Meropenem I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Meropenem I.V. is indicated as single agent therapy for the treatment of the following infections when caused by susceptible isolates of the designated microorganisms:
Pharmacodynamics
Meropenem is a broad-spectrum carbapenem antibiotic. It is active against Gram-positive and Gram-negative bacteria. Meropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death.
Half life
Approximately 1 hour in adults and children 2 years of age and older with normal renal function. Approximately 1.5 hours in children 3 months to 2 years of age.
Toxicity
In mice and rats, large intravenous doses of meropenem (2200-4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.
contraindicated
Meropenem is contraindicated in conditions like GI diseases, Hypersensitivity.
Store and temperature
Inj : Store at room temperature, Between 20°C-25°C. Protect from Sunlight
There is no experience with peritoneal dialysis.
Use in Adults With Hepatic Insufficiency:
No dosage adjustment is necessary in patients with impaired hepatic function.
No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.
WARNING: Do not use flexible container in series connections.
Freshly prepared solutions of MEROPENEM I.V. should be used whenever possible. However, constituted solutions of MEROPENEM I.V. maintain satisfactory potency at controlled room temperature 15-25ºC (59- 77°F) or under refrigeration at 4°C (39°F) as described below. Solutions of intravenous MEROPENEM I.V. should not be frozen.
Stability in Plastic I.V. Bags: Solutions prepared for infusion (MEROPENEM I.V. concentrations ranging from 1 to 20 mg/mL) may be stored in plastic intravenous bags with diluents as shown below:
Stability in Baxter Minibag Plus: Solutions of MEROPENEM I.V. (MEROPENEM I.V. concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags with Sodium Chloride Injection 0.9% may be stored for up to 4 hours at controlled room temperatures 15-25°C (59-77°F) or for up to 24 hours at 4°C (39°F). Solutions of MEROPENEM I.V. (MEROPENEM I.V. concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags with Dextrose Injection 5.0% may be stored up to 1 hour at controlled room temperatures 15-25°C (59-77°F) or for up to 6 hours at 4°C (39°F).
Stability in Plastic Syringes, Tubing and Intravenous Infusion Sets: Solutions of MEROPENEM I.V. (MEROPENEM I.V. concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0.9% (for up to 4 hours) or in Dextrose Injection 5.0% (for up to 2 hours) at controlled room temperatures 15-25°C (59-77°F) are stable in plastic tubing and volume control devices of common intravenous infusion sets.
Solutions of I.V. (MEROPENEM I.V. concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0.9% (for up to 48 hours) or in Dextrose Injection 5% (for up to 6 hours) are stable at 4ºC (39ºF) in plastic syringes.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Meropenem I.V. is indicated as single agent therapy for the treatment of the following infections when caused by susceptible isolates of the designated microorganisms:
Pharmacodynamics
Meropenem is a broad-spectrum carbapenem antibiotic. It is active against Gram-positive and Gram-negative bacteria. Meropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death.
Half life
Approximately 1 hour in adults and children 2 years of age and older with normal renal function. Approximately 1.5 hours in children 3 months to 2 years of age.
Toxicity
In mice and rats, large intravenous doses of meropenem (2200-4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.
contraindicated
Meropenem is contraindicated in conditions like GI diseases, Hypersensitivity.
Store and temperature
Inj : Store at room temperature, Between 20°C-25°C. Protect from Sunlight
DOSAGE AND ADMINISTRATION
Adults
The recommended dose of Meropenem I.V. is 500 mg given every 8 hours for skin and skin structure infections and 1 g given every 8 hours for intra-abdominal infections.MeropenemI.V. should be administered by intravenous infusion over approximately 15 to 30 minutes. Doses of 1 g may also be administered as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.
Use in Adults with Renal Impairment
Dosage should be reduced in patients with creatinine clearance less than 51 mL/min. (see dosing table below).Dosage Schedule for Adults With Impaired Renal Function
| Creatinine Clearance (mL/min) | Dose (dependent on type of infection) | Dosing Interval |
| ≥ 51 | Recommended dose (500 mg cSSSI and 1g Intra-abdominal) | Every 8 hours |
| 26-50 | Recommended dose | Every 12 hours |
| 10-25 | One-half recommended dose | Every 12 hours |
| < 10 | One-half recommended dose | Every 24 hours |
When only serum creatinine is available, the following formula (Cockcroft and Gault equation)5 may be used to estimate creatinine clearance
| Creatinine clearance for males = | [140-age (years)]× [body wt (kg)] 72 × [serum creatinine (mg/dL)] |
| Creatinine clearance for females = | [140-age (years)]× [body wt (kg)]× 0.85 72 × [serum creatinine (mg/dL)] |
There is inadequate information regarding the use of MEROPENEM I.V. in patients on hemodialysis.
There is no experience with peritoneal dialysis.
Use in Adults With Hepatic Insufficiency:
No dosage adjustment is necessary in patients with impaired hepatic function.
No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.
