ofloxacin (Rx)

Brand and Other Names:Floxin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
  • 300mg
  • 400mg
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Bronchitis Exacerbation

400 mg PO q12hr 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 PO q12hr for 10 days

Skin & Skin Structure Infections

400 mg PO q12hr for 10 days

Acute, Uncomplicated Urethral and Cervical Gonorrhea

No longer recommended for gonorrhea owing to widespread resistance in the US

400 mg PO single dose

Nongonococcal Cervicitis/Urethritis or Mixed Infection of Cervix/Urethra

300 mg PO q12hr for 7 days

Acute Pelvic Inflammatory Disease

400 mg PO q12hr for 10-14 days

Uncomplicated Cystitis

Due to E. coli or K. pneumoniae: 200 mg PO q12hr for 3 days

Due to other approved pathogens: 200 mg PO q12hr for 7 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections

Complicated UTIs

200 mg PO q12hr for 10 days

Prostatitis Due to E. Coli

300 mg PO q12hr for 6 weeks

Traveler's Diarrhea (Off-label)

300 mg PO q12hr for 1-3 days

Dosage Modifications

Renal impairment

  • CrCl 20-50 mL/min: Give q24hr
  • CrCl <20 mL/min: Give one-half usual dose q24hr

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 needed to isolate and identify organisms

Safety and efficacy not established

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Interactions

Interaction Checker

and ofloxacin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nausea (3-10%)

            Headache (1-9%)

            Insomnia (3-7%)

            Dizziness (1-5%)

            Vaginitis (1-5%)

            Diarrhea (1-4%)

            Vomiting (1-4%)

            Appetite decreased (1-3%)

            Abdominal cramps (1-3%)

            Abnormal taste (1-3%)

            Chest pain (1-3%)

            External genital pruritis in women (1-3%)

            Fatigue (1-3%)

            Flatulence (1-3%)

            GI distress (1-3%)

            Nervousness (1-3%)

            Pharyngitis (1-3%)

            Pyrexia (1-3%)

            Rash/pruritis (1-3%)

            Sleep disorders (1-3%)

            Visual disturbances (1-3%)

            Xerostomia (1-3%)

            <1%

            Prolonged QT interval

            Torsades de pointes

            Syncope

            Vasculitis

            Edema

            HTN

            Palpitations

            Vasodilation

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Agranulocytosis

            Aplastic anemia

            Pancytopenia

            Thrombocytopenia

            Thrombocytopenic purpura

            Acute hepatitis

            Hepatic failure

            Hepatic necrosis

            Immune hypersensitivity reaction

            Rupture of tendon, Tendinitis

            Peripheral neuropathy

            Seizure

            Acute renal failure

            Interstitial nephritis

            Renal impairment

            Tourette's syndrome

            Decr hearing acuity

            Tinnitus

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            Warnings

            Black Box Warnings

            Serious adverse effects

            • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects
            • Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions
            • May exacerbate muscle weakness in patients with myasthenia gravis; fluoroquinolones should be avoided in patients with known history of myasthenia gravis
            • Because fluoroquinolones have been associated with serious adverse reactions, reserve drug use in patients who have no alternative treatment options for the following indications: Acute bacterial sinusitis; acute bacterial exacerbation of chronic bronchitis

            Contraindications

            Hypersensitivity to ofloxacin or any member of the quinolone class of antibacterials

            Cautions

            Fluoroquinolones been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient; adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); discontinue treatment immediately at the first signs or symptoms of any serious adverse reaction; avoid use in patients who have experienced any of these serious adverse reactions

            Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages; adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons (see Black Box Warnings)

            In prolonged therapy, perform periodic evaluations of organ system function (eg, renal, hepatic, hematopoietic); superinfections may occur with prolonged or repeated antibiotic therapy

            Phototoxicity reactions may occur; avoid excessive sunlight

            Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent

            Serious, sometimes fatal hypoglycemia reported including in patients without a history of hypoglycemia (common with gatifloxacin, which is no longer marketed); monitor glucose levels closely in patients with diabetes; if hypoglycemic reaction occurs, discontinue therapy and initiate appropriate therapy immediately

            Avoid use in presence of drugs or conditions that prolong QT interval, patients with known prolongation of the QT interval, patients with ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions, patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia or patients with hypokalemia or hypomagnesemia

            Not drug of 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 (ie, CrCl <50 mL/min)

            Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis 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
            • 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 with an alternative non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk

            CNS effects

            • Fluoroquinolones have been associated with an increased risk of CNS effects, including: convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis
            • May also cause CNS events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care
            • Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)

            FDA MedWatch Safety Alert

            • Issued July 10, 2018
            • The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects
            • Hypoglycemia, sometimes resulting in coma, occurred more frequently in elderly patients or in diabetic patients taking oral hypoglycemic medicine or insulin
            • Alert patients regarding hypoglycemic symptoms and carefully monitor blood glucose levels; instruct patients how to treat themselves if symptoms of hypoglycemia occur
            • This safety alert affects only systemic formulations; early signs and symptoms of low blood glucose include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, and/or unusual anxiety
            • Mental health side effects are to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium
            • Inform patients of the potential risk of psychiatric adverse reactions that can occur after just 1 dose
            • Immediately discontinue treatment if CNS adverse effects occur, including psychiatric adverse reactions, or blood glucose disturbances occur and switch to a nonfluoroquinolone antibiotic if possible
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: excreted in breast milk, discontinue drug or do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits bacterial DNA gyrase, which in turn inhibits DNA replication and transcription, DNA repair, recombination and transposicion, causing bacterial cell death.

            Absorption

            Well absorbed; food causes only minor alterations

            Bioavailability: 98%

            Distribution

            Protein Bound: 32%

            Vd: 2.4-3.5 L/kg

            Elimination

            Half-Life: 4-5 hr

            Excretion: Urine (up to 80% unchanged; <5% metabolites); feces 4-8%

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            Administration

            Oral Administration

            Do not take with antacids or dairy products

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.