Cefotiam

Visa No.: 893110180324

Product: Tiafo 1g

API: Cefotiam

Product Category: Antibiotics

Version approved leaflet: 7733/QLD-ĐK_19/07/2023

INDICATIONS

• Septicemia
• Deep skin infections, chronic skin infections, trauma/burns, and surgical wounds
• Secondary infections
• Osteomyelitis and arthritis
• Pharyngitis (including tonsillitis and peritonsillar abscess), acute bronchitis
• Secondary infections of pneumonia, lung abscess, suppurative inflammation, and chronic respiratory tract lesions
• Cystitis, nephritis, prostatitis (acute and chronic)
• Peritonitis
• Cholecystitis
• Bartholinitis, uterine infections, and intrauterine infections
• Purulent meningitis
• Otitis media and sinusitis
   

DOSAGE AND ADMINISTRATION

Dosage: 
Adults: For intravenous injection or infusion, the recommended dose is 0.5–2 g/day, pided into 2–4 doses, administered at intervals of 6–12 hours.
Septicemia: the dose may be increased to 4 g/day, administered intravenously.
Children: For intravenous administration, the recommended dose is 40–80 mg/kg/day, pided into 3–4 doses at intervals of 6–8 hours. In severe infections, including septicemia and meningitis, the dose may be increased to 160 mg/kg/day
Renal impairment: If creatinine clearance is > 20 mL/min, no dose adjustment is required; however, the total daily dose should not exceed 400 mg/24 hours. If creatinine clearance is < 16.6 mL/min or < 20 mL/min, the dose should be reduced to 75% of the usual dose when administered every 6–8 hours; no dose adjustment is required when dosing every 12 hours.
Dose adjustments should be made based on the patient’s age and severity of the disease.

Method of administration: 
The combination of cefotiam with bromhexine hydrochloride solution 2 mg/mL (2 mL), dipyridamole 5 mg/mL (2 mL), or gabexate mesilate 100 mg/vial is incompatible, resulting in changes in appearance, pH, and antibacterial activity of cefotiam after reconstitution.
Intravenous infusion: 
Dissolve 1 g of cefotiam in 100 mL of 0.9% sodium chloride solution or 100 mL of 5% dextrose solution to obtain a final concentration of approximately 10 mg/mL. After reconstitution, intravenous drip infusion should be administered over 30 minutes to 2 hours.
Intravenous injection:
Dissolve 1 g of cefotiam in 10 mL of sterile water for injection to obtain a final concentration of approximately 100 mg/mL. Alternatively, dissolve 1 g of cefotiam in 5 mL of 0.9% sodium chloride solution or 5 mL of 5% dextrose solution to obtain a final concentration of approximately 200 mg/mL.
Stability of reconstituted solutions:
Cefotiam solution reconstituted with sterile water for injection to a concentration of approximately 100 mg/mL remains stable for 24 hours when stored under refrigeration at 5 ± 3°C. Cefotiam solution reconstituted with 0.9% sodium chloride solution or 5% dextrose solution to a concentration of approximately 200 mg/mL remains stable for 24 hours when stored under refrigeration at 5 ± 3°C.
 

CONTRAINDICATIONS

•    Hypersensitivity to any component of the product or to cephalosporin antibiotics.
•    Hypersensitivity to amide-type local anesthetics, such as lidocaine.
 

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.