moxifloxacin hydrochloride


Also found in: Dictionary.

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.

Mentioned in ?
References in periodicals archive ?
Formulation and evaluation of an in situ gel-forming ophthalmic formulation of moxifloxacin hydrochloride. Int J Pharm Investig 2(2), 78-82, 2012.
Surana, "Quantitative determination of moxifloxacin hydrochloride in bulk and ophthalmic solution by UV-spectrophotometry and first order derivative using area under curve," Der Pharmacia Lettre, vol.
Hosny, "Development and validation of spectrophotometric, atomic absorption and kinetic methods for determination of moxifloxacin hydrochloride," Analytical Chemistry Insights, vol.
Avelox(R) Tablet 400mg Product Summary Product name: Avelox(R) Tablet 400mg Generic name: Moxifloxacin hydrochloride Acquisition of import approval: October 11, 2005 NHI drug price listing: December 9, 2005 Date of market launch: December 9, 2005 Main characteristics: Expected to have significant clinical efficacy as a respiratory quinolone because of its excellent antibacterial effect on all the major bacterial causes of respiratory tract infections and good migration to all tissues in the respiratory tract.
The company added that its Moxifloxacin Hydrochloride Tablets, 400 mg is the therapeutic equivalent generic version of Avelox (moxifloxacin HCl) tablets 400 mg.
Today's US launch followed Moxifloxacin Hydrochloride Tablets' prior approval by the US Food & Drug Administration (US FDA).
Watson has filed an ANDA seeking FDA approval to market moxifloxacin hydrochloride ophthalmic solution USP 0.5%, a genetic version of Alcon Inc.'s brand name antibiotic solution indicated for the treatment of bacterial conjunctivitis.
Moxifloxacin hydrochloride tablets, Teva Pharmaceuticals 11/30/2006
Tenders are invited for Moxifloxacin Hydrochloride 0.5 Percent W/V Eye Drop Self Preserved Minimum 5Ml.
Pharma giant Lupin Limited has announced that its US arm, Gavis Pharmaceuticals, has won a tentative approval from the US FDA for the sale of Moxifloxacin hydrochloride tablets, a generic version of Bayer Healthcare Pharmaceuticals' Avelox tablets.