Marbeta 25 Kit

MARBETA 25 KIT- betamethasone sodium phosphate and betamethasone acetate, bupivacaine hydrochloride, povidine iodine
Asclemed USA, Inc.

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WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE IN OBSTETRICAL ANESTHESIA

There have been reports of cardiac arrest with difficult resuscitation or death during use of Bupivacaine Hydrochloride for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of Bupivacaine Hydrochloride is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

Bupivacaine Hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].

Limitations of Use

Not all blocks are indicated for use with Bupivacaine Hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions ( 5.1, 5.5, 5.7, 5.9)] .

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

  • Bupivacaine Hydrochloride injection is not for intrathecal use.
  • Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
  • Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Bupivacaine Hydrochloride injection is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
  • Mixing or the prior or intercurrent use of any other local anesthetic with Bupivacaine Hydrochloride is not recommended because of insufficient data on the clinical use of such mixtures.

    Administration Precautions

    • Bupivacaine Hydrochloride injection is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed.
    • Use Bupivacaine Hydrochloride injection only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.2), Adverse Reactions (6), Overdosage (10)].
    • The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with Bupivacaine Hydrochloride injection [see Warnings and Precautions (5.2), Drug Interactions (7.1), Overdosage (10)].
    • Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting Bupivacaine Hydrochloride injection, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions (5.9)] .
    • Avoid rapid injection of a large volume of Bupivacaine Hydrochloride injection and use fractional (incremental) doses when feasible.
    • During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of Bupivacaine Hydrochloride injection that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions.
    • Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.

2.2 Recommended Concentrations and Dosages of Bupivacaine Hydrochloride injection

The dosage of Bupivacaine Hydrochloride injection 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. Administer the smallest dosage and concentration required to produce the desired result.

The types of block and recommended Bupivacaine Hydrochloride injection concentrations are shown in Table 1.

Table 1. Types of Block and Recommended Bupivacaine Hydrochloride Injection Concentrations

Type of Block

Bupivacaine Hydrochloride injection

0.25% (2.5 mg/mL)

0.5% (5 mg/mL)

0.75% (7.5 mg/mL)*

Local infiltration

Peripheral nerve block

Retrobulbar block

Sympathetic block

Caudal block

Lumbar epidural block

✓ (not for obstetrical anesthesia)

Epidural test dose

Dental block

* Bupivacaine Hydrochloride injection0.75% (7.5 mg/mL) is not recommended for nonobstetrical surgical procedures in pregnant patients.

✓= indicated use [see Warnings and Precautions (5.1)].

At recommended dosages, Bupivacaine Hydrochloride injection produces complete sensory block, but the effect on motor function differs among the three concentrations. Table 2 provides information on the expected effect on motor function for the three concentrations.

Table 2. Bupivacaine Hydrochloride injection Concentration vs. Motor Function

Bupivacaine Hydrochloride injection Concentration

Motor Function

0.25%

(2.5 mg/mL)

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% (5 mg/mL) or 0.75% (7.5 mg/mL) solutions.

0.5%

(5 mg/mL)

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%

(7.5 mg/mL)

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 Bupivacaine Hydrochloride injection is such that for most indications, a single-dose is sufficient.

The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site.

The dosages in Table 3 are recommended as a guide for use in the average adult. These doses may be repeated once every three hours. Do not exceed a total daily dosage of 400 mg in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.

Table 3. Recommended Concentrations and Doses of Bupivacaine Hydrochloride injection in Adults

Type of Block

Concentration of Bupivacaine Hydrochloride injection

Each Dose

Motor Block a

mL

mg of Bupivacaine Hydrochloride injection

Local infiltration

0.25%

(2.5 mg/mL) b

Up to 70

(without epinephrine)

Up to 175

(without epinephrine)

Peripheral nerve block

0.5%

(5 mg/mL) b

5-35

(without epinephrine)

25-175

(without epinephrine)

moderate to complete

0.25%

(2.5 mg/mL) b

5-70

(without epinephrine)

12.5-175

(without epinephrine)

moderate to complete

Retrobulbar block

[see Dosage and Administration (2.6)]

0.75%

(7.5 mg/mL)

2-4

15-30

complete

Sympathetic block

0.25%

(2.5 mg/mL)

20-50

50-125

Caudal block

0.5%

(5 mg/mL) b

15-30

75-150

moderate to complete

0.25%

(2.5 mg/mL) b

15-30

37.5-75

moderate

Lumbar epidural block

[see Dosage and Administration (2.3)]

0.75%

(7.5 mg/mL) c

10-20

75-150

complete

0.5%

(5 mg/mL) b

10-20

50-100

moderate to complete

0.25%

(2.5 mg/mL) b

10-20

25-50

partial to moderate

  1. With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% (5 mg/mL) may produce complete motor block. Intercostal nerve block with 0.25% (2.5 mg/mL) also may produce complete motor block for intra-thoracic and upper intra-abdominal surgery.
  2. Solutions with or without epinephrine (i.e., applies to Bupivacaine Hydrochloride injection)
  3. For single-dose use; not for intermittent epidural technique. Not for obstetrical anesthesia.

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