Avelox


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moxifloxacin hydrochloride

Avelox, Moxeza, Vigamox

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.

• Fluoroquinolones, including Avelox, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Avelox in patients with known history of myasthenia gravis.

Action

Selectively inhibits DNA synthesis by disrupting DNA replication and transcription and suppressing protein synthesis, causing bacterial cell death

Availability

Injection (premixed): 400 mg/250-ml bag

Ophthalmic solution: 5% (3 ml in 4-ml bottle)

Tablets: 400 mg

Indications and dosages

Acute bacterial sinusitis

Adults: 400 mg P.O. or I.V. q 24 hours for 10 days

Acute bacterial exacerbation of chronic bronchitis

Adults: 400 mg P.O. or I.V. q 24 hours for 5 days

Community-acquired pneumonia

Adults: 400 mg P.O. or I.V. q 24 hours for 7 to 14 days

Uncomplicated skin and skin-structure infections

Adults: 400 mg P.O. or I.V. q 24 hours for 7 days

Bacterial conjunctivitis

Adults: Instill one drop of Vigamox ophthalmic solution into affected eye t.i.d. for 7 days or one drop of Moxeza ophthalmic solution into affected eye b.i.d. for 7 days.

Contraindications

• Hypersensitivity to drug, its components, or other fluoroquinolones

Precautions

Use cautiously in:
• known or suspected CNS disorders that may predispose to seizures or lower seizure threshold, peripheral neuropathy, diarrhea, renal impairment, cirrhosis, bradycardia, acute myocardial ischemia, dialysis
• prolonged QTc interval, hypokalemia, and drugs that prolong QT interval
• history of myasthenia gravis (avoid use)
• elderly patients
• pregnant or breastfeeding patients (safety not established except in post-exposure inhalation anthrax)
• children younger than age 18 (except in post-exposure inhalation anthrax)
• children younger than age 4 months (Moxeza ophthalmic use) or age 1 (Vigamox ophthalmic use).

Administration

• Give premixed I.V. dose over 60 minutes. Avoid bolus or rapid infusion.
• Don't mix with other drugs in same I.V. line.
• Know that although milk or yogurt may impair absorption of P.O. moxifloxacin, drug may be given with other calcium products.

Adverse reactions

CNS: dizziness, drowsiness, headache, confusion, light-headedness, insomnia, agitation, hallucinations, acute psychoses, tremor, seizures

CV: hypertension, vasodilation, tachycardia, prolonged QT interval, arrhythmias

EENT: conjunctivitis; decreased visual acuity; keratitis; eye dryness, discomfort, pain, pruritus, and hyperemia; subconjunctival hemorrhage; tearing; otitis media; pharyngitis; rhinitis (all with ophthalmic solution)

GI: nausea, diarrhea, abdominal pain, pseudomembranous colitis

GU: vaginitis

Hematologic: eosinophilia, thrombocytopenia, leukopenia

Musculoskeletal: joint pain, tendinitis, tendon rupture

Respiratory: increased cough (with ophthalmic solution)

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

Other: altered taste (with ophthalmic solution), phlebitis at I.V. site, superinfection, fever, exacerbation of myasthenia gravis, hypersensitivity reactions including anaphylaxis

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 salts, sucralfate, zinc salts: decreased moxifloxacin absorption

Nonsteroidal anti-inflammatory drugs: increased risks of CNS stimulation and seizures

Theophylline: increased theophylline blood level and possible toxicity

Warfarin and its derivatives: enhanced anticoagulant effect

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, lactate dehydrogenase, platelets: increased levels

Drug-food.Concurrent tube feedings, milk, yogurt: impaired absorption of P.O. moxifloxacin

Drug-herbs.Dong quai, St. John's wort: phototoxicity

Fennel: decreased moxifloxacin absorption

Drug-behaviors.Sun exposure: phototoxicity

Patient monitoring

Watch for hypersensitivity reaction (such as anaphylaxis) and other allergic reactions, which may occur after initial dose. Discontinue drug at first sign of rash, jaundice, or other signs or symptoms of hypersensitivity.
• Monitor cardiovascular and neurologic status closely.

Stay alert for tendinitis and Achilles tendon rupture. Discontinue drug if tendon pain or inflammation occurs.
• Monitor CBC and liver function tests.
• Assess GI status. Report signs or symptoms of pseudomembranous colitis. Be aware that if pseudomembranous colitis is suspected or confirmed, ongoing antibiotic use not directed against Clostridium difficile may need to be discontinued.
• Watch closely for superinfection.
• Discontinue drug if peripheral neuropathy or phototoxicity occurs.
• Closely monitor prothrombin time, International Normalized Ratio, or other suitable anticoagulation tests if drug is given concomitantly with warfarin or its derivatives.

Patient teaching

• Advise patient to take tablets once a day with or without food, 4 hours before or 8 hours after antacids, multivitamins, sucralfate, or preparations containing aluminum, magnesium, iron, or zinc.

Tell patient drug may cause serious allergic reactions even several days after therapy begins. Advise him to stop taking drug and report these reactions immediately.

