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Basic Drug Info
Drug Name:ofloxacin
Manufacturer:Ranbaxy Pharmaceuticals Inc.
Other Info:



Clinical Trials:


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 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-susceptibleStaphylococcus 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.

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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

CHRONIC BRONCHITIS -- condition characterized by persistent coughing, increased secretion from the bronchial mucosa, obstruction of the respiratory passages, scanty or profuse expectoration, and necrosis and fibrosis of the respiratory tract.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Nonspecific urethritis --

Uterine Cervicitis -- Inflammation of the UTERINE CERVIX.

PELVIC INFLAMMATORY DISEASE ACUTE --

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Cystitis -- Inflammation of the URINARY BLADDER, either from bacterial or non-bacterial causes. Cystitis is usually associated with painful urination (dysuria), increased frequency, urgency, and suprapubic pain.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

prostatitis -- Prostatitis: inflammation of the prostate, appreciated clinically as an enlarged, soft or tender prostate. Prostatic secretions contain large numbers of leukocytes.

BACTERIAL RESISTANCE --

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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ofloxacin.

Post-marketing surveillance reports indicate that the risk may be increased in patients receiving corticosteroids, especially the elderly.

(See PRECAUTIONS) Ofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon.

Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.

Tendon rupture can occur during or after therapy with quinolones, including ofloxacin.
Branded Drugs
The following US Branded drugs contain ofloxacin


FLOXIN -- ORTHO MCNEIL PHARMACEUTICAL INC

FLOXIN IN DEXTROSE 5% -- ORTHO MCNEIL PHARMACEUTICAL INC

FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- ORTHO MCNEIL PHARMACEUTICAL INC

OCUFLOX -- ALLERGAN INC

FLOXIN OTIC -- DAIICHI PHARMACEUTICAL CORP

FLOXIN -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC


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