Meropenem

Meropenem Manufacturers

• Fresenius Kabi Usa, Llc
  

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  Meropenem | Westminster Pharmaceuticals, Llc

  

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  The recommended dose is one drop of Brimonidine Tartrate Ophthalmic Solution, 0.2% in the affected eye(s) three times daily, approximately 8 hours apart.

  Brimonidine Tartrate Ophthalmic Solution, 0.2% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

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• Sandoz Inc
  

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  Meropenem | Sandoz Inc

  

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  2.1 Adult Patients

  The recommended dose of Meropenem for Injection is 500 mg given every 8 hours for skin and skin structure infections and 1 g given every 8 hours for intra-abdominal infections. Meropenem for Injection 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 to 5 minutes.

  2.2 Use in Adult Patients with Renal Impairment

  Dosage 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 Meropenem for Injection Dosage Schedule for Adult Patients With Renal Impairment

  Creatinine

  Clearance

  (mL/min)

  Dose

  (dependent on

  type of infection)

  Dosing Interval

  >50

  Recommended dose (500 mg

  cSSSI and 1g Intra-abdominal)

  Every 8 hours

  >25-50

  Recommended dose

  Every 12 hours

  10-25

  One-half recommended dose

  Every 12 hours

  <10

  One-half recommended dose

  Every 24 hours

  There is inadequate information regarding the use of Meropenem for Injection in patients on hemodialysis or peritoneal dialysis.

  2.3 Use in Pediatric Patients (≥ 3 Months only)

  For pediatric patients from 3 months of age and older, the Meropenem for Injection 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 for Injection 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 for Injection 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 to 5 minutes.

  There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 g) bolus dose.

  Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients 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 g

  Every 8 hours

  Meningitis

  40

  2 g

  Every 8 hours

  There is no experience in pediatric patients with renal impairment.

  2.4 Preparation of Solution

  For Intravenous Bolus Administration

  Constitute injection vials (500 mg and 1 g) 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 g

  20

  20

  50

  For Infusion

  Infusion vials (500 mg and 1 g) may be directly constituted with a compatible infusion fluid. 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 DOSAGE AND ADMINISTRATION (2.5) and (2.6)].

  WARNING: Do not use flexible container in series connections.

  2.5 Compatibility

  Compatibility of Meropenem with other drugs has not been established. Meropenem should not be mixed with or physically added to solutions containing other drugs.

  2.6 Stability and Storage

  Freshly prepared solutions of Meropenem should be used whenever possible. However, constituted solutions of Meropenem maintain satisfactory potency at controlled room temperature 15-25°C (59-77°F) or under refrigeration at 4°C (39°F) as described below. Solutions of intravenous Meropenem should not be frozen.

  Intravenous Bolus Administration

  Meropenem for Injection injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) 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 for Injection infusion vials constituted with Sodium Chloride Injection 0.9% (Meropenem 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 for Injection constituted with Dextrose Injection 5% (Meropenem 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 concentrations ranging from 1 to 20 mg/mL) may be stored in plastic intravenous bags with diluents as shown below:

  * NORMOSOL is a registered trademark of Hospira Inc.

  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%

  4

  24

  Dextrose Injection 5%

  1

  4

  Dextrose Injection 10%

  1

  2

  Dextrose and Sodium Chloride Injection 5%/0.9%

  1

  2

  Dextrose and Sodium Chloride Injection 5%/0.2%

  1

  4

  Potassium Chloride in Dextrose

  Injection 0.15%/5%

  1

  6

  Sodium Bicarbonate in Dextrose

  Injection 0.02%/5%

  1

  6

  Dextrose Injection 5% in Normosol®-

  M*

  1

  8

  Dextrose Injection 5% in Ringers

  Lactate Injection

  1

  4

  Dextrose and Sodium Chloride Injection

  2.5%/0.45%

  3

  12

  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%

  1

  4

  Stability in Baxter Minibag Plus® (Manufactured by Baxter, Inc.): Solutions of Meropenem for Injection (Meropenem 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 for Injection (Meropenem concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus® bags with Dextrose Injection 5% 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 for Injection (Meropenem 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% (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 Meropenem for Injection (Meropenem for Injection 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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• App Pharmaceuticals, Llc
  

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  Meropenem | Mylan Pharmaceuticals Inc.

  

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  As individual monotherapy, quinapril is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg and hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg. In clinical trials of quinapril/hydrochlorothiazide combination therapy using quinapril doses of 2.5 mg to 40 mg and hydrochlorothiazide doses of 6.25 mg to 25 mg, the antihypertensive effects increased with increasing dose of either component.