Urge patient to stop taking drug and promptly report tendon pain, diarrhea with blood or pus, and signs and symptoms of superinfection.
• Teach patient how to use eye drops. Caution him to avoid touching applicator tip to eye, finger, or other object.
• Instruct patient being treated for bacterial conjunctivitis not to wear contact lenses.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• 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.

moxifloxacin

(mox-i-flox-a-sin) ,

Avelox

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: fluoroquinolones
Pregnancy Category: C

Indications

Treatment of the following bacterial infections:
  • Respiratory tract infections, including acute sinusitis, acute exacerbations of chronic bronchitis, and community-acquired pneumonia (CAP),
  • Uncomplicated and complicated skin and skin structure infections,
  • Intra-abdominal infections.

Action

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase enzyme.

Therapeutic effects

Death of susceptible bacteria.
Active against gram-positive pathogens, including:
  • Staphylococcus aureus,
  • Streptococcus pyogenes,
  • Streptococcus pneumoniae (including multi-drug resistant strains).
Gram-negative spectrum notable for activity against:
  • Escherichia coli,
  • Klebsiella pneumoniae,
  • Haemophilus influenzae,
  • Haemophilus parainfluenzae,
  • Moraxella catarrhalis.
Additional spectrum includes:
  • Chlamydophylia pneumoniae,
  • Mycoplasma pneumoniae.

Pharmacokinetics

Absorption: Well absorbed (90%) following oral administration.
Distribution: Widely distributed; tissue concentrations may exceed plasma concentrations.
Metabolism and Excretion: Mostly metabolized by the liver; 20% excreted unchanged in urine, 25% excreted unchanged in feces.
Half-life: 12 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POwithin 1 hr1–3 hr24 hr
IVrapidend of infusion24 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).
Use Cautiously in: Known or suspected CNS disorder; Concurrent use of erythromycin, antipsychotics, and tricyclic antidepressants (↑risk of QTc interval prolongation and torsade de pointes); Bradycardia; Acute myocardial ischemia; Concurrent use of corticosteroids (↑ risk of tendinitis/tendon rupture); Hepatic dysfunction; Kidney, heart, or lung transplant patients (↑ risk of tendinitis/tendon rupture); Geriatric: ↑ risk of adverse reactions; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • elevated intracranial pressure (including pseudotumor cerebri) (life-threatening)
  • seizures (life-threatening)
  • agitation
  • anxiety
  • confusion
  • depression
  • dizziness
  • hallucinations
  • headache
  • insomnia
  • nightmares
  • paranoia
  • tremor

Cardiovascular

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

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • abdominal pain
  • dyspepsia
  • ↑ liver enzymes
  • vomiting

Dermatologic

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

Musculoskeletal

  • tendinitis
  • tendon rupture

Neurologic

  • peripheral neuropathy

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use ofamiodarone, disopyramide, erythromycin, procainamide, dofetilide, quinidine, some antipsychotics, sotalol, or tricyclic antidepressants ↑ risk of torsade de pointes in susceptible individuals (avoid concurrent use). May ↑ risk of bleeding with warfarin.Iron supplements and aluminum-, calcium-, or magnesium-containing antacids, bismuth subsalicylate, sucralfate, multivitamins with zinc, or didanosine (chewable/buffered tablets of pediatric suspension) ↓ absorption (take at least 2 hr before or 4 hr).Serum levels of fluoroquinolones may be ↓ by antineoplastics.Cimetidine may interfere with elimination of fluoroquinolones.May ↑ risk of nephrotoxicity from cyclosporine.Concurrent corticosteroid therapy may ↑ risk of tendon rupture.

Route/Dosage

Oral Intravenous (Adults) Bacterial sinusitis—400 mg once daily for 10 days; Community-acquired pneumonia—400 mg once daily for 7–14 days. Acute bacterial exacerbation of chronic bronchitis—400 mg once daily for 5 days. Complicated intra-abdominal infection—400 mg once daily for 5–14 days. Skin/skin structure infections—400 mg/day for 7–21 days.

Availability

Tablets: 400 mg
Premixed infusion: 400 mg/250 mL 0.8% NaCl

Nursing implications

Nursing assessment

  • Assess for infection (vital signs, appearance of sputum, WBC) 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.
  • Assess for signs and symptoms of peripheral neuropathy (pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation) periodically during therapy. Symptoms may be irreversible; discontinue moxifloxacin if symptoms occur.
  • Lab Test Considerations: Monitor for ↑ serum AST, ALT, LDH, bilirubin, and alkaline phosphatase.
    • May cause hyperglycemia, hyperlipidemia, and altered prothrombin time.
    • May also cause ↑ or ↓ glucose.

