Actropen INJ.
Actropen is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:
o Hospital and Community acquired lower respiratory tract infection
o Complicated urinary tract infection
o Febrile neutropenia
o Intra-abdominal and gynaecological (poly microbial) infections
o Complicated skin and skin structure infections
o Meningitis
o Septicaemia
Therapeutic Class
Dosage Form & Composition
Injection: Each vial Contains: Meropenem USP equivalent to Anhydrous Meropenem 1000 mg Sodium Carbonate
Pack Size: Actropen 1000 injection pack in a carton.
Indications
Actropen is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:
o Hospital and Community acquired lower respiratory tract infection
o Complicated urinary tract infection
o Febrile neutropenia
o Intra-abdominal and gynaecological (poly microbial) infections
o Complicated skin and skin structure infections
o Meningitis
o Septicaemia
Contra-indications
Hypersensitivity to ingredients, Hypersensitivity to penicillin of or other beta-lactam antibiotics. Pseudomembranous colitis.
Actropen is contraindicated in patients who have demonstrated hypersensitivity to this product.
Dosage & Administration
Adults
Usual dose
500 mg to 1 g by intravenous administration every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient.
Exceptions
1. Febrile episodes in neutropenic patients – the dose should be 1 g every 8 hour.
2. Meningitis – the dose should be 2 g every 8 hours.
As with other antibiotics, caution may be required in using meropenem as monotherapy in critically ill patients with known or suspected Pseudomonas aeruginosa lower respiratory
Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.
Actropen should be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes,
Dosage schedule for adults with impaired renal function
Dosage should be reduced in patients with creatinine clearance less than 51 mL/min, as scheduled below.
| Creatinine Clearance | Dose (based on unit doses of 500 mg, 1 g, 2 g) | Frequency |
| 26 to 50 | One-unit dose | Every 12 hours |
| 10 to 25 | One-half unit dose | Every 12 hours |
| <10 | One-half unit dose | Every 24 hours |
Meropenem is cleared by haemodialysis. If continued treatment with Actropen is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations.
There is no experience with peritoneal dialysis.
Use in adults with hepatic insufficiency
No dosage adjustment is necessary in patients with impaired hepatic metabolism,
Elderly patients
No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/min.
Children
For infants and children over 3 months and up to 12 years of age the recommended intravenous dose is 10 to 40 mg/kg every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. In children over 50 kg weight, adult dosage should be used.
Exceptions
1. Febrile episodes in neutropenic patients – the dose should be 20 mg/kg every 8 hours.
2. Meningitis – the dose should be 40 mg/kg every 8 hours.
Actropen should be (liven as an IV bolus over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes.
There is no experience in children with renal impairment.
Method of administration
Actropen to be used for bolus intravenous injection should be constituted with sterile Water for Injections (10 mL per 500 mg meropenem). This provides an approximate available concentration of 50 mg/mL Constituted solutions are both clear and colourless
to pale yellow.
Actropen for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 mL) with the compatible infusion fluid.
Shake constituted solution before use. All vials are for single use only, Standard aseptic technique should be employed during constitution and administration.
Compatibility and stability
Actropen is compatible with the following infusion fluids:
o 0.9% sodium chloride intravenous infusion
o 5% or 10% glucose intravenous infusion
o 5% glucose intravenous infusion with 0,02% sodium bicarbonate
o 0.9% sodium chloride and 5% glucose intravenous infusion
o 5% glucose with 0.225% sodium chloride intravenous infusion
o 5% glucose with 0,15% potassium chloride intravenous infusion
o 2.5% and 10% mannitol intravenous infusion
OVERDOSAGE
The pharmacological properties and mode of administration make it unlikely that intentional overdose will occur: Accidental overdosage could occur during therapy, particularly in patients with renal impairment. Treatment of overdosage should be symptomatic. In normal individuals rapid renal elimination will occur. In subjects with renal impairment haemodialysis will remove meropenem and its metabolite.
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