Acetylcysteine inhalation

Name: Acetylcysteine inhalation

What is acetylcysteine inhalation?

Acetylcysteine is a drug that breaks down mucus, the substance that lubricates many parts of the body such as the mouth, throat, and lungs.

Acetylcysteine inhalation is used to thin the mucus in people with certain lung conditions such as cystic fibrosis, emphysema, bronchitis, pneumonia, or tuberculosis. Acetylcysteine inhalation is also used during surgery or anesthesia, and to prepare the throat or lungs for a medical test.

Acetylcysteine inhalation may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Acetylcysteine Solution, USP

Sterile
Not For Injection

Dosage guide and preparation

Doses in relation to body weight are:

Loading Dose of Acetylcysteine **
**If patient weighs less than 20 kg (usually patients younger than 6 years), calculate the dose of acetylcysteine. Each mL of 20% acetylcysteine solution contains 200 mg of acetylcysteine.  The loading dose is 140 mg per kilogram of body weight. The maintenance dose is 70 mg/kg. Three (3) mL of diluent are added to each mL of 20% acetylcysteine solution. Do not decrease the proportion of diluent.
      grams   mL of 20%   mL of   Total mL of
 Body Weight  Acetylcysteine  Acetylcysteine  Diluent  5% Solution
 (kg)  (lb)        
  100-109   220-240   15   75   225   300
 90-99  198-218  14  70  210  280
 80-89  176-196  13  65  195  260
 70-79  154-174  11  55  165  220
 60-69  132-152  10  50  150  200
 50-59  110-130  8  40  120  160
 40-49  88-108  7  35  105  140
 30-39  66-86  6  30  90  120
 20-29  44-64  4  20  60  80
 Maintenance Dose**
 (kg)  (lb)        
  100-109   220-240   7.5   37   113   150
 90-99  198-218  7  35  105  140
 80-89  176-196  6.5  33  97  130
 70-79  154-174  5.5  28  82  110
 60-69  132-152  5  25  75  100
 50-59  110-130  4  20  60  80
 40-49  88-108  3.5  18  52  70
 30-39  66-86  3  15  45  60
 20-29  44-64  2  10  30  40

Estimating Potential for Hepatoxicity

The following nomogram has been developed to estimate the probability that plasma levels in relation to intervals post ingestion will result in hepatoxicity.

Plasma or Serum Acetaminophen Concentration v Time Post-acetaminophen Ingestion

PRINICPAL DISPLAY PANEL - 10 mL (20%) Container & Carton

NDC 0517-7610-03

ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent)
or Oral Administration
(Acetaminophen Antidote)

NOT FOR INJECTION

10 mL VIAL
PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY,  NY  11967

ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

NDC 0517-7610-03
3 x 10 mL VIALS

Rx Only

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION      PRESERVATIVE FREE

Each mL contains: Acetylcysteine 200 mg (20%), Edetate Disodium 0.025%, Water for Injection q.s. pH adjusted with Sodium Hydroxide and, if necessary, Hydrochloric Acid is added. pH (range 6.0 to 7.5).  CONTAINS ONE PLASTIC DROPPER FOR DISPENSING.
WARNING: DISCARD OPENED CONTAINER AFTER 96 HOURS. Store at 20° -25°C (68° -77°F); excursions permitted to 15°-30° (59°-86°F) (See USP Controlled Room Temperature).
STORE IN REFRIGERATOR 2°-8°C (36°-46°F) AFTER OPENING. A change in color may occur after opening, this does not change the efficacy of the drug. Acetylcysteine may be diluted to a lesser concentration with an appropriate solution.
Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/11

For the Consumer

Applies to acetylcysteine: oral capsule, oral capsule extended release, oral powder, oral solution, oral tablet, oral tablet effervescent

Other dosage forms:

  • inhalation solution
  • intravenous solution

Along with its needed effects, acetylcysteine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking acetylcysteine:

Incidence not known
  • Difficulty with breathing or swallowing
  • fever
  • hives or itching
  • nausea
  • rash with or without a fever
  • reddening of the skin, especially around the ears
  • severe or ongoing vomiting
  • swelling of the eyes, face, or inside of the nose
  • unusual tiredness or weakness

Some side effects of acetylcysteine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Mild nausea
  • stomach upset
  • vomiting

Usual Adult Dose for Diagnostic Bronchograms

Nebulized into a face mask, mouth piece, or tracheostomy:
Recommended dosage: 3 to 5 mL of 20% solution, or 6 to 10 mL of 10% solution, 3 to 4 times a day
Dosage range: 1 to 10 mL of 20% solution, or 2 to 20 mL of 10% solution, every 2 to 6 hours

Nebulization tent, Croupette:
Recommended dose: The volume of 10% or 20% solution that will maintain a very heavy mist in the tent or Croupette for the desired period.
-This requires very large solution volumes, as much as 300 mL in a single treatment period.
-Intermittent or continuous prolonged administration periods, including overnight, may be desirable.
-Nebulization into a tent or Croupette must be individualized.
-Take into account the available equipment.

