Trade Names:Zagam- Tablets 200 mg
Interferes with microbial DNA synthesis.
Oral bioavailability of sparfloxacin is 92%; antacids containing aluminum hydroxide or magnesium hydroxide reduce bioavailability by as much as 50%. C max is approximately 1.3 mcg/mL; AUC is approximately 34 mcg•h/mL; T max is between 3 and 6 h. Oral absorption is unaffected by milk, food, or high fat meals.
Sparfloxacin distributes well into the body. Vd is approximately 3.9 L/kg. Sparfloxacin has low protein binding (approximately 45%).
Sparfloxacin is metabolized by the liver and does not interfere with CYP-450.
Total Cl is approximately 11.4 L/h; renal Cl is approximately 1.5 L/h. Ten percent of an orally administered dose is excreted in urine. Sparfloxacin t ½ is about 20 h.
In CrCl below 50 mL/min, t ½ is lengthened. Single or multiple doses in patients with varying degrees of renal impairment typically produce plasma concentrations that are twice those observed in healthy subjects.Hepatic Function Impairment
The kinetics of sparfloxacin are not altered in patients with mild to moderate hepatic impairment without cholestasis.
Treatment of community acquired pneumonia or bacterial exacerbation of chronic bronchitis caused by susceptible organisms.
History of hypersensitivity or photosensitivity reactions; drugs known to prolong the electrocardiogram QT c interval such as disopyramide and amiodarone or patients with underlying QT c prolongation (torsades de pointes has been reported in such patients); patients whose lifestyle or occupation prevents avoidance of sun, bright natural light, or ultraviolet rays while taking this drug and for 5 days after treatment is stopped; tendonitis or tendon rupture associated with quinolone use.
PO 400 mg on day 1 (loading dose) followed by 200 mg every day for a total 10 days of therapy.Renal Function Impairment (CrCl less than 50 mL)Adults
PO 400 mg on day 1 (loading dose) followed by 200 mg every 48 h for a total of 9 days of therapy.TuberculosisAdults
PO 200 mg/day (max, 200 mg/day).
Store at room temperature in tightly closed container.
Reduced absorption leading to lower bioavailability and efficacy.Bepridil, cisapride, erythromycin, pentamidine, phenothiazines and related antipsychotics, tricyclic antidepressants, any other drug known to prolong the QT c interval
Increased risk of torsades de pointes or other malignant ventricular arrhythmias.
False-negative results for Mycobacterium tuberculosis cultures.
QT c prolongation (possibly leading to serious ventricular arrhythmias); vasodilation.
Headache; dizziness; insomnia; somnolence.
Photosensitivity; pruritus; rash.
Diarrhea; nausea; dyspepsia; abdominal pain; dry mouth; vomiting; flatulence.
Category C .
Excreted in breast milk.
Safety and efficacy not established.
Acute anaphylactic reactions and serious dermatologic hypersensitivity reactions have been reported. Stop sparfloxacin if a rash or any other sign of photosensitivity develops.
Dose adjustment necessary if CrCl is less than 50 mL/min.
Use of antibiotics may result in bacterial or fungal overgrowth.
Moderate to severe phototoxic reactions have been reported. Patients must avoid exposure to direct or indirect sunlight or other sources of UV light while taking this medication and for 5 days thereafter. Patients must discontinue therapy at first sign or symptom of a phototoxic reaction (eg, sensation of skin burning, redness, swelling, blistering, rash, itching, dermatitis).
CNS stimulation, lowering of the seizure threshold, and psychotic reactions have been reported. Use with caution in patients with seizures or other CNS disorders.
Consider possibility in patients with diarrhea.
Inflammation and rupture of tendons has been associated with the use of fluoroquinolone antibiotics.
May be prolonged in some patients.
Possible QT c prolongation.