Ceftalin IV Injeciton
Ceftaroline fosamil
600mg
Eskayef Pharmaceuticals Ltd.
| Pack size | 1's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 3500.00 AED |
Indications
Ceftalin IV Injeciton is used for:
Community-acquired pneumonia, Complicated skin and skin structure infections
Adult Dose
Community-Acquired Bacterial Pneumonia
600 mg IV every 12 hours; infuse over 5-60 minutes for 5-7 days
Skin & Skin Structure Infections
Indicated for acute bacterial skin and skin structure infections, including MRSA
600 mg IV every 12 hours; infuse over 5-60 minutes for 5-14 days
Child Dose
Community-Acquired Bacterial Pneumonia
Indicated in children for treatment of 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 (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli
2 months to <2 years: 8 mg/kg IV every 8 hours for 5-14 days
>2 years to <18 years (<33 kg): 12 mg/kg IV every 8 hours for 5-14 days
>2 years to <18 years (>33 kg): 400 mg every 8 hours OR 600 mg every 12 hours IV for 5-14 days
>18 years: 600 mg IV every 12 hours; infuse over 5-60 minutes for 5-7 days
Skin & Skin Structure Infections
Indicated in children for treatment of 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, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca
0 (Gestational age 34 weeks and older and postnatal age 12 days and older) to 2 months: 6 mg/kg IV every 8 hours for 5-14 days
2 months to <2 years: 8 mg/kg IV every 8 hours for 5-14 days
>2 years to <18 years (<33 kg): 12 mg/kg IV every 8 hours for 5-14 days
>2 years to <18 years (>33 kg): 400 mg every 8 hours OR 600 mg every 12 hours for IV for 5-14 days
>18 years: 600 mg IV every 12 hours; infuse over 5-60 minutes for 5-14 days
Renal Dose
Renal impairment
CrCl 31-50 mL/min: 400 mg IV q12hr
CrCl 15-30 mL/min: 300 mg IV q12hr
ESRD (including hemodialysis): 200 mg IV q12hr
Administration
Reconstitution
Add 20 mL of sterile water for inj to a vial containing 400 or 600 mg to provide a 20 or 30 mg/mL soln, respectively. Further dilute reconstituted soln in 50-250 mL (based on patient’s volume requirement) of compatible soln to a final concentration not exceeding 12 mg/mL.
IV Administration
Administer IV injection via volumetric infusion pump
Infuse over 5-60 minutes
Contra Indications
Hypersensitivity to cephalosporins, immediate and severe hypersensitivity to other β-lactam antibacterials (e.g. penicillins, carbapenems).
Precautions
Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Teflaro. If a hypersensitivity reaction occurs, discontinue Ceftaroline.
Clostridioides 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.
Direct Coombs’ test seroconversion has been reported with Ceftaroline. If anemia develops during or after therapy, a diagnostic workup for druginduced hemolytic anemia should be performed and consideration is given to discontinuation of Ceftaroline.
Pregnancy-Lactation
Pregnancy
No data in pregnant women are available
Animal studies
In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation
In rabbits exposed to ceftaroline during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity
Lactation
No data are available regarding presence in human milk, or the effects on breastfed infants or on milk production
Interactions
Contraindicated (2)
BCG intravesical live
typhoid vaccine live
Serious (2)
cholera vaccine
microbiota oral
Adverse Effects
Side effects of Ceftaroline fosamil :
1-10%
Diarrhea (5%)
Nausea (4%)
Rash (3%)
Constipation (2%)
Vomiting (2%)
Increased transaminases (2%)
Hypokalemia (2%)
Phlebitis (2%)
Pyrexia (3%)
Pruritus (<3%)
Mechanism of Action
Beta-lactam cephalosporin with activity against aerobic and anaerobic gram-positive and aerobic gram-negative bacteria
Demonstrates activity in vivo against resistant methicillin-resistant Staphylococcus aureus (MRSA) strains and in vitro against vancomycin-resistant and linezolid-resistant S aureus
Note
Ceftalin 600mg IV Injeciton manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Ceftaroline fosamil. Ceftalin is availble in Bangladesh.
Farmaco BD drug index information on Ceftalin IV Injeciton is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.