Naropin

Naropin Manufacturers

• Fresenius Kabi Usa, Llc
  

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  Naropin | Aurobindo Pharma Limited

  

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  Table 1. Recommended Daily Dosage by Indication   Initial Dose Titration
  (Increments) Target Dose Effective Dose
  Range Schizophrenia: adults (2.1)
  2 mg
  1 to 2 mg
  4 to 8 mg
  4 to 16 mg
  Schizophrenia:
  adolescents (2.2)
  0.5 mg
  0.5 to 1 mg
  3 mg
  1 to 6 mg
  Bipolar mania: adults (2.2)
  2 to 3 mg
  1 mg
  1 to 6 mg
  1 to 6 mg
  Bipolar mania:
  children and
  adolescents (2.2)
  0.5 mg
  0.5 to 1 mg
  1 to 2.5 mg
  1 to 6 mg
  Irritability in autistic disorder (2.3)
  0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg)
   
  0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg)
  After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg)
   
  0.5 mg (body weight greater than or equal to 20 kg)
  0.5 mg: (body weight less than 20 kg)
   
   
  1 mg: (body weight
  greater than or equal to 20 kg)
  0.5 to 3 mg
  

  Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of one week or longer 

  2.1 Schizophrenia
  

  Adults
  
  Usual Initial Dose
  
  Risperidone oral solution can be administered once or twice daily. Initial dosing is 2 mg per day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 mg to 16 mg per day. However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg per day has not been evaluated in clinical trials [see Clinical Studies (14.1)].
  
  Adolescents
  
  The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to a recommended dose of 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.
  
  Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.
  
  Maintenance Therapy
  
  While it is unknown how long a patient with schizophrenia should remain on risperidone oral solution, the effectiveness of risperidone oral solution 2 mg per day to 8 mg per day at delaying relapse was demonstrated in a controlled trial in adult patients who had been clinically stable for at least 4 weeks and were then followed for a period of 1 to 2 years [see Clinical Studies (14.1)]. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode. Patients should be periodically reassessed to determine the need for maintenance treatment.
  
  Reinitiation of Treatment in Patients Previously Discontinued
  
  Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off risperidone oral solution, the initial titration schedule should be followed.
  
  Switching From Other Antipsychotics
  
  There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to risperidone oral solution, or treating patients with concomitant antipsychotics.

  2.2 Bipolar Mania
  

  Usual Dose
  
  Adults
  
  The initial dose range is 2 mg to 3 mg per day. The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg per day. The effective dose range is 1 mg to 6 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term (3 week) anti-manic efficacy was demonstrated in a flexible dosage range of 1 mg to 6 mg per day [see Clinical Studies (14.2, 14.3)]. Risperidone oral solution doses higher than 6 mg per day were not studied. 
  
  Pediatrics
  
  The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to the recommended target dose of 1 mg to 2.5 mg per day. Although efficacy has been demonstrated in studies of pediatric patients with bipolar mania at doses between 0.5 mg and 6 mg per day, no additional benefit was observed above 2.5 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied. 
  
  Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily. 
  
  Maintenance Therapy
  
  There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with risperidone oral solution. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of risperidone oral solution in such longer-term treatment (i.e., beyond 3 weeks). The physician who elects to use risperidone oral solution for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

  2.3 Irritability Associated with Autistic Disorder - Pediatrics (Children and Adolescents)
  

  The dosage of risperidone oral solution should be individualized according to the response and tolerability of the patient. The total daily dose of risperidone oral solution can be administered once daily, or half the total daily dose can be administered twice daily.
  
  For patients with body weight less than 20 kg, initiate dosing at 0.25 mg per day. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day. After a minimum of four days, the dose may be increased to the recommended dose of 0.5 mg per day for patients less than 20 kg and 1 mg per day for patients greater than or equal to 20 kg. Maintain this dose for a minimum of 14 days. In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.25 mg per day for patients less than 20 kg, or increments of 0.5 mg per day for patients greater than or equal to 20 kg. The effective dose range is 0.5 mg to 3 mg per day. No dosing data are available for children who weigh less than 15 kg.
  
  Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. The physician who elects to use risperidone oral solution for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
  
  Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose.

