Gracevit: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Sitafloxacin

Indications/Uses

Laryngopharyngitis, tonsillitis (including peritonsillitis & peritonsillar abscess), acute bronchitis, pneumonia, & secondary infection of chronic resp diseases; cystitis, pyelonephritis, & urethritis; cervicitis; otitis media & sinusitis; periodontitis, pericoronitis, & osteitis of jaw.

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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 if poor response to usual dosage is suspected. 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 if poor response to usual dosage is suspected. Acute cystitis 50 mg bid or 100 mg once daily for 3 days. May be increased to 100 mg bid if poor response to usual dosage is suspected. Acute pyelonephritis & complicated UTI 50 mg bid or 100 mg once daily for 7-14 days. May be increased to 100 mg bid if poor response to usual dosage is suspected. Acute exacerbation of chronic otitis media & sinusitis 100 mg bid for 7 days. Renal impairment weighing 60 kg w/ CrCl ≤50 mL/min 50 mg bid or 100 mg once daily, ≤30 to <50 mL/min 50 mg once daily, ≤10 to <30 mL/min 50 mg w/ at least 48 hr interval.

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Overdosage

View Gracevit overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: Take at least 2 hr before taking Al- or Mg-containing antacids & drugs containing Ca or Fe.

Contraindications

History of hypersensitivity to sitafloxacin or other quinolones. Pregnancy. Ped patients (low birth wt infants, newborn infants, infants & toddlers, childn & adolescents).

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Special Precautions

Aortic aneurysm or aortic dissection; high incidence of diarrhea & loose stools. Patients w/ convulsive diseases eg, epilepsy or history of convulsive disease; myasthenia gravis. Carefully observe pain in abdomen, chest, or back & consider imaging assessment in patients complicated w/ aortic aneurysm or aortic dissection, or those who have previous history, +ve family history, or risk factors (Marfan or Loeys-Dietz syndrome) of aortic aneurysm or aortic dissection. May affect ability to drive or operate machinery. Persistent increased serum conc in patients w/ renal impairment. Not be used during pregnancy. Avoid breast-feeding during treatment. Ped patients. Elderly (tendon disorders are more likely to occur).

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Use In Pregnancy & Lactation

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Adverse Reactions

Rash; headache; loose stool, diarrhea, abdominal pain; increased ALT, AST, & γ-GTP; increased eosinophil count, TEN, SJS, erythema multiforme.

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Drug Interactions

Reduced effect w/ Al- or Mg-containing antacids or drugs containing Ca or Fe. Convulsion may occur w/ NSAIDs of phenylacetic or propionic acid derivatives (eg, ketoprofen). Increased risk of tendon disorders w/ corticosteroids (oral & inj) eg, prednisolone, hydrocortisone.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Gracevit detailed prescribing information

Storage

View Gracevit storage conditions for details to ensure optimal shelf-life.

Description

View Gracevit description for details of the chemical structure and excipients (inactive components).

Action

View Gracevit mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Quinolones

ATC Classification

J01MA21 - sitafloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

Thai FDA Category

Presentation/Packing

Form

Gracevit FC tab 50 mg

Packing/Price

1 × 10's

Gracevit

Manufacturer:

Daiichi Sankyo Thailand

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo Thailand