mg/mL and 40 mg/mL are recommended; however,
lower concentrations may be used if desired. Reconstitute vials
or ''piggyback'' bottles with an appropriate IV
diluent (see COMPATIBILITY
AND STABILITY subsection, below).
|
Vial Dosage Size
|
Amount of Diluent to be Added
|
|
250 mg
|
2.4 mL
|
|
500 mg
|
4.8 mL
|
|
1 gm
|
9.6mL
|
|
2 gm
|
19.2 mL
|
After reconstitution, each 1 mL solution
contains approximately 100 mg equivalent
of ceftriaxone. Withdraw entire
contents and dilute to the desired concentration
with the appropriate
IV diluent.
|
Piggyback Bottle Dosage Size
|
Amount of Diluent to be Added
|
|
1 gm
|
10 mL
|
|
2 gm
|
20 mL
|
After reconstitution, further dilute to 50 mL or 100 ML volumes
with the appropriate
IV diluent.
COMPATIBILITY AND STABILITY
Rocephin sterile powder
should be stored at room
temperature—77°F (25°C)—or below and protected from light.
After reconstitution, protection from normal
light is not necessary.
The color of solutions
ranges from light yellow
to amber, depending on the length
of storage, concentration and diluent
used.
Rocephin intramuscular
solutions remain stable
(loss of potency less
than 10%) for the following time
periods:
|
Diluent
|
Concentration
mg/mL
|
Storage
|
|
Room Temp. (25°C)
|
Refrigerated (4° C)
|
|
Sterile Water for
Injection
|
100
250, 350
|
3 days
24 hours
|
10 days
3 days
|
|
0.9% Sodium
Chloride Solution
|
100
250,350
|
3 days
24 hours
|
10 days
3 days
|
| 5% Dextrose
Solution |
100
250, 350
|
3 days
24 hours
|
10 days
3 days
|
| Bacteriostatic
Water + 0.9% Benzyl Alcohol |
100
250, 350
|
24 hours
24 hours
|
10 days
3 days
|
|
1% Lidocaine Solution
(without epinephrine)
|
100
250,350
|
24 hours
24 hours
|
10 days
3 days
|
Rocephin intravenous
solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable
(loss of potency less
than 10%) for the following time
periods stored in glass
or PVC containers:
|
Diluent
|
Storage
|
|
Room Temp. (25° C)
|
Refrigerated (4° C)
|
| Sterile Water |
3 days
|
10 days
|
| 0.9% Sodium Chloride
Solution |
3 days
|
10 days
|
| 5% Dextrose Solution
|
3 days
|
10 days
|
| 10% Dextrose Solution
|
3 days
|
10 days
|
| 5% Dextrose + 0.9%
Sodium Chloride Solution* |
3 days
|
Incompatible
|
| 5% Dextrose + 0.45%
Sodium Chloride Solution |
3 days
|
Incompatible
|
Similarly, Rocephin intravenous
solutions, at concentrations of 100 mg/mL, remain stable
in the IV piggyback glass
containers for the above specified time
periods.
The following intravenous
Rocephin solutions are stable
at room temperature (25°C)
for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium
Lactate (PVC container), 10% Invert Sugar (glass container), 5%
Sodium Bicarbonate (glass container), Freamine III (glass container),
Normosol-M in 5% Dextrose (glass and PVC
containers), lonosol-B in 5% Dextrose (glass container), 5% Mannitol
(glass container), 10% Mannitol (glass container).
After the indicated stability
time periods, unused portions
of solutions should be discarded.
Rocephin reconstituted with 5% Dextrose or 0.9% Sodium Chloride
solution at concentrations between 10 mg/mL and 40 mg/mL, and then
stored in frozen state (–20°C) in PVC
or polyolefin containers, remains stable
for 26 weeks.
Frozen solutions should be thawed at room
temperature before
use. After thawing, unused portions should be discarded. DO NOT
REFREEZE.
Rocephin solutions should not be physically mixed
with or piggybacked into solutions containing other antimicrobial
drugs or into diluent
solutions other than those listed above, due to possible incompatibility.