  2.4 Dosing in Patients with Severe Renal or Hepatic Impairment
  

  For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic impairment (10 to 15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater [see Use in Specific Populations (8.6 and 8.7)].

  2.5 Dose Adjustments for Specific Drug Interactions
  

  When risperidone oral solution is co-administered with enzyme inducers (e.g., carbamazepine), the dose of risperidone oral solution should be increased up to double the patient's usual dose. It may be necessary to decrease the risperidone oral solution dose when enzyme inducers such as carbamazepine are discontinued [see Drug Interactions (7.1)]. Similar effect may be expected with co-administration of risperidone oral solution with other enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital).
  
  When fluoxetine or paroxetine is co-administered with risperidone oral solution, the dose of risperidone oral solution should be reduced. The risperidone oral solution dose should not exceed 8 mg per day in adults when co-administered with these drugs. When initiating therapy, risperidone oral solution should be titrated slowly. It may be necessary to increase the risperidone oral solution dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued [see Drug Interactions (7.1)].

  2.6 Administration of Risperidone Oral Solution
  

  Risperidone

  oral solution can be administered directly from the

  dispensing syringe, or can be mixed with a beverage prior to administration. Risperidone

  oral solution is compatible in the following beverages: water, coffee, orange juice, and low-fat milk; it is NOT compatible with either cola or tea.

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• App Pharmaceuticals, Llc
  

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  Naropin | App Pharmaceuticals, Llc

  

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  The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used.  The smallest dose and concentration required to produce the desired result should be administered.
  
  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient.  Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients.  To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.
  
  Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block.  This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.  Allow adequate time for onset of anesthesia following administration of each test dose.
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Solutions which are discolored or which contain particulate matter should not be administered.

  
  Table 7 Dosage Recommendations *   = Not Applicable †   = The dose for a major nerve block must be adjusted according to site of administration and patient status.  Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see PRECAUTIONS). ‡   = Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours. §   = Cumulative doses up to 770 mg of Naropin over 24 hours (intraoperative block plus postoperative infusion);  Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, ie, 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up. Conc. Volume Dose Onset Duration mg/mL (%) mL mg min hours SURGICAL ANESTHESIA Lumbar Epidural 5 (0.5%) 15-30 75-150 15-30 2-4 Administration 7.5 (0.75%) 15-25 113-188 10-20 3-5 Surgery 10 (1%) 15-20 150-200 10-20 4-6 Lumbar Epidural 5 (0.5%) 20-30 100-150 15-25 2-4 Administration 7.5 (0.75%) 15-20 113-150 10-20 3-5 Cesarean Section Thoracic Epidural 5 (0.5%) 5-15 25-75 10-20 n/a*   Administration 7.5 (0.75%) 5-15 38-113 10-20 n/a*   Surgery Major Nerve Block†   5 (0.5%) 35-50 175-250 15-30 5-8 (eg, brachial plexus block) 7.5 (0.75%) 10-40 75-300 10-25 6-10 Field Block 5 (0.5%) 1-40 5-200 1-15 2-6

  (eg, minor nerve blocks

  and infiltration) LABOR PAIN MANAGEMENT Lumbar Epidural Administration Initial Dose 2 (0.2%) 10-20 20-40 10-15 0.5-1.5

  Continuous

  infusion‡   2 (0.2%)

  6-14

  mL/h

  12-28

  mg/h n/a*   n/a*  

  Incremental

  injections (top-up)‡   2 (0.2%)

  10-15

  mL/h

  20-30

  mg/h n/a*   n/a*   POSTOPERATIVE PAIN MANAGEMENT  Lumbar Epidural Administration 

  Continuous

  infusion§    2  (0.2%) 

  6-14

  mL/h  

  12-28

  mg/h  n/a*    n/a*   

  Thoracic Epidural

  Administration  2  (0.2%) 

  6-14

  mL/h 

  12-28

  mg/h  n/a*    n/a*    Continuous infusion§            Infiltration  2 (0.2%)  1-100  2-200  1-5  2-6  (eg, minor nerve block)   5  (0.5%)  1-40  5-200  1-5  2-6 

  The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.  Individual variations in onset and duration occur.  The figures reflect the expected average dose range needed.  For other local anesthetic techniques standard current textbooks should be consulted.
  
