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Ofloxacin information from DrugsUpdate  

See Available Brands of Ofloxacin in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation
FI - Food *
LI - Lab *

Ofloxacin is a fluoroquinolone antibiotic considered to be a second-generation fluoroquinolone. Floxin (branded version) had been discontinued by the manufacturer, in the United States, effective June 18, 2009, though generic equivalents continue to be available.

Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin. When levofloxacin disks were not available in early clinical trials, a 5-pg Floxin (ofloxacin –floxacin) disk was substituted. The U.S. Food and Drug Administration (FDA) medical reviewers considered the two drugs to be one and the same and hence interchangeable.

Like other quinolones, ofloxacin has been associated with a significant number of serious adverse drug reactions, such as tendon damage (including spontaneous tendon ruptures) and peripheral neuropathy (which may be irreversible); such reactions may manifest long after therapy had been completed, and, in severe cases, may result in life-long disabilities.Ofloxacin has also been associated with severe psychiatric adverse reactions.

Hepatotoxicity has also been reported with the use of ofloxacin.Case reports of hepatitis have been published for the older fluoroquinolones including ciprofloxacin, ofloxacin, and norfloxacin.

Pharmacodynamics

Pharmacokinetics

Ofloxacin is a fluoroquinolone which inhibits bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination. It has activity against a wide range of gram-negative and gram-positive microorganisms.

Absorption

Rapidly and well absorbed from the GI tract (oral); peak plasma concentrations after 0.5-2 hr. Rate, but not extent, delayed by the presence of food.

Distribution
Widely distributed into body fluids, CSF, tissues, bile (high concentrations); crosses the placenta and enters breast milk. Protein-binding: 20-32%.

Metabolism
<10% of a single dose is metbolised. Converted to desmethyl and N-oxide metabolites; desmethylofloxacin has moderate antibacterial activity.

Excretion

Via urine within 24-48 hr by tubular secretion and glomerular filtration (75-80% as unchanged, <5% as metabolites); via faeces (4-8%). Elimination is biphasic with half-lives of 4-5 hr and 20-25 hours; prolonged in renal impairment (15-60 hours).

Ofloxacin Indications / Ofloxacin Uses

Information Not Available

Ofloxacin Adverse Reactions / Ofloxacin Side Effects

Nausea, vomiting, abdominal pain, diarrhoea; headache, dizziness, insomnia, hallucinations; leucopenia and eosinophilia; vaginitis; dysgeusia; tendon damage and rupture; anorexia; tremor; photosensitivity; hypersensitivity reactions. Discontinue if psychiatric, neurological or hypersensitivity reactions occur.

Potentially Fatal: Anaphylaxis; rarely seizures.

Precautions

Prescribing Ofloxacin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adequate hydration of patients receiving Ofloxacin should be maintained to prevent the formation of a highly concentrated urine.

Special Precautions

Epilepsy or other predisposition to seizures; known or suspected CNS disorders; renal, hepatic impairment; myasthaenia gravis; superinfection; children <18 yr; exposure to strong sunlight and UV light; ensure adequate hydration; elderly.

Other Drug Interactions

Probenecid decreases elimination. Antacids may reduce ofloxacin absorption, avoid for 2 hr either side of administration. Cimetidine may increase ofloxacin concentrations. Monitor blood glucose in patients on antidiabetic medication.

Potentially Fatal: Corticosteroids may increase risk of tendon rupture. Increases effects of oral anticoagulants, ciclosporin, theophylline. Increased risk of seizures with NSAIDs. Avoid in patients taking QT prolonging medication (e.g. class Ia or III antiarrythmics, astemizole, terfenadine, cisapride, erythromycin, pentamidine, phenothiazines and some TCA).

Other Interactions

Food Interactions


Absorption delayed in the presence of food.

Dosage

Oral
Leprosy
Adult: As part of a multidrug therapy: 400 mg daily or intermittently, depending on regimen.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min):     Dosage Recommendation:
20-50                  Reduce dose by half or give usual dose only every 24 hr. 
 <20.                  100 mg every 24 hr.
   