  The side effects (see WARNINGS) of quinapril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of quinapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens that combine low doses of hydrochlorothiazide with quinapril produce minimal effects on serum potassium. In clinical trials of quinapril and hydrochlorothiazide tablets, the average change in serum potassium was near zero in subjects who received HCTZ 6.25 mg in the combination, and the average subject who received 10 mg to 40 mg/12.5 mg to 25 mg experienced a milder reduction in serum potassium than that experienced by the average subject receiving the same dose of hydrochlorothiazide monotherapy.

  To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

  Therapy Guided by Clinical Effect

  Patients whose blood pressures are not adequately controlled with quinapril monotherapy may instead be given quinapril and hydrochlorothiazide tablets 10 mg/12.5 mg or 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve blood pressure control with less electrolyte disturbance if they are switched to quinapril and hydrochlorothiazide tablets 10 mg/12.5 mg or 20 mg/12.5 mg.

  Replacement Therapy

  For convenience, patients who are adequately treated with 20 mg of quinapril and 25 mg of hydrochlorothiazide and experience no significant electrolyte disturbances may instead wish to receive quinapril and hydrochlorothiazide tablets 20 mg/25 mg.

  Use in Renal Impairment

  Regimens of therapy with quinapril and hydrochlorothiazide tablets need not take account of renal function as long as the patient’s creatinine clearance is > 30 mL/min/1.73 m2 (serum creatinine roughly ≤ 3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides. Therefore, quinapril and hydrochlorothiazide tablets are not recommended for use in these patients.

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• Fresenius Kabi Usa, Llc
  

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  Meropenem | Fresenius Kabi Usa, Llc

  

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  2.1 Adult Patients

  The recommended dose of Meropenem for injection (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. 
  Meropenem for injection (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 to 5 minutes.

  2.2 Use in Adult Patients with Renal Impairment

  Dosage 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 Meropenem for injection (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 to 50
  Recommended dose
  Every 12 hours
  10 to 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 Meropenem for injection (I.V.) in patients on hemodialysis or peritoneal dialysis.

  
  2.3 Use in Pediatric Patients

  Pediatric Patients 3 Months of Age and Older
  For pediatric patients from 3 months of age and older, the Meropenem for injection (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 Meropenem for injection (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. Meropenem for injection (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 Meropenem for injection (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 Meropenem for injection (I.V.) dose is based on gestational age (GA) and postnatal age (PNA). (See dosing table below). Meropenem for injection (I.V.) should be given as intravenous infusion over 30 minutes.  

  
  Recommended Meropenem for injection (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 Solution

  For 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 Compatibility

  Compatibility of Meropenem with other drugs has not been established. Meropenem should not be mixed with or physically added to solutions containing other drugs.

  2.6 Stability and Storage

  Freshly prepared solutions of Meropenem should be used. However, constituted solutions of Meropenem maintain satisfactory potency under the conditions described below. Solutions of intravenous Meropenem should not be frozen.

  Intravenous Bolus Administration

  Meropenem injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) may be stored for up to 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F).

  Intravenous Infusion Administration

  Solutions prepared for infusion (Meropenem 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 25°C (77°F) or 15 hours at up to 5°C (41°F).
  Solutions prepared for infusion (Meropenem 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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• Cardinal Health
  

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  Meropenem | Neutrogena Corporation

  

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  Cleanse twice a day. Wet face with warm water. Apply to hands, add warm water and massage face gently. Rinse thoroughly.

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• Hospira, Inc.
  

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  Meropenem | Hospira, Inc.

  

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  2.1 Adult Patients

  The recommended dose of Meropenem for Injection 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.

  Meropenem for Injection 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 to 20 mL) over approximately 3 minutes to 5 minutes.

  2.2 Use in Adult Patients with Renal Impairment

  Dosage 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 Meropenem for Injection 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 to 50

  Recommended dose

  Every 12 hours

  10 to 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 Meropenem for Injection I.V. in patients on hemodialysis or peritoneal dialysis.

  2.3 Use in Pediatric Patients Pediatric Patients 3 Months of Age and Older

  For pediatric patients from 3 months of age and older, the Meropenem for Injection 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 Meropenem for Injection 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. Meropenem for Injection 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-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 Meropenem for Injection 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 Meropenem for Injection I.V. dose is based on gestational age (GA) and postnatal age (PNA). (See dosing table below). Meropenem for Injection I.V. should be given as intravenous infusion over 30 minutes.

  Recommended Meropenem for Injection 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 Solution

  For 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 Compatibility

  Compatibility of Meropenem with other drugs has not been established. Meropenem should not be mixed with or physically added to solutions containing other drugs.

  2.6 Stability and Storage

  Freshly prepared solutions of Meropenem should be used. However, constituted solutions of Meropenem maintain satisfactory potency under the conditions described below. Solutions of intravenous Meropenem should not be frozen.

  Intravenous Bolus Administration

  Meropenem for Injection I.V. vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) may be stored for up to 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F).

  Intravenous Infusion Administration

  Solutions prepared for infusion (Meropenem for Injection 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 (Meropenem for Injection 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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