Levin

Levin

levofloxacin

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Mild, moderate, & severe susceptible infections eg, acute bacterial sinusitis (ABS); acute bacterial exacerbation of chronic bronchitis (ABECB); community-acquired & nosocomial pneumonia; complicated skin & skin structure infections (SSSI); mild to moderate uncomplicated SSSI including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections; mild to moderate complicated & uncomplicated UTI; mild to moderate acute pyelonephritis; chronic bacterial prostatitis.
Dosage/Direction for Use
Adult ≥18 yr ABECB 500 mg every 24 hr for 7 days. Community-acquired pneumonia 500 mg every 24 hr for 7-14 days. Nosocomial pneumonia 750 mg every 24 hr for 7-14 days. ABS 500 mg every 24 hr for 10-14 days. Complicated SSSI 750 mg every 24 hr for 7-14 days. Uncomplicated SSSI 500 mg every 24 hr for 7-10 days. Complicated UTI, acute pyelonephritis 250 mg every 24 hr for 10 days. Uncomplicated UTI 250 mg every 24 hr for 3 days. Chronic bacterial prostatitis 500 mg every 24 hr for 28 days. Renal impairment: CrCl 20-49 mL/min ABECB, community-acquired pneumonia, acute maxillary sinusitis, uncomplicated SSSI Initial dose: 500 mg. Subsequent dose: 250 mg every 24 hr. Complicated SSSI Initial dose: 750 mg. Subsequent dose: 750 mg every 48 hr. CrCl 10-19 mL/min ABECB, community-acquired pneumonia, acute maxillary sinusitis, uncomplicated SSSI Initial dose: 500 mg. Subsequent dose: 250 mg every 48 hr. Complicated SSSI Initial dose: 750 mg. Subsequent dose: 500 mg every 48 hr. Complicated UTI, acute pyelonephritis Initial dose: 250 mg. Subsequent dose: 250 mg every 48 hr. Hemodialysis & CAPD ABECB, community-acquired pneumonia, acute maxillary sinusitis, uncomplicated SSSI Initial dose: 500 mg. Subsequent dose: 250 mg every 48 hr. Complicated SSSI Initial dose: 750 mg. Subsequent dose: 500 mg every 48 hr.
Administration
May be taken with or without food: Take at least 2 hr before or after Fe salts, antacids & sucralfate. Ensure adequate fluid intake.
Contraindications
Hypersensitivity to levofloxacin, or other quinolone antibacterials.
Special Precautions
Discontinue immediately at 1st appearance of skin rash, jaundice, or any other sign of hypersensitivity; if patient develops signs & symptoms of hepatitis. Increased risk of tendinitis & tendon rupture. May increase intracranial pressure & CNS stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, & rarely suicidal thoughts or acts; discontinue use if these reactions occur. Patients w/ known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold. Clostridium difficile-associated diarrhea. Discontinue if patient experiences symptoms of neuropathy including pain, burning, tingling, numbness &/or weakness or other alterations of sensation; or if hypoglycemic reaction occurs. Patients w/ known risk factors for QT prolongation eg, congenital long QT syndrome, concomitant use of QT interval prolonging-drugs, uncorrected electrolyte imbalance, elderly, cardiac disease. Exacerbation of myasthenia gravis; avoid in patients w/ known myasthenia gravis history. Vision disorders. Musculoskeletal disorders in ped patients. Blood glucose disturbances including symptomatic hyper- & hypoglycemia. Moderate to severe photosensitivity/phototoxicity reactions; avoid excessive exposure to sun or UV light & discontinue if photosensitivity/phototoxicity occurs. Increased risk of developing drug-resistant bacteria if prescribed in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication. Pregnancy & lactation. Elderly w/ renal impairment.
Adverse Reactions
Nausea, diarrhea, vaginitis, insomnia, abdominal pain, pruritus, dizziness, dyspepsia, rash, genital moniliasis, taste pervasion, vomiting, constipation, fungal infection, genital pruritus, headache, moniliasis, nervousness, rash erythematous, urticaria.
Drug Interactions
Known QT interval prolonging-drugs (eg, class IA & III antiarrhythmics, TCA, macrolides, antipsychotics). May interfere w/ GI absorption w/ chelation agents eg, antacids containing Mg & Al, sucralfate, metal cations (eg, Fe) & multivit prep (eg, Zn). Elevations of prothrombin time of warfarin. Blood glucose disturbances including hyper- & hypoglycemia w/ antidiabetic agents. May increase risk of CNS stimulation & convulsive seizures w/ NSAIDs. Prolonged elimination t½, elevated serum levels & increased AR risk of theophylline. May produce false positive urine screening results for opiates.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Levin FC tab 500 mg
Packing/Price
3 × 10's
Form
Levin FC tab 250 mg
Packing/Price
3 × 10's
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