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Uncomplicated gonorrhoea
Adult: 400 mg as a single dose.
Oral
Acute bacterial exacerbation of chronic bronchitis
Adult: 400 mg bid for 10 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)                  Dosage Recommendation
20-50                         Reduce dose by half or give usual dose only every 24 hr.
<20                        100 mg every 24 hr
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Community-acquired pneumonia
Adult: 400 mg bid for 10 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)                Dosage Recommendation
20-50                       Reduce dose by half or give usual dose only every 24 hr.
<20                       100 mg every 24 hr
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Uncomplicated skin infections
Adult: 400 mg bid for 10 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Non-gonococcal cervicitis/urethritis due to Chlamydia trachomatis
Adult: 200-300 mg bid for 7 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Mixed infection of the urethra and cervix due to C. trachomatis and Neisseria gonorrhoeae
Adult: 200-300 mg bid for 7 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Pelvic inflammatory disease
Adult: 400 mg bid for 14 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Uncomplicated cystitis
Adult: 200 mg bid for 3 days if due to E. Coli or Klebsiella pneumoniae; 7 days if due to other susceptible organisms.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Complicated urinary tract infections
Adult: 200 mg bid for 10 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Prostatitis due to E. coli
Adult: 300 mg bid for 6 wk.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Traveller's diarrhoea
Adult: 300 mg bid for 1-3 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral

Postexposure prophylaxis after suspected or confirmed exposure to inhalational anthrax
Adult: 400 mg bid for ≥60 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral

Legionnaire's disease
Adult: 400 mg bid for 2-3 wk.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Oral
Typhoid fever caused by susceptible Salmonella typhi
Adult: 200-400 mg bid for 7-14 days.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Intravenous

Complicated urinary tract infections
Adult: 200 mg daily by IV infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Intravenous
Lower respiratory tract infections
Adult: 200 mg bid by IV infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Intravenous
Septicaemia
Adult: 200 mg bid by IV infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                      100 mg every 24 hr.
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Intravenous

Skin and soft tissue infections
Adult: 400 mg bid infused over at least 1 hr.
Renal impairment: Initial dose as normal then reduce.
CrCl (ml/min)    Dosage Recommendation
20-50                      Reduce dose by half or give usual dose only every 24 hr.
<20                     100 mg every 24 hr
Hepatic impairment: Clearance is reduced in severe hepatic impairment, lower doses should be used. Max: 400 mg daily.

Ophthalmic
Bacterial conjunctivitis
Adult: As 0.3% ophth solution: 1-2 drops in the affected eye instilled every 2-4 hr for the first 2 days then 4 times daily for the next 5 days of treatment.
Child: >1 yr: 1-2 drops in the affected eye instilled every 2-4 hr for the first 2 days then 4 times daily for the next 5 days of treatment.

Ophthalmic
Bacterial corneal ulcer
Adult: As 0.3% ophth solution: Days 1-2: Instill 1-2 drops into the affected eye every 30 min while awake. Awaken approximately 4 and 6 hr after retiring and instill 1-2 drops. Days 3-7 (or 9 if necessary): Instill 1-2 drops hrly while awake. Thereafter: Instill 1-2 drops 4 times daily until condition fully resolved.
Child: >1 yr: Days 1-2: Instill 1-2 drops into the affected eye every 30 min while awake. Awaken approximately 4 and 6 hr after retiring and instill 1-2 drops. Days 3-7 (or 9 if necessary): Instill 1-2 drops hrly while awake. Thereafter: Instill 1-2 drops 4 times daily until condition fully resolved.

Otic/Aural
Otic infections
Adult: Apply 10 drops of 0.3% solution in the affected ear once daily for 7 days. Lie with the affected ear upwards for 5 min to facilitate penetration into the ear canal.
Child: 6 mth-13 yr: 5 drops of 0.3% solution in the affected ear once daily for 7 days. >13 yr: 10 drops of 0.3% solution in the affected ear once daily for 7 days. Lie with the affected ear upwards for 5 min to facilitate penetration into the ear canal.

Food(before/after)

Should be taken on an empty stomach. (Take on an empty stomach 1 hr before or 2 hr after meals. Do not take w/dairy products.)

List of Contraindications

Ofloxacin and Pregnancy

 Contraindicated in pregnancy.


Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.



Ofloxacin and Lactation

Contraindicated in lactation

Ofloxacin and Children

Safety and efficacy not established in children younger than 1 yr of age. Safety and efficacy not established in children younger than 18 yr of age (otic).

Ofloxacin and Geriatic

Information Not Available

Ofloxacin and Other Contraindications

Hypersensitivity to quinolones; pregnancy and lactation; prolongation of the QT interval; uncorrected hypokalaemia.

Storage

Ophthalmic
Store at 15-25°C.

Oral
Store at 20-25°C

Otic/Aural
Store at 15-25°C.

Lab interference

Ophthalmic
Store at 15-25°C.

Oral
Store at 20-25°C

Otic/Aural
Store at 15-25°C.

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