Ofloxacin 400 MG Oral Tablet
Generic Name: OFLOXACIN
Brand Name: Ofloxacin
- Substance Name(s):
- OFLOXACIN
WARNINGS
Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects: Fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient.
Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).
These reactions can occur within hours to weeks after starting ofloxacin.
Patients of any age or without pre-existing risk factors have experienced these adverse reactions (see Warnings ) Discontinue ofloxacin immediately at the first signs or symptoms of any serious adverse reaction.
In addition, avoid the use of fluoroquinolones, including ofloxacin, in patients whohave experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinopathy and Tendon Rupture Fluoroquinolones, including ofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages.
This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon and has been reported with rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons.
Tendinitis or tendon rupture can occur within hours or days of starting ofloxacin, or as long as several months after completion of fluoroquinolone therapy.
Tendinitis and tendon rupture can occur bilaterally.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Other factors, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.
Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Discontinue ofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.
Avoid fluoroquinolones, including ofloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture (see Adverse Reactions ).
Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
Peripheral Neuropathy: Fluoroquinolones, including ofloxacin, have been associated with an increased risk of peripheral neuropathy.
Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ofloxacin.
Symptoms may occur soon after initiation of norfloxacin and may be irreversible in some patients (see ).
Discontinue ofloxacin immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition.
Avoid fluoroquinolones, including ofloxacin, in patients who have previously experienced peripheral neuropathy (see Adverse Reactions) Central Nervous System Effects Psychiatric Adverse Reactions : Fluoroquinolones, including ofloxacin, have been associated with an increased risk of psychiatric adverse reactions, including toxic psychoses or hallucinations; agitation; delirium, confusion, disorientation, or disturbances in attention; nervousness or restlessness, memory impairment.
If these reactions occur in patients receiving ofloxacin, the drug should be discontinued and appropriate measures instituted.
Central Nervous System Adverse Reactions: Fluoroquinolones have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), lightheadedness, or tremors.The effects of ofloxacin on brain function or on the electrical activity of the brain have not been tested.
Therefore, until more information becomes available, ofloxacin, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors which predispose to seizures (see ADVERSE REACTIONS ).
Exacerbation of Myasthenia Gravis Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis.
Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis.
Avoid ofloxcain in patients with known history of myasthenia gravis [see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS, PostMarketing Adverse Events ).
THE SAFETY AND EFFICACY OF OFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED (see PRECAUTIONS: Pediatric Use , Pregnancy , and Nursing Mothers Subsections.) In the immature rat, the oral administration of ofloxacin at 5 to 16 times the recommended maximum human dose based on mg/kg or 1 to 3 times based on mg/m 2 increased the incidence and severity of osteochondrosis.
The lesions did not regress after 13 weeks of drug withdrawal.
Other quinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.
(See ANIMAL PHARMACOLOGY .
) Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including ofloxacin.
These reactions often occur following the first dose.
Some reactions have been accompanied by 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, urticaria, itching, and other serious skin reactions.
This drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated (see PRE C AUTIONS and ADVERSE REACTIONS .
) Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ofloxacin.
These events may be severe and generally occur following the administration of multiple doses.
Clinical manifestations may include one or more of the following: fever, rash, severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice or any other sign of hypersensitivity and supportive measures instituted.
(See PRECAUTIONS, Information for Patients and ADVERSE REACTIONS .
) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ofloxacin tablets, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile .
C.
difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated (see ADVERSE REACTIONS .) Ofloxacin has not been shown to be effective in the treatment of syphilis.
Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin.
In these patients, careful monitoring of blood glucose is recommended.
Severe cases of hypoglycemia resulting in coma or death have been reported.
If a hypoglycemic reaction occurs in a patient being treated with ofloxacin, discontinue ofloxacin and initiate appropriate therapy immediately.
Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis.
All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis.
Patients treated with ofloxacin for gonorrhea should have a follow-up serologic test for syphilis after three months and, if positive, treatment with an appropriate antimicrobial should be instituted.
DRUG INTERACTIONS
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 Videx ® , (didanosine), 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 co-administered 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 co-administered.
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 .)
