Fulspec 500mg/vial

IV Injection or Infusion
Meropenem Trihydrate
ACME Laboratories Ltd

Other Strength:
- Fulspec 250mg/vial
- Fulspec 1gm/vial

Alternative:
- Neopenem 500mg/vial
- Specbac 500mg/vial
- Penomer 500mg/vial



Fulspec
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.

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