Zetaro 600 mg/vial

INDICATIONS

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram positive and Gram negative microorganisms- Staphylococcus aureus (including methicillin-susceptible and resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae ... Read moreAcute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram positive and Gram negative microorganisms- Staphylococcus aureus (including methicillin-susceptible and resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca.Community-Acquired Bacterial Pneumonia (CABP) caused by susceptible isolates of the following Gram positive and Gram negative microorganisms- Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli.

PHARMACOLOGY

Ceftaroline is a cephalosporin with activity against Gram-positive and Gram-negative bacteria. In vitro studies have shown that ceftaroline is bactericidal, due to inhibition of bacterial cell wall synthesis by binding to penicillin binding proteins (PBPs). Ceftaroline is also active against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-nonsusceptible Streptococcus pneumoniae (PNSP) due to its affinity for the altered PBPs found in these organisms.

DOSAGE & ADMINISTRATION

The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.



Indications
Age Range
Dosage
Infusion Time
Duration


Acute Bacterial Skin and Skin Structure Infections
18 years and older
600 mg every 12 hours
5 to 60 minutes
5 to 14 days


≥2 years to <18 years (>33 kg)
600 mg every 12 hours
5 to 60 minutes
5 to 14 days


≥2 years to <18 years (≤33kg)
12 mg/kg every 8 hours
5 to 60 minutes
5 to 14 days


2 months to <2 years
8 mg/kg every 8 hours
5 to 60 minutes
5 to 14 days


0 to <2 months
6 mg/kg every 8 hours
30 to 60 minutes
5 to 14 days


Community Acquired BacterialPneumonia
18 years and older
600 mg every 12 hours
5 to 60 minutes
5 to 14 days


≥2 years to <18 years (>33 kg)
600 mg every 12 hours
5 to 60 minutes
5 to 14 days


≥2 years to <18 years (≤33kg)
12 mg/kg every 8 hours
5 to 60 minutes
5 to 14 days


2 months to <2 years
8 mg/kg every 8 hours
5 to 60 minutes
5 to 14 days

INTERACTION

No clinical drug-drug interaction studies have been conducted with Ceftaroline. There is minimal potential for drug-drug interactions between Ceftaroline and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

SIDE EFFECTS

The common side effects include diarrhea, nausea, vomiting, abdominal pain, headache, dizziness, rash, pruritus, increased transaminases, phlebitis, pyrexia and infusion site reactions (erythema, phlebitis, pain). The uncommon side effects are anemia, leucopenia, thrombocytopenia, hypersensitivity/anaphylaxis, urticaria, Clostridium difficile colitis, prolonged prothrombin time, increased blood creatinine; and rarely eosinophilia.

PREGNANCY & LACTATION

No clinical data on pregnancy is available for Ceftaroline. Animal studies with Ceftaroline fosamil do not indicate harmful effects with respect to fertility, pregnancy, parturition or postnatal development. Ceftaroline should not be used during pregnancy unless clearly necessary and only if the potential benefit outweighs the possible risk. It is not known whether Ceftaroline is excreted in human milk, but because many beta-lactams are excreted in breast milk, women who are breast-feeding should be treated with Ceftaroline only if clearly indicated. Interruption of breast-feeding is recommended.

PRECAUTIONS & WARNINGS

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

USE IN SPECIAL POPULATIONS

Use in pediatric patients: Safety and effectiveness of Ceftaroline 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 Ceftaroline in pediatric patients below the age of 2 months for the treatment of CABP have not been established as no data are available.Renal Impairment: Dosage adjustment is required in adult patients with moderate (CrCl >30 to ≤50 ml/min) or severe (CrCl ≥15 to ≤30 ml/min) renal impairment and in patients with end-stage renal disease (ESRD – defined as CrCl<15 ml/min), including patients on hemodialysis (HD). There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl <50 ml/min.Hepatic Insufficiency: The pharmacokinetics of Ceftaroline in patients with hepatic impairment have not been established. As Ceftaroline does not appear to undergo significant hepatic metabolism, the systemic clearance of Ceftaroline is not expected to be significantly affected by hepatic impairment.

THERAPEUTIC CLASS

Fifth generation Cephalosporins

STORAGE CONDITIONS

Prior to reconstitution, do not store Ceftaroline Fosamil powder for infusion above 30°C and should be used immediately after reconstitution. The diluted solution in the infusion bottle should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2° to 8°C Keep away from light and out of the reach of children.