OVERDOSAGE
IInformation on overdosage with ofloxacin is limited.
One incident of accidental overdosage has been reported.
In this case, an adult female received 3 grams of ofloxacin intravenously over 45 minutes.
A blood sample obtained 15 minutes after the completion of the infusion revealed an ofloxacin level of 39.3 mcg/mL.
In 7 h, the level had fallen to 16.2 mcg/mL, and by 24 h to 2.7 mcg/mL.
During the infusion, the patient developed drowsiness, nausea, dizziness, hot and cold flushes, subjective facial swelling and numbness, slurring of speech, and mild to moderate disorientation.
All complaints except the dizziness subsided within 1 h after discontinuation of the infusion.
The dizziness, most bothersome while standing, resolved in approximately 9 h.
Laboratory testing reportedly revealed no clinically significant changes in routine parameters in this patient.
In the event of an acute overdose, the stomach should be emptied.
The patient should be observed and appropriate hydration maintained.
Ofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.
DESCRIPTION
Ofloxacin tablets are synthetic broad-spectrum antimicrobial agent for oral administration.
Chemically, ofloxacin, a fluorinated carboxyquinolone, is the racemate, (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido[1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid.
The chemical structure is: C 18 H 20 FN 3 O 4 M.W.
361.4.
Ofloxacin USP is pale yellowish white to light yellowish white crystals or crystalline powder.
The molecule exists as a zwitterion at the pH conditions in the small intestine.
The relative solubility characteristics of ofloxacin at room temperature, as defined by USP nomenclature, indicate that ofloxacin is considered to be soluble in aqueous solutions with pH between 2 and 5.
It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9.
Ofloxacin USP has the potential to form stable coordination compounds with many metal ions.
This in vitro chelation potential has the following formation order: Fe +3 > Al +3 > Cu +2 > Ni +2 > Pb +2 > Zn +2 > Mg +2 > Ca +2 > Ba +2 .
Ofloxacin tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose 5 cP, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinised starch, sodium starch glycolate, synthetic yellow iron oxide (for 200 mg and 400 mg tablet), and titanium dioxide.
structure
HOW SUPPLIED
Ofloxacin tablets 200 mg are yellow coloured capsule shaped, biconvex film coated tablets embossed ‘R’ on one side and ‘160’ on the other side and are supplied in bottles of 30, 50, 100, 500 and unit-dose package of 100 (10 x 10).
Bottles of 30 55111-160-30 Bottles of 50 55111-160-50 Bottles of 100 55111-160-01 Bottles of 500 55111-160-05 Unit dose package of 100 (10 x 10) 55111-160-78 Ofloxacin tablets 300 mg are white, capsule shaped, biconvex film coated tablets embossed ‘R’ on one side and ‘161’ on the other side and are supplied in bottles of 30, 50, 100, 500 and unit-dose package of 100 (10 x 10).
Bottles of 30 55111-161-30 Bottles of 50 55111-161-50 Bottles of 100 55111-161-01 Bottles of 500 55111-161-05 Unit dose package of 100 (10 x 10) 55111-161-78 Ofloxacin tablets 400 mg are yellow coloured capsule shaped, biconvex film coated tablets embossed ‘R’ on one side and ‘162’ on the other side and are supplied in bottles of 30, 50, 100, 500 and unit-dose package of 100 (10 x 10).
Bottles of 30 55111-162-30 Bottles of 50 55111-162-50 Bottles of 100 55111-162-01 Bottles of 500 55111-162-05 Unit dose package of 100 (10 x 10) 55111-162-78 STORAGE Store ofloxacin tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Ofloxacin tablets should be stored in well-closed containers.
Keep out of the reach of children.
GERIATRIC USE
Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ofloxacin.
This risk is further increased in patients receiving concomitant corticosteroid therapy.
Tendinitis or tendon rupture can involves the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported.
Caution should be used when prescribing ofloxacin to elderly patients especially those on corticosteroids.
Patients should be informed of this potential side effect and advised to discontinue ofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur (See BOXED WARNING , WARNINGS , and ADVERSE REACTIONS / Post-Marketing Adverse Event Reports ).
