BUPIVACAINE HCI AND EPINEPHRINE (Page 4 of 5)

DOSAGE & 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. The smallest dose and concentration required to produce the desired result should be administered. Dosages of Sensorcaine should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should

be used when feasible.

For specific techniques and procedures, refer to standard textbooks.

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

In recommended doses, Sensorcaine (bupivacaine HCl) produces complete sensory block, but the effect on motor function differs among the three concentrations.

0.25%—when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions.

0.5%—provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.

0.75%—produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia.

The duration of anesthesia with Sensorcaine is such that for most indications, a single dose is sufficient.

Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Sensorcaine up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case.

These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses have been up to 400 mg. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.

The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for elderly or debilitated patients. Until further experience is gained, Sensorcaine is not recommended for pediatric patients younger than 12 years.

Sensorcaine is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block).

Use in Epidural Anesthesia

During epidural administration of Sensorcaine, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservative and therefore should not be used for these procedures.

Use in Dentistry

The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of

1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time (see CLINICAL PHARMACOLOGY). The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient

(ten 1.8 mL injections of 0.5% sensorcaine with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, sensorcaine in dentistry is not recommended for pediatric patients younger than 12 years.

Unused portions of solution not containing preservatives, i.e., those supplied in single dose ampules and single dose vials, should be discarded following initial use.

This product 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 1. Recommended Concentrations and Doses of Sensorcaine (bupivacaine HCl) Injections

DOSAGE
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1 With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with 0.25% may also produce complete motor block for intra-abdominal surgery.

2 For single dose use, not for intermittent epidural technique. Not for obstetrical anesthesia.

3 See PRECAUTIONS.

4 Solutions with or without epinephrine.

HOW SUPPLIED

SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE INJECTION, USP) WITH EPINEPHRINE is supplied in the following dosage forms.
NDC 51662-1399-1
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE INJECTION, USP) WITH EPINEPHRINE 1:200,000 (AS BITARTRATE) 0.5% 250mg per 50mL (5mg per mL) 50mL VIAL

NDC 51662-1399-2

Pouch Containing 1 Vial of SENSORCAINE® W/ EPI 1:200,000 (AS BITARTRATE) 0.5% 250mg/50mL (5mg/mL) 50mL VIAL

NDC 51662-1399-3

Case Containing 25 Pouches of 1 Vial per Pouch of SENSORCAINE® W/ EPI 1:200,000 (AS BITARTRATE) 0.5% 250mg/50mL (5mg/mL) 50mL VIAL

HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

These solutions are not for spinal anesthesia.

Sensorcaine-MPF (methylparaben free) is available in the following forms:

With Epinephrine:

HOW SUPPLIED 1
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Without Epinephrine:

HOW SUPPLIED 2
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Sensorcaine (preserved with methylparaben) is available in the following forms:

With Epinephrine:

HOW SUPPLIED 3
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Without Epinephrine:

HOW SUPPLIED 4
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For single dose vials: Discard unused portion.

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

Solutions containing epinephrine should be protected from light.

The injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

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