Composition
Each film coated scored tablet contains: 500 mg or 250 mg levofloxacin.
Properties
Levoxin® (levofloxacin) is a new generation fluoroquinolone with enhanced antimicrobial activity and tissue penetration. It is the levorotatory isomer of ofloxacin and is twice as active as ofloxacin.
Levoxin® is rapidly and completely absorbed after oral administration with a bioavailability reaching up to 99% after oral dose. Its absorption is not affected by food intake. Therefore, it can be administered without regard to food.
Levoxin® has a wide distribution into body tissues and fluids especially into blister fluid, lung tissues, bile, gall bladder, prostate, testis, epididymis, semen and uterine tissues. About 25% of the oral dose is bound to plasma protein.
Levoxin® undergoes minimal hepatic metabolism, and about 90% of the oral dose is excreted as unchanged drug in the urine with an elimination half-life of about 8 hours.
Antimicrobial activity
Levoxin® has a potent bactericidal activity by inhibiting DNA gyrase enzyme which is required for DNA replication, transcription, repair and recombination.
Unlike other quinolones, Levoxin® has an excellent activity against Gram-positive organisms, including streptococcal spp. and anaerobes ; in addition to most Gram-ve organisms and atypical bacteria.
Aerobic Gram positive bacteria
Different species of Staphylococci e.g.,
- Staph. aureus ( even penicillinase producer or methicillin resistant)
- Staph. epidermidis
- Staph. saprophyticus
Different species of Streptococci e.g.,
- S. pneumoniae (even penicillin resistant species)
- S. pyogenes
- S. viridans
- S. faecalis
Other Gram positive bacteria e.g.,
- Listeria monocytogenes
- Mycobacterium tuberculosis
Aerobic Gram negative bacteri
- Haemophilus influenzae,
- Morganella morganii.
- Legionella pneumophilla
- Providencia spp.
- Klebsiella pneumoniae
- Salmonella spp.
- Escherichia coli
- Proteus mirabilis
- Moraxella catarrhalis
- Shigella spp.
- Neisseria gonorrhoea
- Yersinia spp.
- Pseudomonas aeruginosa
- Enterobacter spp.
Anaerobic bacteria
- Bacteroides fragilis
- Clostridium perfringens
Atypical bacteria
- Chlamydia pneumoniae
- Chlamydia trachomatis
- Mycoplasma pneumoniae
Indications
- Acute maxillary sinusitis
- Acute bacterial exacerbation of chronic bronchitis
- Community acquired pneumonia due to typical or atypical bacteria
- Skin and skin structure infections: e.g., abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections.
- Complicated or uncomplicated urinary tract infections, e.g. Upper UTI: e.g., acute pyelonephritis & Lower UTI: e.g., urethritis, cystitis, prostatitis
Contraindications
- Hypersensitivity to quinolones
- Patients with a history of epilepsy especially those using nonsteroidal anti-inflammatory drugs
- During pregnancy and breast feeding
- Children and adolescent below the age of 18 years
Precautions
- Exposure to excessive sunlight may cause photosensitivity and should be avoided.
- Hypoglycemic reactions may occur rarely in patients using hypoglycemic drugs.
Adverse Reactions
In very rare cases, nausea, diarrhea or sleep disorders may occur.
Dosage
Acute bacterial exacerbation of chronic bronchitis: 500 mg once daily for 7 days.
Community acquired pneumonia: 500 mg once daily for 7-14 days.
Acute maxillary sinusitis: 500 mg once daily for 10-14 days.
Skin and skin structure infections: 500 mg once daily for 7-10 days
Complicated UTI: 250 mg once daily for 10 days.
Patients with impaired renal function
| Infection | Creatinine clearance | Initial dose | Subsequent dose |
| Respiratory tract and skin infections | 49-20 ml/min | 500 mg. | 250 mg once daily. |
| Respiratory tract and skin infections | 19-10 ml/min | 500 mg. | 250 mg every other day. |
| Urinary tract infections |
19-10 ml/min | 250 mg | 250 mg every other day. |
N.B. :
- No dose adjustment is needed above these figures.
- Levoxin® is not removed by dialysis
- No dose reduction is required in patients with impaired hepatic function.
Drug interactions
Unlike other quinolones, Levoxin® has no significant drug interactions with theophylline, warfarin, digoxin, cyclosporine.
Antacid and metal cations, e.g., Iron, zinc, may interfere with the absorption of Levoxin®, therefore these preparations should be taken 2 hours before or 2 hours after Levoxin® administration.
How Supplied
Levoxin® 500 mg or 250 mg: Strips of 5 scored tablets in packs of 1 strip.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: J01MA12