Cravit/Cravit IV

Cravit/Cravit IV

levofloxacin

Manufacturer:

Daiichi

Marketer:

Kalbe Farma
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Adults (≥18 yr) w/ mild, moderate & severe infections caused by susceptible strains of designated microorganisms: Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial & community-acquired pneumonia, chronic bacterial prostatitis, complicated skin & skin structure infections (SSSI), complicated UTI, acute pyelonephritis.
Dosage/Direction for Use
Patient w/ normal renal function CrCl >80 mL/min 250-750 mg orally every 24 hr. 250-500 mg by slow infusion over 60 min every 24 hr or 750 mg by slow infusion over 90 min every 24 hr. Community acquired pneumonia 500 mg every 24 hr for 7-14 days or 750 mg every 24 hr for 5 days. Nosocomial pneumonia 750 mg every 24 hr for 7-14 days. Acute bacterial sinusitis 500 mg every 24 hr for 7-14 days or 750 mg every 24 hr for 5 days. Acute bacterial exacerbation of chronic bronchitis 500 mg every 24 hr for 7 days or 750 mg every 24 hr for 3-5 days. Chronic bacterial prostatitis 500 mg every 24 hr for 28 days. Complicated SSSI, UTI & acute pyelonephritis 250-750 mg once daily for 7-14 days depending on the severity of the disease. Patient w/ impaired renal function CrCl >50 mL/min 250 or 500 mg/24 hr, CrCl 50-20 mL/min Initially 250 mg then 125 mg/24 hr or 500 mg then 250 mg/24 hr, CrCl 19-10 mL/min Initially 250 mg then 125 mg/48 hr or 500 mg then 125 mg/24 hr, CrCl <10 mL/min including hemodialysis & continuous ambulatory peritoneal dialysis Initially 250 mg then 125 mg/48 hr or 500 mg then 125 mg/24 hr.
Administration
May be taken with or without food: Ensure adequate fluid intake.
Contraindications
Hypersensitivity to levofloxacin, quinolones. Epilepsy, history of tendon disorder related to fluoroquinolone administration. Pregnancy & breast feeding women. Childn or growing adolescent.
Special Precautions
Not for IM, intrathecal, intraperitoneal, or SC administration. Avoid rapid or bolus IV infusion. Maintain adequate hydration. Excessive exposure to sunlight should be avoided. Patients w/ a known or suspected CNS disorder that may predispose to seizures or lower seizure threshold. Careful monitoring of blood glucose is recommended. Discontinue use if hypoglycemic reaction, phototoxicity, tendon pain, inflammation or rupture occurs. Periodic assessment of renal, hepatic & hematopoietic function. Antacids containing Mg or Al, as well as sucralfate, Fe & multivit prep w/ Zn should be taken at least 2 hr before or after levofloxacin administration. Discontinue use at the first sign of skin rash, hives or other skin reactions, rapid heartbeat, difficulty in swallowing or breathing, angioedema, or other symptoms of allergic reaction. Pseudomembranous colitis. May impair ability to drive & operate machinery due to dizziness, lightheadedness. Renal insufficiency.
Adverse Reactions
Diarrhea, nausea, vaginitis, flatulence, pruritus, rash, abdominal pain, genital moniliasis, dizziness, dyspepsia, insomnia, taste perversion, vomiting, anorexia, anxiety, constipation, edema, fatigue, headache, increased sweating, leukorrhea, malaise, nervousness, sleep disorders, tremor, urticaria.
Drug Interactions
Decreased absorption by antacids containing Al or Mg & drugs containing Fe. Increased risk of CNS stimulation & convulsive seizures w/ NSAIDs. Disturbances of blood glucose w/ antidiabetic agents. May give false negative result in bacteriological diagnosis of TB. May enhance effects of warfarin.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cravit IV infusion 750 mg/150 mL
Packing/Price
(Flexy bag) 1's (Rp350,000/kantung infus)
Form
Cravit IV infusion 500 mg/100 mL
Packing/Price
(flexy bag) 1's (Rp255,000/kantung infus)
Form
Cravit FC tab 500 mg
Packing/Price
10's (Rp390,000/pak)
Form
Cravit FC tab 250 mg
Packing/Price
10's (Rp250,000/pak)
Form
Cravit FC caplet 750 mg
Packing/Price
10's (Rp440,000/pak)
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