Description: Faropenem Sodium Tablets used in Dentistry ,Oral Surgery,for treating respiratory infections.Faropenem Sodium is a class of beta-lactam antibiotics which possess potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative bacteria and are extremely stable to hydrolysis by beta-lactamases.
Pharmacokinetics: The pharmacokinetics of Faropenem Sodium Tablets were studied in single and multiple dose regimens. A single-dose, open-label, randomized, four-period crossover dose study was carried out in 12 healthy volunteers.The subjects received intravenous infusion of 100,200,400 or 600 mg faropenem. 8 subjects were given 200mg of faropenem q8h for 7 days.The concentrations of faropenem in serum and urine were determined by HPLC method. The main pharmacokinetic parameter of the four groups (100,200,400 and 600 mg) were as follows:Cmax=(8.42±1.96) mg/L,(16.64±3.09) mg/L,(24.73±3.58) mg/L, (44.43±3.93) mg/L, T1/2=(1.72±0.72)h,(1.60±0.33)h, (1.56±0.21)h, (1.36±0.09)h, AUC0-t= (13.90±2.96) mg·h /L, (26.98±5.75) mg·h /L, (38.29±5.29) mg·h /L,(70.58±10.33) mg·h /L, respectively. Almost 30% of the administered drug was excreted unchanged in urine up to 12h after dosing.The steady-state pharmacokinetic parameters including Cmax,T1/2, AUC0-8,DF and Cav were (15.83±3.96)mg/L, (1.11±0.27)h,(21.93±3.59) mg·h/L,(5.34±1.30) and (2.74±0.45) mg/L, respectively. In single-dose study, Cmax and AUC demonstrated linear pharmacokinetics from 100 to 600 mg. The accumulated recovery rates obtained in urine indicate renal excretion is the main pathway for the elimination of faropenem.
Indications: Administered orally. Lower respiratory tract infections, ENT infections, and genitourinary infections Hypersensitivity to Faropenem and other beta lac tams.
Precautions: Lactation : Use with caution. Padiatrics : Safety in infant has not been established. Geriatrics : Start with a dose of 150mg. Pregnancy Safety has not been established. Stop the medicine if diarrhea and loose bowel movement occur Patient with family history of atopy
Adverse reaction: Diarrhea, abdominal pain, loose bowel movement, nausea, and rash are the most frequent adverse effects.