Brilinta

Brilinta Manufacturers

• Cardinal Health
  

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  Brilinta | American Sales Company

  

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  • take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs

  adults & children 12 yrs & over

  30 mL (2 TBSP) every 6 hrs

  children 4 to under 12 yrs

  ask a doctor

  children under 4 yrs

  do not use

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• Astrazeneca Lp
  

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  Brilinta | Hospira, Inc.

  

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  Adults
  The dosage recommendations for Imipenem and Cilastatin for Injection (I.V.) represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

  The total daily dosage for Imipenem and Cilastatin for Injection (I.V.) should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.

  Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥70 kg
  Doses cited in Table 3 are based on a patient with normal renal function and a body weight of 70 kg. These doses should be used for a patient with a creatinine clearance of ≥71 mL/min/1.73 m2 and a body weight of ≥70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables 4 and 5.)

  Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.

  TABLE 3: INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥70 kg

  Type or
  Severity
  of Infection

  A
  Fully susceptible organisms including
  gram- positive and gram-negative aerobes
  and anaerobes

  B
  Moderately susceptible
  organisms, primarily some
  strains of P. aeruginosa

  Mild

   

  250 mg q6h
  (TOTAL DAILY DOSE = 1g)

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

  Moderate

   

  500 mg q8h
  (TOTAL DAILY DOSE = 1.5g)
  or
  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)
  or
  1 g q8h
  (TOTAL DAILY DOSE = 3g)

  Severe, life
     threatening
     only

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

   

  1 g q8h
  (TOTAL DAILY DOSE = 3g)
  or
  1 g q6h
  (TOTAL DAILY DOSE = 4g)

  Uncomplicated
     urinary tract
        infection

  250 mg q6h
  (TOTAL DAILY DOSE = 1g)

  250 mg q6h
  (TOTAL DAILY DOSE = 1g)

  Complicated
     urinary tract
       infection

  500 mg q6h
  (TOTAL DAILY DOSE = 2g)

  500 mg q6h
  (TOTAL DAILY DOSE = 2g) 

  Due to the high antimicrobial activity of Imipenem and Cilastatin for Injection (I.V.), it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy. However, patients over twelve years of age with cystic fibrosis and normal renal function have been treated with Imipenem and Cilastatin for Injection (I.V.) at doses up to 90 mg/kg/day in divided doses, not exceeding 4 g/day.

  Reduced Intravenous Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg

  Patients with creatinine clearance of ≤70 mL/min/1.73 m2 and/or body weight less than 70 kg require dosage reduction of Imipenem and Cilastatin for Injection (I.V.) as indicated in the tables below. Creatinine clearance may be calculated from serum creatinine concentration by the following equation:

  Tcc (Males) =   (wt. in kg) (140 – age)        
                           (72) (creatinine in mg/dL)

  Tcc (Females) = 0.85 × above value

  To determine the dose for adults with impaired renal function and/or reduced body weight:

  1. Choose a total daily dose from  Table 3 based on infection characteristics. 2. a) If the total daily dose is 1 g, 1.5 g, or 2 g, use the appropriate subsection of  Table 4 and continue with step 3.
  b) If the total daily dose is 3 g or 4 g, use the appropriate subsection of  Table 5 and continue with step 3. 3. From Table 4 or 5:
  a) Select the body weight on the far left which is closest to the patient's body weight (kg).
  b) Select the patient's creatinine clearance category.
  c) Where the row and column intersect is the reduced dosage regimen. TABLE 4: REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg

  And
  Body
  Weight
  (kg)
  is:

  If TOTAL DAILY DOSE from TABLE 3 is:

  1 g/day

  1.5 g/day

  2 g/day

  and creatinine clearance
  (mL/min/1.73 m2) is:

  and creatinine clearance
  (mL/min/1.73 m2) is:

  and creatinine clearance
  (mL/min/1.73 m2) is:

  ≥71

  41 to
  70

  21 to
  40

  6 to
  20

  ≥71

  41 to
  70

  21 to
  40

  6 to
  20

  ≥71

  41 to
  70

  21 to
  40

  6 to
  20

   

  then the reduced dosage regimen (mg) is:

  then the reduced dosage regimen (mg) is:

  then the reduced dosage regimen (mg) is:

  ≥70

  250

  q6h

  250

  q8h

  250

  q12h

  250

  q12h

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  500

  q6h

  500

  q8h

  250

  q6h

  250

  q12h

  60

   

