FULSPEC
Meropenem
ANTI-INFECTIVE
INDICATION
Skin and Skin Structure Infections,
Pneumonia & Hospital-Acquired Pneumonia,
Intra-abdominal Infections such as Peritonitis,
Meningitis,
Respiratory Tract Infections in cystic fibrosis patients,
Gynaecological infection, such as endometritis,
Septicemia,
Urinary Tract Infections,
Billiary Tract Infections,
Infections in Immunocompromised Patients (with neutropenia in adults),
Surgical prophylaxis & Other Polymicrobial Infections.
DOSAGE AND ADMINISTRATION
Adults : It is given by slow intravenous injection over 3 to 5 minutes or by intravenous infusion over 15 to 30 minutes in a usual dose of 500 mg to 1 g every 8 hours.
The recommended daily dosage for adult in : ? Skin and skin structure infections : 500 mg IV for every 8 hours.? Hospital acquired pneumonia, peritonitis, septicaemia, intra-abdominal infections & infections in neutropenic patients : 1 g IV for every 8 hours.? Meningitis & Infections of chronic lower respiratory tract infections in cystic fibrosis : 2 g IV for every 8 hours.
Adults with Renal Impairment : Dosage should be reduced in patients with creatinine clearance less than 51 ml / min as below schedule :
| Creatinine clearance (ml/min) | Dose (dependent of type of infection) | Dosing interval |
| 51 | Recommended dose | Every 8 hours |
| 26-50 | Recommended dose | Every 12 hours |
| 10-25 | ½ of recommended dose | Every 12 hours |
| <10 | ½ of recommended dose | Every 24 hours |
Adults with Hepatic Insufficiency: No dosage adjustment is necessary in patients with impaired hepatic function.
Use in Elderly Patients : No dosage adjustment is required for elderly patients with creatinine clearance values above 50 ml/min.
Use in Children : Efficacy and tolerability in infants under 3 months old have not been recognized; consequently, Fulspec (Meropenem) is not recommended for below this age.
Children over 3 months to 12 years : 10 to 20 mg / kg body weight every 8 hours.
Children over 50 kg body weight : adult dose.
Meningitis : 40 mg / kg body weight for every 8 hours.
Children over 4 – 18 years with cystic fibrosis : 25 to 40 mg / kg body weight for every 8 hours.
There is no experience in children with renal impairment.
COMPOSITION
Fulspec 250 mg: Each vial contains sterile powder of Meropenem USP equivalent to 250 mg Meropenem
Fulspec 500 mg IV Injection : Each vial contains sterile powder of Meropenem USP equivalent to 500 mg Meropenem.
Fulspec 1 g IV Injection : Each vial contains sterile powder of Meropenem USP equivalent to 1 g Meropenem
