ofloxacin

REMS

PO: Treatment of the following infections:
- Acute bacterial exacerbations of chronic bronchitis (should be used only when there are no other alternative treatment options),
- Community-acquired pneumonia (CAP),
- Acute uncomplicated cervical and urethral gonorrhea,
- Nongonococcal urethritis and cervicitis,
- Mixed infections of the urethra and cervix,
- Acute pelvic inflammatory disease,
- Urinary tract infections (should be used for acute uncomplicated cystitis only when there are no other alternative treatment options),
- Prostatitis,
- Uncomplicated skin and skin structure infections.
Otitis externa or otitis media.

Action ⬆ ⬇

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase enzyme.

Therapeutic effects:

Death of susceptible bacteria.

Spectrum:

Active against gram-positive pathogens including:
- Staphylococcus aureus,
- Staphylococcus epidermidis,
- Streptococcus pyogenes,
- Streptococcus pneumoniae.
Gram-negative spectrum notable for activity against:
- Escherichia coli,
- Klebsiella pneumoniae,
- Enterobacter aerogenes,
- Proteus mirabilis,
- Haemophilus influenzaeNeisseria gonorrhoeae,
- Moraxella catarrhalis.
Additional spectrum includes:
- Chlamydophylia pneumoniae,
- Legionella pneumoniae,
- Mycoplasma pneumoniae.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (98%) following oral administration.

Distribution: Widely distributed. High tissue and urinary levels are achieved. Appears to cross the placenta; enters breast milk.

Metabolism/Excretion: 70–80% excreted unchanged by the kidneys.

Half-Life: 5–7 hr.

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1–2 hr	12 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity (cross-sensitivity within class may exist);
QTc interval prolongation;
Uncorrected hypokalemia or hypomagnesemia;
Concurrent use of Class IA antiarrhythmics (disopyramide, quinidine, procainamide) or Class III antiarrhythmics (amiodarone, sotalol) (↑risk of QTc interval prolongation and torsade de pointes);
History of myasthenia gravis (may worsen symptoms including muscle weakness and breathing problems);
Lactation: Lactation.

Use Cautiously in:

Known or suspected CNS disorder;
Renal impairment (dose reduction recommended if CCr ≤50 mL/min );
Cirrhosis;
Concurrent use of corticosteroids (↑ risk of tendinitis/tendon rupture);
Kidney, heart, or lung transplant patients (↑ risk of tendinitis/tendon rupture);
Patients with or at risk for aortic aneurysms;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; .
Pedi: Safety and effectiveness not established in children;
Geri: risk for tendon disorders/rupture, hepatotoxicity, aortic aneurysm/dissection (within 2 mo following discontinuation), and QT interval prolongation.

Adv. Reactions/Side Effects ⬆ ⬇

CV: QT interval prolongation, AORTIC ANEURYSM/DISSECTION, TORSADE DE POINTES

Derm: photosensitivity, rash, STEVENS-JOHNSON SYNDROME

Endo: hyperglycemia, hypoglycemia

GI: diarrhea, nausea, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), abdominal pain, vomiting

GU: vaginitis

MS: arthralgia, myalgia, tendinitis, tendon rupture

Neuro: agitation, anxiety, confusion, depression, dizziness, ELEVATED INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), hallucinations, headache, insomnia, nightmares, paranoia, peripheral neuropathy, SEIZURES, SUICIDAL THOUGHTS, toxic psychosis, tremor

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use ofamiodarone, disopyramide, procainamide, dofetilide, quinidine, or sotalol↑ risk of potentially dangerous arrhythmias in susceptible individuals (avoid concurrent use).
May ↑ theophylline levels and the risk of toxicity.
Administration withantacids, iron salts, bismuth subsalicylate,sucralfate, and zinc salts↓ absorption.
May ↑ the effects of warfarin.
Levels and effectiveness may be ↓ by antineoplastic agents.
Cimetidine may interfere with elimination.
Probenecid↓ renal elimination.
May ↑ risk of nephrotoxicity from cyclosporine.
Concurrent corticosteroid therapy may ↑ risk of tendon rupture.
May ↑ risk of hypoglycemia when used with antidiabetic agents.

Absorption is impaired by concurrent enteral feeding (because of metal cations).
Absorption of ofloxacin is ↓ by foods and/or dairy products.

Route/Dosage ⬆ ⬇

Acute Bacterial Exacerbations of Chronic Bronchitis

PO (Adults ): 400 mg every 12 hr for 10 days.