In phase 2/3 clinical trials with ofloxacin, 688 patients (14.2%) were ≥ 65 years of age.
Of these, 436 patients (9%) were between the ages of 65 and 74 and 252 patients (5.2%) were 75 years or older.
There was no apparent difference in the frequency or severity of adverse reactions in elderly adults compared with younger adults.
The pharmacokinetic properties of ofloxacin in elderly subjects are similar to those in younger subjects.
Drug absorption appears to be unaffected by age.
Dosage adjustment is necessary for elderly patients with impaired renal function (creatinine clearance rate ≤ 50 mL/min) due to reduced clearance of ofloxacin.
In comparative studies, the frequency and severity of most drug-related nervous system events in patients ≥ 65 years of age were comparable for ofloxacin and control drugs.
The only differences identified were an increase in reports of insomnia (3.9% vs 1.5%) and headache (4.7% vs 1.8%) with ofloxacin.
It is important to note that these geriatric safety data are extracted from 44 comparative studies where the adverse reaction information from 20 different controls (other antibiotics or placebo) were pooled for comparison with ofloxacin.
The clinical significance of such a comparison is not clear.(See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION .) Elderly patients may be more sensitive to drug-associated effects on the QT interval.
Therefore, precaution should be taken when using ofloxacin with concomitant drugs that can result in prolongation of the QT interval (e.g.
class IA or class III antiarrhythmics) or in patients with risk factors for Torsade de pointes (e.g.
known QT prolongation, uncorrected hypokalemia).
(See PRECAUTIONS: General: Torsades de pointes )
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets and other antibacterial drugs, ofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Ofloxacin tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below.
Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae .
Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings ), and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options.
Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae .
Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.
Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae .
(See WARNINGS .) Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis .
(See WARNINGS .) Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae.
(See WARNINGS .) Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae .
(See WARNINGS .) NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.
Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa .
Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see WARNINGS ), and for some patients uncomplicated cystitis is self-limiting, reserve ofloxacin for treatment of uncomplicated cystitis in patients who have no alternative treatment options.
Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus*, or Pseudomonas aeruginosa*.
Prostatitis due to Escherichia coli .
* = Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to ofloxacin.
Therapy with ofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin.
Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients and adolescents below the age of 18 years have not been established.
Ofloxacin causes arthropathy (arthrosis) and osteochondrosis in juvenile animals of several species.(See WARNINGS .)
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 .)
NUSRING MOTHERS
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 .)
BOXED WARNING
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 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 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: Acute exacerbation of chronic bronchitis Uncomplicated cystitis (see INDICATIONS and USAGE )
INFORMATION FOR PATIENTS
Information for Patients Advise the patient to read the FDA -approved patient labeling (Medication Guide)
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.
Infection DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE .) Unit Dose Frequency Duration Daily Dose Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg q12h 10 days 800 mg Comm.
Acquired Pneumonia 400 mg q12h 10 days 800 mg Uncomplicated Skin and Skin Structure Infections 400 mg q12h 10 days 800 mg Acute, Uncomplicated Urethral and Cervical Gonorrhea 400 mg single dose 1 day 400 mg Nongonococcal Cervicitis/Urethritis due to C.
trachomatis 300 mg q12h 7 days 600 mg Mixed Infection of the urethra and cervix due to C.
trachomatis and N.
gonorrhoeae 300 mg q12h 7 days 600 mg Acute Pelvic Inflammatory Disease 400 mg q12ho 10–14 days 800 mg Uncomplicated Cystitis due to E.
coli or K.
pneumoniae 200 mg q12h 3 days 400 mg Uncomplicated Cystitis due to other approved pathogens 200 mg q12h 7 days 400 mg Complicated UTI’s 200 mg q12h 10 days 400 mg Prostatitis due to E.Coli 300 mg q12h 6 weeks 600 mg Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx ® (didanosine) 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: Creatinine Clearance Maintenance Dose Frequency 20 to 50 mL/min the usual recommended unit dose q24h <20 mL/min 1/2 the usual recommended unit dose q24h When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140-age) 72× serum creatinine (mg/dL) Women: 0.85× 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.