Ofloxacin
Ofloxacin (Floxin)
Ofloxacin
(oh- FLOX-ah-zeen)
Pregnancy Category: C Floxin Floxin Otic Ocuflox (Rx)

Classification: Antibacterial, fluoroquinolone

See Also: See also Anti-Infectives .

Action/Kinetics: Effective against a wide range of gram-positive and gram-negative aerobic and anaerobic bacteria. Penicillinase has no effect on the activity of ofloxacin. Widely distributed to body fluids. Maximum serum levels: 1-2 hr. t 1/2, first phase: 5-7 hr; second phase: 20-25 hr. Peak serum levels at steady state, after PO doses: 1.5 mcg/mL after 200-mg doses, 2.4 mcg/mL after 300-mg doses, and 2.9 mcg/mL after 400-mg doses. Between 70% and 80% is excreted unchanged in the urine.

Uses: Systemic: (1) Pneumonia or acute bacterial exacerbations of chronic bronchitis or community-acquired pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae. Not a drug of first choice in the treatment of presumed or confirmed pneumococcal pneumonia. Not effective for syphilis. (2) Acute, uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae; nongonococcal urethritis, and cervicitis due to Chlamydia trachomatis. Mixed infections of the urethra and cervix due to N. gonorrhoeae and C. trachomatis. (3) Mild to moderate skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes or Proteus mirabilis. (4) Uncomplicated cystitis due to Citrobacter diversus, Enterobacter aerogenes, E. coli, Klebsiella pneumoniae, Proteus mirabilis or Pseudomonas aeruginosa. (5) Complicated UTIs due to Escherichia coli, K. pneumoniae, P. mirabilis, C. diversus or P. aeruginosa. (6) Prostatitis due to E. coli. Monotherapy for PID.
Ophthalmic: Treatment of conjunctivitis caused by S. aureus, Staphylococcus epidermidis, S. pneumoniae, Enterobacter cloacae, H. influenzae, P. mirabilis and P. aeruginosa. Corneal ulcers caused by susceptible organisms.
Otic: (1) Otitis externa due to S. aureus and P. aeruginosa in clients one year of age and older. (2) Acute otitis media with tympanostomy tubes due to S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, and P. aeruginosa (from age one to twelve). (3) Chronic suppurative otitis media due to S. aureus, P. mirabilis, and P. aeruginosa in those twelve years and older who have perforated tympanic membranes.

Contraindications: Hypersensitivity to quinolone antibacterial agents. Use during lactation. Use for syphilis (ineffective). Ophthalmic use in dendritic keratitis, vaccinia, varicella, mycobacterial infections of the eye, fungal diseases of the eye, and with steroid combinations after uncomplicated removal of a corneal foreign body.

Special Concerns: Safety and effectiveness of the systemic forms have not been established in children, adolescents under the age of 18 years, pregnant women, and lactating women. Safety and effectiveness of the ophthalmic form have not been established in children less than 1 year of age. Use with caution in clients with known or suspected CNS disorders such as severe cerebral atherosclerosis, epilepsy, or factors that predispose to seizures.

Side Effects: See also Side Effects for Fluroquinolones.
GI: Nausea, diarrhea, vomiting, abdominal pain or discomfort, dry or painful mouth, dyspepsia, flatulence, constipation, pseudomembranous colitis, dysgeusia, decreased appetite. CNS: Headache, dizziness, fatigue, malaise, somnolence, depression, insomnia, seizures, sleep disorders, nervousness, anxiety, cognitive change, dream abnormality, euphoria, hallucinations, vertigo. CV: Chest pain, edema, hypertension, palpitations, vasodilation. Hypersensitivity reactions: Dyspnea, anaphylaxis. GU: External genital pruritus in women, vaginitis, vaginal discharge; burning, irritation, pain, and rash of the female genitalia; glucosuria, proteinuria, hematuria, pyuria, dysmenorrhea, menorrhagia, metrorrhagia, urinary frequency or pain. Respiratory: Cough, rhinorrhea. Dermatologic: Diaphoresis, vasculitis, photosensitivity, rash, pruritus. Hematologic: Leukocytosis, lymphocytopenia, eosinophilia. Musculoskeletal: Asthenia, extremity pain, arthralgia, myalgia, possibility of osteochondrosis. Miscellaneous: Chills, malaise, syncope, hyperglycemia or hypoglycemia, whole body pain, thirst, weight loss, photophobia, trunk pain, paresthesia, visual disturbances, hypersensitivity, hearing loss, fever.
After ophthalmic use: Transient ocular burning or discomfort, stinging, redness, itching, photophobia, tearing, and dryness.
After otic use: Pruritus, application site reaction, dizziness, earache, vertigo, taste perversion, paresthesia, rash.

Laboratory Test Alterations: ALT, AST.

How Supplied: Ophthalmic solution: 0.3%; Otic Solution: 0.3%; Tablet: 200 mg, 300 mg, 400 mg

Dosage
?Tablets Pneumonia, exacerbation of chronic bronchitis.
400 mg q 12 hr for 10 days.
Acute uncomplicated gonorrhea.
One 400-mg dose. The Centers for Disease Control also recommend adding doxycycline.
Cervicitis/urethritis due to C. trachomatis or N. gonorrhoeae.
300 mg q 12 hr for 7 days.
Mild to moderate skin and skin structure infections.
400 mg q 12 hr for 10 days.
Cystitis due to E. coli or K. pneumoniae.
200 mg q 12 hr for 3 days.
Cystitis due to other organisms.
200 mg q 12 hr for 7 days.
Complicated UTIs.
200 mg q 12 hr for 10 days.
Prostatitis.
300 mg q 12 hr for 6 weeks.
Chlamydia.
300 mg PO b.i.d. for 7 days.
Epididymitis.
300 mg PO b.i.d. for 10 days.
PID, outpatient.
400 mg PO b.i.d. for 14 days.

NOTE: The dose should be adjusted in clients with a C _CR of 50 mL/min or less. If the C _CR is 10-50 mL/min, the dosage interval should be q 24 hr, and if C _CR is less than 10 mL/min, the dose should be half the recommended dose given q 24 hr.