Community-Acquired Pneumonia

PO (Adults ): 400 mg every 12 hr for 10 days.

Uncomplicated Skin/Skin Structure Infections

PO (Adults ): 400 mg every 12 hr for 10 days.

Uncomplicated Urethral and Cervical Gonorrhea

PO (Adults ): 400 mg single dose.

Nongonococcal Urethritis/Cervicitis

PO (Adults ): 300 mg every 12 hr for 7 days.

Mixed Infection of the Urethra and Cervix

PO (Adults ): 300 mg every 12 hr for 7 days.

Acute Pelvic Inflammatory Disease

PO (Adults ): 400 mg every 12 hr for 10–14 days.

Urinary Tract Infections

PO (Adults ): Uncomplicated cystitis due to E. coli or Klebsiella pneumoniae: 200 mg every 12 hr for 3 days; Uncomplicated cystitis due to Citrobacter diversus, Enterobacter aerogenes, Proteus mirabilis, or Pseudomonas aeruginosa: 200 mg every 12 hr for 7 days; Complicated urinary tract infection: 200 mg every 12 hr for 10 days.

Prostatitis

PO (Adults ): 300 mg every 12 hr for 6 wk.

Renal Impairment

PO (Adults ): CCr 20–50 mL/min: 100% of the usual dose every 24 hr; CCr <20 mL/min: 50% of the usual dose every 24 hr.
(Adults and Children ≥6 mo): Otitis externa 6 mo to 13 yr: : 5 drops instilled into affected ear once daily for 7 days; Otitis externa ≥13 yr: 10 drops instilled into affected ear once daily for 7 days. Acute otitis media in patients 1–12 yr old with tympanostomy tubes: 5 drops instilled into the affected ear twice daily for 10 days. Chronic suppurative otitis media with perforated tympanic membranes in patients ≥12 yr: 10 drops instilled into the affected ear twice daily for 14 days.

Availability ⬆ ⬇

(Generic available)

Tablets: 200 mg; 300 mg; 400 mg
Otic solution: 0.3%

Assessment ⬆ ⬇

Assess patient for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC; urinalysis; frequency and urgency of urination; cloudy or foul-smelling urine) at beginning of and during therapy.
Obtain specimens for culture and sensitivity prior to initiating therapy. First dose may be given before receiving results.
Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify physician or other health care professional immediately if these problems occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridioides difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.
Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.

Lab Test Considerations:

May cause ↑ serum AST, ALT, LDH, bilirubin, and alkaline phosphatase.
- May also cause ↑ or ↓ serum glucose.

Implementation ⬆ ⬇

PO: Administer on an empty stomach 1 hr before or 2 hr after meals, with a full glass of water. Products or foods containing calcium, magnesium, aluminum, iron, or zinc should not be ingested for 4 hr before and 2 hr after administration.
Otic: Warm solution by holding bottle in hand for 1–2 min to avoid dizziness from instillation of cold solution. Patient should lie with the affected ear upward, before instilling drops. Maintain position for 5 minutes. Repeat for opposite ear, if necessary. For otitis media: Pump the tragus 4 times by pushing inward to facilitate penetration into middle ear after instillation.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed at evenly spaced times and to finish drug completely, even if feeling better. Take missed doses as soon as possible, unless almost time for next dose. Do not double doses. Advise patient that sharing of this medication may be dangerous.
Advise patients to notify health care professional immediately if they are taking theophylline.
Encourage patient to maintain a fluid intake of at least 1500–2000 mL/day to prevent crystalluria.
Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will decrease absorption and should not be taken within 4 hr before and 2 hr after taking this medication.
May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, or recent myocardial ischemia or if fainting spells or palpitations occur. Patients with this history should not receive ofloxacin.
Caution patient to use sunscreen and protective clothing to prevent phototoxicity reactions during and for 5 days after therapy. Notify health care professional if a sunburn-like reaction or skin eruption occurs.
Advise patient that frequent mouth rinses, good oral hygiene, and sugarless gum or candy may minimize dry mouth.
Instruct patients being treated for gonorrhea that partners also must be treated.
Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
Instruct patient to notify health care professional immediately if rash, jaundice, signs of hypersensitivity, or tendon (shoulder, hand, Achilles, and other) pain, swelling, or inflammation occur. If tendon symptoms occur, avoid exercise and use of the affected area. Increased risk in >65 yrs old, kidney, heart and lung transplant recipients, and patients taking corticosteroids concurrently. Therapy should be discontinued.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Otic: Instruct parent in correct administration technique.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