Floxin


ofloxacin

Exocin (UK), Floxin, Ocuflox, Tarivid (UK)

Pharmacologic class: Fluoroquinolone

Therapeutic class: Anti-infective

Pregnancy risk category C

FDA Box Warning

• Fluoroquinolones for systemic use are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in patients usually over age 60, with concomitant use of corticosteroids, and in kidney, heart, and lung transplant recipients.

• Drug may exacerbate muscle weakness in patients with myasthenia gravis. Avoid use in patients with known history of myasthenia gravis.

Action

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase in susceptible bacteria

Availability

Ophthalmic solution: 3 mg/ml (0.3%)

Otic solution: 0.3%

Tablets: 200 mg, 300 mg, 400 mg

Indications and dosages

➣ Prostatitis caused by Escherichia coli

Adults: 300 mg P.O. q 12 hours for 6 weeks

➣ Complicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, or Proteus mirabilis

Adults: 200 mg P.O. q 12 hours for 10 days

➣ Uncomplicated cystitis caused by E. coli or K. pneumoniae

Adults: 200 mg P.O. q 12 hours for 3 days

➣ Acute uncomplicated urethral and cervical gonorrhea

Adults: 400 mg P.O. as a single dose

➣ Nongonococcal cervicitis or urethritis caused by Chlamydia trachomatis; mixed infections of cervix or urethra caused by C. trachomatis or Neisseria gonorrhoeae

Adults: 300 mg P.O. q 12 hours for 7 days

➣ Acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, and uncomplicated skin and skin-structure infections caused by susceptible organisms

Adults: 400 mg P.O. q 12 hours for 10 days

➣ Acute pelvic inflammatory disease

Adults: 400 mg P.O. q 12 hours for 10 to 14 days

➣ Bacterial conjunctivitis

Adults and children ages 1 and older: One to two drops of ophthalmic solution in affected eye q 2 to 4 hours on days 1 and 2; then one to two drops q.i.d. on days 3 through 7

➣ Corneal ulcers

Adults: One to two drops of ophthalmic solution in affected eye q 30 minutes while awake on days 1 and 2, then one to two drops q hour while awake on days 3 to 7, then one to two drops q.i.d. while awake on days 7 to 9

➣ Otitis externa

Adults and children ages 13 and older: 10 drops of otic solution into affected ear daily for 7 days

➣Chronic suppurative otitis media with perforated tympanic membrane

Adults and children ages 12 and older: 10 drops of otic solution into affected ear b.i.d. for 14 days

Dosage adjustment

• Renal impairment

• Severe hepatic impairment

Contraindications

• Hypersensitivity to drug or other fluoroquinolones

Precautions

Use cautiously in:

• underlying CNS disease, renal impairment, cirrhosis, bradycardia, acute myocardial ischemia

• known history of myasthenia gravis (avoid use)

• history of tendinitis or tendon rupture with fluoroquinolone use

• dialysis patients

• elderly patients

• pregnant or breastfeeding patients (safety not established except in postex-posure inhalation or cutaneous anthrax).

• children younger than age 18 (except in postexposure inhalation or cutaneous anthrax and in ophthalmic and otic use).

Administration

• Don't give zinc- or iron-containing drugs within 2 hours of ofloxacin.

Adverse reactions

CNS: dizziness, drowsiness, headache, light-headedness, insomnia, acute psychoses, agitation, confusion, tremors, hallucinations, increased intracranial pressure, seizures

CV: chest pain, vasodilation

GI: nausea, diarrhea, constipation, abdominal pain, pseudomembranous colitis

GU: interstitial cystitis, vaginitis

Hematologic: eosinophilia, leukopenia

Musculoskeletal: tendinitis, tendon rupture, joint pain, back pain

Skin: rash, photosensitivity, phototoxicity, Stevens-Johnson syndrome

Other: altered taste, superinfection, myasthenia gravis exacerbation

Interactions

Drug-drug. Amiodarone, bepridil, disopyramide, erythromycin, pentamidine, phenothiazines, pimozide, procainamide, quinidine, sotalol, tricyclic antidepressants: increased risk of serious adverse cardiovascular reactions

Antacids, bismuth subsalicylate, iron or zinc salts, sucralfate: decreased ofloxacin absorption

Corticosteroids: increased risk of tendon rupture

Probenecid: decreased renal elimination of ofloxacin

Theophylline: increased theophylline blood level and possible toxicity

Warfarin: increased warfarin effects

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, platelets: increased levels

Hemoglobin, hematocrit: decreased values

Drug-food. Milk or yogurt (consumed alone), tube feedings: impaired drug absorption

Drug-herbs. Fennel: decreased drug absorption

Dong quai, St. John's wort: phototoxicity

Drug-behaviors. Sun exposure: phototoxicity

Patient monitoring

• Assess patient for signs and symptoms of superinfection.