HOW SUPPLIED
Rocephin is supplied as a sterile
crystalline powder
in glass vials and piggyback
bottles. The following packages are available:
Vials containing 250 mg equivalent
of ceftriaxone. Box of 1 (NDC 0004-1962-02) and box of 10 (NDC 0004-1962-01).
Vials containing 500 mg equivalent
of ceftriaxone. Box of 1 (NDC 0004-1963-02) and box of 10 (NDC 0004-1963-01).
Vials containing 1 gm equivalent
of ceftriaxone. Box of 1 (NDC 0004-1964-04) and box of 10 (NDC 0004-1964-01).Piggyback
bottles containing 1 gm equivalent
of ceftriaxone. Box of 1 (NDC 0004-1964-02).
Vials containing 2 gm equivalent of ceftriaxone. Box of
10 (NDC 0004-1965-01).Piggyback bottles containing 2 gm equivalent
of ceftriaxone. Box of 1 (NDC 0004-1965-02).
Bulk pharmacy containers,
containing 10 gm equivalent
of ceftriaxone. Box of 1 (NDC 0004-1971-01). NOT FOR DIRECT ADMINISTRATION.
Rocephin is also supplied in an Intramuscular Convenience Kit,
available in two strengths, consisting of a vial
of ceftriaxone sodium
as a sterile crystalline powder
and a vial of Xylocaine®
-MPF 1% (lidocaine HCl Injection, USP).
The following strengths are available:
Kit containing 1 vial
of 500 mg equivalent
of ceftriaxone, plus 1 vial of 2.1 mL Xylocaine (NDC 0004-2014-92).
Kit containing 1 vial
of 1 gm equivalent
of ceftriaxone, plus 1 vial of 2.1 mL Xylocaine (NDC 0004-2013-92).
Xylocaine® –MPF 1% (lidocaine HCl Injection, USP) is manufactured
for Roche Laboratories Inc. by Astra USA, Inc., Westborough, MA
01581.
Rocephin is also supplied as a sterile
crystalline powder
in ADD-Vantage®* Vials as follows:
ADD-Vantage Vials containing 1 gm equivalent
of ceftriaxone. Box of 10 (NDC 0004-1964-05)
ADD-Vantage Vials containing 2 gm equivalent
of ceftriaxone. Box of 10 (NDC 0004-1965-05).
Rocephin (ceftriaxone sodium
injection) also supplied premixed as a frozen, iso-osmotic, sterile,
norpyrogenic solution
of ceftriaxone sodium
in 50 mL single dose Galaxy®†
containers (PL 2040 plastic), is manufactured for Roche Laboratories
Inc., by Baxter Healthcare Corporation, Deerfield, Illinois 60015.
The following strengths are available:
1 gm equivalent
of ceftriaxone, iso-osmotic with approximately 1.9 gm Dextrose Hydrous,
USP, added (NDC 0004-2002-78).
2 gm equivalent
of ceftriaxone, iso-osmotic with approximately 1.2 gm Dextrose Hydrous,
USP, added (NDC 0004-2003-78).
NOTE: Store Rocephin in the frozen state
at or below: -20°C/ -4°F.
* Registered trademark of Abbott Laboratories: Inc.
† Registered trademark of Baxter International Inc.
REFERENCES:
1. National Committee for Clinical Laboratory Standards,
Performance Standards for Antimicrobial Disk Susceptibility Tests.
5th ed. Villanova, PA: 1993. Approved Standard NCCLS Document M2–A5,
Vol. 13, No. 24 NCCLS.
2. National Committee for Clinical Laboratory Standards,
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria
That Grow Aerobically. 3rd ed. Villanova, PA: 1993. Approved
Standard NCCLS Document M7-A3, Vol. 13, No. 25. NCCLS.
3. Barnett ED, Teele DW, Klein JO, et al. Comparison
of Ceftriaxone and Trimethoprim-Sulfamethoxazole for-Acute Otitis
Media. Pediatrics. Vol. 99, No. 1, January 1997.
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