No

Antibiotic, Quinolone

Treatment of adults with community-acquired pneumonia caused by C. pneumoniae, H. influenzae, H. parainfluenzae, M. catarrhalis, M. pneumoniae or S. pneumoniae; treatment of acute bacterial exacerbations of chronic bronchitis caused by C. pneumoniae, E. cloacae, H. influenzae, H. parainfluenzae, K. pneumoniae, M. catarrhalis, S. aureus or S. pneumoniae

C

Clinical effects on the fetus: Avoid use in pregnant women unless the benefit justifies the potential risk to the fetus

Breast-feeding/lactation: Quinolones are known to distribute well into breast milk; consequently use during lactation should be avoided if possible

Hypersensitivity to sparfloxacin, any component, or other quinolones; a concurrent administration with drugs which increase the Q-T interval including: amiodarone, bepridil, bretylium,cisapride, disopyramide, furosemide, procainamide, quinidine, sotalol, albuterol, astemizole, chloroquine, cisapride, halofantrine, phenothiazines, prednisone, terfenadine, and tricyclic antidepressants

Not recommended in children <18 years of age, other quinolones have caused transient arthropathy in children; CNS stimulation may occur (tremor, restlessness, confusion, and very rarely hallucinations or seizures); use with caution in patients with known or suspected CNS disorder or renal dysfunction; prolonged use may result in superinfection; if an allergic reaction (itching, urticaria, dyspnea, pharyngeal or facial edema, loss of consciousness, tingling, cardiovascular collapse) occurs, discontinue the drug immediately; use caution to avoid possible photosensitivity reactions during and for several days following fluoroquinolone therapy; pseudomembranous colitis may occur and should be considered in patients who present with diarrhea

>1%:

Central nervous system: Insomnia, agitation, sleep disorders, anxiety, delirium

Gastrointestinal: Diarrhea, abdominal pain, vomiting

Hematologic: Leukopenia, eosinophilia, anemia

Hepatic: Increased LFTs

<1%: Photosensitivity, rash, myalgia, arthralgia

Symptoms of overdose include acute renal failure, seizures

GI decontamination and supportive care; not removed by peritoneal or hemodialysis

Decreased effect: Decreased absorption with antacids containing aluminum, magnesium, and/or calcium, sucralfate, didanosine and by products containing zinc and iron salts when administered concurrently. Take > 4 hours after sparfloxacin. Phenytoin serum levels may be reduced by quinolones; antineoplastic agents may also decrease serum levels of fluoroquinolones

Increased toxicity/serum levels: Quinolones cause increased levels of caffeine, warfarin, cyclosporine, and theophylline (although one study indicates that sparfloxacin may not affect theophylline metabolism), cimetidine and probenecid increase quinolone levels; an increased incidence of seizures may occur with foscarnet. Avoid use with drugs which increase Q-T interval as significant risk of cardiotoxicity may occur. Concurrent use with cisapride is contraindicated.

Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA

Absorption: Oral absorption is unaffected by food or milk but can be reduced by approximately 50% by concurrent administration of aluminum- and magnesium-containing antacids

Distribution: Widely distributed throughout the body

Metabolism: Sparfloxacin is metabolized in the liver, but does not utilize the cytochrome P-450 system

Half-life: Mean terminal half-life: 20 hours (range: 16-30 hours)

Elimination: Equally excreted in both the urine and feces; ~10% of an oral dose is excreted unchanged in the urine

Adults: Oral:

Maintenance: 1 tablet (200 mg) daily for 10 days total therapy (total 11 tablets)

Dosing adjustment in renal impairment: Cl_cr <50 mL/minute: Administer 400 mg on day 1, then 200 mg every 48 hours for a total of 9 days of therapy (total 6 tablets)

Evaluation of organ system functions (renal, hepatic, ophthalmologic, and hematopoietic) is recommended periodically during therapy; the possibility of crystalluria should be assessed; WBC and signs and symptoms of infection

May cause agitation, anxiety, insomnia, or delirium; quinolones reported to cause restlessness, hallucinations, euphoria, depression, panic, and paranoia

May cause leukopenia; use caution with clozapine and carbamazepine; contraindicated with TCAs and phenothiazines

