Ofloxacin

Dosage Forms & Strengths

tablet

• 200mg
• 300mg
• 400mg

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 due 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

Not indicated

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.

Ofloxacin is an antibiotic that is used to treat bacterial infections. It belongs to the fluoroquinolone class of antibiotics which includes levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Tequin), norfloxacin (Noroxin), moxifloxacin (Avelox), trovafloxacin (Trovan) and others. Ofloxacin stops the multiplication of bacteria by inhibiting the reproduction and repair of their genetic material (DNA). The FDA approved ofloxacin in December 1990.

PREPARATIONS: Tablets: 200, 300, and 400mg.

Ofloxacin should be stored in a closed container at 15 C - 30 C (59 F - 86 F).

Common Side Effects of Ofloxacin

Oral form: Tell your doctor if any of the following side effects of become severe or don't go away:

• Nausea, mild diarrhea, constipation, gas, or vomiting
• Stomach pain or cramps
• Loss of appetite
• Change in ability to taste food
• Headache
• Dry mouth
• Dizziness
• Excessive tiredness
• Pain, swelling, or itching of the vagina

Ear drops: Tell your doctor know if any of the following side effects become severe or don't go away:

• Ear pain or itching
• Changes in taste
• Dizziness

Eye drops: Tell your doctor if any of the following side effects become severe or don't go away:

• Blurred vision
• Burning, itching, stinging, redness, or discomfort in the eye
• Dry eyes, eye pain, or tearing
• Sensitivity to sunlight

Serious Side Effects of Ofloxacin

Oral form: Tell your doctor right away if you experience any of the symptoms listed in the Ofloxacin Warnings section above, or any of the following serious side effects:

• Severe diarrhea
• Confusion or hallucinations
• Nightmares or difficulty sleeping
• Depression, anxiety, or suicidal thoughts
• Uncontrollable shaking of a part of the body
• Restlessness
• Vision changes
• Fever
• Skin peeling or blistering
• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, throat, feet, ankles, or lower legs)
• Hoarseness
• Fast heartbeat
• Fainting
• Loss of consciousness
• Dark-colored urine, or a decrease in the amount of urine produced
• Yellowing of the skin or eyes (jaundice)
• Seizures
• Unusual bleeding or bruising
• Joint or muscle pain

Ear drops: Tell your doctor right away if you experience any of the following serious side effects:

• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, throat, feet, ankles, or lower legs)

Eye drops: Tell your doctor right away if you experience any of the following serious side effects:

• Signs of an infection, which may include fever, chills, or sore throat
• Severe itching
• Loss of consciousness
• Severe sensitivity to light
• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)

• Chlamydia in Women (Symptoms and Cures)
• Gonorrhea In Women
• STDs in Men
• Urinary Tract Infections (UTIs)

Ofloxacin is part of the drug class:

• Fluoroquinolones

Take ofloxacin exactly as prescribed.

Oral:

Ofloxacin comes in tablet form and is taken twice a day.

You may take ofloxacin with or without food, but you should drink plenty of water while taking ofloxacin.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of ofloxacin at the same time.

Topical:

Ofloxacin comes in a solution for ear drops. Do not use the ear drops in the eyes.

Ofloxacin comes in a solution for eye drops. Do not use the eye drops in the ears.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of ofloxacin at the same time.

WARNING: 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 over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

In the U.S.

• Floxin

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Applies to ofloxacin: intravenous solution, oral tablet

General

This drug was generally well tolerated, and side effects were mild in nature. In clinical trials, 11% of patients experienced side effects. Therapy was discontinued due to side effects in 4% of patients.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, abdominal pain and cramps, dry mouth, flatulence, gastrointestinal distress, constipation
Uncommon (0.1% to 1%): Abdominal pain
Rare (0.01% to 0.1%): Enterocolitis (sometimes hemorrhagic)
Frequency not reported: Dyspepsia
Postmarketing reports: Pseudomembranous colitis, gastrointestinal hemorrhage, intestinal perforation, hiccough, pyrosis, painful oral mucosa, pancreatitis, stomatitis[Ref]

The onset of pseudomembranous colitis symptoms has been reported during or after antimicrobial therapy.

