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 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antimicrobial Agents>
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Ofloxacin

Paul A. Pham Pharm.D. and John G. Bartlett M.D.
10-20-2010

Zambia Specific Information

  • Available formulation in Zambia: Tablet: 200 mg; 400 mg.
  • MDRTB standardized regimen: ofloxacin 600 mg/d (<65 kg); 800 mg/d (>65 kg) plus ethionamide, kanamycin, pyrazinamide, and ethambutol x 4 month, then based on culture conversion and sensitivity, continue with ethionamide, ofloxacin, and ethambutol for 12-18 months.
  • Compared to ciprofloxacin, more active against Chlamydia trachomatis
Zambia Information Author: Paul A. Pham Pharm.D.

INDICATIONS

FDA

  • Acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumonia (CAP)
  • Pelvic Inflammatory Disease (PID). Endocervical and urethral gonorrhea (note: high resistance rates in U.S. and world-wide, no longer recommended) and chlamydia infections. Nongonococcal urethritis and cervicitis due to C. trachomatis.
  • Uncomplicated and complicated UTI
  • Prostatitis due to E. coli
  • Skin and soft tissue infections
  • Otitis externa, chronic suppurative otitis media, otitis media (otic solution)
  • Conjunctivitis, keratitis and corneal ulcers (ophthalmic solution)
NON-FDA APPROVED USES

  • Peritonitis, spontaneous bacterial & secondary
  • Proctitis [sexually transmitted]
  • Sexually-associated reactive arthritis (SARA)

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
FloxinOfloxacinOrtho-McNeil and generic manufacturerPO
tab
200mg
 $4.78
      PO
tab
300mg
$5.69
      PO
tab
400mg
$6.00
OcufloxOfloxacinAllergan; Bausch & Lombophthalmic
gtt
0.3% (5ml)
$56.75
      ophthalmic
gtt
0.3% (10mL)
$83.23
Floxin OfloxacinFalcon otic
gtt
0.3%(10mL)
$127.11
      otic
gtt
0.3% (5mL)
$84.23

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

  • CAP, soft tissue infection and AECB : 400mg PO twice daily.
  • Uncomplicated UTI : 200 mg PO twice daily x 3-7d.
  • NonGC cervicitis/urethritis: 300mg twice daily x 7d.
  • Conjunctivitis, keratitis: 1-2 ophthalmic drops q 2-4 hrs x 2 d then q6h for a total of 7-10 d.
  • Corneal ulcer: 1-2 ophthalmic drops every 30 minutes while awake x 2d, then hourly while awake during days 3-9, then four times daily (consult ophthalmology).
  • Otitis externa : 10 drops (otic solution) into affected ear(s) once daily x 7d.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

200-400 mg q24h.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

100-200 mg q24h.

DOSING IN HEMODIALYSIS

200 mg, then 100mg q24h.

DOSING IN PERITONEAL DIALYSIS

100-200mg q24h.

DOSING IN HEMOFILTRATION

No data. Consider 400 mg q24h.

ADVERSE DRUG REACTIONS

GENERAL

  • Generally well tolerated
OCCASIONAL

  • GI: diarrhea
  • CNS: headache, malaise, insomnia, restlessness, dizziness
  • Allergic reactions: rash, hives
  • C. difficile colitis
  • Photosensitivity/phototoxicity (can be severe)
RARE

  • Tendon rupture (increased incidence seen in older pts with concurrent use of corticosteroids)
  • Increased LFTs
  • Peripheral neuropathy
  • QTc prolongation
  • Seizure
  • Severe allergic reactions (TEN, Stevens-Johnsons syndrome, allergic pneumonitis, hepatitis, and bone marrow suppression)
  • Interstitial nephritis

DRUG INTERACTIONS

  • Antiarrhythmic agents (prolong the QT interval including class Ia or class III): avoid especially in pts with hypokalemia, significant bradycardia, or cardiomyopathy.
  • Divalent or trivalent cations (e.g., antacids, sucralfate, buffered ddI, vitamins, and minerals): interferes with ofloxacin absorption. Do not co-administer or give ofloxacin 2 hrs before cations.
  • NSAIDS: may increase risk of CNS side effects (clinical significance unknown). Monitor closely.
  • Procainamide: procainamide levels may be increased. Monitor closely with co-administration.
  • Warfarin: may increase INR with co-administration. Monitor closely.

SPECTRUM

Detailed Spectrum of Activity

RESISTANCE

  • Staphylococcus spp. breakpoints: < 1 mcg/mL (sensitive); 2 mcg/mL (intermediate); > 4 mcg/mL (resistant).
  • S. pneumoniaebreakpoints: < 2 mcg/mL (sensitive); 4 mcg/mL (intermediate); > 8 mcg/mL (resistant).

PHARMACOLOGY

Pharmacology

COMMENTS

Oral FQ that has been largely supplanted by levofloxacin,its more active L-isomer. IV formulation is no longer available. Ofloxacin ophthalmic drops is equivalent to ciprofloxacin ophthalmic drops in the treatment of corneal ulcer. Ofloxacin is preferred over cipro due to a 20% incidence crystalline precipitate in the epithelial defect seen with ciprofloxacin drops. May result in false-positive opiate urine screen (JAMA 2001; 286: 3115).

REFERENCES

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