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.
Indications : • 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 & 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.