Dyspepsia, flatulence, and constipation have also been reported during postmarketing experience. According to some authorities, pseudomembranous colitis was reported very rarely.[Ref]

Nervous system

Seizures were more likely to occur in elderly patients and in patients with renal dysfunction.

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.

A survey reported 6 cases of peripheral neuropathy associated with this drug. In 1 case, a 49-year-old female developed diffuse numbness, "pins and needles" sensation, burning pain, memory loss, visual impairment, joint pain, palpitations, altered sense of smell, insomnia, tinnitus, and severe panic attacks, with some symptoms persisting after 3 years.

Disturbances of taste, smell, hearing, and equilibrium were usually reversible after the drug was stopped.

Syncope and tremor have also been reported during postmarketing experience. According to some authorities, peripheral sensory neuropathy, peripheral sensory motor neuropathy, and convulsion were reported very rarely.[Ref]

Common (1% to 10%): Headache, dizziness, dysgeusia, somnolence
Uncommon (0.1% to 1%): Vertigo
Rare (0.01% to 0.1%): Paresthesia, parosmia
Very rare (less than 0.01%): Extrapyramidal symptoms or other disorders of muscular coordination, tinnitus, hearing loss
Frequency not reported: Seizures, cognitive change, syncope, tremor, decreased hearing acuity, sensory axonal polyneuropathy, sensorimotor axonal polyneuropathy, idiopathic intracranial hypertension
Postmarketing reports: Peripheral neuropathy (may be irreversible), peripheral sensory neuropathy, convulsion, peripheral sensory motor neuropathy, ataxia, incoordination, exacerbation of myasthenia gravis, exacerbation of extrapyramidal disorders, dysphasia, lightheadedness, taste disturbance, smell disturbance, hearing disturbance, equilibrium disturbance, dyskinesia, ageusia, hearing impaired[Ref]

Renal

Common (1% to 10%): Increased serum creatinine, increased BUN
Very rare (less than 0.01%): Acute renal failure
Frequency not reported: Nephrogenic diabetic insipidus
Postmarketing reports: Renal calculi, renal failure, interstitial nephritis, acute interstitial nephritis[Ref]

Hepatic

Common (1% to 10%): Elevated AST, elevated ALT
Rare (0.01% to 0.1%): Elevated liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase), elevated blood bilirubin
Very rare (less than 0.01%): Cholestatic jaundice
Postmarketing reports: Hepatic dysfunction (including hepatic necrosis, jaundice [cholestatic or hepatocellular], hepatitis [including severe cases]), hepatic failure (including fatal cases), elevated liver function tests (including GGT, LDH, bilirubin), severe liver injury (including acute liver failure [sometimes fatal])[Ref]

Severe liver injury (including cases of acute liver failure [sometimes fatal]) has been reported, primarily in patients with underlying liver disorders.[Ref]

Hematologic

Anemia (including hemolytic), leukopenia, and thrombocytopenia have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, elevated erythrocyte sedimentation rate
Very rare (less than 0.01%): Hemolytic anemia
Postmarketing reports: Aplastic anemia, hemorrhage, pancytopenia, agranulocytosis, reversible bone marrow depression, thrombotic thrombocytopenic purpura, petechiae, prothrombin time prolongation, ecchymosis/bruising, bone marrow failure[Ref]

Local

IV formulation:
-Common (1% to 10%): Injection site reactions (including phlebitis, swelling, erythema, pain)[Ref]

Musculoskeletal

Rare (0.01% to 0.1%): Tendinitis
Very rare (less than 0.01%): Arthralgia, myalgia, tendon rupture (e.g., Achilles tendon)
Postmarketing reports: Muscular weakness, rhabdomyolysis, myopathy, muscle tear, muscle rupture, ligament rupture, arthritis[Ref]

Tendinitis and tendon rupture have also been reported during postmarketing experience. Tendon rupture (sometimes bilateral) has been reported within 48 hours of starting therapy.[Ref]

Cardiovascular

Torsades de pointes were reported primarily in patients with risk factors for QT prolongation. This drug was associated with 2 cases of torsades de pointes reported to the US FDA between 1996 and 2001.

