Naropin Dosage

Generic name: ropivacaine hydrochloride
Dosage form: injection, solution

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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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