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Ofloxacin (Systemic)

Pronunciation

Pronunciation

(oh FLOKS a sin)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Generic: 200 mg [DSC], 300 mg, 400 mg

Pharmacologic Category

  • Antibiotic, Fluoroquinolone

Pharmacology

Ofloxacin is a DNA gyrase inhibitor. DNA gyrase is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; bactericidal

Absorption

Well absorbed

Distribution

Widely distributed into body tissues and fluids, including blister fluid, cervix, lung, ovary, prostatic tissue, skin, and sputum; Vd: 2.4 to 3.5 L/kg

Excretion

Urine: 65% to 80% (as unchanged drug); feces: 4% to 8%; <10% is metabolized

Time to Peak

Serum: 1 to 2 hours

Half-Life Elimination

~9 hours (biphasic: 4 to 5 hours [6.4 to 7.4 hours in elderly patients] and 20 to 25 hours [accounts for <5%]); prolonged with renal impairment

Protein Binding

20% to 32%

Special Populations: Renal Function Impairment

Clearance is reduced in patients with CrCl <50 mL/minute.

Use: Labeled Indications

Treatment of acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections (uncomplicated), urethral and cervical gonorrhea (acute, uncomplicated), urethritis and cervicitis (nongonococcal) due to Chlamydia trachomatis infection, mixed infections of the urethra and cervix, pelvic inflammatory disease (acute), cystitis (uncomplicated), urinary tract infections (complicated), prostatitis

Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.

Use: Unlabeled

Epididymitis (nongonococcal), leprosy, Traveler's diarrhea

Contraindications

Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation

Dosing: Adult

Cervicitis/urethritis: Oral:

Nongonococcal (due to Chlamydia trachomatis): 300 mg every 12 hours for 7 days

Gonococcal (acute, uncomplicated): 400 mg as a single dose; Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.

Chronic bronchitis (acute exacerbation), community-acquired pneumonia, skin and skin structure infections (uncomplicated): Oral: 400 mg every 12 hours for 10 days

Pelvic inflammatory disease (acute): Manufacturer's labeling: 400 mg every 12 hours for 10 to 14 days. Note: The CDC recommends use only if standard cephalosporin therapy is not feasible (patients with severe cephalosporin allergy) and community prevalence of quinolone-resistant gonococcal organisms is low. CDC recommends use in combination with metronidazole. Follow-up and culture and sensitivity must be confirmed (CDC [Workowski 2015]).

Prostatitis: Oral: 300 mg every 12 hours for 6 weeks

UTI: Oral:

Uncomplicated: 200 mg every 12 hours for 3 to 7 days

Complicated: 200 mg every 12 hours for 10 days

Epididymitis (off-label use): Oral:

Likely caused by enteric organisms: 300 mg twice daily for 10 days (CDC [Workowski 2015]) or 200 mg twice daily for 14 days (Canadian STI Guidelines 2008 [Update 2014])

Likely caused by sexually transmitted chlamydia and gonorrhea and enteric organisms in men who practice insertive anal sex: 300 mg once daily for 10 days in combination with ceftriaxone (CDC [Workowski 2015])

Leprosy (multibacillary) (off-label use): Oral: 400 mg once daily (in combination with dapsone and rifampin) for 12 months (WHO 2012) or alternatively, 400 mg once monthly (in combination with monthly rifampin and minocycline) for 24 months (Villahermosa 2004; WHO 1998; WHO 2012).

Leprosy (paucibacillary) (off-label use): Oral:

Multiple-dose regimen: 400 mg once daily (in combination with rifampin) for 4 weeks (Balagon 2010).

Single-dose regimen: 400 mg as a single dose (in combination with single doses of rifampin and minocycline) (Manickam 2012). Note: Found to be less effective than standard WHO multiple drug therapy (WHO-MDT) for paucibacillary leprosy; should only be used if close follow-up of relapse is possible (Manickam 2012; Setia 2011).

Spontaneous bacterial peritonitis (off-label use): Oral: 400 mg twice daily (AASLD [Runyon 2012]; Navasa 1996)

Traveler's diarrhea (off-label use): Oral: 200 mg twice daily for 3 days (Hill 2006)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Adults: Oral: After a normal initial dose, adjust as follows:

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl 20 to 50 mL/minute: Administer usual recommended dose every 24 hours.

CrCl <20 mL/minute: Administer half the usual recommended dose every 24 hours.

