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Naropin (Ropivacaine Hydrochloride Monohydrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE:

Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management.

Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration

DOSAGE AND ADMINISTRATION:

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.

HOW SUPPLIED:

Naropin® Single Dose Vials

Product No.

NDC No.

Strength Size

PRX278523

63323-285-28

2 mg/mL (0.2%) 

20 mL fill, in a 20 mL single dose vial, in packages of 25.
PRX278623 63323-286-27 5 mg/mL (0.5%) 20 mL fill, in a 20 mL single dose vial, in packages of 25.
PRX278635
63323-286-38 
5 mg/mL (0.5%)
30 mL fill, in a 30 mL single dose vial, in packages of 25.

Naropin® Single Dose Infusion Bottles

Product No.  

NDC No.

Strength Size

PRX278565

63323-285-68 

2 mg/mL (0.2%) 

100 mL Infusion Bottle.
PRX278564 63323-285-73 2 mg/mL (0.2%) 200 mL Infusion Bottle.

The solubility of ropivacaine is limited at pH above 6.  Thus, care must be taken as precipitation may occur if Naropin is mixed with alkaline solutions.

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.

When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended.  It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.  When a container is required to have a sterile outside, a Sterile-Pak should be chosen.  Glass containers may, as an alternative, be autoclaved once.  Stability has been demonstrated using a targeted F0 of 7 minutes at 121°C.

Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature].

This container closure is not made with natural rubber latex.

These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly.  In addition, continuous infusion bottles should not be left in place for more than 24 hours.

NAROPIN is a trademark of Fresenius Kabi USA, LLC.

PREMIERPro™Rx is a trademark of Premier, Inc., used under license.

 

Manufactured by:

Fresenius Kabi USA, LLC

Lake Zurich, IL 60047

451350A

Revised: April 2014


 

 

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