Adult Dosing
Treatment of bacterial infections caused by susceptible gram positive and gram negative bacteria
- Usual Adult dosage is 200-400 mg PO q12 hrs
- Max: 800 mg/day
- The duration of treatment and further modification of dosage depends on the nature of the infection, clinical symptoms and response to therapy
Bronchitis (acute bacterial exacerbation of chronic bronchitis)
- 400 mg PO q12 hrs for 10 days
Pneumonia (community acquired)
- 400 mg PO q12 hrs for 10 days
Uncomplicated skin and skin structure infections
- 400 mg PO q12 hrs for 10 days
Gonorrhea (acute uncomplicated urethral and cervical)
- 400 mg PO as a single dose
- Note that fluoroquinolone resistant gonococci have become increasingly common
Cervicitis/urethritis (nongonococcal)
- 300 mg PO q12 hrs for 7 days
Mixed infection of the urethra and cervix
- 300 mg PO q12 hrs for 7 days
Acute pelvic inflammatory disease
- 400 mg PO q12 hrs for 10-14 days
Uncomplicated cystitis due to E. coli or K. pneumoniae
- 200 mg PO q12 hrs for 3 days
Uncomplicated cystitis due to other approved pathogens
- 200 mg PO q12 hrs for 7 days
Urinary tract infections
- Treatment of uncomplicated UTI's: 200 mg PO q12 hrs for 3-7 days
- Treatment of complicated UTI's: 200 mg PO q12 hrs for 10 days
Prostatitis due to E.Coli
- 300 mg PO q12 hrs for 6 wks
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment: (Based on CrCl)
- 20-50 mL/min: Use usual oral dose q24 hrs
- < 20 mL/min: Use half of the usual recommended dose q24 hrs
- Hemodialysis: 100-200 mg after dialysis
Hepatic Dose Adjustment
- Liver cirrhosis: Max 400 mg/day
See Supplemental Patient Information
- Patients of all ages receiving fluoroquinolones including ofloxacin are at an increased risk of tendinitis and tendon rupture. Older patients usually >60 yrs of age, patients taking corticosteroid drugs, patients with kidney, heart or lung transplants have a further increased risk [US Black Box Warning]. This adverse reaction most frequently involves the achilles tendon and rupture of the achilles tendon, and often requires surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have occurred. Strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis are the factors associated with increased tendon rupture. Tendinitis and tendon rupture have also occurred in patients without above risk factors
- Tendon ruptures have occurred during or after completion of therapy; cases occurring for up to several months after completion of therapy has occurred. Discontinue therapy if the patient experiences pain, swelling, inflammation or rupture of a tendon
- Safety and efficacy of ofloxacin in patients < 18 yrs of age, pregnant women, and lactating women have not been established
- Convulsions, increased intracranial pressure, and toxic psychosis have occurred in patients receiving this drug
- Stimulates CNS leading to tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rare suicidal thoughts or acts. Discontinue therapy and institute appropriate measures on occurrence of these events
- Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have occurred in patients receiving therapy with this drug. Cardiovascular collapse, hypotension, shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath and acute respiratory distress), dyspnea, urticarias, itching, and other serious skin reactions have occurred
- Immediately discontinue therapy at the first instance of appearance of a skin rash or any other sign of hypersensitivity
- Provide treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated on occurrence of serious acute hypersensitivity reactions
- Fever, rash or severe dermatologic reactions, vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency/failure, hepatitis, jaundice, acute hepatic necrosis/failure, anemia, including hemolytic and aplastic, thrombocytopenia, including thrombotic thrombocytopenic purpura, leukopenia, agranulocytosis, pancytopenia, and/or other hematologic abnormalities have occurred
- Rare occasions of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have occurred in patients
- Discontinue therapy if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition
- Clostridium difficile associated diarrhea (CDAD) which may range from mild diarrhea to fatal colitis has been reported. It can occur during therapy or >2mo after discontinuation. Consider diagnosis if diarrhea presents after antibiotic administration
- Reserve use for serious infections where less toxic agents are inappropriate; avoid use in nonbacterial infections such as most URTIs
- Antibiotic may alter colon flora, leading to C. difficile overgrowth. C. difficile produces toxins A and B which contribute to CDAD. Hypertoxin producing strains cause increased morbidity and mortality since these infections can be refractory to antibiotic therapy and may require colectomy
- On suspection/confirmation of CDAD discontinue use. Patients may need fluid, electrolyte, and protein supplementation along with antibiotics for C. difficile, surgical evaluation as needed
- To reduce the development of drug-resistant bacteria, use only to treat infections proven or strongly suspected to be caused by susceptible bacteria. Obtain susceptibility tests before starting therapy
- Therapy is ineffective for the treatment of syphilis. Conduct serologic test for syphilis at the time of diagnosis in all patients with gonorrhea. Conduct follow-up serologic test for syphilis after three months and, if positive, institute treatment with an appropriate antimicrobial
- Maintain adequate hydration to prevent the formation of a highly concentrated urine
- Carefully monitor and conduct appropriate laboratory tests in patients with known or suspected renal or hepatic insufficiency/impairment
- Moderate to severe photosensitivity/phototoxicity reactions have occurred
- Potentiation of the hypoglycemic action has occurred on concomitant use of oral hypoglycemic drugs or insulin with fluoroquinolone
- Periodically assess organ system functions including renal, hepatic, and hematopoietic
- Prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia have occurred. Rare cases of torsades de pointes have been reported during post-marketing surveillance. Avoid use in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents
Cautions: Use cautiously in
- Renal dysfunction
- Hepatic insufficiency
- Dehydration
- Seizure disorder
- CNS disorder
- Known or suspected CNS disorder
- Severe cerebral arteriosclerosis
- Epilepsy
- Use with drug therapy lowering seizure threshold
- Diabetes mellitus
- kidney transplant
- Heart transplant
- Lung transplant
- Proarrhythmic condition
- Patients >60 yrs
Supplemental Patient Information
- Advise patients to rest at the first sign of tendinitis or tendon rupture, and to communicate their healthcare provider regarding changing to a non-quinolone antimicrobial drug
- Advise patients to consult a clinician on occurrence of hypoglycemic reactions
Pregnancy Category:C
Breastfeeding: Insufficient data is available to prove or disprove that calcium in milk might prevent absorption of the small amounts of fluoroquinolones in milk. Developmental problems have occurred in two infants exposed to ofloxacin in breastmilk. Since their mothers were also exposed to several drugs during pregnancy and during breastfeeding, the problems cannot necessarily be attributed to ofloxacin. Short-term use of ofloxacin is acceptable in nursing mothers. Avoid breastfeeding for 4 to 6 hrs after a dose to decrease the exposure of the infant to ofloxacin in breastmilk. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). This drug is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 21 January 2011). Ofloxacin exhibits potential for serious adverse reactions in nursing infants, a decision is necessary to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Ofloxacin 300 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
14 mg = $65.99
42 mg = $185.95
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
