ceftriaxone sodium


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Related to ceftriaxone sodium: Cephalosporins, Rocephin

ceftriaxone sodium

Rocephin

Pharmacologic class: Third-generation cephalosporin

Therapeutic class: Anti-infective

Pregnancy risk category B

GI: nausea, vomiting, diarrhea, abdominal cramps, oral candidiasis, pseudomembranous colitis, pancreatitis, Clostridium difficile-associated diarrhea

Action

Interferes with bacterial cell-wall synthesis and division by binding to cell wall, causing cell to die. Active against gram-negative and gram-positive bacteria, with expanded activity against gram-negative bacteria. Exhibits minimal immunosuppressant activity.

Availability

Powder for injection: 250 mg, 500 mg, 1 g, 2 g

Premixed containers: 1 g/50 ml, 2 g/50 ml

Indications and dosages

Infections of respiratory system, bones, joints, and skin; septicemia
Adults: 1 to 2 g/day I.M. or I.V. or in equally divided doses q 12 hours. Maximum daily dosage is 4 g.

Uncomplicated gonorrhea
Adults: 250 mg I.M. as a single dose

Surgical prophylaxis
Adults: 1 g I.V. as a single dose within 1 hour before start of surgical procedure

Meningitis
Adults: 1 g to 2 g I.V. q 12 hours for 10 to 14 days
Children: Initially, 100 mg/kg/day I.M. or I.V. (not to exceed 4 g). Then 100 mg/kg/day I.M. or I.V. once daily or in equally divided doses q 12 hours (not to exceed 4 g) for 7 to 14 days.

Otitis media
Children: 50 mg/kg I.M. as a single dose; maximum of 1 g/dose.

Skin and skin-structure infections
Children: 50 to 75 mg/kg/day I.V. or I.M. once or twice daily. Maximum dosage is 2 g daily.

Other serious infections
Children: 50 to 75 mg/kg/day I.V. or I.M. once or twice daily

Dosage adjustments

• Hepatic dysfunction with significant renal impairment

Off-label uses

• Disseminated gonorrhea

• Endocarditis

• Epididymitis

• Gonorrhea-associated meningitis

• Lyme disease

Neisseria meningitides carriers

• Pelvic inflammatory disease

Contraindications

• Neonates (28 days or younger)

Precautions

Use cautiously in:

• hypersensitivity to cephalosporins or penicillins, allergies

• renal impairment, hepatic disease, gallbladder disease, phenylketonuria

• history of GI disease, diarrhea following antibiotic therapy

• pregnant or breastfeeding patients.

Administration

• Obtain specimens for culture and sensitivity testing as necessary before starting therapy.

Be aware that drug mustn't be given with or within 48 hours of calcium-containing I.V. solutions, including calcium-containing continuous infusions such as parenteral nutrition, because of risk of precipitation of ceftriaxone calcium salt (particularly in neonates).

• Know that drug for I.V. injection is compatible with sterile water, normal saline solution, dextrose 5% in water (D5W), half-normal saline solution, and D5W and normal saline solution.

• After reconstituting, dilute further to desired concentration for intermittent I.V. infusion. Infuse over 30 minutes.

• For I.M. use, reconstitute powder for injection with compatible solution by adding 0.9 ml of diluent to 250-mg vial, 1.8 ml to 500-mg vial, 3.6 ml to 1-g vial, or 7.2 ml to 2-g vial, to yield a concentration averaging 250 mg/ml.

• Divide high I.M. doses equally and administer in two separate sites. Inject deep into large muscle mass.

Adverse reactions

CNS: headache, confusion, hemiparesis, lethargy, paresthesia, syncope, seizures

CV: hypotension, palpitations, chest pain, vasodilation

EENT: hearing loss

GI: nausea, vomiting, diarrhea, abdominal cramps, oral candidiasis, pseudomembranous colitis, pancreatitis, Clostridium difficile-associated diarrhea

GU: vaginal candidiasis

Hematologic: lymphocytosis, eosinophilia, bleeding tendency, hemolytic anemia, hypoprothrombinemia, neutropenia, thrombocytopenia, agranulocytosis, bone marrow depression

Hepatic: jaundice, hepatomegaly

Musculoskeletal: arthralgia

Respiratory: dyspnea

Skin: urticaria, maculopapular or erythematous rash

Other: chills, fever, superinfection, pain at I.M. injection site, anaphylaxis, serum sickness