Direct Instillation:
Dose range: 1 to 2 mL of 10% to 20% solution, as often as every hour.
-Routine tracheostomy care: 1 to 2 mL of 10% to 20% solution, every 1 to 4 hours, instilled into the tracheostomy
-Percutaneous intratracheal catheter: 1 to 2 mL of 20% solution, or 2 to 4 mL of 10% solution, every 1 to 4 hours, via a syringe attached to the catheter
-Direct pulmonary installation: 2 to 5 mL of 20% solution
--Introduce directly into a particular segment of the bronchopulmonary tree by inserting (under local anesthesia and direct vision) a small plastic catheter into the trachea; instill using a syringe connected to the catheter.

Diagnostic Bronchograms:
Recommended dosing: 1 to 2 mL of the 20% solution, or 2 to 4 mL of the 10% solution, by nebulization or by instillation intratracheally, two or three times prior to the procedure.

Comments:
-The 20% solution may be diluted to a lesser concentration with either Sodium Chloride Injection, Sodium Chloride Inhalation Solution, Sterile Water for Injection, or Sterile Water for Inhalation.
-The 10% solution may be used undiluted.
-Use compressed tank gas (air) or an air compressor to provide pressure for nebulizing the solution.
-Oxygen may also be used but should be used with the usual precautions in patients with severe respiratory disease and CO2 retention.

Use: Adjuvant therapy for abnormal, viscid, or inspissated mucous secretions, such as in:
Chronic bronchopulmonary disease (chronic emphysema or asthmatic bronchitis, emphysema with bronchitis, tuberculosis, bronchiectasis, or primary pulmonary amyloidosis)
Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)
Pulmonary complications of cystic fibrosis
Tracheostomy care
Pulmonary complications associated with surgery
Use during anesthesia
Post-traumatic chest conditions
Atelectasis due to mucous obstruction
Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)

Usual Pediatric Dose for Acetaminophen Overdose

Injectable:
The total dose is 300 mg/kg, given as 3 separate doses, administered over a total of 21 hrs.
Dose preparation is weight based:

5 to 20 kg:
Loading Dose: 150 mg/kg in 3 mL/kg diluent, infused over 1 hour
Second Dose: 50 mg/kg in 7 mL/kg diluent, infused over 4 hours
Third Dose: 100 mg/kg in 14 mL/kg diluent, infused over 16 hours

21 to 40 kg:
Loading Dose: 150 mg/kg in 100 mL diluent, infused over 1 hour
Second Dose: 50 mg/kg in 250 mL diluent, infused over 4 hours
Third Dose: 100 mg/kg in 500 mL diluent, infused over 16 hours

41 to 100 kg:
Loading Dose: 150 mg/kg in 200 mL diluent, infused over 1 hour
Second Dose: 50 mg/kg in 500 mL diluent, infused over 4 hours
Third Dose: 100 mg/kg in 1,000 mL diluent, infused over 16 hours

Over 100 kg:
Loading Dose: 15,000 mg in 200 mL diluent, infused over 1 hour
Second Dose: 5,000 mg in 500 mL diluent, infused over 4 hours
Third Dose: 10,000 mg in 1,000 mL diluent, infused over 16 hours

Compatible diluents: 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection

Comments:
-Limited information is available regarding dosing patients weighing more than 100 kg; there are no specific studies.
-The critical ingestion to treatment interval is 0 to 8 hours for maximal protection against severe hepatic injury.
-Efficacy diminishes progressively after 8 hours.
-Initiating treatment 15 to 24 hours post-ingestion yields limited efficacy, but does not appear to worsen the patient's condition and it should not be withheld, as reported ingestion time may not be correct.
-Determine serum acetaminophen level at least 4 hours after ingestion of suspected overdose to determine the need for treatment with acetylcysteine.
-If patient presents after 4 hours post-ingestion, determine the serum acetaminophen level immediately.
-Administer within 8 hours from acetaminophen ingestion for maximal protection against hepatic injury for patients whose serum acetaminophen levels fall above the "possible" toxicity line on the Rumack-Matthew nomogram (line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours); the manufacturer product information should be consulted.
-Administer immediately if time of ingestion is unknown, or serum acetaminophen level is not available/cannot be interpreted/is not available within 8 hours of ingestion.
-Administer immediately if 24 hours or less have elapsed from the reported time of overdose, regardless of the ingested quantity reported.

Use: Antidote for Acute Ingestion or Repeated Supratherapeutic Ingestion (RSI) acetaminophen overdose, to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen.

