Ofloxacin (oral)
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From MedlinePlus, U.S. National Library of Medicine
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WARNING SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: • Tendinitis and tendon rupture • Peripheral neuropathy • Central nervous system effects (see WARNINGS ). Discontinue ofloxacin immediately and avoid the use of fluoroquinolones, including ofloxacin, in patients who experience any of these serious adverse reactions (see WARNINGS).
• Fluoroquinolones, including ofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ofloxacin in patients with a known history of myasthenia gravis (See WARNINGS). •Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see WARNINGS), reserve ofloxacin for use in patients who have no alternative treatment options for the following indications: o Acute exacerbation of chronic bronchitis o Uncomplicated cystitis (see INDICATIONS and USAGE )
Quinolone Antimicrobial
Dosing in kidney impairment
DOSAGE AND ADMINISTRATION The usual dose of ofloxacin tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance < 50 mL/min), see the Patients With Impaired Renal Function subsection. [See table below.] Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or didanosine, chewable/buffered tablets or the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin (see PRECAUTIONS ).
Patients With Impaired Renal Function Dosage should be adjusted for patients with a creatinine clearance < 50 mL/min. After a normal initial dose, dosage should be adjusted as follows: [See table below.] < 20 mL/min ½ the usual recommended unit dose q24h When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
Women: 0.85 x the value calculated for men. The serum creatinine should represent a steady-state of renal function. Patients With Cirrhosis: The excretion of ofloxacin may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of ofloxacin per day should therefore not be exceeded. ofloxacin-fig3-formula
| Creatinine Clearance | Maintenance Dose | Frequency |
| 20 to 50 mL/min | the usual recommended unit dose | q24h |
| < 20 mL/min | ½ the usual recommended unit dose | q24h |
Drug interactions
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- Ofloxacin (oral)
Label text (6 paragraphs)
Drug Interactions Antacids, Sucralfate, Metal Cations, Multivitamins Quinolones form chelates with alkaline earth and transition metal cations. Administration of quinolones with antacids containing calcium, magnesium, or aluminum, with sucralfate, with divalent or trivalent cations such as iron, or with multivitamins containing zinc or with didanosine, chewable/buffered tablets or the pediatric powder for oral solution may substantially interfere with the absorption of quinolones resulting in systemic levels considerably lower than desired.
These agents should not be taken within the two-hour period before or within the two-hour period after ofloxacin administration (see DOSAGE AND ADMINISTRATION ). Caffeine Interactions between ofloxacin and caffeine have not been detected. Cimetidine Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in half-life and AUC of some quinolones. The potential for interaction between ofloxacin and cimetidine has not been studied. Cyclosporine Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones.
The potential for interaction between ofloxacin and cyclosporine has not been studied. Drugs Metabolized by Cytochrome P450 Enzymes Most quinolone antimicrobial drugs inhibit cytochrome P450 enzyme activity. This may result in a prolonged half-life for some drugs that are also metabolized by this system (e.g., cyclosporine, theophylline/methylxanthines, warfarin) when coadministered with quinolones. The extent of this inhibition varies among different quinolones (see other Drug Interactions ).
Non Steroidal Anti-Inflammatory Drugs The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures (see WARNINGS and PRECAUTIONS , General ). Probenecid The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion. The effect of probenecid on the elimination of ofloxacin has not been studied. Theophylline Steady-state theophylline levels may increase when ofloxacin and theophylline are administered concurrently.
As with other quinolones, concomitant administration of ofloxacin may prolong the half-life of theophylline, elevate serum theophylline levels, and increase the risk of theophylline-related adverse reactions. Theophylline levels should be closely monitored and theophylline dosage adjustments made, if appropriate, when ofloxacin is coadministered. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level (see WARNINGS and PRECAUTIONS , General ). Warfarin Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives.
Therefore, if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives, the prothrombin time or other suitable coagulation test should be closely monitored. Antidiabetic Agents (e.g., Insulin, Glyburide/Glibenclamide) Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly (see PRECAUTIONS , General and Information for Patients ).
Supplement interactions
Dietary supplement interactions
3 noted- Simultaneous use of calcium supplements and quinolone antibiotics—such as ciprofloxacin (Cipro), gemifloxacin (Factive), and moxifloxacin (Avelox)—can reduce the absorption of quinolones. Taking the antibiotic 2 hours before or 2 hours after calcium supplements prevents this effect.
- Magnesium can form insoluble complexes with tetracyclines, such as demeclocycline (Declomycin) and doxycycline (Vibramycin), and with quinolone antibiotics, such as ciprofloxacin (Cipro) and levofloxacin (Levaquin). These antibiotics should be taken at least 2 hours before or 4 to 6 hours after a magnesium-containing supplement.
- Both quinolone antibiotics (such as Cipro) and tetracycline antibiotics (such as Achromycin and Sumycin) might interact with zinc in the gastrointestinal tract, which could inhibit the absorption of both zinc and the antibiotic if they are taken at the same time. Taking the antibiotic at least 2 hours before or 4 to 6 hours after the zinc supplement minimizes this interaction.
Contraindications
Ofloxacin tablets are contraindicated in persons with a history of hypersensitivity associated with the use of ofloxacin or any member of the quinolone group of antimicrobial agents.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ALikelihood score A: Well established but rare cause of clinically apparent liver injury.
Ofloxacin is a second generation fluoroquinolone that was previously used widely for therapy of mild-to-moderate bacterial infections, but which has been replaced by more potent and less toxic fluoroquinolones and is now used largely topically as eye and ear drops. Ofloxacin has been linked to rare instances of acute hepatocellular injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Pregnancy Teratogenic Effects Pregnancy Category C Ofloxacin has not been shown to have any teratogenic effects at oral doses as high as 810 mg/kg/day (11 times the recommended maximum human dose based on mg/m 2 or 50 times based on mg/kg) and 160 mg/kg/day (4 times the recommended maximum human dose based on mg/m 2 or 10 times based on mg/kg) when administered to pregnant rats and rabbits, respectively. Additional studies in rats with oral doses up to 360 mg/kg/day (5 times the recommended maximum human dose based on mg/m 2 or 23 times based on mg/kg) demonstrated no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn.
Doses equivalent to 50 and 10 times the recommended maximum human dose of ofloxacin (based on mg/kg) were fetotoxic (i.e., decreased fetal body weight and increased fetal mortality) in rats and rabbits, respectively. Minor skeletal variations were reported in rats receiving doses of 810 mg/kg/day, which is more than 10 times higher than the recommended maximum human dose based on mg/m 2 . There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see WARNINGS ).
Lactation
Nursing Mothers In lactating females, a single oral 200 mg dose of ofloxacin resulted in concentrations of ofloxacin in milk that were similar to those found in plasma. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS and ADVERSE REACTIONS ).
Breastfeeding (LactMed)
Ofloxacin appears in breastmilk in low levels. Fluoroquinolones have traditionally not been used in infants because of concern about adverse effects on the infants’ developing joints. However, recent studies indicate little risk. The calcium in milk might prevent absorption of the small amounts of fluoroquinolones in milk. Insufficient data exist to prove or disprove this assertion. Developmental problems have been reported in two infants exposed to ofloxacin in breastmilk, but their mothers were also exposed to several drugs during pregnancy and during breastfeeding, so the problems cannot necessarily be attributed to ofloxacin. Use of ofloxacin is acceptable in nursing mothers with monitoring of the infant for possible effects on the flora, such as diarrhea or candidiasis (thrush, diaper rash).
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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