Ceftaroline

Pregnancy Category: B

Lactation: unknown whether distributed in breast milk, caution advised

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.

IV Compatibilities

Solution: 0.9% NaCl; D5W; 2.5% dextrose/0.45% NaCl; Lactated Ringer’s solution

IV Preparation

Reconstitute vial by adding 20 mL sterile water for injection, 0.9% NaCl, D5W, or lactated ringer’s injection; mix gently and check to ensure all powder has dissolved completely

Resulting approximate concentrations: 400 mg vial (20 mg/mL); 600 mg vial (30 mg/mL)

Color of solution ranges from clear to light-to-dark yellow depending on concentration and storage conditions

Dilution of the constituted solution

• Withdraw total volume from vial and add to 50-250 mL of 0.9% NaCl, D5W, 2.5% dextrose/0.45% NaCl, or lactated ringer’s solution; use the same diluent that was used for reconstituting (unless sterile water for injection was used)

Dilution of the constituted solution in 50 mL infusion bags

• Preparation of 600 mg dose in 50 mL infusion bag (for adult patients): withdraw 20 mL from bag before adding constituted drug; resulting concentration ~12 mg/mL
• Preparation of 400 mg dose in 50 mL infusion bag (for adult and pediatric patients weighing >33 kg): Withdraw 20 mL from bag before adding constituted drug; resulting concentration ~8 mg/mL

Preparation for children weighing ≤33 kg

• Preparation of dose in infusion bag for pediatric patients weighing ≤33 kg: Amount of solution withdrawn from the constituted vial for dilution in the infusion bag will vary according to the weight and age of the child; infusion solution concentration should not exceed 12 mg/mL ceftaroline

IV Administration

Administer IV injection via volumetric infusion pump

Infuse over 5-60 minutes

Storage

Unreconstituted vials: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

Stability of diluted drug in infusion bag or 50-mL bag

• Room temperature: 6 hr
• Refrigerated 2-8°C (36-46°F): 24 hr

Ceftaroline is part of the drug class:

• Other cephalosporins and penems

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ceftaroline, there are no specific foods that you must exclude from your diet when receiving this medication.

The ceftaroline dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function

The recommended dose for ceftaroline in adults is 600 mg twice a day.

Ceftaroline is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Ceftaroline is used to treat skin infections or pneumonia caused by bacteria.

Ceftaroline may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Applies to ceftaroline: intravenous powder for injection

General

The most common side effects reported in adults using this drug were diarrhea, headache, nausea, pruritus, and rash.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, constipation, vomiting, abdominal pain
Uncommon (0.1% to 1%): Clostridium difficile colitis
Frequency not reported: C difficile-associated diarrhea, dyspepsia[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, generalized pruritus
Uncommon (0.1% to 1%): Urticaria[Ref]

In clinical trials using this drug every 12 hours or every 8 hours, rash was common; however, in a subgroup of Asian patients using this drug every 8 hours, rash was very common (18.5%).[Ref]

Metabolic

Common (1% to 10%): Hypokalemia
Frequency not reported: Decreased appetite, hyperglycemia, hyperkalemia[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis, hypertension, increased blood pressure
Frequency not reported: Bradycardia, palpitations[Ref]

Hepatic

Common (1% to 10%): Increased transaminases, increased ALT
Frequency not reported: Abnormal hepatic function, hepatitis, increased AST[Ref]

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterials.[Ref]

Uncommon (0.1% to 1%): Hypersensitivity (e.g., urticaria, lip and face swelling), anaphylaxis[Ref]

Renal

Uncommon (0.1% to 1%): Increased blood creatinine
Frequency not reported: Renal failure[Ref]

Hematologic

In clinical trials, direct antiglobulin test seroconversion was reported in 10.7% of adult patients using this drug every 12 hours (600 mg infused over 1 hour every 12 hours) and in 32.3% of those using this drug every 8 hours (600 mg infused over 2 hours every 8 hours). Seroconversion from negative to positive direct Coombs test result was reported in 17.9% of children using this drug.

Agranulocytosis and leukopenia have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Direct antiglobulin test/Coombs test seroconversion (up to 32.3%), positive direct Coombs test
Uncommon (0.1% to 1%): Anemia, leukopenia, neutropenia, thrombocytopenia, prolonged prothrombin time, prolonged activated partial thromboplastin time, increased INR
Rare (0.01% to 0.1%): Agranulocytosis
Frequency not reported: Eosinophilia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Convulsion[Ref]

Other

Common (1% to 10%): Pyrexia, infusion site reactions (e.g., erythema, phlebitis, pain)
Frequency not reported: Asthenia[Ref]

Genitourinary

Frequency not reported: Urinary tract infection[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Some side effects of ceftaroline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

600 mg via IV infusion every 12 hours

Duration of therapy:
-Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
-Community-acquired bacterial pneumonia (CABP): 5 to 7 days

Uses:
-For the treatment of ABSSSI due to susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, and K oxytoca
-For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K pneumoniae, K oxytoca, and E coli

LactMed Record Number

823

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.