Beta Inject Kit

Name: Beta Inject Kit

- Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP (6 mg/ mL) -

Rx Only

How is Beta Inject Kit Supplied

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01

SHAKE WELL BEFORE USING.

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Revised December 2009

NOTE: The products accompanying this insert do not contain epinephrine.

Adults

For normal healthy adults, the individual maximum recommended dose of lidocaine hydrochloride without epinephrine should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg.

The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides (see also discussion of paracervical block in PRECAUTIONS).

TABLE 1 RECOMMENDED DOSAGES OF LIDOCAINE HYDROCHLORIDE INJECTION

(WITHOUT EPINEPHRINE) FOR VARIOUS ANESTHETIC PROCEDURES IN NORMAL HEALTHY ADULTS




PROCEDURE

LIDOCAINE HYDROCHLORIDE INJECTION

(WITHOUT EPINEPHRINE)

CONCENTRATION

(%)

VOLUME

(mL)

TOTAL DOSE

(mg)

INFILTRATION

PERCUTANEOUS

0.5 or 1

1 to 60

5 to 300

PERIPHERAL NERVE BLOCKS, E.G.

BRACHIAL

1.5

15 to 20

225 to 300

DENTAL

2

1 to 5

20 to 100

INTERCOSTAL

1

3

30

PARAVERTEBRAL

1

3 to 5

30 to 50

PUDENDAL (EACH SIDE)

1

10

100

PARACERVICAL

OBSTETRICAL ANALGESIA

(EACH SIDE)

1

10

100

S YMPATHETIC NERVE BLOCKS, E.G.

CERVICAL (STELLATE GANGLION)

1

5

50

LUMBAR

1

5 to 10

50 to 100

THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.

Children

It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over three years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (1.5 to 2 mg/lb).

In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% Sodium Chloride Injection in order to obtain the required final concentration.

Sterilization, Storage and Technical Procedures

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 as they have been related to incidents of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and therefore are not to be used.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever the solution and container permit. The injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Principal Display Panel – Lidocaine Vial Label

NDC 63323-201-10

20110

Lidocaine HCl Injection, USP

1% (10 mg/mL)

For Infiltration and Nerve Block.

Not for Epidural or Caudal Use.

10 mL Multiple Dose Vial

Rx only

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