  When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered.  Experience to date indicates that a cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management:  ie, 2016 mg.  Caution should be exercised when administering Naropin for prolonged periods of time, eg, > 70 hours in debilitated patients.
  
  For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL  Naropin is induced via an epidural catheter.  Analgesia is maintained with an infusion of Naropin, 2 mg/mL (0.2%).  Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block.  With this technique a significant reduction in the need for opioids was demonstrated.  Clinical experience supports the use of Naropin epidural infusions for up to 72 hours.

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• App Pharmaceuticals, Llc
  

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  Naropin | App Pharmaceuticals, Llc

  

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  The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used.  The smallest dose and concentration required to produce the desired result should be administered.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Naropin is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient.  Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients.  To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.

  Use an adequate test dose (3 to 5 mL of a short-acting local anesthetic solution containing epinephrine) prior to induction of complete block.  This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.  Allow adequate time for onset of anesthesia following administration of each test dose.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Solutions which are discolored or which contain particulate matter should not be administered.

                                                                                   Table 7

                                                                 Dosage Recommendations

  
  
  

  Conc.

  Volume

  Dose

  Onset

  Duration

  
  

  mg/mL

  (%)

  mL

  mg

  min

  hours

  SURGICAL ANESTHESIA

  Lumbar Epidural

  5

  (0.5%)

  15 to 30

  75 to 150

  15 to 30

  2 to 4

  Administration

  7.5

  (0.75%)

  15 to 25

  113 to 188

  10 to 20

  3 to 5

  Surgery

  10

  (1%)

  15 to 20

  150 to 200

  10 to 20

  4 to 6

  Lumbar Epidural

  5

  (0.5%)

  20 to 30

  100 to 150

  15 to 25

  2 to 4

  Administration

  7.5

  (0.75%)

  15 to 20

  113 to 150

  10 to 20

  3 to 5

  Cesarean Section

  Thoracic Epidural

  5

  (0.5%)

  5 to 15

  25 to 75

  10 to 20

  n/a*

  Administration

  7.5

  (0.75%)

  5 to 15

  38 to 113

  10 to 20

  n/a*

  Surgery

  Major Nerve Block†

  5

  (0.5%)

  35 to 50

  175 to 250

  15 to 30

  5 to 8

  (eg, brachial plexus block)

  7.5

  (0.75%)

  10 to 40

  75 to 300

  10 to 25

  6 to 10

  Field Block

  5

  (0.5%)

  1 to 40

  5 to 200

  1 to 15

  2 to 6

  (eg, minor nerve blocks and infiltration)

  LABOR PAIN MANAGEMENT

  Lumbar Epidural Administration

  Initial Dose

  2

  (0.2%)

  10 to 20

  20 to 40

  10 to 15

  0.5 to 1.5

  Continuous infusion‡

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Incremental

  injections (top-up)‡

  2

  (0.2%)

  10 to 15

  mL/h

  20 to 30

  mg/h

  n/a*

  n/a*

  POSTOPERATIVE PAIN MANAGEMENT

  Lumbar Epidural Administration

  Continuous infusion§

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Thoracic Epidural

  Administration

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Continuous infusion§

  Infiltration

  2

  (0.2%)

  1 to 100

  2 to 200

  1 to 5

  2 to 6

  (eg, minor nerve block)

  5

  (0.5%)

  1 to 40

  5 to 200

  1 to 5

  2 to 6

  *  =  Not Applicable

  †  =  The dose for a major nerve block must be adjusted according to site of administration and patient status.  Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see PRECAUTIONS).

  ‡ =   Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours.

  §  =  Cumulative doses up to 770 mg of Naropin over 24 hours (intraoperative block plus postoperative infusion);  Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, ie, 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up.

  The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.  Individual variations in onset and duration occur.  The figures reflect the expected average dose range needed.  For other local anesthetic techniques standard current textbooks should be consulted.

  When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered.  Experience to date indicates that a cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management: ie, 2016 mg.  Caution should be exercised when administering Naropin for prolonged periods of time, eg, > 70 hours in debilitated patients.

