Ceftriaxone

Ceftriaxone is used to treat a wide variety of bacterial infections. Ceftriaxone belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria.

Ceftriaxone is not recommended for use in newborns with high blood bilirubin levels and premature infants due to increased risk of side effects. Ask the doctor or pharmacist for details.

Ceftriaxone may also be used before dental procedures in people with certain heart conditions (such as artificial heart valves) to help prevent serious infection of the heart (bacterial endocarditis).

Ceftriaxone is available under the following different brand names: Rocephin.

Dosages of Ceftriaxone:

Adult and Pediatric Dosage Forms and Strengths

Injectable solution

• 1 g/50 mL
• 2 g/50mL

Powder for injection

• 250 mg
• 500 mg
• 1 g
• 2 g
• 10 g (adult only)
• 100 g (adult only)

Dosage Considerations – Should be Given as Follows:

Intra-abdominal Infections

• Complicated, mild-to-moderate, community-acquired: 1-2 g/day intravenously (IV) in single daily dose or divided every 12 hours for 4-7 days, in combination with metronidazole

Acute Bacterial Otitis Media

• Adult: 50 mg/kg intramuscularly (IM) once
• Persistent or treatment failures: 50 mg/kg intravenously/intramuscularly (IV/IM) for 3 days
• Pediatric: 50 mg/kg IM in single-dose; not to exceed 1 g

Pelvic Inflammatory Disease

• 250 mg intramuscularly (IM) as a single dose with doxycycline, with or without metronidazole for 14 days

Septic/toxic Shock (Off-label)

• 2 g intravenously (IV) once daily; with clindamycin for toxic shock

Skin and Soft Necrotizing Infection (Off-label)

• Due to Aeromonas hydrophilia: 1-2 g intravenously (IV) once/day in combination with doxycycline
• Due to Vibrio vulnificus; 1 g IV once/day in combination with doxycycline
• Continue treatment until further debridement is not necessary, the clinical improvement observed, and the patient is afebrile for 48-72 hours
• Children over 12 years: 1-2 g/day intravenously/intramuscularly (IV/IM) in a single daily dose or divided every 12 hours for 7-14 days, depending on type and severity of infection

Severe Acute Bacterial Rhinosinusitis (Off-label)

• Infection requiring hospitalization: 1-2 g intravenously (IV) every 12-24 hours for 5-7 days

Prosthetic Joint Infection

• 2 g intravenously (IV) every 24 hours for 2-6 weeks; continue treatment until clinical improvement is observed and the patient is afebrile for 48-72 hours

Meningitis

• Adult: 2 g intravenously (IV) every 12 hours for 7-14 days
• Pediatric: 100 mg/kg/day intravenously/intramuscularly (IV/IM) in single daily dose or divided every 12 hours for 7-14 days; not to exceed 4 g/day
• Serious Infections Other Than Meningitis, Pediatric
• 50-75 mg/kg/day intravenously/intramuscularly (IV/IM) divided every 12 hours for 7-14 days

Acute Uncomplicated Pyelonephritis

• 1-2 g intravenously (IV) once/day

Surgical Prophylaxis

Prophylaxis of surgical infection

• 1 g intravenously (IV) 0.5-2 hours before the procedure

Uncomplicated Gonococcal Infections

Adult: Uncomplicated gonococcal infection of pharynx, cervix, urethra, or rectum: ceftriaxone 250 mg intramuscularly (IM) once plus azithromycin 1 g orally once (preferred) or alternatively, doxycycline 100 mg orally every 12 hours for 7 days

Centers for Disease Control (CDC) Sexually Transmitted Diseases (STD) guidelines: MMWR Recommendations Rep. June 5, 2015:64(RR3);1-137

Sexual assault

• Prophylaxis of sexually transmitted diseases (STDs) such as gonorrhea after sexual assault per CDC guidelines includes the following 3-drug regimen:
  • Ceftriaxone 250 mg intramuscularly (IM) once, PLUS
  • Azithromycin 1 g orally once, PLUS
  • Metronidazole or tinidazole 2 g orally once
  • If alcohol has been recently ingested or emergency contraception is provided, metronidazole or tinidazole can be taken by the victim at home rather than as directly observed therapy to avoid drug interactions

