Ofloxacin (Systemic)

• It is used to treat bacterial infections.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how ofloxacin affects you.
• Do not use longer than you have been told. A second infection may happen.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Tell your doctor if you have signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
• Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take ofloxacin.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Drink lots of noncaffeine liquids after using ofloxacin unless told to drink less liquid by your doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Rarely, very bad and sometimes deadly effects have happened with this medicine. These include muscle or joint, kidney, liver, blood, and other problems. Talk with the doctor if you have questions.
• If you are over the age of 60, use ofloxacin (systemic) with care. You could have more side effects.
• This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Use ofloxacin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take with a full glass of water.
• Do not take dairy products, antacids, didanosine, sucralfate, multivitamins, or other products that contain calcium, magnesium, aluminum, iron, or zinc within 2 hours before or 2 hours after taking this medicine.
• To gain the most benefit, do not miss doses.
• Keep using ofloxacin as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Antibiotic, Fluoroquinolone

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

Epididymitis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines and the Canadian Guidelines on Sexually Transmitted Infections, ofloxacin is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend ofloxacin in combination with ceftriaxone for acute epididymitis likely caused by sexually transmitted chlamydia and gonorrhea and enteric organisms in men who practice insertive anal sex.

Leprosy (multibacillary)

Data from a limited number of patients in an open-label, parallel assessment study suggest that ofloxacin, in combination with rifampin and minocycline (ROM), may be beneficial for the treatment of multibacillary leprosy [Villahermosa 2004]. Additional data may be necessary to further define the role of ofloxacin in this condition.

The World Health Organization Expert Committee on Leprosy (Eighth report) and the National Hansen's Disease Program also supports the use of ofloxacin as a second line agent in the treatment of multibacillary leprosy for patients who cannot take clofazimine (no longer commercially available in the US).

Leprosy (paucibacillary)

Data from a randomized double-blind trial comparing a daily dose of ofloxacin (in combination with daily doses of rifampin) for 4 weeks with the standard 6-month WHO-MDT regimen supports the use of a daily ofloxacin regimen for this condition [Balagon 2010]. Another randomized double-blind study suggests the use of single dose ofloxacin, in combination with rifampin and minocycline (ROM), may be beneficial as an alternative treatment regimen for paucibacillary leprosy in patients where careful follow-up for relapse is possible [Manickam 2012]. Additional trials may be necessary to further define the role of multiple and single dose ofloxacin regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend ofloxacin for the treatment of paucibacillary leprosy.

Spontaneous bacterial peritonitis (treatment)

According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), ofloxacin may be considered as an alternative therapy to IV third-generation cephalosporins in patients with uncomplicated SBP who are not infected with a suspected quinolone-resistant organism. If fluoroquinolone-resistant, gram-negative bacteria are suspected as the causative organisms, when fluoroquinolones have been used for prophylaxis, or when patients are located in areas where incidence of quinolone-resistant bacterial infections are high, cefotaxime is the treatment of choice.

Traveler's diarrhea

Based on the Infectious Diseases Society of America 2006 Guidelines for the Practice of Travel Medicine, ofloxacin is an effective and recommended fluoroquinolone for antibiotic treatment of traveler’s diarrhea.

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)

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%), drowsiness (1% to 3%), sleep disorder (1% to 3%), nervousness (1% to 3%), pain (trunk)

Dermatologic: Pruritus (≤3%), skin rash (≤3%), genital pruritus (women: 1% to 3%)

Gastrointestinal: Nausea (3% to 10%), diarrhea (1% to 4%), vomiting (1% to 4%), abdominal cramps (1% to 3%), constipation (1% to 3%), decreased appetite (1% to 3%), dysgeusia (1% to 3%), flatulence (1% to 3%), gastrointestinal distress (1% to 3%), xerostomia (1% to 3%)

Genitourinary: Vaginitis (1% to 5%)

Ophthalmic: Visual disturbance (1% to 3%)

Respiratory: Pharyngitis (1% to 3%)

Miscellaneous: Fever (1% to 3%)

<1% (Limited to important or life-threatening): Abnormal dreams, anaphylaxis, anxiety, auditory disturbance (decreased acuity), blurred vision, chills, cognitive dysfunction, cough, depression, ecchymosis, edema, erythema nodosum, euphoria, exacerbation of myasthenia gravis, Gilles de la Tourette's syndrome, hallucination, hepatic insufficiency, hepatic failure, hepatitis, hepatotoxicity (idiosyncratic; Chalasani 2014), hyperglycemia, hypoglycemia, hypertension, increased intracranial pressure, increased thirst, interstitial nephritis, limb pain, malaise, palpitations, paresthesia, peripheral neuropathy, photophobia, pneumonitis, pseudotumor cerebri, psychotic reaction, rhabdomyolysis, rupture of tendon, seizure, skin photosensitivity, Stevens-Johnson syndrome, syncope, tendonitis, tinnitus, torsades de pointes, toxic epidermal necrolysis, vasculitis, vasodilatation, vertigo, weakness, weight loss

• 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.