Roin 90 mg/5 ml (Powder for Suspension)

60 ml bottle: ৳ 480.00

Medicine Details

Category Details
Generic Ceftibuten dihydrate
Company Ziska pharmaceuticals ltd
Also available as
Roin 400 mg capsule

Indications

  • Mild-to-moderte infections treatment
  • Acute bacterial exacerbations of chronic bronchitis
  • Acute bacterial otitis media treatment
  • Pharyngitis and tonsillitis treatment

Pharmacology

  • Ceftibuten as dihydrate salt
  • Semi-synthetic Cephalosporin antibiotic
  • Bactericidal action
  • Inhibition of cell-wall synthesis

Dosage & Administration

  • Adult dosage for Otitis Media: 400 mg orally every 24 hours for 10 days
  • Pediatric dosage for Otitis Media: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
  • Adult dosage for Tonsillitis/Pharyngitis: 400 mg orally every 24 hours for 10 days
  • Pediatric dosage for Tonsillitis/Pharyngitis: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
  • Adult dosage for Bronchitis: 400 mg orally every 24 hours for 10 days
  • Pediatric dosage for Bronchitis: >12 years: 400 mg orally every 24 hours for 10 days
  • Adult dosage for Cystitis: 400 mg orally every 24 hours for 7 days
  • Pediatric dosage for Cystitis: >12 years: 400 mg orally every 24 hours for 7 days
  • Adult dosage for Pneumonia: 200 mg orally every 12 hours for 7 to 14 days
  • Pediatric dosage for Pneumonia: >12 years: 200 mg orally every 12 hours for 7 to 14 days
  • Adult dosage for Sinusitis: 400 mg orally every 24 hours for 10 to 14 days
  • Pediatric dosage for Sinusitis: >12 years: 400 mg orally every 24 hours for 10 to 14 days
  • Adult dosage for Urinary tract Infection: 400 mg orally every 24 hours for 10 days
  • Pediatric dosage for Urinary tract Infection: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Interaction

  • Theophylline & Antacid: No alteration to pharmacokinetics
  • Ranitidine: Increases Cmax & AUC of Roin

Contraindications

  • Known allergy to cephalosporin group of antibiotics

Side Effects

  • Nausea
  • Headache
  • Diarrhea
  • Dyspepsia
  • Dizziness
  • Abdominal pain
  • Vomiting

Pregnancy & Lactation

  • Pregnancy Category B
  • No controlled data on use in pregnant women
  • Caution in nursing women

Precautions & Warnings

  • Possible emergence and overgrowth of resistant organisms
  • Observation of the patient is essential
  • Dose adjustment for patients with renal insufficiency
  • Prescribed with caution to individuals with history of gastrointestinal disease

Use in Special Populations

  • Renal Impairment: Dosage adjustment based on CrCl
  • Hepatic Impairment: No dose adjustment necessary

Therapeutic Class

  • Third generation Cephalosporins

Reconstitution

  • Reconstitution process for suspension
  • Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator

Storage Conditions

  • Store below 25°C, protected from light and moisture
  • Suspension: Usable for 14 days while stored at 2° to 8°C

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