Interactions

Drug-drug. Aminoglycosides, loop diuretics: increased risk of nephrotoxicity

Calcium-containing solutions: possibly fatal reactions caused by ceftriaxone calcium precipitates

Probenecid: decreased excretion and increased blood level of ceftriaxone

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, eosinophils, gamma-glutamyltransferase, lactate dehydrogenase: increased levels
Coombs' test, urinary 17-ketosteroids, nonenzyme-based urine glucose tests (such as Clinitest): false-positive results

Hemoglobin, platelets, white blood cells: decreased values

Drug-herbs. Angelica, anise, arnica, asafetida, bogbean, boldo, celery, chamomile, clove, danshen, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, horse chestnut, horseradish, licorice, meadowsweet, onion, papain, passionflower, poplar, prickly ash, quassia, red clover, turmeric, wild carrot, wild lettuce, willow: increased risk of bleeding.

Patient monitoring

Monitor for extreme confusion, tonic-clonic seizures, and mild hemiparesis when giving high doses.

• Monitor coagulation studies.

• Assess CBC and kidney and liver function test results.

• Monitor for signs and symptoms of superinfection and other serious adverse reactions.

• Be aware that cross-sensitivity to penicillins and cephalosporins may occur.

Patient teaching

• Instruct patient to report persistent diarrhea, bruising, or bleeding.

• Caution patient not to use herbs unless prescriber approves.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved
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References in periodicals archive ?
(i) Standard solutions of ceftriaxone sodium (reference standard): they were prepared by dissolving 10.0 mg ceftriaxone sodium reference substance in ultrapure water in a 10 mL volumetric flask (1000 [micro]g [mL.sup.-1]).
(ii) Ceftriaxone sodium solutions: aliquot volumes of standard stock solution containing 1000.0 [micro]g [mL.sup.-1] reference substances were transferred to 25 mL volumetric flasks and diluted with ultrapure water to obtain suitable concentrations containing 10.0-20.0 [micro]g [mL.sup.-1].
In order to assess the validity of the assay, 10 mg ceftriaxone sodium reference substance was dissolved in ultrapure water in 100 mL volumetric flask (1000.0 [micro]g [mL.sup.-1]).
The accuracy of the method was evaluated by addition of three different amounts of ceftriaxone sodium reference standard solution to sample solution.
The absorption spectrum showed maximum absorption peak of 241 nm, using an aqueous solution of ceftriaxone sodium to 16 [micro]g [mL.sup.-1].
We could conclude that the proposed spectrophotometric method is simple, rapid, and with low reagent cost and can therefore be applied for the determination of ceftriaxone sodium in lyophilized powder for injection.
Ceftriaxone sodium was obtained as a gift sample from Orchid Chemicals and Pharmaceutical Ltd., Chennai, India.
A stock solution was prepared by dissolving 100 mg of ceftriaxone sodium pure drug in 100 mL of distilled water to get standard stock solution (1mg/mL).
To a set of 10 mL volumetric flasks, aliquot volumes containing the drug were quantitatively transferred from standard stock solution and made up to the mark with distilled water to obtain final concentrations of 5-50 [micro]g/mL of ceftriaxone sodium. The absorbance was measured at 241 nm and calibration graph was constructed by plotting the absorbance versus the concentration of the drug.
Three levels of standard drug (10%, 20%, and 30%) were spiked individually with the 100 mg equivalent of powder for injection dosage form ceftriaxone sodium and analysed in six replicates during the same day (intraday precision) and six consecutive days (interday precision).
A linear correlation was found between absorbance at [lambda] max and various concentrations of ceftriaxone sodium. The linearity graph obeyed Beer's law in the range from 5 to 50 [micro]g/mL and it was described by regression equation (y = mx + c) and correlation coefficient ([r.sup.2]) which were displayed on the graph.
A 2 mL aliquot of standard stock solution of ceftriaxone sodium (1 mg/mL) was taken in four replicates in a volumetric flask (100 mL) and mixed with 10 mL of 0.1 N HCl (acid hydrolysis) or 0.1 N NaOH (alkaline hydrolysis) or 5% [H.sub.2][O.sub.2] (oxidative degradation) and set aside for 1 h at room temperature.