Potential Nursing Diagnoses

Risk for infection (Patient/Family Teaching)

Implementation

  • Oral: May be administered without regard to meals. Products or foods containing calcium, magnesium, aluminum, iron, or zinc should not be ingested for 4 hr before and 8 hr after administration.
  • Intravenous Administration
  • Intermittent Infusion: Diluent: Premixed bags are diluted in sodium chloride 0.8% and should not be further diluted. Use transfer set whose piercing pin does not require excessive force; insert with a gentle twisting motion until pin is firmly seated. Concentration: 1.6 mg/mL.
  • Rate: Administer over 60 min. Avoid rapid or bolus infusion.
  • Intermittent Infusion: Diluent: Premixed bags are diluted in sodium chloride 0.8% and should not be further diluted. Use transfer set whose piercing pin does not require excessive force; insert with a gentle twisting motion until pin is firmly seated. Concentration: 1.6 mg/mL.
  • Rate: Administer over 60 min. Avoid rapid or bolus infusion.
  • Y-Site Compatibility: alemtuzumab, amifostine, anidulafungin, argatroban, bivalirudin, bleomycin, bumetanide, busulfan, calcium acetate, caclium chloride, calcium gluconate, carboplatin, carmustine, caspofungin, ceftaroline, chlorpromazine, cisatracurium, cisplatin, cyclophosphamide, cyclosporine, cytarabine, dacarbacine, dactinomycin, daptomycin, daunorubicin, dexmedetonidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, doripenem, ertapenem, mycophenolate, docetaxel, dolasetron, dopamine, doripenem, doxacurium, doxorubicin, doxorubicin liposome, droperidol, enalaprilat, epinephrine, epirubicin, ertapenem, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fludarabine, gallium nitrate, gemcitabine, glycopyrrolate, granisetron, haloperidol, heparin, hetastarch, hydralazine, hydrocortisone sodium succinate, idarubicin, insulin, irinotecan, isoproterenol, ketorolac, labetalol, leucovorin, lidocaine, magnesium sulfate, mannitol, mechlorethamine, melphalan, mesna, methotrexate, methyldopate, methylprednisolone, metoclopramide, metoprolol, minrinone, mitomycin, mitoxantrone, mivacuroum, mycophenolate, naloxone, nesiritide, nicardipine, nitroglycerin, norepinephrine, octreotide, ondansetron, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, pemetrexed, phentolamine, phenylephrine, potassium acetate, potassium chloride, potassium phosphates, procainamide, prochlorperazine, promethazine, propranolol, ranitidine, rocuronium, sodium acetate, sodium bicarbonate, sodium phosphate, streptozocin, succinylcholine, tacrolimus, teniposide, theophylline, thiotepa, tigecycline, tirofiban, topotecan, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, zoledronic acid
  • Y-Site Incompatibility: allopurinol, aminophylline, amphotericin B lipid complex, dantrolene, fluorouracil, fosphenytoin, furosemide, nitroprusside, pantoprazole, phenytoin, vancomycin, voriconazole

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.
  • 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 or 8 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 moxifloxacin.
  • 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 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.
  • Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
  • 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, sign of hypersensitivity, or tendon (shoulder, hand, Achilles, and other) pain, swelling, or inflammation occurs. If tendon symptoms occur, avoid exercise and use of the affected area. Increased risk in >65 yr old, kidney, heart and lung transplant recipients, and patients taking corticosteroids concurrently. Therapy should be discontinued.

Evaluation/Desired Outcomes

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

Avelox

(ä′və-lŏks′)
A trademark for the drug moxifloxacin.

Avelox

A brand name for MOXIFLOXACIN.
References in periodicals archive ?
On Tuesday, Dr Reddy s Laboratories Ltd launched Moxifloxacin Hydrochloride Tablets, 400 mg, a therapeutic equivalent generic version of Avelox (moxifloxacin HCl) tablets 400mg in the US market.
It includes pharmaceuticals, starting with Bayer's anti-infective Avelox, and this year the firms started joint marketing activities.
You assess top products, including these: -- Zyvox -- Augmentin -- Cubicin -- Generic amoxicillin -- Avelox.
org, will have her story published in new book to raise awareness about the dangers of fluoroquinolone antibiotics, which include Levaquin, Cipro, and Avelox.
Special Considerations: Avelox can cause QT prolongation, but no adverse cardiovascular effects were seen in premarketing trials or in a postmarketing study of more than 18,000 patients with respiratory infections, according to Bayer.
You assess top products, including these, seeing what sales they can achieve: - Zyvox - Cubicin - Augmentin - Zosyn/Tazocin - Avelox - Invanz - Generic amoxcillin - Tedizolid.
AVELOX was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering-Plough under a licensing agreement.
TreatmentTrends: Gram-Negative Infections (US) finds the fluoroquinolones, including ciprofloxacin, Bayer/Merck's Avelox and Janssen's Levaquin, also are frequently used to treat GNIs; however surveyed ID specialists report high treatment failure rates among patients treated with these drugs and frequently cite decreasing their prescribing of the fluoroquinolones due to resistance to the drug class.
Sales of the antibiotic AVELOX were up 24 percent to $142 million as a
Sales of the antibiotic AVELOX were up 12 percent to $115 million as a
Generic versions of anti-bacterials including Pfizer's Zithromax (azithromycin), Abbott's Biaxin (clarithromycin), Johnson & Johnson's Levaquin (levofloxacin) and Bayer's Avelox (moxifloxacin) have captured the ENT therapeutics market.