Use in Pediatric Patients
For pediatric patients from 3 months of age and older, the MEROPENEM I.V. dose is 10, 20 or 40 mg/kg every 8 hours (maximum dose is 2 g every 8 hours), depending on the type of infection (complicated skin and skin structure, intra-abdominal or meningitis). (See dosing table below.) Pediatric patients weighing over 50 kg should be administered MEROPENEM I.V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every 8 hours for intra-abdominal infections and 2 g every 8 hours for meningitis. MEROPENEM I.V. should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.Recommended MEROPENEM I.V. Dosage Schedule for Pediatrics With Normal Renal Function
| Type of Infection | Dose (mg/kg) | Up to a Maximum Dose | Dosing Interval |
| Complicated skin | 10 | 500 mg | Every 8 hours |
| Skin structure Intra-abdominal | 20 | 1 g | Every 8 hours |
| Meningitis | 40 | 2 g | Every 8 hours |
There is no experience in pediatric patients with renal impairment.
PREPARATION OF SOLUTION
For Intravenous Bolus Administration
Constitute injection vials (500 mg and 1g) with sterile Water for Injection. (See table below.) Shake to dissolve and let stand until clear.
| Vial size | Amount of Diluent Added (mL) | Approximate Withdrawable Volume (mL) | Approximate Average Concentration (mg/mL) |
| 500 mg | 10 | 10 | 50 |
| 1g | 20 | 20 | 50 |
For Infusion
Infusion vials (500 mg and 1g) may be directly constituted with a compatible infusion fluid (See Compatibility And Stability) Alternatively, an injection vial may be constituted, then the resulting solution added to an I.V. container and further diluted with an appropriate infusion fluid. (See Compatibility And Stability)WARNING: Do not use flexible container in series connections.
Compatibility And Stability
Compatibility of MEROPENEM I.V. with other drugs has not been established. MEROPENEM I.V. should not be mixed with or physically added to solutions containing other drugs.Freshly prepared solutions of MEROPENEM I.V. should be used whenever possible. However, constituted solutions of MEROPENEM I.V. maintain satisfactory potency at controlled room temperature 15-25ºC (59- 77°F) or under refrigeration at 4°C (39°F) as described below. Solutions of intravenous MEROPENEM I.V. should not be frozen.
Intravenous Bolus Administration
MEROPENEM I.V. injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of MEROPENEM I.V.) may be stored for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 12 hours at 4°C (39°F).Intravenous Infusion Administration
Stability in Infusion Vials: MEROPENEM I.V. infusion vials constituted with Sodium Chloride Injection 0.9% (MERREM I.V. concentrations ranging from 2.5 to 50 mg/mL) are stable for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 18 hours at 4°C (39°F). Infusion vials of MEROPENEM I.V. constituted with Dextrose Injection 5% (MEROPENEM I.V. concentrations ranging from 2.5 to 50 mg/mL) are stable for up to 1 hour at controlled room temperature 15-25°C (59-77°F) or for up to 8 hours at 4°C (39°F).Stability in Plastic I.V. Bags: Solutions prepared for infusion (MEROPENEM I.V. concentrations ranging from 1 to 20 mg/mL) may be stored in plastic intravenous bags with diluents as shown below:
| | Number of Hours Stable at Controlled Room Temperature 15-25°C (59-77°F) | Number of Hours Stable at 4°C (39°F) |
| Sodium Chloride Injection 0.9% | 04 | 24 |
| Dextrose Injection 5.0% | 01 | 4 |
| Dextrose Injection 10.0% | 01 | 02 |
| Dextrose and Sodium Chloride Injection 5.0%/0.9% | 01 | 02 |
| Dextrose and Sodium Chloride Injection 5.0%/0.2% | 01 | 04 |
| Potassium Chloride in Dextrose Injection 0.15%/5.0% | 01 | 06 |
| Sodium Bicarbonate in Dextrose Injection 0.02%/5.0% | 01 | 06 |
| Dextrose Injection 5.0% in Normosol®-M | 01 | 08 |
| Dextrose Injection 5.0% in Ringers Lactate Injection | 01 | 04 |
| Dextrose and Sodium Chloride Injection | 03 | 12 |
| 2.5%/0.45% | | |
| Mannitol Injection 2.5% | 2 | 16 |
| Ringers Injection | 4 | 24 |
| Ringers Lactate Injection | 4 | 12 |
| Sodium Lactate Injection 1/6 N | 2 | 24 |
| Sodium Bicarbonate Injection 5.0% | 01 | 04 |
Stability in Plastic Syringes, Tubing and Intravenous Infusion Sets: Solutions of MEROPENEM I.V. (MEROPENEM I.V. concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0.9% (for up to 4 hours) or in Dextrose Injection 5.0% (for up to 2 hours) at controlled room temperatures 15-25°C (59-77°F) are stable in plastic tubing and volume control devices of common intravenous infusion sets.
Solutions of I.V. (MEROPENEM I.V. concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0.9% (for up to 48 hours) or in Dextrose Injection 5% (for up to 6 hours) are stable at 4ºC (39ºF) in plastic syringes.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Unknown - Saturday 23 April 2011
