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Ofloxacin

Brand Name: Floxin

Generic Name: Ofloxacin

Drug Class: Fluoroquinolones

What Is Ofloxacin and How Does It Work?

Ofloxacin is a broad-spectrum fluoroquinolone antibiotic used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.

Ofloxacin is available under the following different brand names: Floxin.

Dosages of Ofloxacin

What Are Dosages of Ofloxacin?

Dosages of Ofloxacin:

Dosage Forms and Strengths

Tablet

  • 200 mg
  • 300 mg
  • 400 mg
Dosage Considerations – Should be Given as Follows:

Bronchitis Exacerbation

  • 400 mg orally every 12 hours for 10 days
  • Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Community-Acquired Pneumonia

  • 400 mg orally every 12 hours for 10 days

Skin and Skin Structure Infections

  • 400 mg orally every 12 hours for 10 days

Acute, Uncomplicated Urethral and Cervical Gonorrhea

  • No longer recommended for gonorrhea due to widespread resistance in the U.S.
  • 400 mg orally single dose

Non-gonococcal Cervicitis/Urethritis or Mixed Infection of Cervix/Urethra

  • 300 mg orally every 12 hours for 7 days

Acute Pelvic Inflammatory Disease

  • 400 mg orally every 12 hours for 10-14 days

Uncomplicated Cystitis

  • Due to E. coli or K. pneumoniae: 200 mg orally every 12 hours for 3 days
  • Due to other approved pathogens: 200 mg orally every 12 hours for 7 days
  • Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections

Complicated Urinary Tract Infections (UTIs)

  • 200 mg orally every 12 hours for 10 days

Prostatitis Due to E. coli

  • 300 mg orally every 12 hours for 6 weeks

Traveler's Diarrhea (Off-label)

  • 300 mg orally every 12 hours for 1-3 days

Dosage Modifications

Renal impairment

  • CrCl 20-50 mL/min: Give every 24 hours
  • CrCl less than 20 mL/min: Give one-half usual dose every 24 hours

Other Indications and Uses

  • Mild to moderate infection due to susceptible strains of designated microorganisms
  • Chlamydia trachomatis, Citrobacter spp, Enterobacter spp, E. coli, Klebsiella pneumoniae, N. gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, S. aureus, S. pneumoniae
  • Culture and susceptibility tests are needed to isolate and identify organisms

Not indicated for pediatric use

What Are Side Effects Associated with Using Ofloxacin?

Common side effects of ofloxacin include:

Less common side effects of ofloxacin include:

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Ofloxacin?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

  • Ofloxacin has no known severe interactions with other drugs.
  • Ofloxacin has serious interactions with at least 42 different drugs.
  • Ofloxacin has moderate interactions with at least 162 different drugs.
  • Ofloxacin has mild interactions with at least 94 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

What Are Warnings and Precautions for Ofloxacin?

Warnings

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system (CNS) effects.

Discontinue the drug immediately and avoid the use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions.

May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with a known history of myasthenia gravis.

Serious adverse effects and limitations-of-use:

  • Both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system.
  • These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.
  • Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (UTIs), that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.
  • For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option.

This medication contains ofloxacin. Do not take Floxin if you are allergic to ofloxacin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Documented hypersensitivity

Effects of Drug Abuse

  • None

Short-Term Effects

  • See "What Are Side Effects Associated with Using Ofloxacin?"

Long-Term Effects

  • See "What Are Side Effects Associated with Using Ofloxacin?"

Cautions

  • May produce false-positive urine opiate screening.
  • No longer recommended for gonorrhea due to widespread resistance in the U.S.
  • In prolonged therapy, perform periodic evaluations of organ system functions (e.g., renal, hepatic, hematopoietic); adjust the dose in renal function impairment; super-infections may occur with prolonged or repeated antibiotic therapy.
  • Not drug of the first choice in pediatrics due to increased incidence of adverse events compared to controls, including arthropathy; no data exist for dose for pediatric patients with renal impairment (i.e., CrCl less than 50 mL/min).
  • Convulsions increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis was reported with fluoroquinolones.
  • Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190.
  • Peripheral neuropathy:
    • Peripheral neuropathy may occur rapidly after initiating therapy and may potentially become permanent.
    • The development of peripheral neuropathy appears to be unrelated to the duration of therapy or the age of the patient.
    • If peripheral neuropathy develops, discontinue the fluoroquinolone and treat it with an alternative non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.

Pregnancy and Lactation

Use of ofloxacin with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

Ofloxacin is excreted in breast milk. Discontinue the drug or do not a nurse.