Absolute Contraindications: Severe Allergies
For any medication, a known serious hypersensitivity is the primary reason for a contraindication. For ceftaroline (marketed as Teflaro®), the manufacturer's labeling explicitly states that it is contraindicated in patients with a known serious hypersensitivity to the drug or to other members of the cephalosporin class of antibiotics. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported. If a patient has a history of an allergic reaction to ceftaroline, they should not receive it.
Cross-Sensitivity with Other Beta-Lactam Antibiotics
Patients with known allergies to other beta-lactam antibiotics, such as penicillins or carbapenems, must be treated with extreme caution. The possibility of cross-sensitivity between beta-lactams is well-established. Before starting ceftaroline therapy, a thorough medical history should be taken to determine if a patient has had any previous hypersensitivity reactions to these related drugs. If a patient has a history of penicillin allergy, a healthcare provider will need to weigh the risks carefully.
Signs of a Serious Allergic Reaction
Patients and caregivers should be vigilant for signs of a serious allergic reaction, which warrant immediate medical attention. These symptoms may include:
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or wheezing
- Hives, rash, or blistering skin
- Rapid heartbeat
- Nausea or vomiting
- Dizziness or fainting
Relative Contraindications and Precautions
While not absolute contraindications, several medical conditions require significant precaution and dose adjustment when administering ceftaroline. Healthcare providers must carefully evaluate the risk-benefit ratio for these individuals.
Renal Impairment
Ceftaroline is eliminated primarily through the kidneys. For patients with moderate to severe renal impairment, or end-stage renal disease, dose adjustments are necessary to prevent the accumulation of the drug and potential toxicity. In elderly patients, who are more likely to have age-related decreases in kidney function, extra caution and renal function monitoring are advised.
History of Colitis
Antibiotics, including ceftaroline, can alter the normal flora of the colon, potentially leading to the overgrowth of Clostridioides difficile. This can cause C. difficile-associated diarrhea (CDAD), which can range in severity from mild diarrhea to fatal colitis. Patients with a history of severe diarrhea, especially with a link to prior antibiotic use, should be treated with caution.
Seizure Disorders
Neurological side effects, including seizures, have been reported in some individuals treated with ceftaroline. Patients with a known history of seizures or other central nervous system disorders should be monitored closely during treatment.
Ceftaroline and Specific Populations
Special considerations apply to certain patient groups where the safety of ceftaroline has not been fully established or where unique risks exist.
Pregnancy
There are no adequate and well-controlled studies of ceftaroline in pregnant women. Animal studies did not show adverse developmental effects, but this data may not translate to humans. Therefore, ceftaroline should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Breastfeeding
It is not known whether ceftaroline is excreted in human milk. Caution should be exercised when administering the drug to nursing mothers, as many medications can pass into breast milk. Some sources, like LactMed, consider cephalosporins acceptable during breastfeeding but advise monitoring the infant for potential side effects.
Pediatrics
Safety and effectiveness in very young pediatric patients have not been fully established. For acute bacterial skin and skin structure infections (ABSSSI), safety data is limited in pediatric patients under 12 days postnatal age and 34 weeks gestational age. For community-acquired bacterial pneumonia (CABP), safety and effectiveness have not been established in patients under 2 months of age.
Drug Interactions with Ceftaroline
Patients should inform their healthcare providers of all medications they are taking, as some can interact with ceftaroline. While the drug is not a significant inhibitor or inducer of major cytochrome P450 enzymes, which minimizes many drug-drug interactions, some are noteworthy.
- Live Vaccines: Ceftaroline is known to interact with live vaccines such as BCG intravesical live and typhoid vaccine live. This is because antibiotics can antagonize the effects of these vaccines. Vaccination should be delayed or completed a few days before antibiotic treatment begins.
- Probenecid: Probenecid, a medication often used to treat gout, can increase serum concentrations of ceftaroline by inhibiting its renal clearance. This could potentially increase the risk of toxicity, and close monitoring is recommended if both drugs are prescribed concurrently.
- Anticoagulants: Although less common, there are reported moderate to minor interactions with anticoagulants like warfarin, potentially affecting their efficacy.
Comparison of Patient Factors for Ceftaroline
| Factor | Guideline for Ceftaroline Use |
|---|---|
| Known Hypersensitivity | CONTRAINDICATED. Do not use. A serious or fatal allergic reaction can occur. |
| History of Penicillin Allergy | Use with caution. Risk of cross-sensitivity exists. Monitor closely for allergic reactions. |
| Renal Impairment | Use with caution, dose adjustment required. Monitor renal function and drug levels. |
| Pregnancy | Use with caution, only if benefits outweigh risks. Limited human data available. |
| Breastfeeding | Use with caution, monitor infant for side effects. Limited data on excretion in breast milk. |
| History of Colitis | Use with caution, monitor for severe diarrhea. Risk of CDAD exists. |
| Seizure Disorder | Use with caution, monitor for neurological symptoms. Risk of seizures is reported. |
| Concomitant Live Vaccines | CONTRAINDICATED concurrently. Delay vaccination or finish antibiotic course beforehand. |
Conclusion
While ceftaroline is a valuable antibiotic for treating serious infections like MRSA-related skin infections and community-acquired pneumonia, it is not suitable for everyone. The most critical contraindication is a known serious allergy to ceftaroline or other cephalosporin antibiotics, with an additional high-risk factor being a documented penicillin allergy due to the potential for cross-reactivity. Furthermore, patient safety dictates that individuals with renal impairment, a history of colitis, seizure disorders, or those who are pregnant or breastfeeding require careful consideration and monitoring by a healthcare professional. Ensuring all relevant medical history, allergies, and concurrent medications are communicated to the prescribing doctor is the most important step for patients to take to avoid dangerous adverse reactions. For more in-depth clinical information, refer to the official FDA Teflaro® label.