Tachycardia has also been reported during postmarketing experience. Tachycardia and hypotension have occurred during IV infusion (during postmarketing experience); in very rare cases, such a decrease in blood pressure has been severe.[Ref]

Rare (0.01% to 0.1%): Tachycardia, hypotension
Frequency not reported: Cardiac arrest, hypertension, palpitations, vasodilation
Postmarketing reports: Cerebral thrombosis, hypotension/shock, ventricular arrhythmias, ECG QT prolonged, torsades de pointes[Ref]

Hypersensitivity

According to some authorities, anaphylactic reaction and anaphylactoid reaction were reported rarely and anaphylactic shock and anaphylactoid shock were reported very rarely.[Ref]

Postmarketing reports: Anaphylactic reactions/shock, anaphylactoid reactions/shock, serum sickness[Ref]

Genitourinary

Hematuria has also been reported during postmarketing experience.

Crystalluria and cylindruria have been reported with other quinolones.[Ref]

Common (1% to 10%): External genital pruritus in women, vaginitis, vaginal discharge, glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria
Frequency not reported: Dysuria; urinary frequency; urinary retention; dysmenorrhea; menorrhagia; metrorrhagia; burning, irritation, pain, and rash of the female genitalia
Postmarketing reports: Vaginal candidiasis, albuminuria, candiduria, anuria, polyuria

Quinolones:
-Frequency not reported: Crystalluria, cylindruria[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Rare (0.01% to 0.1%): Urticaria, hyperhidrosis, pustular rash
Very rare (less than 0.01%): Erythema multiforme, toxic epidermal necrolysis, drug eruption, vascular purpura, vasculitis (sometimes leading to skin necrosis)
Frequency not reported: Angioedema, diaphoresis
Postmarketing reports: Hyperpigmentation, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption, purpura, acute generalized exanthematous pustulosis, drug rash[Ref]

A 75-year-old male developed toxic epidermal necrolysis and died of complications after receiving a total of 23.6 g of this drug orally over 51 days.

Angioedema, erythema multiforme, and toxic epidermal necrolysis have also been reported during postmarketing experience. According to some authorities, angioedema was reported rarely and photosensitivity was reported very rarely.[Ref]

Ocular

Common (1% to 10%): Visual disturbances
Uncommon (0.1% to 1%): Eye irritation
Frequency not reported: Photophobia
Postmarketing reports: Diplopia, nystagmus, blurred vision, conjunctivitis, uveitis

Quinolones:
-Frequency not reported: Ophthalmologic abnormalities (including cataracts, multiple punctate lenticular opacities)[Ref]

Ophthalmologic abnormalities (including cataracts and multiple punctate lenticular opacities) have been reported with other quinolones.[Ref]

Other

Asthenia has also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Fatigue, chest pain, fever, trunk pain, elevated alkaline phosphatase
Uncommon (0.1% to 1%): Fungal infection, pathogen resistance
Rare (0.01% to 0.1%): Hot flushes
Frequency not reported: Asthenia, chills, malaise, edema, extremity pain, pain, thirst, weight loss
Postmarketing reports: Elevated serum triglycerides, elevated serum cholesterol, elevated serum potassium, pyrexia, pain (including back, chest, extremities)[Ref]

Respiratory

Dyspnea (including severe dyspnea) and bronchospasm have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Pharyngitis
Uncommon (0.1% to 1%): Cough, nasopharyngitis
Rare (0.01% to 0.1%): Dyspnea, bronchospasm
Frequency not reported: Respiratory arrest, rhinorrhea, epistaxis
Postmarketing reports: Allergic pneumonitis, pulmonary edema, stridor[Ref]

