Oditen 200 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Ceftibuten dihydrate |
| Company | Opsonin pharma ltd |
| Also available as |
Indications
- Acute Bacterial Exacerbations of Chronic Bronchitis
- Acute Bacterial Otitis Media
- Pharyngitis and Tonsillitis
Pharmacology
Ceftibuten is the dihydrate salt of Ceftibuten, a semi-synthetic Cephalosporin antibiotic for oral administration.
Dosage & Administration
- Otitis Media:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
- Tonsillitis/Pharyngitis:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
- Bronchitis:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days
- Cystitis:
- Adult Dosage: 400 mg orally every 24 hours for 7 days
- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days
- Pneumonia:
- Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
- Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days
- Sinusitis:
- Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days
- Urinary tract Infection:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
Interaction
Theophylline & Antacid do not alter the pharmacokinetic profile of Oditen. Ranitidine increases the Cmax & AUC of Oditen.
Contraindications
Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Side Effects
- Nausea
- Headache
- Diarrhea
- Dyspepsia
- Dizziness
- Abdominal pain
- Vomiting
Pregnancy & Lactation
Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ceftibuten is administered to nursing women.
Precautions & Warnings
As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Oditen may require adjustment in patients with varying degrees of renal insufficiency. Oditen should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.
Use in Special Populations
- Renal Impairment:
- CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
- CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day
- Hepatic Impairment: Dose adjustment is not necessary.
Therapeutic Class
Third generation Cephalosporins
Reconstitution
- The small bottle contains purified water and large bottle contains granules
- Pour the purified water completely into large bottle
- Tighten the cap of the large bottle and shake the bottle for at least one minute
- Use a measuring cup or dropper for reconstituted suspension
Storage Conditions
Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.