Pediatric:

Neonates

• Ophthalmia neonatorum: 25-50 mg/kg intravenously/intramuscularly (IV/IM) once; not to exceed 125 mg
• Disseminated gonococcal infections and gonococcal scalp abscesses: 25-50 mg/kg/day IV/IM in single daily dose for 7 days; if meningitis is documented, treat for 10-14 days
• Prophylaxis for infants of mothers with gonococcal infection: 25-50 mg/kg IV/IM once; not to exceed 125 mg

Children

• Less than 45 kg with uncomplicated gonococcal vulvovaginitis, cervicitis, urethritis, pharyngitis, or proctitis: 125 mg intramuscularly (IM) once
• Less than 45 kg with bacteremia or arthritis: 50 mg/kg/day intravenously/intramuscularly (IV/IM) in single daily dose for 7 days; daily dose not to exceed 1 g
• Greater than 45 kg with bacteremia or arthritis: 50 mg/kg/day IM/IV in single daily dose for 7 days
• Greater than 45 kg: 1-2 g intravenously (IV) every 12 hours

Other Gonococcal Infections (Off-label)

• Gonococcal conjunctivitis: 1 g intramuscularly (IM) once
• Disseminated gonococcal infection: 1 g/day intravenously/intramuscularly (IV/IM); continued for at least 24-48 hours after improvement is observed, then continued with cefixime 400 mg orally every 12 hours to complete at least 1 week of therapy
• Gonococcal endocarditis: 1-2 g intravenously (IV) every 12 hours for 4 weeks
• Gonococcal meningitis: 1-2 g IV every 12 hours for 10-14 days
• Acute epididymitis: 250 mg IM once with doxycycline

Epiglottis, Pediatric (Off-label)

• 100 mg/kg/day intravenously (IV) on first day; follow with 50 mg/kg on day 2 or 75 mg/kg once/day for 10-14 days

Acute Epididymitis, Pediatric (Off-label)

• Children over 8 years and greater than 45 kg: 250 mg intramuscularly (IM) once with concomitant doxycycline regimen

Dosing Considerations

Susceptible organisms

• Anaerobic cocci, Bacteroides fragilis, Borrelia burgdorferi, Clostridium spp, Enterobacter spp, Escherichia coli, Haemophilus influenzae, Klebsiella spp, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitides, Proteus mirabilis, Providencia rettgeri, Pseudomonas spp, Serratia spp, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes

Common side effects of ceftriaxone include:

• Injection site reactions (swelling, redness, pain, a hard lump, or soreness)
• Eosinophilia
• Increased blood platelets (thrombocytosis)
• Diarrhea
• Elevated liver transaminases
• Low white blood cell count (leukopenia)
• Rash
• Increased blood urea nitrogen (BUN)
• Pain

Less common side effects of ceftriaxone include:

• Agranulocytosis
• Anemia
• Basophilia
• Blood in the urine
• Bronchospasm
• Changes in taste
• Chills
• Dizziness
• Excess sweating
• Flushing
• Gallstones
• Headache
• Hemolytic anemia
• Increase in lymphocytes in the blood (lymphocytosis)
• Increase in monocytes in the blood (monocytosis)
• Increase in white blood cells (leukocytosis)
• Increased alkaline phosphatase or bilirubin
• Increased creatinine
• Itching
• Loss of appetite
• Low levels of lymphocytes in the blood (lymphopenia)
• Low platelet count (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Nausea
• Overactive reflexes
• Pain or swelling in your tongue
• Phlebitis
• Prolonged or decreased prothrombin time (PT)
• Renal stones
• Serum sickness
• Severe allergic reaction (anaphylaxis)
• Sugar in the urine
• Upset stomach
• Urinary casts
• Vaginal itching or discharge (vaginitis)
• Vomiting
• Vomiting
• Yeast infection (candidiasis)
• Yellowing skin and eyes (jaundice)

Postmarketing side effects of ceftriaxone reported include:

• Pancreatitis, stomatitis and swollen tongue
• Urinating less than usual, ureteric obstruction, post-renal acute renal failure
• Exanthema, allergic dermatitis, hives, swelling (edema); acute generalized exanthematous pustulosis (AGEP) and isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis)
• Convulsions

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Ceftriaxone has no known severe interactions with other drugs.

