Ceftriaxone

What is Ceftriaxone?

• Ceftriaxone (Rocephin), is a sterile, semisynthetic, broad-spectrum cephalosporin antibacterial.

Ceftriaxone

Ceftriaxone-skeletal

Ceftriaxone ball-and-stick

What are the uses of this medicine?

Ceftriaxone (Rocephin), is used for the treatment of the following infections caused by susceptible isolates of the designated bacteria:

• Lower Respiratory Tract Infections
• Skin and Skin Structure Infections
• Complicated and Uncomplicated Urinary Tract Infections
• Pelvic Inflammatory Disease
• Bacterial Septicemia
• Bone and Joint infections
• Intra-abdominal Infections
• Meningitis
• Surgical Prophylaxis

How does this medicine work?

• The sodium salt form of ceftriaxone, a beta-lactam, third-generation cephalosporin antibiotic with bactericidal activity.
• Ceftriaxone is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
• Ceftriaxone has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.
• Ceftriaxone binds to and inactivates penicillin-binding proteins (PBP) located on the inner membrane of the bacterial cell wall.
• PBPs participate in the terminal stages of assembling the bacterial cell wall, and in reshaping the cell wall during cell division.
• Inactivation of PBPs interferes with the cross-linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity.
• This results in the weakening of the bacterial cell wall and causes cell lysis.
• Compared to the second and first generation cephalosporins, ceftriaxone is more active against gram-negative bacteria and less active against gram-positive bacteria.
• Ceftriaxone also crosses the blood-brain barrier and reaches therapeutic concentrations in the central nervous system (CNS).

Ceftriaxone has been shown to be active against most isolates of the following bacteria: Gram-negative Bacteria:

• Acinetobacter calcoaceticus
• Enterobacter aerogenes
• Enterobacter cloacae
• Escherichia coli
• Haemophilus influenzae
• Haemophilus parainfluenzae
• Klebsiella oxytoca
• Klebsiella pneumoniae
• Moraxella catarrhalis
• Morganella morganii
• Neisseria gonorrhoeae
• Neisseria meningitidis
• Proteus mirabilis
• Proteus vulgaris
• Pseudomonas aeruginosa
• Serratia marcescens

Gram-positive Bacteria:

• Staphylococcus aureus
• Staphylococcus epidermidis
• Streptococcus pneumoniae
• Streptococcus pyogenes
• Viridans group streptococci

Anaerobic Bacteria:

• Bacteroides fragilis
• Clostridium species
• Peptostreptococcus species

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a history of anaphylaxis to ceftriaxone or the cephalosporin class of antibacterials, penicillins, or other beta-lactam antibacterials

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• chloramphenicol, and warfarin (Coumadin, Jantoven).

Is this medicine FDA approved?

• Ceftriaxone is a third generation cephalosporin was was approved for use in the United States in 1984, and it continues to be widely used.

How should this medicine be used?

Recommended dosage:

In 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 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.

In 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.
• 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 preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.
• Generally, Ceftriaxone Injection, USP 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 hepatic impairment or mild to moderate renal impairment.

Administration:

• Ceftriaxone injection comes as a powder to be mixed with liquid, or as a premixed product, to be injected intravenously over a period of 30 or 60 minutes.
• Ceftriaxone injection can also be given intramuscularly.
• It is sometimes given as a single dose and sometimes given once or twice a day for 4-14 days, depending on the type of infection being treated.
• You may receive ceftriaxone injection in a hospital or doctor's office, or you may administer the medication at home.
• If you will be receiving ceftriaxone injection at home, your healthcare provider will show you how to use the medication.
• Be sure that you understand these directions, and ask your healthcare provider if you have any questions.
• You should begin to feel better during the first few days of your treatment with ceftriaxone injection.
• If your symptoms do not improve or get worse, call your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ceftriaxone Injection

This medicine is available in fallowing brand namesː

• Rocephin

What side effects can this medication cause?

The most common side effects of this medicine may include:

• diarrhea, eosinophilia, thrombocytosis, leukopenia, and elevations of SGOT and SGPT.

Less common, but serious side effects may include:

• Hypersensitivity reactions
• Ceftriaxone-calcium precipitates
• Clostridium difficile-associated diarrhea
• Hemolytic anemia

What special precautions should I follow?

• Serious, occasionally fatal, hypersensitivity (anaphylactic) reactions have been reported with ceftriaxone. If an allergic reaction to Ceftriaxone for Injection, USP occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated.
• Precipitation of ceftriaxone-calcium can occur when Ceftriaxone for Injection, USP is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone for Injection must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions.
• Serious neurological adverse reactions have been reported with ceftriaxone use. If neurological adverse reactions associate with Ceftriaxone for Injection therapy occur, discontinue Ceftriaxone for Injection and institute appropriate supportive measures. Make appropriate dosage adjustments in patients with severe renal impairment.
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including ceftriaxone. If a patient develops anemia while on Ceftriaxone for Injection, USP, the diagnosis of a cephalosporin-associated anemia should be considered and Ceftriaxone for Injection, USP stopped until the etiology is determined.
• There have been reports of sonographic abnormalities in the gallbladder of patients treated with ceftriaxone sodium; some of these patients also had symptoms of gallbladder disease. Therefore, ceftriaxone should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above.
• In patients with both hepatic and significant renal disease, Ceftriaxone for Injection dosage should not exceed 2 grams daily.
• In patients with both hepatic impairment and significant renal disease, Ceftriaxone for Injection dosage should not exceed 2 grams per day.
• Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported in patients treated with ceftriaxone sodium. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
• Alterations in prothrombin times have occurred in patients treated with ceftriaxone sodium. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.
• Ceftriaxone is also associated with rare instances of immunoallergic, usually cholestatic hepatitis similar to the injury associated with other cephalosporins.
• Ceftriaxone is excreted in human breast milk. Caution should be exercised when Ceftriaxone for Injection is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• encephalopathy, seizures, myoclonus, and non -convulsive status epilepticus.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis.
• There is no specific antidote.
• Treatment of overdosage should be symptomatic.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Ceftriaxone is contraindicated in neonates (≤ 28 days) 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.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ceftriaxone sodium

Inactive Ingredients:

• none

Who manufactures and distributes this medicine?

• Mfd. for SAGENT Pharmaceuticals
• Schaumburg, IL (USA)
• Made in Italy
• Sagent Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from light.

• Dailymed label info on Ceftriaxone
• FDA Ceftriaxone

Ceftriaxone Resources
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