Intermittent hemodialysis (IHD): 100 to 200 mg after dialysis (Aronoff 2007)

Peritoneal dialysis: 200 mg every 24 hours (Aronoff 2007)

Continuous renal replacement therapy (CRRT): 300 mg every 24 hours (Aronoff 2007)

Dosing: Hepatic Impairment

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Severe impairment (eg, cirrhosis with or without ascites): Maximum dose: 400 mg/day

Administration

Administer with or without food. Do not take within 2 hours of sucralfate, didanosine, iron, zinc, or antacids containing magnesium, calcium, or aluminum.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

Agomelatine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Agomelatine. Avoid combination

Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy

Antacids: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Exceptions: Sodium Bicarbonate. Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bendamustine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Bendamustine. Concentrations of the active metabolites of bendamustine may be decreased. Monitor therapy

Blood Glucose Lowering Agents: Quinolone Antibiotics may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Calcium Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Calcium Chloride. Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

CloZAPine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of CloZAPine. Management: Reduce the dose of clozapine to one-third of the original dose when adding a strong CYP1A2 inhibitor, and monitor patient response closely. Return to the original clozapine dose when the strong CYP1A2 inhibitor is removed. Consider therapy modification

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolone Antibiotics. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

CYP1A2 Substrates: CYP1A2 Inhibitors (Strong) may decrease the metabolism of CYP1A2 Substrates. Consider therapy modification

Delamanid: Quinolone Antibiotics may enhance the QTc-prolonging effect of Delamanid. Management: Avoid concomitant use of delamanid and quinolone antibiotics if possible. If coadministration is considered to be unavoidable, frequent monitoring of electrocardiograms (ECGs) throughout the full delamanid treatment period should occur. Consider therapy modification

Didanosine: Quinolone Antibiotics may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Consider therapy modification

DULoxetine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of DULoxetine. Avoid combination

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Iron Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral iron salts. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification

Ivabradine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Lanthanum: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolone antibiotics at least two hours before or after lanthanum. Consider therapy modification

Magnesium Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Consider therapy modification

MiFEPRIStone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolone Antibiotics. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolone Antibiotics. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Consider therapy modification

Mycophenolate: Quinolone Antibiotics may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Monitor therapy

Nadifloxacin: May enhance the adverse/toxic effect of Quinolone Antibiotics. Avoid combination

Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolone Antibiotics. Monitor therapy

Pentoxifylline: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Pentoxifylline. Monitor therapy

Pirfenidone: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Pirfenidone. Management: See full monograph for specific recommendations. Canadian product labeling specifically lists the use of pirfenidone with fluvoxamine as contraindicated. Consider therapy modification

Pomalidomide: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Pomalidomide. Management: Avoid when possible. Monitor toxicity closely when combined. In patients also receiving a P-gp inhibitor and strong CYP3A4 inhibitor, reduce pomalidomide dose by 50% (Canadian labeling says to reduce dose with any use of a strong CYP1A2 inhibitor). Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Probenecid: May decrease the excretion of Quinolone Antibiotics. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Probenecid may increase the serum concentration of Quinolone Antibiotics. Monitor therapy

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Quinapril: May decrease the serum concentration of Quinolone Antibiotics. Management: Separate doses of quinapril and oral quinolones by at least 2 hours in order to reduce the risk of interaction. Monitor for reduced efficacy of the quinolone if these products are used concomitantly. Consider therapy modification

Rasagiline: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Rasagiline. Management: Limit rasagiline dose to 0.5 mg once daily in patients taking strong CYP1A2 inhibitors. Consider therapy modification

Sevelamer: May decrease the absorption of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Strontium Ranelate: May decrease the serum concentration of Quinolone Antibiotics. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Avoid combination

Sucralfate: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after the sucralfate dose. Greater separation of doses may further lessen the risk for a significant interaction. Consider therapy modification

Tasimelteon: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Tasimelteon. Avoid combination

Theophylline Derivatives: Quinolone Antibiotics may decrease the metabolism of Theophylline Derivatives. Ciprofloxacin and enoxacin are of greatest concern. Theophylline/quinolone therapy might augment the seizure-producing potential of each of the individual agents. Exceptions: Dyphylline. Consider therapy modification

TiZANidine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of TiZANidine. Management: Tizanidine use with ciprofloxacin or fluvoxamine is contraindicated. If use with another strong inhibitor cannot be avoided, initiate tizanidine at an adult dose of 2 mg and increase in 2-4 mg increments based on response. Monitor closely. Avoid combination

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Varenicline: Quinolone Antibiotics may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concurrent use of levofloxacin or other quinolone antibiotics, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Vinflunine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Vitamin K Antagonists (eg, warfarin): Quinolone Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Zinc Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral zinc salts. Exceptions: Zinc Chloride. Consider therapy modification

Test Interactions

Some quinolones may produce a false-positive urine screening result for opioids using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opioid screens by more specific methods should be considered.