  For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL Naropin is induced via an epidural catheter.  Analgesia is maintained with an infusion of Naropin, 2 mg/mL (0.2%).  Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block.  With this technique a significant reduction in the need for opioids was demonstrated.  Clinical experience supports the use of Naropin epidural infusions for up to 72 hours.

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• General Injectables & Vaccines, Inc
  

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  Naropin | General Injectables & Vaccines, Inc

  

  ---

  The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Naropin is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients. To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.

  Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. Allow adequate time for onset of anesthesia following administration of each test dose.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.

  The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur. The figures reflect the expected average dose range needed. For other local anesthetic techniques standard current textbooks should be consulted.

  When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Experience to date indicates that a cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management:  ie, 2016 mg. Caution should be exercised administering Naropin for prolonged periods of time, eg, >70 hours in debilitated patients.

  For treatment of postoperative pain, the following technique can be recommended:  If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL Naropin is induced via an epidural catheter. Analgesia is maintained with an infusion of Naropin, 2 mg/mL (0.2%). Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block. With this technique a significant reduction in the need for opioids was demonstrated. Clinical experience supports the use of Naropin epidural infusions for up to 72 hours.

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• Fresenius Kabi Usa, Llc
  

  ×

  Naropin | Fresenius Kabi Usa, Llc

  

  ---

  The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used.  The smallest dose and concentration required to produce the desired result should be administered.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Naropin is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient.  Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients.  To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.

  Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block.  This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.  Allow adequate time for onset of anesthesia following administration of each test dose.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Solutions which are discolored or which contain particulate matter should not be administered.

   

                                                                                   Table 7

                                                                 Dosage Recommendations

  
  
  

  Conc.

  Volume

  Dose

  Onset

  Duration

  
  

  mg/mL

  (%)

  mL

  mg

  min

  hours

  SURGICAL ANESTHESIA

  Lumbar Epidural

  5

  (0.5%)

  15 to 30

  75 to 150

  15 to 30

  2 to 4

  Administration

  7.5

  (0.75%)

  15 to 25

  113 to 188

  10 to 20

  3 to 5

  Surgery

  10

  (1%)

  15 to 20

  150 to 200

  10 to 20

  4 to 6

  Lumbar Epidural

  5

  (0.5%)

  20 to 30

  100 to 150

  15 to 25

  2 to 4

  Administration

  7.5

  (0.75%)

  15 to 20

  113 to 150

  10 to 20

  3 to 5

  Cesarean Section

  Thoracic Epidural

  5

  (0.5%)

  5 to 15

  25 to 75

  10 to 20

  n/a*

  Administration

  7.5

  (0.75%)

  5 to 15

  38 to 113

  10 to 20

  n/a*

  Surgery

  Major Nerve Block†

  5

  (0.5%)

  35 to 50

  175 to 250

  15 to 30

  5 to 8

  (eg, brachial plexus block)

  7.5

  (0.75%)

  10 to 40

  75 to 300

  10 to 25

  6 to 10

  Field Block

  5

  (0.5%)

  1 to 40

  5 to 200

  1 to 15

  2 to 6

  (eg, minor nerve blocks and infiltration)

  LABOR PAIN MANAGEMENT

  Lumbar Epidural Administration

  Initial Dose

  2

  (0.2%)

  10 to 20

  20 to 40

  10 to 15

  0.5 to 1.5

  Continuous infusion‡

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Incremental

  injections (top-up)‡

  2

  (0.2%)

  10 to 15

  mL/h

  20 to 30

  mg/h

  n/a*

  n/a*

  POSTOPERATIVE PAIN MANAGEMENT

  Lumbar Epidural Administration

  Continuous infusion§

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Thoracic Epidural

  Administration

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Continuous infusion§

  Infiltration

  2

  (0.2%)

  1 to 100

  2 to 200

  1 to 5

  2 to 6

  (eg, minor nerve block)

  5

  (0.5%)

  1 to 40

  5 to 200

  1 to 5

  2 to 6

  *  =  Not Applicable

  †  =  The dose for a major nerve block must be adjusted according to site of administration and patient status.  Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see PRECAUTIONS).

  ‡  =   Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours.

