Other antibacterial drugs

  • Chemical Composition

    Sparfloxacin 200 mg

  • Packing

    6Coated Tablets - 11Coated Tablets

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  • License date


Mechanism Of Action Sparfloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Sparfloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription. Sparfloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections: Aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae (penicillin-susceptible strains), Aerobic gram-negative microorganisms: Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Other microorganisms: Chlamydia pneumoniae, Mycoplasma pneumoniae
INDICATIONS SPARO-F (sparfloxacin) is indicated for the treatment of adults (>/= 18 years of age) with the following infections caused by susceptible strains of the designated microorganisms: Community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae , or Streptococcus pneumoniae Acute bacterial exacerbations of chronic bronchitis caused by Chlamydia pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus , or Streptococcus pneumoniae
CONTRAINDICATIONS Sparfloxacin is contraindicated for individuals with a history of hypersensitivity or photosensitivity reactions
Side EFFECTS The most frequently reported side effects include photosensitivity reaction, diarrhea, nausea, headache, dyspepsia, dizziness, insomnia, abdominal pain, pruritus, taste perversion, QT c interval prolongation, vomiting, flatulence, and vasodilatation
WARNINGS EXPOSURE TO DIRECT AND INDIRECT SUNLIGHT (EVEN WHEN USING SUNSCREENS OR SUNBLOCKS SHOULD BE AVOIDED WHILE TAKING SPARFLOXACIN AND FOR FIVE DAYS FOLLOWING THERAPY. SPARFLOXACIN THERAPY SHOULD BE DISCONTINUED IMMEDIATELY AT THE FIRST SIGNS OR SYMPTOMS OF PHOTOTOXICITY, SUCH AS A SENSATION OF SKIN BURNING, REDNESS, SWELLING, BLISTERS, RASH, ITCHING OR DERMATITIS. As with other quinolones, sparfloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy). If an allergic reaction to sparfloxacin occurs, the drug should be discontinued immediately. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including sparfloxacin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis." Sparfloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Tendon rupture can occur at any time during or after therapy with sparfloxacin. Sparfloxacin should be administered with caution in the presence of renal insufficiency. Adjustment of the dosage regimen is necessary for patients with impaired renal function-creatinine clearance <50 ml/min. Sparfloxacin may prolong the QT c, therefore, avoid the concomitant prescription of medications known to prolong the QT c interval, e.g., erythromycin, terfenadine, astemizole, pentamidine, tricyclic antidepressants, some antipsychotics including phenothiazines. Sparfloxacin is not recommended for use in patients with pro-arrhythmic conditions (e.g., hypokalemia, significant bradycardia, congestive heart failure, myocardial ischemia, and atrial fibrillation). Sparfloxacin may cause neurologic adverse effects (e.g., dizziness, lightheadedness) and that patients should know how they react to sparfloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination
DRUG INTERACTIONS Aluminum and magnesium cations in antacids and sucralfate form chelation complexes with sparfloxacin. The oral bioavailability of sparfloxacin is reduced when an aluminum-magnesium suspension is administered between 2 hours before and 2 hours after sparfloxacin administration. The oral bioavailability of sparfloxacin is not reduced when the aluminum-magnesium suspension is administered 4 hours following sparfloxacin administration. Absorption of quinolones is reduced significantly by using zinc or iron preparations. These products may be taken 4 hours after sparfloxacin administration. Drug/Laboratory Test Interactions: Sparfloxacin therapy may produce false-negative culture results for Mycobacterium tuberculosis by suppression of mycobacterial growth
Pregnancy And lactations Sparfloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Sparfloxacin should not be taken during breast-feeding. It is not recommended in children younger than 18 years of age.
Dosage And Administration SPARO-F (sparfloxacin) can be taken with or without food. The recommended daily dose of SPARO-F in patients with normal renal function is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 24 hours for a total of 10 days of therapy. The recommended daily dose of SPARO-F in patients with renal impairment (creatinine clearance <50 ml/min) is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 48 hours for a total of 9 days of therapy
OVERDOSE In case of overdosage, the patient should be monitored in a suitably equipped medical facility and advised to avoid sun exposure for five days. ECG monitoring is recommended due to the possible prolongation of the QT c interval. There is no known antidote for sparfloxacin overdosage.
Storage Conditions - Store below 30 C, Protect from heat and light. - Keep out of reach of children