WARNING - FDA records indicate that this drug has been recalled.

Hospira Inc.

Product Description:	1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Status:	Ongoing
City:	Lake Forest
State:	IL
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Press Release
Distribution Pattern:	Nationwide.
Classification:	Class I
Product Quantity:	120,900 vials
Reason For Recall:	Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Recall Initiation Date:	20140418
Report Date:	20150211

Mucus Relief

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Mucus Relief Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Mucus Relief Manufacturers

Sam’s West Inc

Mucus Relief | Sam's West Inc

take with a full glass of water adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

No Recall
Medinatura Inc

Mucus Relief | Medinatura Inc

At first sign of symptoms:

Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.

Standard dosage: Adults and children 4 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

For children under 4, consult your health professional.

Allow tablets to dissolve completely in the mouth, do not swallow.

No Recall
Target Corporation

Mucus Relief | Target Corporation

take with a full glass of water

adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

children under 12 years: do not use

No Recall
Hyvee Inc

Mucus Relief | Dr.sankunni's Ayurvedic Research Foundation Private Limited

Directions:
use only as directed apply generously to affected area 3 to 4 times daily children under 12, consult a doctor before use.

No Recall
Avema Pharma Solutions

Mucus Relief | Avema Pharma Solutions

adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years of age: do not use

No Recall
L.n.k. International, Inc.

Mucus Relief | L.n.k. International, Inc.

take with a full glass of water adults and children 12 years of age and over: 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

No Recall
Nash-finch Company

Mucus Relief | Nash-finch Company

take with a full glass of water

adults and children 12 years of age and over: 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours.

children under 12 years: do not use

No Recall
Major Pharmaceuticals

Mucus Relief | Major Pharmaceuticals

take with a full glass of water adults and children 12 years of age and over: 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

No Recall
Avema Pharma Solutions

Mucus Relief | Avema Pharma Solutions

adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed more than 6 doses in 24 hours. children under 12 years of age: do not use

No Recall
Major Pharmaceuticals Inc

Mucus Relief | Major Pharmaceuticals Inc

Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

No Recall
Sam’s West Inc

Mucus Relief | Stila Styles, Llc

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses

No Recall
Walgreen Co.

Mucus Relief | Kroger Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours
Weight (lb)

Age (yr)

Dose (mL or tsp)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Meijer Distribution Inc

Mucus Relief | Meijer Distribution Inc

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

No Recall
H E B

Mucus Relief | H E B

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

No Recall
Similasan Corporation

Mucus Relief | Similasan Corporation

For adults:
5 ml, 3 to 6 times daily (every 4 hours) Replace cap tightly after every use
Or use as directed by a licensed health care professional.

No Recall
Geri-care Pharmaceuticals, Corp

Mucus Relief | Geri-care Pharmaceuticals, Corp

take with full glass of water
do not exceed recommended dose adults and children 12 years
of age and over
1 tablet, every 4 hours, while
symptoms persist • do not
exceed 6 doses in 24 hours
children under 12 years of age
do not use

No Recall
Rite Aid Corporation

Mucus Relief | Rite Aid Corporation

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

No Recall
Clinical Solutions Wholesale

Mucus Relief | Clinical Solutions Wholesale

Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

No Recall
Target Corporation

Mucus Relief | Target Corporation

adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours. children under 12 years of age: do not use

No Recall
Family Dollar

Mucus Relief | Family Dollar

take with a full glass of water adults and children 12 years of age and over: 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

No Recall
P And L Development Of New York Corporation (Readyincase)

Mucus Relief | P And L Development Of New York Corporation (readyincase)

adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours. children under 12 years of age: do not use

No Recall
The Kroger Co.

Mucus Relief | The Kroger Co.

adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours. children under 12 years of age: do not use

No Recall
Safeway

Mucus Relief | Safeway

• do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours. • children under 12 years of age: do not use

No Recall
Safeway

Mucus Relief | Amerisource Bergen

• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over

30 mL (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 mL (1 TBSP) every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

No Recall
Family Dollar (Family Wellness)

Mucus Relief | South Jersey Welding Supply

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Costco Wholesale Corporation

Mucus Relief | Smiths Medical Asd, Inc.

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacture.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

INSTRUCTIONS FOR USE

To open ampuls, using gauze, place thumb and forefinger on color line, break at constriction.

Table I (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.