No information available to require special precautions

No effects or complications reported

Take per recommended schedule around-the-clock. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). Take complete prescription and do not skip doses; if dose is missed take as soon as possible, do not double doses. Do not take with antacids. You may experience dizziness, lightheadedness, anxiety, insomnia, or confusion; use caution when driving or engaging in tasks that require alertness until response to drug is known. Small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may reduce nausea, vomiting, or taste disturbances. You may experience photosensitivity; use sunscreen, wear protective clothing and eyewear, and avoid direct sunlight. Report palpitations or chest pain; persistent diarrhea or GI disturbances or abdominal pain; muscle tremor or pain; pain, inflammation, or rupture of tendon; yellowing of eyes or skin, easy bruising or bleeding; unusual fatigue; fever, chills, signs of infection; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if pregnant. Do not breast-feed.

Tablet: 200 mg

Aubier M, Verster R, Regamey C, et al, "Once-Daily Sparfloxacin Versus High-Dosage Amoxicillin in the Treatment of Community-Acquired, Suspected Pneumococcal Pneumonia in Adults. Sparfloxacin European Study Group," Clin Infect Dis, 1998, 26(6):1312-20.

Ballow CH, Jones RN, Johnson DM, et al, "Comparative In Vitro Assessment of Sparfloxacin Activity and Spectrum Using Results From Over 14,000 Pathogens Isolated at 190 Medical Centers in the USA. SPAR Study Group," Diagn Microbiol Infect Dis, 1997, 29(3):173-86.

DeAbate CA, Henry D, Bensch G, et al, "Sparfloxacin vs Ofloxacin in the Treatment of Acute Bacterial Exacerbations of Chronic Bronchitis: A Multicenter, Double-Blind, Randomized, Comparative Study. Sparfloxacin Multicenter ABECB Study Group," Chest, 1998, 114(1):120-30.

Goa KL, Bryson HM, and Markham A, "Sparfloxacin. A Review of Its Antibacterial Activity, Pharmacokinetic Properties, Clinical Efficacy, and Tolerability in Lower Respiratory Tract Infections," Drugs, 1997, 53(4):700-25.

Henry D, Ellison W, Sullivan J, et al, "Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection With Sparfloxacin Versus Ofloxacin. The Sparfloxacin Multi Center UUTI Study Group," Antimicrob Agents Chemother, 1998, 42(9):2262-6.

Hoogkamp-Korstanje JA, " In vitro Activities of Ciprofloxacin, Levofloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Sparfloxacin, and Trovafloxacin Against Gram-Positive and Gram-Negative Pathogens From Respiratory Tract Infections," J Antimicrob Chemother, 1997, 40(3):427-31.

Jones RN, Ballow CH, Schentag JJ, et al, " In Vitro Evaluation of Sparfloxacin Activity and Spectrum Against 24,940 Pathogens Isolated in the United States and Canada, the Final Analysis," Diagn Microbiol Infect Dis, 1998, 31(1):313-25.

Martin SJ, Meyer JM, Chuck SK, et al, "Levofloxacin and Sparfloxacin: New Quinolone Antibiotics," Ann Pharmacother, 1998, 32(3):320-36.

Pfaller MA and Jones RN, "Comparative Antistreptococcal Activity of Two Newer Fluoroquinolones, Levofloxacin and Sparfloxacin," Diagn Microbiol Infect Dis, 1997, 29(3):199-201.

"Sparfloxacin and Levofloxacin," Med Lett Drugs Ther, 1997, 39(999):41-3.

Stein GE and Havlichek DH, "Sparfloxacin: Potential Clinical and Economic Impact in the Treatment of Respiratory Infections," Pharmacotherapy, 1997, 17(6):1139-47.

Trautman M, Ruhnke M, Borner K, et al, "Pharmacokinetics of Sparfloxacin and Serum Bactericidal Activity Against Pneumococci," Antimicrob Agents Chemother, 1996, 40(3):776-9.

Zix JA, Geerdes-Fenge HF, Rau M, et al, "Pharmacokinetics of Sparfloxacin and Interaction With Cisapride and Sucralfate," Antimicrob Agents Chemother, 1997, 41(8):1668-72.