Ofloxacin

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Side Effects & Adverse Reactions

Tendinopathy and Tendon Rupture

Fluoroquinolones, including ofloxacin, are 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 may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, 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 been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. 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.

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).

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 ofloxacin in patients with known history of myasthenia gravis (see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS, Postmarketing Adverse Events).

Central Nervous System Effects

Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving quinolones, including ofloxacin. Quinolones, including ofloxacin, may also cause central nervous system stimulation which may lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ofloxacin, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with ofloxacin than some other products in the quinolone class. As with all quinolones, ofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction) (see PRECAUTIONS, General, Information for Patients, Drug Interactions and ADVERSE REACTIONS).

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 PRECAUTIONS and ADVERSE REACTIONS).

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely 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, or 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 skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS).

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 ofloxacin and may be irreversible. Ofloxacin should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensations including light touch, pain, temperature, position sense or vibratory sensation.

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.

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.

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Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ofloxacin Tablets, USP and other antibacterial drugs, Ofloxacin Tablets, USP 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, USP 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 due to Haemophilus influenzae or Streptococcus pneumoniae.

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.

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, USP. Therapy with ofloxacin, USP 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, USP. 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.

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History

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Other Information

Ofloxacin Tablets, USP is a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin,USP, 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:

Its empirical formula is C 18H 20FN 3O 4 and its molecular weight is 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP 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.

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Ofloxacin Manufacturers

Larken Laboratories, Inc.

Ofloxacin | Larken Laboratories, Inc.

The usual dose of Ofloxacin Tablets, USP 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† Unit Dose Frequency Duration Daily Dose † DUE TO THE DESIGNATED PATHOGENS (see INDICATIONS AND USAGE). 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 q12h 10 to 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 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:
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
When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
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.

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Dr. Reddy’s Laboratories Limited

Ofloxacin | Dr. Reddy's Laboratories Limited

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 Functionsubsection.
Infection* Unit Dose Frequency Duration Daily Dose * DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.) 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 20–50 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.

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Rebel Distributors Corp

Ofloxacin | Rebel Distributors Corp

Otitis Externa
The recommended dosage regimen for the treatment of otitis externa is:
For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Acute Otitis Media in pediatric patients with tympanostomy tubes
The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is:
Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear. Chronic Suppurative Otitis Media with perforated tympanic membranes
The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:
Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

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Hi-tech Pharmacal Co., Inc.

Ofloxacin | Hi-tech Pharmacal Co., Inc.

Otitis Externa
The recommended dosage regimen for the treatment of otitis externa is:
For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Acute Otitis Media in pediatric patients with tympanostomy tubes
The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is:
Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear. Chronic Suppurative Otitis Media with perforated tympanic membranes
The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:
Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

No Recall
Preferred Pharmaceuticals, Inc.

Ofloxacin | Preferred Pharmaceuticals, Inc.

Otitis Externa
The recommended dosage regimen for the treatment of otitis externa is:
For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Acute Otitis Media in pediatric patients with tympanostomy tubes
The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is:
Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear. Chronic Suppurative Otitis Media with perforated tympanic membranes
The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:
Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

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Remedyrepack Inc.

Ofloxacin | Remedyrepack Inc.

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† UnitDose Frequency Duration DailyDose 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 q12h 10 to 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
† DUE TO THE DESIGNATED PATHOGENS (see INDICATIONS AND USAGE).
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).

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 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 × the value calculated for men.
The serum creatinine should represent a steady-state of renal function.

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.

No Recall
Pd-rx Pharmaceuticals, Inc.

Ofloxacin | Pd-rx Pharmaceuticals, Inc.

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.
† DUE TO THE DESIGNATED PATHOGENS (see INDICATIONS AND USAGE).
Infection† UnitDose Frequency Duration DailyDose 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 q12h 10 to 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 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:
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
When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
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.

No Recall
Teva Pharmaceuticals Usa Inc

Ofloxacin | Teva Pharmaceuticals Usa Inc

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†
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
q12h
10 to 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
† DUE TO THE DESIGNATED PATHOGENS (see INDICATIONS AND USAGE).
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:
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
When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
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.

No Recall
Cadila Pharmaceuticals Limited

Ofloxacin | Cadila Pharmaceuticals Limited

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*
UnitDose
Frequency
Duration
DailyDose
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
q12h
10 to 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

* DUE TO THE DESIGNATED PATHOGENS (see INDICATIONS AND USAGE).
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:

Creatinine Clearance
Maintenance Dose
Frequency
20 - 50 mL/min
the usual recommended unit dose
q24h
< 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 × 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.

No Recall