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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM I.V. and other antibacterial drugs, MERREM 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.
MERREM I.V. is useful as presumptive therapy in the indicated condition (e.g., intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity.
For information regarding use in pediatric patients see Indications and Usage (1.1), (1.2) or (1.3); Dosage and Administration (2.3), Adverse Reactions (6.1), and Clinical Pharmacology (12.3).
MERREM I.V. is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
MERREM I.V. is indicated as a single agent therapy for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
MERREM I.V. is indicated as a single agent therapy for the treatment of bacterial meningitis caused by Streptococcus pneumoniae‡, Haemophilus influenzae, and Neisseria meningitidis.
‡ The efficacy of meropenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of Streptococcus pneumoniae has not been established.
MERREM I.V. has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
History
There is currently no drug history available for this drug.
Other Information
MERREM® I.V. (meropenem for injection) is a sterile, pyrogen-free, synthetic, broad-spectrum, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S•3H2O with a molecular weight of 437.52. Its structural formula is:
MERREM I.V. is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.
When constituted as instructed, each 1 gram MERREM I.V. vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg MERREM I.V. vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)].
Sources
Mens Maca Root Energising Face Protector Spf15 Manufacturers
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The Body Shop Wake Forest
Mens Maca Root Energising Face Protector Spf15 | Astrazeneca Pharmaceuticals Lp
2.1 Adult PatientsThe recommended dose of MERREM I.V. is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P.aeruginosa, a dose of 1 gram every 8 hours is recommended.
MERREM I.V. should be administered by intravenous infusion over approximately 15 minutes to 30 minutes. Doses of 1 gram may also be administered as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes -5 minutes.
2.2 Use in Adult Patients with Renal ImpairmentDosage should be reduced in patients with creatinine clearance of 50 mL/min or less. (See dosing table below.)
When only serum creatinine is available, the following formula (Cockcroft and Gault equation)5 may be used to estimate creatinine clearance.
Males: Creatinine Clearance (mL/min) =
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Females: 0.85 x above value
Recommended MERREM I.V. Dosage Schedule for Adult Patients with Renal Impairment
Creatinine Clearance (mL/min)
Dose (dependent on type of infection)
Dosing Interval
Greater than 50
Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal)
Every 8 hours
Greater than 25-50
Recommended dose
Every 12 hours
10-25
One-half recommended dose
Every 12 hours
Less than 10
One-half recommended dose
Every 24 hours
There is inadequate information regarding the use of MERREM I.V. in patients on hemodialysis or peritoneal dialysis.
2.3 Use in Pediatric PatientsPediatric Patients 3 Months of Age and Older
For pediatric patients 3 months of age and older, the MERREM I.V. dose is 10 mg/kg, 20 mg/kg, or 40 mg/kg every 8 hours (maximum dose is 2 grams 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 MERREM I.V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 gram every 8 hours for intra-abdominal infections and 2 grams every 8 hours for meningitis. MERREM I.V. should be given as intravenous infusion over approximately 15 minutes to 30 minutes or as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes.
There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 grams) bolus dose.
Recommended MERREM I.V. Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function
Type of Infection
Dose (mg/kg)
Up to a Maximum Dose
Dosing Interval
Complicated skin and skin structure
10
500 mg
Every 8 hours
Intra-abdominal
20
1 gram
Every 8 hours
Meningitis
40
2 grams
Every 8 hours
There is no experience in pediatric patients with renal impairment.
When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended.
Pediatric Patients Less Than 3 Months of Age
For pediatric patients (with normal renal function) less than 3 months of age, with intra-abdominal infections, the MERREM I.V. dose is based on gestational age (GA) and postnatal age (PNA). See dosing table below. MERREM I.V. should be given as intravenous infusion over 30 minutes.
Recommended MERREM I.V. Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-Abdominal Infections and Normal Renal Function
Age Group
Dose (mg/kg)
Dose Interval
Infants less than 32 weeks GA and PNA less than 2 weeks
20
Every 12 hours
Infants less than 32 weeks GA and PNA 2 weeks and older
20
Every 8 hours
Infants 32 weeks and older GA and PNA less than 2 weeks
20
Every 8 hours
Infants 32 weeks and older GA and PNA 2 weeks and older
30
Every 8 hours
There is no experience in pediatric patients with renal impairment.
2.4 Preparation of SolutionFor Intravenous Bolus Administration
Constitute injection vials (500 mg and 1 gram) 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
1 gram
20
20
50
For Infusion
Infusion vials (500 mg and 1 gram) may be directly constituted with a compatible infusion fluid. Alternatively, an injection vial may be constituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid [see Dosage and Administration (2.5) and (2.6)].
WARNING: Do not use flexible container in series connections.
2.5 CompatibilityCompatibility of MERREM I.V. with other drugs has not been established. MERREM I.V. should not be mixed with or physically added to solutions containing other drugs.
2.6 Stability and StorageFreshly prepared solutions of MERREM I.V. should be used. However, constituted solutions of MERREM I.V. maintain satisfactory potency under the conditions described below. Solutions of intravenous MERREM I.V. should not be frozen.
Intravenous Bolus Administration
MERREM I.V. injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of MERREM I.V.) may be stored for up to 3 hours at up to 25oC (77oF) or for 13 hours at up to 5oC (41oF).
Intravenous Infusion Administration
Solutions prepared for infusion (MERREM I.V. concentrations ranging from 1 mg/mL to 20 mg/mL) constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25oC (77oF) or 15 hours at up to 5oC (41oF).
Solutions prepared for infusion (MERREM I.V. concentrations ranging from 1 mg/mL to 20 mg/mL) constituted with Dextrose Injection 5% should be used immediately.
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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