• Inspect for rash. Check for signs and symptoms of hypersensitivity reaction.

See Watch for fever with diarrhea; diarrhea containing pus; or severe, persistent diarrhea; and tendinitis or tendon rupture.

• Evaluate neurologic status closely.

Patient teaching

• Encourage patient to maintain fluid intake of at least 1,500 ml daily to prevent crystalluria.

• Inform patient being treated for gonorrhea that partners must be treated.

See Tell patient to immediately report fever and diarrhea, especially if stool contains blood, pus, mucus. Caution him not to treat diarrhea without consulting prescriber.

See Instruct patient to stop taking drug and immediately report rash or tendon pain or inflammation.

• Instruct patient not to take iron- or zinc-containing drugs or antacids within 2 hours of ofloxacin.

• Teach patient ways to counteract photosensitivity, such as by wearing sunglasses and avoiding excessive exposure to bright light.

• Teach patient how to use eye or ear drops. Caution him not to touch dropper tip to any surface (including eye or ear).

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

ofloxacin

(oh-flox-a-sin) ofloxacin,

Floxin

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: fluoroquinolones
Pregnancy Category: C
See for ophthalmic use

Indications

Oral: Treatment of the following bacterial infections:
  • Urinary tract and gynecologic infections, including cystitis, gonorrhea, nongonococcal urethritis and cervicitis, acute pelvic inflammatory disease, and prostatitis,
  • Respiratory tract infections, including acute exacerbations of chronic bronchitis, and community-acquired pneumonia,
  • Uncomplicated skin and skin structure infections.
Otic: Otitis externa or otitis media.

Action

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase enzyme.

Therapeutic effects

Death of susceptible bacteria.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 and Excretion: 70–80% excreted unchanged by the kidneys.Half-life: 5–7 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POrapid1–2 hr12 hr

Contraindications/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); Pediatric: Children (safety and effectiveness not established); Obstetric: Pregnancy.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); Geriatric: ↑ risk of adverse reactions; Lactation: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • dizziness (most frequent)
  • drowsiness
  • headache (most frequent)
  • insomnia (most frequent)
  • agitation
  • confusion
  • peripheral neuropathy

Cardiovascular

  • torsade de pointes (life-threatening)
  • QT interval prolongation

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • abdominal pain
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting

Genitourinary

  • vaginitis

Dermatologic

  • stevens-johnson syndrome (life-threatening)
  • photosensitivity
  • rash

Endocrinologic

  • hyperglycemia
  • hypoglycemia

Musculoskeletal

  • tendinitis
  • tendon rupture

Neurologic

  • peripheral neuropathy

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use ofamiodarone, disopyramide, procainamide, dofetilide, quinidine, or sotalol ↑ risk of potentially dangerous arrhythmias in susceptible individuals (avoid concurrent use).↑ serum theophylline levels and may lead to toxicity.Administration withantacids, iron salts, bismuth subsalicylate,sucralfate, and zinc salts ↓ absorption.May increase the effects of warfarin.Serum levels 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.Absorption is impaired by concurrent enteral feeding (because of metal cations).Absorption of ofloxacin is ↓ by foods and/or dairy products.

Route/Dosage

Oral (Adults) Most infections—400 mg q 12 hr (for 3–10 days depending infection). Urethritis/cervicitis—300 mg q 12 hr (for 7 days). Prostatitis—300 mg q 12 hr (for 6 weeks). Urinary tract infections—200 mg q 12 hr. Gonorrhea—400 mg single dose.

Renal Impairment

Oral (Adults) CCr 20–50 mL/min—100% of the usual dose q 24 hr; CCr <20 mL/min—50% of the usual dose q 24 hr.Otic (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%

Nursing implications

Nursing 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 pseudomembranous colitis. May begin up to several weeks 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.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Oral: 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.
  • Otic: Instruct parent in correct administration technique.

Evaluation/Desired Outcomes

  • Resolution of the signs and symptoms of bacterial infection. Time for complete resolution depends on organism and site of infection.

Floxin

(flŏk′sĭn) A trademark for the drug ofloxacin.