Ceftriaxone dosing, indications, interactions, adverse effects, and more (original) (raw)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

powder for injection

Intra-abdominal Infections

Complicated, mild-to-moderate, community acquired: 1-2 g/day IV in single daily dose or divided q12hr for 4-7 days, in combination with metronidazole

Acute Bacterial Otitis Media

50 mg/kg IM once

Persistent or treatment failures: 50 mg/kg IV/IM for 3 days

Pelvic Inflammatory Disease

250 mg IM as single dose with doxycycline, with or without metronidazole for 14 days

Prosthetic Joint Infection

2 g IV q24hr for 2-6 weeks; continue treatment until clinical improvement observed and patient is afebrile for 48-72 hr

Meningitis

2 g IV q12hr for 7-14 days

Acute Uncomplicated Pyelonephritis

1-2 g IV qDay

Surgical Prophylaxis

Prophylaxis of surgical infection

1 g IV 0.5-2 hours before procedure

Uncomplicated Gonococcal Infections

Indicated for uncomplicated gonococcal infection of pharynx, cervix, urethra, or rectum

Weight <150 kg: Ceftriaxone 500 mg IM once

Weight ≥150 kg: Ceftriaxone 1,000 mg IM once

If chlamydial infection has not been excluded, add doxycycline 100 mg BID x 7 days, or if pregnant give azithromycin 1,000 mg

Update to CDC’s Treatment Guidelines for Gonococcal Infection, 2020

Sexual assault

Septic/toxic Shock (Off-label)

2 g IV once daily; with clindamycin for toxic shock

Acute Epididymitis (Off-label)

Sexually transmitted chlamydia and gonorrhea

Sexually transmitted chlamydia, gonorrhea, and enteric organisms

Enteric organisms

Skin and Soft Necrotizing Infection (Off-label)

Due to Aeromonas hydrophilia: 1-2 g IV qDay in combination with doxycycline

Due to Vibrio vulnificus; 1 g IV qDay in combination with doxycycline

Continue treatment until further debridement not necessary, clinical improvement observed, and patient is afebrile for 48-72 hr

Severe Acute Bacterial Rhinosinusitis (Off-label)

Infection requiring hospitalization: 1-2 g IV q12-24hr for 5-7 days

Other Gonococcal Infections (Off-label)

Gonococcal conjunctivitis: 1 g IM once

Disseminated gonococcal infection: 1 g/day IV/IM; continued for at least 24-48 hours after improvement is observed, then continued with cefixime 400 mg PO q12hr to complete at least 1 week of therapy

Gonococcal endocarditis: 1-2 g IV q12hr for 4 weeks

Gonococcal meningitis: 1-2 g IV q12hr for 10-14 days

Acute epididymitis: 250 mg IM once with doxycycline

Dosing Considerations

Susceptible organisms

Dosage Forms & Strengths

injectable solution

powder for injection

Acute Bacterial Otitis Media

50 mg/kg IM in single dose; not to exceed 1 g

Epiglottis (Off-label)

100 mg/kg/day IV on first day; follow with 50 mg/kg on day 2 or 75 mg/kg qDay for 10-14 days

Meningitis

100 mg/kg/day IV/IM in single daily dose or divided q12hr for 7-14 days; not to exceed 4 g/day

Serious Infections Other Than Meningitis

50-75 mg/kg/day IV/IM divided q12hr for 7-14 days

Skin/Skin Structure Infections

>12 years: 1-2 g/day IV/IM in single daily dose or divided q12hr for 7-14 days, depending on type and severity of infection

Gonococcal Infections

Neonates

Children

Interactions

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Adverse Effects

>10%

Induration after IM injection (5-17%)

1-10%

Eosinophilia (6%)

Thrombocytosis (5%)

Diarrhea (3%)

Elevated hepatic transaminases (3%)

Leukopenia (2%)

Rash (2%)

Increased blood urea nitrogen (BUN) (1%)

Induration at IV site (1%)

Pain (1%)

<1%

Agranulocytosis

Anaphylaxis

Anemia

Basophilia

Bronchospasm

Candidiasis

Chills

Diaphoresis

Dizziness

Dysgeusia

Flushing

Gallstones

Glycosuria

Headache

Hematuria

Hemolytic anemia

Increased alkaline phosphatase or bilirubin

Increased creatinine

Jaundice

Leukocytosis

Lymphocytosis

Lymphopenia

Monocytosis

Nausea

Neutropenia

Phlebitis

Prolonged or decreased prothrombin time (PT)

Pruritus

Renal stones

Serum sickness

Thrombocytopenia

Urinary casts

Vaginitis

Vomiting

Postmarketing reports

Pancreatitis, stomatitis and glossitis

Oliguria, ureteric obstruction, post-renal acute renal failure

Exanthema, allergic dermatitis, urticaria, 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)

Neurological adverse reactions, including encephalopathy, seizures, myoclonus, and non-convulsive status epilepticus