Metabolic

Common (1% to 10%): Decreased appetite, hyperglycemia, hypoglycemia
Rare (0.01% to 0.1%): Anorexia
Postmarketing reports: Acidosis, hypoglycemic coma, porphyria attacks[Ref]

Hyperglycemia and hypoglycemia (especially in diabetic patients on insulin or oral hypoglycemic agents) have also been reported during postmarketing experience. Attacks of porphyria have been reported in patients with porphyria.[Ref]

Psychiatric

In 1 patient, a psychotic reaction to this drug presented with irritability, restlessness, insomnia, and irrational fear. The reaction was treated with haloperidol and resolved within 48 hours. One study suggests that the central nervous system effects of quinolones may be due to an interaction with the benzodiazepine-gamma-aminobutyric acid receptor complex and may be controlled by benzodiazepine administration.

Agitation, nervousness, psychotic reactions, and nightmares have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Insomnia, nervousness, sleep disorders
Uncommon (0.1% to 1%): Agitation
Rare (0.01% to 0.1%): Anxiety, depression, confusional state, psychotic disorder/reactions (e.g., hallucination), nightmares
Frequency not reported: Dream abnormality, euphoria, hallucinations
Postmarketing reports: Restlessness, psychotic disorder and depression with self-endangering behavior (including suicidal ideation, suicide attempt), suicidal thoughts or acts, disorientation, paranoia, phobia, aggressiveness/hostility, manic reaction, emotional lability[Ref]

Some side effects of ofloxacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

200 mg orally every 12 hours for 10 days

Use: For the treatment of complicated urinary tract infections due to E coli, K pneumoniae, P mirabilis, C diversus, or P aeruginosa

IDSA recommendations: 200 mg orally twice a day
Duration of therapy: 24 hours to 3 days

Comments:
-Travelers should be provided with 3 days of treatment and should be advised to reevaluate themselves 24 hours after starting therapy; if not completely well at 24 hours, patients should be advised to continue therapy until well or until they have completed the 3-day regimen.
-Current guidelines should be consulted for additional information.

Administration advice:
-May administer without regard to food
-Administer this drug at least 2 hours before or 2 hours after iron-, zinc-, calcium-, aluminum-, or magnesium-containing products (e.g., antacids, sucralfate, mineral supplements/multivitamins, buffered didanosine).
-Maintain adequate hydration of patients to prevent formation of highly-concentrated urine.

Storage requirements:
-Store at 20C to 25C (68F to 77F) in well-closed container.

General:
-This drug is indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) due to susceptible strains of the designated bacteria.
-Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
-Appropriate culture and susceptibility testing recommended before therapy to isolate and identify infecting organisms and to establish susceptibility to this drug. Therapy may be started before test results are known; appropriate therapy should be continued when results are available.
-Some strains of P aeruginosa may develop resistance relatively quickly during therapy.

Monitoring:
-Hematologic: Organ system functions, including hematopoietic (periodically during prolonged therapy)
-Hepatic: Organ system functions, including hepatic (periodically during prolonged therapy)
-Infections/Infestations: Culture and susceptibility (periodically during therapy)
-Metabolic: Blood glucose in diabetics
-Renal: Organ system functions, including renal (periodically during prolonged therapy)

Patient advice:
-Read the US FDA-approved Medication Guide.
-Drink plenty of fluids.
-Avoid missing doses and complete the entire course of therapy.
-Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Contact physician if sunburn-like reaction or skin eruption develops.
-Do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination until you know how the drug affects you.
-Stop this drug immediately and contact healthcare provider if a serious side effect occurs.
-Stop this drug and contact healthcare provider if tendon pain, swelling, or inflammation develops or you have weakness or are unable to use 1 of your joints; rest and do not exercise.
-Stop this drug at once and contact physician if symptoms of peripheral neuropathy develop.
-Contact physician immediately if any muscle weakness worsens or respiratory problems develop or if watery and bloody stools occur; contact physician if persistent headache (with or without blurred vision) or signs/symptoms of liver injury occur.
-Stop this drug immediately at first sign of rash or other symptoms of allergic reaction.