Severe interactions of ceftriaxone include:

• calcium acetate
• calcium carbonate
• calcium chloride
• calcium citrate
• calcium gluconate

Serious interactions of ceftriaxone include:

• argatroban
• BCG vaccine live
• bivalirudin
• cholera vaccine
• dalteparin
• enoxaparin
• fondaparinux
• heparin
• lepirudin
• tinzaparin
• typhoid vaccine live
• warfarin

Moderate interactions of ceftriaxone include:

• bazedoxifene/conjugated estrogens
• chloramphenicol
• demeclocycline
• dienogest/estradiol valerate
• doxycycline
• erythromycin base
• erythromycin ethylsuccinate
• erythromycin lactobionate
• erythromycin stearate
• minocycline
• probenecid
• sodium picosulfate/magnesium oxide/anhydrous citric acid
• tetracycline
• warfarin

Mild interactions of ceftriaxone include:

• choline magnesium trisalicylate
• furosemide
• rose hips
• willow bark

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains ceftriaxone. Do not take Rocephin if you are allergic to ceftriaxone or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity; hyperbilirubinemic neonates, particularly those who are premature; neonates under 28 days if they receive calcium-containing intravenous (IV) products.
• Intravenous administration of ceftriaxone solutions containing lidocaine.
• Lidocaine contraindications if lidocaine solution used as solvent with ceftriaxone for intramuscular injection.
• Concomitant calcium-ceftriaxone administration:
• Risk of fatal calcium-ceftriaxone precipitant formation in lungs and kidneys of term and preterm neonates
• Infants under 28 days: Do not give any calcium-containing IV drugs or products within 48 hours of ceftriaxone (within 5 days if neonate is under 10 days, per Health Canada)
• Infants over 28 days: Calcium may be given in sequence after ceftriaxone once infusion line has been flushed, but not simultaneously in same bag or line (chemically incompatible)

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Ceftriaxone?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Ceftriaxone?"

Cautions

• 10-g pharmacy bulk package should not be used for direct infusion
• Immune-mediated hemolytic anemia reported; if patient develops anemia while on ceftriaxone, stop antibiotic until etiology determined; severe hemolytic anemia, including fatalities, reported in both adults and children
• May increase INR, especially in nutritionally deficient patients, hepatic or renal disease or prolonged treatment
• Dosage must be adjusted in severe renal insufficiency (high dosages may cause central nervous system [CNS] toxicity)
• Superinfections and promotion of nonsusceptible organisms may occur with prolonged use or repeated therapy
• Use with caution in patients with history of penicillin allergy
• Use with caution in patients with history of gastrointestinal (GI) disease, especially colitis
• Use with caution in breastfeeding women; drug may displace bilirubin from albumin-binding sites, increasing risk of kernicterus
• Abnormal gallbladder sonograms reported, possibly the result of ceftriaxone-calcium precipitates; discontinue if signs or symptoms of gallbladder disease occur
• Ceftriaxone-calcium precipitates in urinary tract observed in patients receiving ceftriaxone; may be detected as sonographic abnormalities; patients may be asymptomatic or may develop symptoms of urolithiasis, and ureteral obstruction and post-renal acute renal failure; appears to be reversible upon discontinuation of therapy and institution of appropriate management; ensure adequate hydration; discontinue therapy in patients who develop signs and symptoms suggestive of urolithiasis, oliguria or renal failure and/or the sonographic findings
• Clostridium difficile-associated diarrhea (CDAD reported with use of nearly all antibacterial agents, including ceftriaxone; If CDAD suspected or confirmed, may consider discontinuing ongoing antibacterial use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation
• Pancreatitis secondary to biliary obstruction reported rarely; use with caution in patients with gallbladder, biliary tract, liver, or pancreatic disease and patients with history of penicillin hypersensitivity
• Use with caution in patients with history of gastrointestinal (GI) disease (e.g., colitis)

Pregnancy and Lactation

• Ceftriaxone may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk
• Ceftriaxone enters breast milk in low concentrations. Use with caution in breastfeeding women. Ceftriaxone may displace bilirubin from albumin-binding sites, increasing the risk of kernicterus.