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Aropen

Meropenem

Meropenem is a carbapenem antibiotic for parenteral use. It is structurally similar to imipenem but is stable to human dehydropeptidase-1 (DHP-1). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria as it can penetrates bacterial cell wall excellently, it has high level of stability to all serine ß-lactamases and it has marked affinity for the Penicillin Binding Proteins (PBPs).

Product Details

Presentation

Aropen 500 mg IV Injection/Infusion: Each vial contains sterile powder of Meropenem Trihydrate USP equivalent to Meropenem 500 mg premixed with Sodium Carbonate.

Aropen 1 g IV Injection/Infusion: Each vial contains sterile powder of Meropenem Trihydrate USP equivalent to Meropenem 1 g premixed with Sodium Carbonate.

Pharmacology

Meropenem is a carbapenem antibiotic for parenteral use. It is structurally similar to imipenem but is stable to human dehydropeptidase-1 (DHP-1). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria as it can penetrates bacterial cell wall excellently, it has high level of stability to all serine ß-lactamases and it has marked affinity for the Penicillin Binding Proteins (PBPs).

Indication

Meropenem IV Injection/Infusion is indicated for the treatment, in adults and children, of the following infections caused by single or multiple susceptible bacteria.
Community acquired Pneumonia and Nosocomial Pneumonias
Urinary Tract Infections, both uncomplicated & complicated
Intra-abdominal Infections
Gynaecological Infections, such as endometritis and pelvic inflammatory disease
Skin and Soft Tissue Infections
Meningitis
Septicaemia
Empiric treatment, for presumed infection in adult patients with febrile neutropenia, used as monotherapy or in combination with antiviral or antifungal agents or other antibacterials

Dosage & Administration

Adults: The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient.
The recommended daily dosage in different infections is as follows:

















Infection Dosage
Pneumonia,UTI,gynaecological,infections such as endometritis, skin and soft tissue infections 500 mg IV every 8 hours
Nosocomial pneumonia, peritonitis, presumed infections in neutropenic patients and septicaemia 1 g IV every 8 hours
Meningitis 2 g IV every 8 hours


Like other antibiotics, caution may be required in using Meropenem as monotherapy in critically ill patients with known or suspected lower respiratory tract infections caused by Pseudomonas aeruginosa. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infections.

Adults with impaired renal function
Dosage should be reduced in patients with creatinine clearance less than 51 ml/min, as scheduled below:











Creatinine Clearance(ml/min) Dose (based on unit doses of 500 mg, 1 g, 2 g every 8 hours) Frequency
26 to 50
10 to 25 < 10
one unit dose
one-half unit dose
one-half unit dose
every 12 hours
every 12 hours
every 24 hours


Meropenem is cleared by haemodialysis. If continued treatment with Meropenem 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 concentration. There is no experience with peritoneal dialysis.

Adults with hepatic insufficiency
No dosage adjustment is necessary in patients with impaired hepatic metabolism.

Elderly
No dosage adjustment is required for the elderly with normal renal function or creatinine clearance value above 50 ml/min.

Children
For infants and children over 3 months to 12 years of age: The usual recommended intravenous dose is 10 - 40 mg/kg every 8 hours depending on type and severity of infection, the susceptibility of the pathogen and the condition of the patient. In children over 50 kg weight, adult dosage should be used.
Febrile episodes in neutropenic patients: The dose should be 20 mg/kg every 8 hours.
In meningitis: The dose should be 40 mg/kg every 8 hours.

Method of administration
Meropenem can be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes using the specific available diluents.

Preparation of solution:

Intravenous bolus administration :
Reconstitute Aropen IV injection (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow. Amount of water for injection would be as follows :
















Vial Size Water for injection (ml) Approximate Average Concentration (mg/ml)
500 mg 10 50
1 g 20 50


Intravenous infusion administration :
Meropenem 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, as needed.

Compatible fluids : 0.9% Sodium Chloride Solution, 5% or 10% Glucose Solution, 5% Glucose Solution with 0.02% Sodium Bicarbonate, 0.9% Sodium Chloride and 5% Glucose Solution, 5% Glucose with 0.225% Sodium Chloride Solution, 5% Glucose with 0.15% Potassium Chloride Solution, 2.5% or 10% Mannitol Solution.
Compatibility of Meropenem with other drugs has not been established. Freshly prepared solutions of Meropenem should be used whenever possible. After reconstitution Meropenem with sterile water for injection is stable at room temperature for 8 hrs and under refrigerator for 18 hrs at 4° C. Solutions of intravenous Meropenem should not be frozen.

Contraindications

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

Warning & Precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with ß-lactams. Before initiating therapy with Meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other ß-lactams, and other allergens. If an allergic reaction to Meropenem occurs, discontinue the drug immediately. Seizures and other adverse CNS experiences have been reported during treatment with Meropenem. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Meropenem.

Side effects

Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhoea, headache, parasthesiae may occur.

Drug interaction

Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion of Meropenem. This leads to statistically significant increase in the elimination half-life (38%) and in the extent of systemic exposure (56%). Therefore, the coadministration of probenecid and Meropenem is not recommended. Meropenem may reduce serum level of valproic acid.

Use in special groups

Use in pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed.

Use in lactation: Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.

Use in children: Efficacy and tolerability in infants under 3 months have not been established.

Packing

Aropen 500 mg IV Injection/Infusion: Combipack of 1 vial of 500 mg of Meropenem Trihydrate USP and 1 ampoule of 10 ml Water for Injection.
Aropen 1 g IV Injection/Infusion: Combipack of 1 vial of 1 g of Meropenem Trihydrate USP and 2 ampoules of 10 ml Water for Injection.

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