Cephazone Pharma Llc

Cephazone Pharma Llc Drugs

• Ceftriaxone
  

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  Ceftriaxone

  

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  Ceftriaxone may be administered intravenously or intramuscularly.

  Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form.  Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line.

  Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site.  However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS).

  There have been no reports of an interaction between ceftriaxone and oral calcium containing products or interaction between intramuscular ceftriaxone and calcium containing products (IV or oral).

  NEONATES

  Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone (see CONTRAINDICATIONS).

  Ceftriaxone is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see 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 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. For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, in order to achieve >90% target attainment. 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, ceftriaxone 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.

  DIRECTIONS FOR USE:

  Intramuscular Administration: Reconstitute ceftriaxone 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, ceftriaxone 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 g 3.6 mL 2.1 mL 2 g 7.2 mL 4.2 mL

  Intravenous Administration: Ceftriaxone 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).

  Vial Dosage Size Amount of Diluent to be added 250 mg 2.4 mL 500 mg 4.8 mL 1 g 9.6 mL 2 g 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.

  Piggyback Bottle Dosage Size Amount of Diluent to be added 1 g 10 mL 2 g 20 mL

  After reconstitution, further dilute to 50 mL or 100 mL volumes with the appropriate IV diluent.

  COMPATIBILITY AND STABILITY: Ceftriaxone has been shown to be compatible with Flagyl® 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, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures. When any of these drugs are 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 ceftriaxone vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result.

  Ceftriaxone for injection 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).

  Ceftriaxone for injection should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protected from light. After reconstitution, protection from normal light is not necessary. The color of solution ranges from light yellow to amber, depending on the lenght of storage, concentration and diluent used.

  Ceftriaxone intramuscular solution remain stable (loss of potency less than 10%) for the following time periods:

  Diluent Concentration Storage mg/mL Room Temp. (25°C) Refrigerated (4°C) Sterile Water for Injection 100, 2 days 10 days 250,350 24 hours 3 days 0.9% Sodium ChlorideSolution 100, 2 days 10 days 250,350 24 hours 3 days 5% Dextrose Solution 100, 2 days 10 days 250,350 24 hours 3 days Bacteriostatic Water + 0.9%Benzyl Alcohol 100, 24 hours 10 days 250,350 24 hours 3 days 1 % Lidocaine Solution(without epinephrine) 100, 24 hours 10 days 250,350 24 hours 3 days

  Ceftriaxone intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss potency less than 10%) for the following time periods stored in glass or PVC containers.

  * Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only. Diluent Storage Room Temp. (25°C) Refrigerated (4°C) 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 ceftriaxone 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.

  Ceftriaxone 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 ceftriaxone for injection should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

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