Ceftaroline fosamil

What is Ceftaroline fosamil?

• Ceftaroline fosamil (Teflaro) is a cephalosporin antibacterial used for the treatment of Acute bacterial skin and skin structure infections (ABSSSI),Community-acquired bacterial pneumonia (CABP).

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What are the uses of this medicine?

Ceftaroline fosamil (Teflaro) is used for the treatment of the following infection caused by designated susceptible bacteria:

• Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age).
• Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older.

How does this medicine work?

• Ceftaroline is a cephalosporin antibacterial drug.
• Ceftaroline is a cephalosporin antibacterial drug with in vitro activity against Gram-positive and gram-negative bacteria.
• The bactericidal action of ceftaroline is mediated through binding to essential penicillin-binding proteins (PBPs).
• Ceftaroline is bactericidal against S. aureus due to its affinity for PBP2a and against Streptococcus pneumoniae due to its affinity for PBP2x.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Teflaro.

Is this medicine FDA approved?

• Ceftaroline received approval from the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin infections on 29 October 2010.

How should this medicine be used?

Recommended dosage: Recommended Dosage in Adult Patients:

• The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥ 18 years of age.

Dosage of Teflaro by Indication in Adults

Indication	Dosage	Frequency	Infusion Time	Recommended Duration of Treatment
ABSSSI	600 mg	Every 12 hours	5 to 60 minutes	5-14 days
CABP	600 mg	Every 12 hours	5 to 60 minutes	5-7 days

Recommended Dosage in Pediatric Patients:

• The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child.

Pediatric Patients 2 Months of Age and Older:

Dosage of Teflaro by Indication in Pediatric Patients 2 Months of Age and Older

Indication	Age Range	Dosage and Frequency	Infusion time	Recommended Duration of Treatment
ABSSSI or CABP	2 months to < 2 years	8 mg/kg every 8 hours	5 to 60 minutes	5-14 days
	> 2 years to < 18 years (< 33 kg)	12 mg/kg every 8 hours

Pediatric Patients Less Than 2 Months of Age:

Dosage of Teflaro in Pediatric Patients less Than 2 Months of Age

Indication	Age Range	Dosage and Frequency	Infusion time	Recommended Duration of Treatment
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)	0* to < 2 months	6 mg/kg every 8 hours	30 to 60 minutes	5-14 days

Administration:

• For pediatric patients 2 months of age and older, Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes.
• Teflaro is administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age.
• Teflaro dosing regimen is only recommended for patients with ABSSSI.

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

This medicine is available in fallowing doasage form:

• As Injection: 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-dose 20 mL vials. The powder is constituted and further diluted for intravenous injection.

This medicine is available in fallowing brand namesː

• Teflaro

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• rash
• vomiting
• pyrexia

What special precautions should I follow?

• Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Teflaro. If a hypersensitivity reaction occurs, discontinue Teflaro.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Teflaro. Evaluate if diarrhea occurs.
• Neurological adverse reactions have been reported in patients treated with cephalosporins, including Teflaro. If neurological adverse reactions occur, consider discontinuing Teflaro or making appropriate dosage adjustments in patients with renal impairment.
• Direct Coombs’ test seroconversion has been reported with Teflaro. If anemia develops during or after therapy, a diagnostic workup for drug-induced hemolytic anemia should be performed and consideration given to discontinuation of Teflaro.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• renal impairment
• neurological sequelae
• encephalopathy

Management of overdosage:

• In the event of overdose, Teflaro should be discontinued and general supportive treatment given.
• Ceftaroline can be removed by hemodialysis.
• However, no information is available on the use of hemodialysis to treat overdosage.

Can this medicine be used in pregnancy?

• There are no adequate studies with Teflaro in pregnant women that informed any drug associated risks.

Can this medicine be used in children?

• The safety and effectiveness of Teflaro in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age).
• The safety and effectiveness of Teflaro in the treatment of CABP have been established in the age groups 2 months to less than 18 years old.
• Safety and effectiveness of Teflaro in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established.
• Safety and effectiveness of Teflaro in pediatric patients below the age of 2 months for the treatment of CABP have not been established as no data are available.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• CEFTAROLINE FOSAMIL

Inactive Ingredients:

• ARGININE

Who manufactures and distributes this medicine?

Distributed by: Allergan USA, Inc. Madison, NJ Teflaro® is a registered trademark of Allergan Sales, LLC

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

• Teflaro vials (unreconstituted) should be stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF).

• Dailymed label info on Ceftaroline fosamil
• FDA Ceftaroline fosamil