Adverse Reactions

1% to 10%:

Cardiovascular: Chest pain (1% to 3%)

Central nervous system: Headache (1% to 9%), insomnia (3% to 7%), dizziness (1% to 5%), fatigue (1% to 3%), somnolence (1% to 3%), sleep disorders (1% to 3%), nervousness (1% to 3%), pyrexia (1% to 3%)

Dermatologic: Rash/pruritus (1% to 3%)

Gastrointestinal: Diarrhea (1% to 4%), vomiting (1% to 4%), GI distress (1% to 3%), abdominal cramps (1% to 3%), flatulence (1% to 3%), abnormal taste (1% to 3%), xerostomia (1% to 3%), appetite decreased (1% to 3%), nausea (3% to 10%), constipation (1% to 3%)

Genitourinary: Vaginitis (1% to 5%), external genital pruritus in women (1% to 3%)

Ocular: Visual disturbances (1% to 3%)

Respiratory: Pharyngitis (1% to 3%)

Miscellaneous: Trunk pain

<1%, postmarketing, and/or case reports (limited to important or life-threatening): Anaphylaxis reactions, anxiety, blurred vision, chills, cognitive change, cough, depression, dream abnormality, ecchymosis, edema, erythema nodosum, euphoria, extremity pain, hallucinations, hearing acuity decreased, hepatic dysfunction, hepatic failure (some fatal), hepatitis, hepatotoxicity (idiosyncratic) (Chalasani, 2014), hyper-/hypoglycemia, hypertension, interstitial nephritis, intracranial pressure increased, lightheadedness, malaise, myasthenia gravis exacerbation, palpitation, paresthesia, peripheral neuropathy, photophobia, photosensitivity, pneumonitis, pseudotumor cerebri, psychotic reactions, rhabdomyolysis, seizure, Stevens-Johnson syndrome, syncope, tendonitis and tendon rupture, thirst, tinnitus, torsade de pointes, Tourette's syndrome, toxic epidermal necrolysis, vasculitis, vasodilation, vertigo, weakness, weight loss

ALERT: U.S. Boxed Warning

Tendonitis and tendon rupture:

Fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients (usually older than 60 years), patients taking corticosteroid drugs, and patients with kidney, heart, or lung transplants.

Myasthenia gravis:

Fluoroquinolones, including ofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ofloxacin in patients with a known history of myasthenia gravis.

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with a history of QTc prolongation, uncorrected hypokalemia, hypomagnesemia, or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).

• CNS effects: Tremor, restlessness, confusion, and very rarely hallucinations, increased intracranial pressure (including pseudotumor cerebri) or seizures may occur; use with caution in patients with known or suspected CNS disorder. Discontinue in patients who experience significant CNS adverse effects (eg, dizziness, hallucinations, suicidal ideations or actions).

• Glucose regulation: Fluoroquinolones have been associated with the development of serious, and sometimes fatal, hypoglycemia. These events have occurred most often in elderly patients with diabetes, but have also been reported in patients without a prior history of diabetes. Prompt identification and treatment of hypoglycemia is essential. Individual quinolones may differ in their potential to cause this effect. It was most evident with gatifloxacin (no longer marketed as s systemic formulation). Hyperglycemia has also been associated with the use of fluoroquinolones. Patients should be monitored closely for signs/symptoms of disordered glucose regulation.

• Hypersensitivity reactions: Severe, sometimes fatal, hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Peripheral neuropathy: Peripheral neuropathy has been reported (rare); may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur.

• Phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate to severe phototoxicity reactions. Discontinue use if photosensitivity occurs.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Tendon inflammation/rupture: [US Boxed Warning]: There have been reports of tendon inflammation and/or rupture with quinolone antibiotics; risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients >60 years of age. Rupture of the Achilles tendon sometimes requiring surgical repair has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps) have also been reported. Strenuous physical activity may be an independent risk factor for tendonitis. Discontinue at first sign of tendon inflammation or pain. May occur even after discontinuation of therapy.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support and deaths have been reported; avoid use in patients with myasthenia gravis.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required. May increase risk of tendon rupture.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.

• Seizures: Use with caution in individuals at risk of seizures (CNS disorders or concurrent therapy with medications which may lower seizure threshold). Potential for seizures, although very rare, may be increased with concomitant NSAID therapy.

• Syphilis: Since ofloxacin is ineffective in the treatment of syphilis and may mask symptoms, all patients should be tested for syphilis at the time of gonorrheal diagnosis and 3 months later. Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in the elderly.

• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with latent or actual G6PD deficiency.

Monitoring Parameters

Monitor CBC, renal and hepatic function periodically if therapy is prolonged.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Ofloxacin crosses the placenta and produces measurable concentrations in the amniotic fluid. Serum concentrations of ofloxacin may be lower during pregnancy than in nonpregnant patients (Giamarellou 1989). Based on available data, an increased risk of teratogenic effects has not been observed following ofloxacin use during pregnancy (Padberg 2014).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience vomiting or nausea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of tendon inflammation or rupture (pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints), signs of nerve problems (sensitivity to heat or cold; decreased sense of touch; burning, numbness, or tingling; pain, or weakness in the arms, hands, legs, or feet), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), angina, tachycardia, abnormal heartbeat, dizziness, passing out, chills, tinnitus, thrush, muscle pain, muscle weakness, hallucinations, nightmares, insomnia, vision changes, seizures, severe headache, severe loss of strength and energy, tremors, abnormal gait, shortness of breath, vaginitis, bruising, bleeding, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (rare) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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