  250

  q8h

  125

  q6h

  250

  q12h

  125

  q12h

  250

  q6h

  250

  q8h

  250

  q8h

  250

  q12h

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  50

   

  125

  q6h

  125

  q6h

  125

  q8h

  125

  q12h

  250

  q6h

  250

  q8h

  250

  q12h

  250

  q12h

  250

  q6h

  250

  q6h

  250

  q8h

  250

  q12h

  40

   

  125

  q6h

  125

  q8h

  125

  q12h

  125

  q12h

  250

  q8h

  125

  q6h

  125

  q8h

  125

  q12h

  250

  q6h

  250

  q8h

  250

  q12h

  250

  q12h

  30

   

  125

  q8h

  125

  q8h

  125

  q12h

  125

  q12h

  125

  q6h

  125

  q8h

  125

  q8h

  125

  q12h

  250

  q8h

  125

  q6h

  125

  q8h

  125

  q12h

  TABLE 5: REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg

  And
  Body
  Weight
  (kg)
  is:

  If TOTAL DAILY DOSE from TABLE 3 is:

  3 g/day

  4 g/day

  and creatinine clearance
  (mL/min/1.73 m2) is:

  and creatinine clearance
  (mL/min/1.73 m2) is:

  ≥71

  41 to 70

  21 to 40

  6 to 20

  ≥71

  41 to 70

  21 to 40

  6 to 20

   

  then the reduced dosage regimen (mg) is:

  then the reduced dosage regimen (mg) is:

  ≥70

   

  1000

  q8h

  500

  q6h

  500

  q8h

  500

  q12h

  1000

  q6h

  750

  q8h

  500

  q6h

  500

  q12h

  60

   

  750

  q8h

  500

  q8h

  500

  q8h

  500

  q12h

  1000

  q8h

  750

  q8h

  500

  q8h

  500

  q12h

  50

   

  500

  q6h

  500

  q8h

  250

  q6h

  250

  q12h

  750

  q8h

  500

  q6h

  500

  q8h

  500

  q12h

  40

   

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  500

  q6h

  500

  q8h

  250

  q6h

  250

  q12h

  30

   

  250

  q6h

  250

  q8h

  250

  q8h

  250

  q12h

  500

  q8h

  250

  q6h

  250

  q8h

  250

  q12h

  Patients with creatinine clearances of 6 to 20 mL/min/1.73 m2 should be treated with Imipenem and Cilastatin for Injection (I.V.) 125 mg or 250 mg every 12 hours for most pathogens. There may be an increased risk of seizures when doses of 500 mg every 12 hours are administered to these patients.

  Patients with creatinine clearance ≤5 mL/min/1.73 m2 should not receive Imipenem and Cilastatin for Injection (I.V.) unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of Imipenem and Cilastatin for Injection (I.V.) for patients undergoing peritoneal dialysis.

  Hemodialysis
  When treating patients with creatinine clearances of ≤5 mL/min/1.73 m2 who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 6 to 20 mL/min/1.73 m2. (See Reduced Intravenous Dosage Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg.) Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive Imipenem and Cilastatin for Injection (I.V.) after hemodialysis and at 12 hour intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, Imipenem and Cilastatin for Injection (I.V.) is recommended only when the benefit outweighs the potential risk of seizures. (See PRECAUTIONS.)

  Pediatric Patients
  See PRECAUTIONS, Pediatric Patients.

  For pediatric patients ≥3 months of age, the recommended dose for non-CNS infections is 15 to 25 mg/kg/dose administered every six hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.

  For pediatric patients ≤3 months of age (weighing ≥1,500 g), the following dosage schedule is recommended for non-CNS infections:

      <1 wk of age: 25 mg/kg every 12 hrs
      1 to 4 wks of age: 25 mg/kg every 8 hrs
      4 wks to 3 mos. of age: 25 mg/kg every 6 hrs.

  Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.

  Imipenem and Cilastatin for Injection (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures.

  Imipenem and Cilastatin for Injection (I.V.) is not recommended in pediatric patients <30 kg with impaired renal function, as no data are available.  

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• Bryant Ranch Prepack
  

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  Brilinta | Bryant Ranch Prepack

  

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  Initiate BRILINTA treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment with 90 mg twice daily.

  After the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

  ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA.

  BRILINTA can be administered with or without food.

  A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.

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