Warnings

Contraindications

Documented hypersensitivity; hyperbilirubinemic neonates, particularly those who are premature; neonates <28 days if they receive calcium-containing 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

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 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 GI disease, especially colitis

Use with caution in breast-feeding 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

Inform patients that use of local anesthetics may cause methemoglobinemia, which must be treated promptly; advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue

Use with caution in patients with history of GI disease (eg, colitis)

Neurological adverse reactions

Pregnancy & Lactation

Pregnancy

Available data from published prospective cohort studies, case series, and case reports over several decades in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes

Animal data

Lactation

Data from published literature report that ceftriaxone is present in human milk; there are no data on effects of drug on breastfed child or on milk production

The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and dextrose injection and any potential adverse effects on breastfed child from antibiotic for Injection and dextrose injection or from mother’s underlying condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

Third-generation cephalosporin with broad-spectrum gram-negative activity; has lower efficacy against gram-positive organisms but higher efficacy against resistant organisms; highly stable in presence of beta-lactamases (penicillinase and cephalosporinase) of gram-negative and gram-positive bacteria; bactericidal activity results from inhibiting cell-wall synthesis by binding to 1 or more penicillin-binding proteins; exerts antimicrobial effect by interfering with synthesis of peptidoglycan (major structural component of bacterial cell wall); bacteria eventually lyse because activity of cell-wall autolytic enzymes continues while cell-wall assembly is arrested

Absorption

IM preparation well absorbed

Peak plasma time: 2-3 hr (IM)

Distribution

Distributed throughout body, including gallbladder, lungs, bone, bile, and CSF (higher concentrations achieved when meninges are inflamed); crosses placenta; enters amniotic fluid and breast milk

Protein bound: 85-95%

Vd: 6-14 L

Metabolism

Metabolized in liver

Elimination

Half-life: 5-9 hr (normal hepatic and renal function); 12-16 hr (mild-to-severe renal impairment)

Excretion: Urine (33-67% as unchanged drug), feces

Administration

IV Incompatibilities

Solution: LR (at drug concentrations >10 mg/mL; compatible at 1 mg/mL)

Additive: Aminophylline, clindamycin, linezolid, theophylline, metronidazole (at metronidazole 15 g/L with ceftriaxone 20 g/L; compatible at metronidazole 7.5 g/L with ceftriaxone 10 g/L)

Syringe: Lidocaine (variable)

Y-site: Alatrofloxacin, amphotericin B cholesteryl sulfate, amsacrine, filgrastim, fluconazole, labetalol, pentamidine, vinorelbine, vancomycin

General: Calcium-containing drugs

IV/IM Preparation

Dilutions are stable for 24 hours at room temperature

IV

IM

IV/IM Administration

IV: Infuse intermittently over 30 minutes

IM: Inject deep into large muscle mass

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Patient Handout

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CEFTRIAXONE - INJECTION

(SEF-trye-AX-one)

COMMON BRAND NAME(S): Rocephin

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

HOW TO USE: This medication is given by injection into a muscle or vein as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment. Drink plenty of fluids while using this medication unless your doctor directs you otherwise.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Avoid mixing ceftriaxone with IV fluids that have calcium in them (such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN). Consult your pharmacist for details about the safe use of IV calcium products in infants, children, and adults (see Precautions section). Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.If you are using the frozen pre-mixed solution, thaw the bag at room temperature or in the refrigerator. If the bag is thawed in the refrigerator, let it sit at room temperature at least 1 hour before using. Do not thaw by putting in a water bath or microwaving. After thawing, shake well and squeeze the bag to check for leaks. Discard solution if the bag leaks. Do not re-freeze the solution after thawing.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: Swelling, redness, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, unusual tiredness, symptoms of gallbladder disease (such as stomach/abdominal pain, nausea, vomiting), signs of kidney problems (such as change in the amount of urine), pink/bloody/dark urine, painful/frequent urination, back/side pain, yellowing eyes/skin, uncontrollable movements, confusion, seizures.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.If ceftriaxone is mixed with a numbing medication (such as lidocaine) before injection into a muscle, it may rarely cause a serious blood problem (methemoglobinemia). Get medical help right away if you have any very serious side effects, including: pale/gray/blue skin, fast heartbeat, shortness of breath.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ceftriaxone, tell your doctor or pharmacist if you are allergic to it; or to other antibiotics (such as penicillins, other cephalosporins); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: gallbladder disease, kidney disease, liver disease, stomach/intestinal diseases (such as colitis).Do not give any products by vein that contain calcium (including IV solutions such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN) to a newborn less than 1 month old who is receiving this medication. Doing so can cause serious problems in the vital organs.Ceftriaxone may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using ceftriaxone before having any immunizations/vaccinations.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant before using this medication.This medication passes into breast milk in small amounts and is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: calcium-containing IV fluids.This medication may interfere with certain lab tests (such as certain urine glucose tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, kidney function tests) should be done while you are using this medication. Keep all medical and lab appointments.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2024. Copyright(c) 2024 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Tier Description
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Code Definition
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.