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Drugs reference index «Moxifloxacin Hydrochloride»

Moxifloxacin Hydrochloride

Pronunciation: (MOX-i-FLOX-a-sin HYE-droe-KLOR-ide)Class: Fluoroquinolone antibiotic

Trade Names:Avelox- Tablets 400 mg

Trade Names:Avelox IV- Injection (premix) 400 mg

Trade Names:Vigamox- Solution, ophthalmic 0.5% (5 mg/mL)

Pharmacology

Interferes with microbial DNA synthesis.

Pharmacokinetics

Absorption

Bioavailability is approximately 90%; AUC is approximately 48 mcg•h/mL; mean C max is 4.5 mcg/mL (multiple 400 mg oral doses).

Distribution

Protein binding is approximately 30% to 50%; Vd is 1.7 to 2.7 L/kg.

Metabolism

Metabolized via glucuronide (approximately 14%) and sulfate (approximately 38%) conjugation in the liver.

Elimination

Moxifloxacin is eliminated in urine (approximately 20% unchanged) and feces (approximately 25%), sulfate conjugate is excreted in feces, and glucuronide conjugate is excreted in urine. The half-life is approximately 12 h; mean apparent total Cl is approximately 12 L/h; renal Cl is approximately 2.6 L/h.

Special Populations

Renal Function Impairment

No dosage adjustment is necessary in patients with renal function impairment, including those requiring hemodialysis or continuous ambulatory peritoneal dialysis.

Hepatic Function Impairment

No dosage adjustment is recommended for mild or moderate hepatic insufficiency. Severe hepatic insufficiency has not been studied.

Elderly

No dosage adjustment is necessary based on age.

Gender

No differences in pharmacokinetics between men and women.

Race

Pharmacokinetics are similar between Japanese men and white men.

Indications and Usage

Treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, complicated intra-abdominal infections, and conjunctivitis caused by susceptible organisms (ophthalmic).

Contraindications

Hypersensitivity to moxifloxacin, any member of the quinolone class of antimicrobial agents, or any component of the product.

Dosage and Administration

Acute Bacterial Exacerbation of Chronic BronchitisAdults

IV / PO 400 mg/day for 5 days.

Acute Bacterial SinusitisAdults

IV / PO 400 mg/day for 10 days.

Community-Acquired PneumoniaAdults

IV / PO 400 mg/day for 7 to 14 days.

Complicated Intra-Abdominal InfectionsAdults

IV / PO 400 mg/day for 5 to 14 days.

Complicated Skin and Skin Structure InfectionsAdults

IV / PO 400 mg/day for 7 to 21 days.

ConjunctivitisAdults and Children 1 yr of age and older

Ophthalmic Instill 1 drop in affected eye(s) 3 times daily for 7 days.

Uncomplicated Skin and Skin Structure InfectionsAdults

IV / PO 400 mg/day for 7 days.

General Advice

  • Injection
  • For IV infusion only. Not for intradermal, intrathecal, intraperitoneal, subcutaneous, or IM administration.
  • Inspect solution visually before administration. Do not administer if solution is cloudy, discolored, or contains particulate matter.
  • Infuse prescribed dose over 60 min by direct infusion or through a Y-type infusion set. Avoid rapid or bolus administration because of risk of prolonging QT interval.
  • Do not add other medications or additives to moxifloxacin injection bag.
  • If other drugs are being administered through the same IV line, administer each medication separately and flush IV line with compatible solution before and after infusion of moxifloxacin.
  • Premixed flexible containers are for single use only; discard any unused solution.
  • Ophthalmic
  • Ophthalmic solution is not for injection and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Avoid high humidity. Store ophthalmic solution at 36° to 77°F. Store flexible injection bags at controlled room temperature (59° to 86°F). Do not refrigerate.

