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CEFTRIAXONE (ROCEPHIN ®)
The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgement. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents
D5W, NS

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]
[0 to 1 gram] [50 ml] [30 min]
[ Over 1 gram] [100 ml] [30 min]

Stability / Miscellaneous
EXP: 1 DAY (RT) / 10 DAYS (REF).
Label: Refrigerate. Total daily dose should not exceed 4 grams.

IM injection preparation:
250 mg/ 0.9 ml;
500mg/ 1.8 ml;
1 gram/3.6 ml;
2grams/ 4.2 or 7.2 ml
(H20; BS-H20; 0.5 to 1% lidocaine)

Usual dose: 1-2g ivpb q24h. Severe: 2g ivpb q12h.

No dosage adjustments required in renal failure.
PD: 750mg ivpb q12h
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DOSAGE AND ADMINISTRATION
Rocephin may be administered intravenously or intramuscularly.
Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Rocephin. Particulate formation can result. Rocephin and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites.

NEONATES
Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin (see package insert for CONTRAINDICATIONS).

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 dose 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 (see INDICATIONS AND USAGE).

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.

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 Chlamydia 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 1/2 to 2 hours before surgery is recommended.

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).

Inject diluent into vial, shake vial thoroughly to form solution. Withdraw entire contents of vial into syringe to equal total labeled dose.

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 3.6 mL 2.1 mL
2 gm 7.2 mL 4.2 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 with an appropriate IV diluent (see COMPATIBILITY AND STABILITY).
Vial Dosage Size Amount of Diluent to be Added
250 mg 2.4 mL
500 mg 4.8 mL
1 gm 9.6 mL
2 gm 19.2 mL
After reconstitution, each 1 mL of solution contains approximately 100 mg equivalent of ceftriaxone. Withdraw entire contents and dilute to the desired concentration with the appropriate IV diluent.

COMPATIBILITY AND STABILITY
Ceftriaxone has been shown to be compatible with Flagyl®2 IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with ceftriaxone 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W). No compatibility studies have been conducted with the Flagyl® IV RTU® (metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

Vancomycin and fluconazole are physically incompatible with ceftriaxone in admixtures. When either of these drugs is to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute Rocephin. Particulate formation can result.

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 (see WARNINGS).

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:
Storage
Diluent Concentration
mg/ml		 Room Temp.
(25°C)		 Refrigerated
(4°C)
Sterile Water for Injection 100
250, 350		 2 days
24 hours		 10 days
3 days
0.9% Sodium Chloride Solution 100
250, 350		 2 days
24 hours		 10 days
3 days
5% Dextrose Solution 100
250, 350		 2 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:
Storage
Diluent Room Temp.
(25°C)		 Refrigerated
(4°C)
*Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only.
Sterile Water 2 days 10 days
0.9% Sodium Chloride Solution 2 days 10 days
5% Dextrose Solution 2 days 10 days
10% Dextrose Solution 2 days 10 days
5% Dextrose + 0.9% Sodium Chloride Solution* 2 days Incompatible
5% Dextrose + 0.45% Sodium Chloride Solution 2 days Incompatible


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), Ionosol-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.

NOTE: Parenteral drug products should be inspected visually for particulate matter before administration.

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 of Rocephin should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

HOW SUPPLIED
Rocephin is supplied as a sterile crystalline powder in glass vials. 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).
Vials containing 2 gm equivalent of ceftriaxone. Box of 10 (NDC 0004-1965-01).
Bulk pharmacy containers, containing 10 gm equivalent of ceftriaxone. Box of 1 (NDC 0004-1971-01). NOT FOR DIRECT ADMINISTRATION.

NOTE: Rocephin sterile powder should be stored at room temperature, 77ºF (25ºC) or below, and protected from light.

Roche Pharmaceuticals
Roche Laboratories, Inc.
340 Kingsland Street
Nutley, NJ 07110–1199
10087320
Revised: August 2007
The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgement. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.