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

These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection, USP will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection, USP may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

Epidural Anesthesia

For an epidural test dose, only the following available specific product of Lidocaine Hydrochloride and Epinephrine Injection, USP by Hospira is recommended:

1.5% with epinephrine 1:200,000.................... 5 mL single-dose ampuls

For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride and Epinephrine Injection, USP by Hospira are recommended:

1% with epinephrine 1:200,000............................ 30 mL single-dose ampuls

30 mL single-dose vials

1.5% with epinephrine 1:200,000.......................... 30 mL single-dose ampuls

30 mL single-dose vials

2% with epinephrine 1:200,000................................ 20 mL single-dose vials

Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single-dose units. These solutions contain no bacteriostatic agent.

In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2-3 mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2-3 mL of 1.5% lidocaine injection should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10-15 µg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride and Epinephrine Injection, USP through the catheter should be avoided, and, when feasible, fractional doses should be administered.

In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

Maximum Recommended Dosages

Adults: For normal healthy adults, the individual maximum dose of Lidocaine Hydrochloride and Epinephrine Injection, USP should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg per lb) of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.

The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients 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).

Pediatric Population: It is difficult to recommend a maximum dose of any drug for pediatric patients, since this varies as a function of age and weight. For pediatric patients over 3 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 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75-100 mg (1.5-2 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.

FOR EPIDURAL USE ONLY.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not use the injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Table I Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic Procedures in Normal Healthy Adults
Lidocaine Hydrochloride Injection, USP (without Epinephrine)

Procedure

Conc. (%)

Vol. (mL)

Total Dose (mg)
Infiltration
Percutaneous
Intravenous Regional
0.5 or 1.0

0.5

1-60

10-60

5-300

50-300

Peripheral Nerve Blocks, e.g.

Brachial

Dental

Intercostal

Paravertebral

Pudendal (each side)

Paracervical Obstetrical Analgesia (each side)

1.5

2.0

1.0

1.0

1.0
1.0
15-20

1-5

3

3-5

10
10
225-300

20-100

30

30-50

100
100
Sympathetic Nerve Blocks, e.g.

Cervical (stellate ganglion)

Lumbar

1.0

1.0

5

5-10

50

50-100

Central Neural Blocks

Epidural*

Thoracic

Lumbar

    Analgesia

    Anesthesia

Caudal

    Obstetrical Analgesia

    Surgical Anesthesia

1.0

1.0

1.5

2.0

1.0
1.5
20-30

25-30

15-20

10-15

20-30
15-20
200-300

250-300

225-300

200-300

200-300
225-300
*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/ dermatome).

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.

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 incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol 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. It is recommended that chemical disinfection be accomplished by wiping the vial stopper or ampul thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.

Do not autoclave.

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.

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

These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.

Epidural Anesthesia

For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:

1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials

1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls

2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampuls

Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2−3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10−15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.

In the event of the known injection of a large volume of local anesthetic solutions into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

Maximum Recommended Dosages

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

Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose 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. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.

The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients 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).

For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

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 3 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 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

Table 1

Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic

Procedures in Normal Healthy Adults

Lidocaine Hydrochloride Injection, USP (without Epinephrine)

Procedure

Conc. (%)

Vol. (mL)

Total Dose (mg)

Infiltration

Percutaneous

0.5 or 1.0

1−60

5−300

Intravenous Regional

0.5

10−60

50−300

Peripheral Nerve Blocks, e.g.

Brachial

1.5

15−20

225−300

Dental

2.0

1−5

20−100

Intercostal

1.0

3

30

Paravertebral

1.0

3−5

30−50

Pudendal (each side)

1.0

10

100

Paracervical

Obstetrical Analgesia

(each side)

1.0

10

100

Sympathetic Nerve Blocks, e.g.

Cervical (stellate ganglion)

1.0

5

50

Lumbar

1.0

5−10

50−100

Central Neural Blocks

Epidural*

Thoracic

1.0

20−30

200−300

Lumbar

Analgesia

1.0

25−30

250−300

Anesthesia

1.5

15−20

225−300

2.0

10−15

200−300

Caudal

Obstetrical Analgesia

1.0

20−30

200−300

Surgical Anesthesia

1.5

15−20

225−300

*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

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.

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 incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol 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. 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.

Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.

Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

Hypersensitivity Reactions

For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

Cardiac Resuscitation

A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility.

Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

Ophthalmologic Use

Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) – use a concentration of 1:10,000 (0.1 mg/mL) to 1:1000 (1 mg/mL).

Regional Anesthesia

A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to 0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)

Recall