Gracevit

Gracevit

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo
Concise Prescribing Info
Contents
Sitafloxacin hydrate
Indications/Uses
Laryngopharyngitis, tonsillitis (including peritonsillitis and peritonsillar abscess), acute bronchitis, pneumonia, & secondary infection of chronic resp diseases; cystitis, pyelonephritis, & urethritis; cervicitis; otitis media & sinusitis; periodontitis, pericoronitis, & osteitis of jaw.
Dosage/Direction for Use
Adult 50 mg bid or 100 mg once daily. Laryngopharyngitis, acute bronchitis, tonsillitis (including peritonsillitis & peritonsillar abscess), periodontitis, pericoronitis & osteitis of jaw 50 mg bid or 100 mg once daily for 3-7 days. May be increased to 100 mg bid in patients suspected of having a poor response to usual dosage. Pneumonia & secondary infections of chronic resp diseases, urethritis, cervicitis, acute otitis media & sinusitis 50 mg bid or 100 mg once daily for 7 days. May be increased to 100 mg bid in patients suspected of having a poor response to usual dosage. Acute cystitis 50 mg bid or 100 mg once daily for 3 days.  May be increased to 100 mg bid in patients suspected of having poor response to usual dosage. Acute pyelonephritis & complicated UTI 50 mg bid or 100 mg once daily for 7-14 days. May be increased to 100 mg bid in patients suspected of having a poor response to usual dosage. Acute exacerbation of chronic otitis media & sinusitis 100 mg bid for 7 days. Renal impairment weighing 60 kg CrCl ≤50 mL/min: 50 mg bid or 100 mg once daily. CrCl ≤30 to <50 mL/min: 50 mg once daily. CrCl ≤10 to <30 mL/min: 50 mg to be administered at an interval of at least 48 hr.
Administration
May be taken with or without food: Take at least 2 hr before or after Fe salts, antacids & sucralfate. Ensure adequate fluid intake.
Contraindications
History of hypersensitivity to sitafloxacin hydrate or other quinolones. Pregnancy & lactation. Ped patients.
Special Precautions
Renal impairment; convulsive diseases eg, epilepsy or history of convulsive disease; myasthenia gravis; patients complicated w/ aortic aneurysm or aortic dissection, or who have a previous history, positive family history or risk factors (Marfan syndrome) of aortic aneurysm or aortic dissection. Concomitant use w/ Al- or Mg-containing antacids; should take Gracevit 2 hr before antacids. May affect ability to drive or operate machinery. Elderly.
Adverse Reactions
Diarrhea, loose stools; increased ALT (GPT), AST (GOT), eosinophil count. Toxic epidermal necrolysis, convulsions, QT prolongation, ventricular tachycardia, jaundice, interstitial pneumonia, rhabdomyolysis, tendon disorders, agranulocytosis, pancytopenia, hemolytic anemia, exacerbation of myasthenia gravis.
Drug Interactions
Effect may be reduced w/ antacids containing Al or Mg, drugs containing Ca or Fe. Convulsion may occur w/ NSAIDs of phenylacetic acid/propionic acid derivatives (eg, ketoprofen).
MIMS Class
ATC Classification
J01MA21 - sitafloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Gracevit FC tab 50 mg
Packing/Price
10's
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