Key Information

Rocephin should not be used by someone who had severe allergic reactions to a type of cephalosporin antibiotic. Also, administering it to a child without a doctor’s advice is not recommended, and to a premature or newborn baby with jaundice. 

Side Effect

The rocephin drug is commonly well accepted. In the case of clinical trials, below are some adverse reactions linked to Rocephin treatment.

Local Reaction- induration, pain, and tenderness is 1 percent. Phlebitis has been stated in <1% following the administration of IV. The prevalence of tightness, warmth, induration was at 17 percent (3/17) when IM is administered at 350 ml, and 5 percent after the application of IM at 250 mg or ml.

General Condition and Administration Setting – injection spot pain at 0.6 percent.

Hypersensitivity – rash 1.7 percent. Less often stated, <1 percent were fever, pruritus, or chills.

Infestations and Infections- genital fungal infection 0.1 percent.

Hematologic – eosinophilia 6%, thrombocytosis 5.1 percent and leukopenia 2.1 percent. Not so often reported <1 percent were neutropenia, hemolytic anemia, anemia, prolongation thrombocytopenia, and lymphopenia.

Blood and Lymphatic Disorder – coagulopathy 0.4 percent, granulocytopenia 0.9 percent.

Gastrointestinal – loose stools/diarrhea 2.7 percent. Less often reported, <1 percent were vomiting or nausea, as well as dysgeusia. The start of pseudomembranous colitis indications might happen during or right after the anti-bacterial treatment.

Epatic – rises of aspartate aminotransferase AST 3.1 percent or alanine aminotransferase ALT 3.3 percent. Less often reported <1 percent were increases of bilirubin and alkaline phosphatase.

Renal – rises off the BUN 1.2 percent. Less often reported <1 percent were increases of creatinine, as well as the incidence of some casts in urine.

Nervous System – dizziness or headache were occasionally stated <1 percent.

Genitourinary – vaginitis or moniliasis were occasionally stated <1 percent.

Miscellaneous – flushing, and diaphoresis were occasionally stated <1 percent.

Investigations – increase in blood creatinine 0.6 percent.

Dosage and Administration

Rocephin- applied intramuscularly or intravenously. It is also not used as a diluent that contains calcium like Hartmann’s solution or Ringer’s solution to reconstitute the drug vial or to offset a reconstituted vial for IV administration. Such is because precipitate could form. The precipitation of ceftriaxone-calcium may also occur the moment Rocephin was mixed with solutions that contain calcium in the very same IV administration line.

Also, it should never be administered concurrently with IV solutions with calcium that includes calcium-comprising infusions like parenteral nutrition via a Y-site. But for patients except for the neonates, the drug and solutions with calcium might be administered successively to one another in case the infusion lines are flush between infusions with a matching fluid.

Neonates

Hyperbilirubinemia neonates, particularly the premature, need not be cured with Rocephin. The drug is contraindicated in early neonates. It is contraindicated in neonates ≤ 28 days if they need treatment with IV solutions with calcium, such as continuous calcium-comprising infusions like parenteral nutrition due to the risk of precipitation of ceftriaxone-calcium.

Intravenous doses need to be given more than 60 minutes in the case of neonates to lessen the danger of bilirubin encephalopathy.

Pediatric Patients

The recommended total daily dosage is 50-75 mg/kg administered once a day for the healing of skin or skin structure infections. The overall daily dosage should never exceed 2 grams.

For acute bacterial otitis media, take one intramuscular dosage of 50 mg/kg.

For the treatment of severe miscellaneous infections, aside from meningitis, the suggested total daily dosage is 50-75 mg/kg, administered in divided doses every 12-hours. The overall daily dosage should not be more than 2 grams.

Adults

The typical adult daily dosage is 1-2 grams provided once a day reliant on the type and seriousness of the infection. The overall daily dosage should not be over 4 grams.

If Chlamydia trachomatis is an alleged pathogen, proper antichlamydial treatment needs to be included, because ceftriaxone sodium has no activity against the organism.

For the treatment of simple gonococcal infections, just a single intramuscular dosage of 250 mg is advised.

Drug Interaction

Patients who have been administered with local anesthetics might be at a heightened risk of acquiring methemoglobinemia when simultaneously subjected to the oxidizing agents below:

•   Nitrates/Nitrites          
•   Antineoplastic agents 
•   Local anesthetics
•   Antibiotics       
•   Anticonvulsants
•   Antimalarials  

Precaution and Warning

Hypersensitivity Reactions

Prior to having a therapy where the drug is introduced, the careful examination needs to be prepared to ascertain if the patient had preceding allergic reactions to penicillins, cephalosporins, and other types of beta-lactam drugs or agents. This product needs to be provided carefully to penicillin, as well as other beta-lactam agent sensitive patients. The administration for anti-bacterial medicines with restraint to patients who showed some types of allergy to some drugs. Severe acute allergic reactions might require the usage of intravenous epinephrine and some emergency procedures.

Contact with Calcium-Containing Product

Never use diluents that have calcium, Hartmann’s solution, or Ringer’s solution, to reconstruct Rocephin containers or further offset a modified bottle for IV administration since a precipitate may form. The precipitation of a ceftriaxone-calcium could also happen when Rocephin gets mixed up with solutions with calcium in the same line of IV administration. Administering the drug instantaneously with IV solutions that contain calcium is not advised, which includes calcium-containing infusions like parenteral nourishment through a Y-site. 

Clostridium difficile -Associated Diarrhea

Clostridium difficile associated diarrhea has been described with the use of anti-bacterial agents, that includes Rocephin, and might vary in seriousness from slight diarrhea up to deadly colitis. The treatment that has anti-bacterial agents changes the typical flora of colon, thus leading to the over-growth of C. difficile.

1. difficile generates toxins A&B that add to the growth of CDAD. Hypertoxin-producing types of C. difficile that cause an increase in mortality and morbidity, as such infections could be intractable to anti-microbial treatment and might need colectomy. Clostridium difficile linked diarrhea needs are in patients who appear with diarrhea that follows antibiotic use. Cautious medical record is essential since it was recounted for CDAD to happen more than 2-months after the usage of anti-bacterial agents.

Hemolytic Anemia

Immune-mediated hemolytic anemia is noticed among patients who are getting cephalosporin class anti-bacterial that includes Rocephin. Severe instances of having hemolytic anemia that includes fatalities were started during the treatment in children and adults. In case a patient gets anemia while taking ceftriaxone, the findings of cephalosporin related anemia need to be considered, and ceftriaxone halted until the reveal of the etiology.

Overdose and Contraindications

When it comes to overdose, drug intensity will not be lessened by peritoneal dialysis or hemodialysis. There is no antidote. The treatment of overdosage needs to be symptomatic.

Clinical Pharmacology

Normal plasma intensities of ceftriaxone following a single 30-minute intravenous (IV) infusion of a 0.5, 1 or 2 gm dosage and intramuscular (IM) application of a single 0.5 or 1 gm dosage in healthy subjects.

Absorption of Ceftriaxone following IM administration with extreme plasma intensities happening between 2- and 3-hours post-dosage. Several IV or IM dosages are varying from 0.5-2 gm at 12- to 24-hour periods that stemmed in 15%-36% buildup of ceftriaxone on top of a single dosage value.