  §  =  Cumulative doses up to 770 mg of Naropin over 24 hours (intraoperative block plus postoperative infusion);  Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, ie, 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up.

   

  The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.  Individual variations in onset and duration occur.  The figures reflect the expected average dose range needed.  For other local anesthetic techniques standard current textbooks should be consulted.

  When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered.  Experience to date indicates that a cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management: ie, 2016 mg.  Caution should be exercised when administering Naropin for prolonged periods of time, eg, > 70 hours in debilitated patients.

  For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL Naropin is induced via an epidural catheter.  Analgesia is maintained with an infusion of Naropin, 2 mg/mL (0.2%).  Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block.  With this technique a significant reduction in the need for opioids was demonstrated.  Clinical experience supports the use of Naropin epidural infusions for up to 72 hours.

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  The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used.  The smallest dose and concentration required to produce the desired result should be administered.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Naropin is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient.  Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients.  To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.
  
  Use an adequate test dose (3 to 5 mL of a short-acting local anesthetic solution containing epinephrine) prior to induction of complete block.  This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.  Allow adequate time for onset of anesthesia following administration of each test dose.
  
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Solutions which are discolored or which contain particulate matter should not be administered.

  Table 7 Dosage Recommendations * = Not Applicable   † = The dose for a major nerve block must be adjusted according to site of administration and patient status.  Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see PRECAUTIONS).   ‡ = Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours.   § = Cumulative doses up to 770 mg of Naropin over 24 hours (intraoperative block plus postoperative infusion);  Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, ie, 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up.   Conc. Volume Dose Onset Duration mg/mL (%) mL mg min hours SURGICAL ANESTHESIA Lumbar Epidural 5 (0.5%) 15 to 30 75 to 150 15 to 30 2 to 4 Administration 7.5 (0.75%) 15 to 25 113 to 188 10 to 20 3 to 5 Surgery 10 (1%) 15 to 20 150 to 200 10 to 20 4 to 6 Lumbar Epidural 5 (0.5%) 20 to 30 100 to 150 15 to 25 2 to 4 Administration 7.5 (0.75%) 15 to 20 113 to 150 10 to 20 3 to 5 Cesarean Section Thoracic Epidural 5 (0.5%) 5 to 15 25 to 75 10 to 20 n/a*      Administration 7.5 (0.75%) 5 to 15 38 to 113 10 to 20 n/a*      Surgery Major Nerve Block†      5 (0.5%) 35 to 50 175 to 250 15 to 30 5 to 8 (eg, brachial plexus block) 7.5 (0.75%) 10 to 40 75 to 300 10 to 25 6 to 10 Field Block 5 (0.5%) 1 to 40 5 to 200 1 to 15 2 to 6

  (eg, minor nerve blocks

  and infiltration) LABOR PAIN MANAGEMENT Lumbar Epidural Administration Initial Dose 2 (0.2%) 10 to 20 20 to 40 10 to 15 0.5 to 1.5

  Continuous

  infusion‡      2 (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h n/a*      n/a*     

  Incremental

  injections (top-up)‡      2 (0.2%)

  10 to 15

  mL/h

  20 to 30

  mg/h n/a*      n/a*      POSTOPERATIVE PAIN MANAGEMENT   Lumbar Epidural Administration  

  Continuous

  infusion§       2  (0.2%) 

  6 to 14

  mL/h  

  12 to 28

  mg/h  n/a*       n/a*      

  Thoracic Epidural

  Administration   2  (0.2%) 

  6 to 14

  mL/h 

  12 to 28

  mg/h  n/a*       n/a*       Continuous infusion§               Infiltration   2 (0.2%)  1 to 100  2 to 200  1 to 5  2 to 6  (eg, minor nerve block)   5  (0.5%)  1 to 40  5 to 200  1 to 5  2 to 6 

  The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.  Individual variations in onset and duration occur.  The figures reflect the expected average dose range needed.  For other local anesthetic techniques standard current textbooks should be consulted.
  
  When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered.  Experience to date indicates that a cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management:  ie, 2016 mg.  Caution should be exercised when administering Naropin for prolonged periods of time, eg, >70 hours in debilitated patients.
  