Drug Interactions

Antacids containing aluminum, calcium, or magnesium; drug formulations containing divalent or trivalent cations (eg, some didanosine formulations); metal cations (eg, iron); multivitamins containing iron or zinc; sucralfate

May decrease the absorption of moxifloxacin. Take moxifloxacin at least 4 h before or 8 h after these agents.

Azole antifungal agents; cisapride; class IA antiarrhythmic agents (eg, procainamide, quinidine); class III antiarrhythmic agents (eg, amiodarone, sotalol); erythromycin; methadone; pentamidine; phenothiazines; tricyclic antidepressants; ziprasidone; any other drug known to prolong the QTc interval

Increased risk of torsades de pointes or other ventricular arrhythmias.

Warfarin

Anticoagulant effect may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitation, QT interval prolongation, tachycardia, vasodilatation (less than 2%); ventricular tachyarrhythmias (postmarketing).

CNS

Dizziness (2%); anxiety, headache, insomnia, nervousness, somnolence, tremor, vertigo (less than 2%); psychotic reaction (postmarketing).

Dermatologic

Rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria (less than 2%); rash (ophthalmic) (1% to 4%); Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, tearing (ophthalmic) (1% to 6%); otitis media, pharyngitis, rhinitis (ophthalmic) (1% to 4%).

Electrolytes

Nausea (6%); diarrhea (5%); anorexia, constipation, dry mouth, dyspepsia, flatulence, GI disorder, glossitis, oral moniliasis, stomatitis, taste perversion, vomiting (less than 2%); pseudomembranous colitis.

Genitourinary

Vaginal moniliasis, vaginitis (less than 2%).

Hematologic-Lymphatic

Eosinophilia, leukopenia, prothrombin decrease (PT/INR increased), thrombocythemia (less than 2%).

Hepatic

Abnormal LFT (less than 2%); hepatic failure, hepatitis (postmarketing).

Lab Tests

Increases in albumin, bilirubin, chloride, globulin, ionized calcium, mean corpuscular hemoglobin, neutrophils, PT ratio, and WBCs; decreases in amylase, basophils, bilirubin, eosinophils, glucose, hemoglobin, neutrophils, pO2, PT ratio, and RBCs (at least 2%); elevated gamma-glutamyl transpeptidase (less than 2%).

Local

Injection-site reactions, including phlebitis (less than 2%).

Metabolic-Nutritional

Amylase increased, lactic acid dehydrogenase increased (less than 2%).

Musculoskeletal

Arthralgia, myalgia (less than 2%); tendon rupture (postmarketing).

Respiratory

Dyspnea (less than 2%); increased cough (ophthalmic) (1% to 4%).

Miscellaneous

Abdominal pain, allergic reaction, asthenia, malaise, moniliasis, pain (less than 2%); fever, infection (ophthalmic) (1% to 4%); anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), phototoxicity (postmarketing).

Precautions

Warnings

Tendonitis

Moxifloxacin has been associated with an increased risk of tendonitis and tendon rupture in patients of all ages. The risk is increased in patients older than 60 yr of age, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants.

Pregnancy

Category C .

Lactation

Undetermined; however, other fluoroquinolones are excreted in breast milk.

Children

PO/IV

Safety and efficacy not established.

Ophthalmic

Safety and efficacy in children younger than 1 yr of age not established.

Hypersensitivity

Acute anaphylactic reactions and serious dermatological hypersensitivity reactions reported.

Superinfection

Use of antibiotics may result in bacterial or fungal overgrowth.

CNS events

Agitation, anxiety, insomnia, nervousness, nightmares, or paranoia may occur.

Convulsions and toxic psychosis

CNS stimulation, lowering of the seizure threshold, and psychotic reactions have been reported with similar agents. Use with caution in patients with seizures or other CNS disorders.

Myasthenia gravis

May be exacerbated by quinolone antimicrobial agents, leading to life-threatening weakness of the respiratory muscles.

Peripheral neuropathy

Sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypesthesia, dysesthesias, and weakness have been reported.

Phototoxicity

Because phototoxicity has been reported with other quinolones, avoid excessive exposure to sunlight or artificial UV light.

Pseudomembranous colitis

Consider possibility in patients with diarrhea.

QT interval

QT interval may be prolonged in some patients; avoid use in patients with known prolongation of QT interval or uncorrected hypokalemia and in patients receiving class IA or III antiarrhythmics.

Serious reactions

Clinical manifestations of serious and sometimes fatal reactions that have been reported with moxifloxacin include acute hepatic necrosis or failure, acute renal insufficiency or failure, agranulocytosis, allergic pneumonitis, anemia (including hemolytic and aplastic), arthralgia, fever, hepatitis, interstitial nephritis, jaundice, leukopenia, myalgia, pancytopenia, rash, serum sickness, Stevens-Johnson syndrome, thrombocytopenia (including thrombotic thrombocytopenic purpura), toxic epidermal necrolysis, and vasculitis.

Tendonitis

Inflammation and rupture of tendons may occur. The risk may be increased in patients receiving corticosteroids, especially in elderly patients.

Overdosage

Symptoms

Possible QTc prolongation.

Patient Information

  • Advise patient to read patient information leaflet before starting therapy and with each refill.
  • Review dosing schedule and prescribed length of therapy with patient.
  • Tablets
  • Advise patient that medication can be taken with a full glass of water without regard to meals, but to take with food if GI upset occurs.
  • Advise patient that if a dose is missed, to take it as soon as remembered. However, if it is nearing the time for the next dose, advise patient to skip the dose and take the next dose at the regularly scheduled time.
  • Advise patient to take moxifloxacin 4 h before or 8 h after sucralfate, antacids containing magnesium or aluminum, didanosine-buffered tablets or pediatric powder, or other products containing iron or zinc.
  • Remind patient to complete entire course of therapy even if symptoms of infection have disappeared.
  • Advise patient to inform health care provider if infection does not improve or worsens.
  • Advise patient to discontinue therapy and contact health care provider immediately if fainting, hives, itching, pain, palpitations, rupture of tendon, shortness of breath, skin rash, or tenderness occur.
  • Advise patient to report the following signs of superinfection to health care provider: black, furry tongue; foul-smelling stools; vaginal itching or discharge; white patches in mouth.
  • Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted, and not to treat at home.
  • Caution patient that drug may cause dizziness and light-headedness, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to avoid unnecessary exposure to direct and indirect sunlight or tanning lamps, and to use sunscreen and wear protective clothing to avoid photosensitivity reactions during therapy. Advise patient to discontinue therapy and notify health care provider if any of the following occur after exposure to sunlight or artificial UV light (eg, sunlamp): blistering, itching, rash, redness, sensation of skin burning, swelling.
  • Ophthalmic Solution
  • Review prescribed dosing schedule with patient.
  • Teach patient proper technique for instilling eye drops: wash hands; do not allow dropper to touch eye. Tilt head back and look up; pull lower eyelid down and instill prescribed number of drops. Close eye for 1 to 2 min and apply gentle pressure to bridge of nose for 3 to 5 min. Do not rub eye.
  • Advise patient that if more than 1 topical ophthalmic drug is being used, to administer the drugs at least 5 min apart.
  • Inform patient that temporary blurred vision, eye itching, eye pain, or discomfort are the most common adverse reactions and to contact health care provider if they occur and are bothersome.
  • Advise patient to contact eye doctor if eye or eyelid inflammation is noted, or if eye symptoms do not improve or worsen.
  • Advise patient that the entire course of therapy must be completed to ensure max benefit and to complete full course of therapy even if symptoms have resolved.
  • Instruct patient not to wear contact lenses during treatment.
  • Injection
  • Advise patient that medication will be prepared and administered by a health care provider in a health care setting when oral therapy is not feasible, but that the patient will be switched to oral therapy when health care provider believes it is appropriate.

Copyright © 2009 Wolters Kluwer Health.

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