  For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL  Naropin is induced via an epidural catheter.  Analgesia is maintained with an infusion of Naropin, 2 mg/mL (0.2%).  Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block.  With this technique a significant reduction in the need for opioids was demonstrated.  Clinical experience supports the use of Naropin epidural infusions for up to 72 hours.

  Close
  No Recall

  More Info
• Fresenius Kabi Usa, Llc
  

  ×

  Naropin | Fresenius Kabi Usa, Llc

  

  ---

  The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used.  The smallest dose and concentration required to produce the desired result should be administered.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Naropin is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient.  Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients.  To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.

  Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block.  This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.  Allow adequate time for onset of anesthesia following administration of each test dose.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  Solutions which are discolored or which contain particulate matter should not be administered.

   

                                                         Table 7

                                        Dosage Recommendations

  
  
  

  Conc.

  Volume

  Dose

  Onset

  Duration

  
  

  mg/mL

  (%)

  mL

  mg

  min

  hours

  SURGICAL ANESTHESIA

  Lumbar Epidural

  5

  (0.5%)

  15 to 30

  75 to 150

  15 to 30

  2 to 4

  Administration

  7.5

  (0.75%)

  15 to 25

  113 to 188

  10 to 20

  3 to 5

  Surgery

  10

  (1%)

  15 to 20

  150 to 200

  10 to 20

  4 to 6

  Lumbar Epidural

  5

  (0.5%)

  20 to 30

  100 to 150

  15 to 25

  2 to 4

  Administration

  7.5

  (0.75%)

  15 to 20

  113 to 150

  10 to 20

  3 to 5

  Cesarean Section

  Thoracic Epidural

  5

  (0.5%)

  5 to 15

  25 to 75

  10 to 20

  n/a*

  Administration

  7.5

  (0.75%)

  5 to 15

  38 to 113

  10 to 20

  n/a*

  Surgery

  Major Nerve Block†

  5

  (0.5%)

  35 to 50

  175 to 250

  15 to 30

  5 to 8

  (eg, brachial plexus block)

  7.5

  (0.75%)

  10 to 40

  75 to 300

  10 to 25

  6 to 10

  Field Block

  5

  (0.5%)

  1 to 40

  5 to 200

  1 to 15

  2 to 6

  (eg, minor nerve blocks and infiltration)

  LABOR PAIN MANAGEMENT

  Lumbar Epidural Administration

  Initial Dose

  2

  (0.2%)

  10 to 20

  20 to 40

  10 to 15

  0.5 to 1.5

  Continuous infusion‡

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Incremental

  injections (top-up)‡

  2

  (0.2%)

  10 to 15

  mL/h

  20 to 30

  mg/h

  n/a*

  n/a*

  POSTOPERATIVE PAIN MANAGEMENT

  Lumbar Epidural Administration

  Continuous infusion§

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Thoracic Epidural

  Administration

  2

  (0.2%)

  6 to 14

  mL/h

  12 to 28

  mg/h

  n/a*

  n/a*

  Continuous infusion§

  Infiltration

  2

  (0.2%)

  1 to 100

  2 to 200

  1 to 5

  2 to 6

  (eg, minor nerve block)

  5

  (0.5%)

  1 to 40

  5 to 200

  1 to 5

  2 to 6

  *  =  Not Applicable

  †  =  The dose for a major nerve block must be adjusted according to site of administration and patient status.  Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see PRECAUTIONS).

  ‡  =   Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours.

  §  =  Cumulative doses up to 770 mg of Naropin over 24 hours (intraoperative block plus postoperative infusion);  Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, ie, 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up.

   

  The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.  Individual variations in onset and duration occur.  The figures reflect the expected average dose range needed.  For other local anesthetic techniques standard current textbooks should be consulted.

  When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered.  Experience to date indicates that a cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management: ie, 2016 mg.  Caution should be exercised when administering Naropin for prolonged periods of time, eg, > 70 hours in debilitated patients.

  For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL Naropin is induced via an epidural catheter.  Analgesia is maintained with an infusion of Naropin, 2 mg/mL (0.2%).  Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block.  With this technique a significant reduction in the need for opioids was demonstrated.  Clinical experience supports the use of Naropin epidural infusions for up to 72 hours.

  Close
  No Recall

  More Info