----

Oral administration of 20% solution for inhalation:
Loading Dose: 140 mg/kg body weight, orally, once as a loading dose (see preparation instructions below)
Maintenance Dose: 70 mg/kg body weight, orally, 4 hours after the loading dose and every 4 hours for 17 total doses, unless repeated acetaminophen assays reveal nontoxic levels (see preparation instructions below)
Dose preparation is weight based:

100 to 109 kg/220 to 240 lb:
Loading dose: 15 g (75 mL) in 225 mL diluent; total volume: 300 mL
Maintenance Dose: 7.5 g (37 mL) in 113 mL diluent; total volume: 150 mL

90 to 99 kg/198 to 218 lb:
Loading dose: 14 g (70 mL) in 210 mL diluent; total volume: 280 mL
Maintenance Dose: 7 g (35 mL) in 105 mL diluent; total volume: 140 mL

80 to 89 kg/176 to 196 lb:
Loading dose: 13 g (65 mL) in 195 mL) in 210 mL diluent; total volume: 260 mL
Maintenance Dose: 6.5 g (33 mL) in 97 mL diluent; total volume: 130 mL

70 to 79 kg/154 to 174 lb:
Loading dose: 11 g (55 mL) in 165 mL) in 210 mL diluent; total volume: 220 mL
Maintenance Dose: 5.5 g (28 mL) in 82 mL diluent; total volume: 110 mL

60 to 69 kg/132 to 152 lb:
Loading dose: 10 g (50 mL) in 150 mL) in 210 mL diluent; total volume: 200 mL
Maintenance Dose: 5 g (25 mL) in 75 mL diluent; total volume: 100 mL

50 to 59 kg/110 to 130 lb:
Loading dose: 8 g (40 mL) in 120 mL) in 210 mL diluent; total volume: 160 mL
Maintenance Dose: 4 g (20 mL) in 60 mL diluent; total volume: 80 mL

40 to 49 kg/88 to 108 lb:
Loading dose: 7 g (35 mL) in 105 mL) in 210 mL diluent; total volume: 140 mL
Maintenance Dose: 3.5 g (18 mL) in 52 mL diluent; total volume: 70 mL

30 to 39 kg/66 to 86 lb:
Loading dose: 6 g (30 mL) in 90 mL) in 210 mL diluent; total volume: 120 mL
Maintenance Dose: 3 g (15 mL) in 45 mL diluent; total volume: 60 mL

20 to 29 kg/44 to 64 lb:
Loading dose: 4 g (20 mL) in 60 mL) in 210 mL diluent; total volume: 80 mL
Maintenance Dose: 2 g (10 mL) in 30 mL diluent; total volume: 40 mL

Less than 20 kg (usually patients younger than 6 years), must calculate diluent volume:
Loading dose: 140 g/kg
Maintenance Dose: 70 g/kg
-Add 3 mL of diluent to each 1 mL (200 mg) of 20% acetylcysteine solution
-Do not decrease the proportion of diluent.

Diluents: Dilute in diet cola or other diet soft drink; if giving via g-tube or Miller-Abbott tube, may dilute with water.

Comments:
-Administer immediately if 24 hours or less from ingestion of an overdose, regardless of the quantity of acetaminophen reported to have been ingested. Do not await acetaminophen assay results before initiating treatment.
The following procedures are recommended:
-Empty stomach promptly by lavage or inducing emesis with syrup of ipecac.
-Activated charcoal may be indicated for a mixed drug overdose, but if used, lavage before administering acetylcysteine. Activated charcoal adsorbs acetylcysteine in vitro and may reduce its effectiveness.
-Draw blood for predetoxification acetaminophen plasma assay and baseline SGOT, SGPT, bilirubin, prothrombin time, creatinine, BUN, blood sugar and electrolytes.
-Administer the loading dose of acetylcysteine.
-Determine subsequent action based on predetoxification plasma acetaminophen information. Choose ONE of the following courses of therapy:

A. Predetoxification plasma acetaminophen level is clearly in the toxic range or cannot be obtained:
Administer first maintenance dose (70 g/kg acetylcysteine) 4 hours after the loading dose; repeat at 4-hour intervals for a total of 17 doses. Monitor hepatic and renal function and electrolytes throughout the detoxification process.

B. Predetoxification acetaminophen level is clearly in the non-toxic range (beneath the dashed line on the nomogram) and you know that overdose occurred at least 4 hours before the level was taken:
Discontinue acetylcysteine.

C. Predetoxification acetaminophen level was in the non-toxic range, but time of ingestion was unknown or less than 4 hours:
Obtain a second plasma level to decide if the full 17 dose treatment is necessary (acetaminophen peak may not be achieved before 4 hours post-ingestion, so the assay level may not be a peak value).

-If the patient vomits an oral dose within 1 hour of administration, repeat that dose.
-If the patient is persistently unable to retain oral acetylcysteine, the antidote may be administered by duodenal intubation.

Use: As an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

Liver Dose Adjustments

Data are not available to determine if dose adjustment is required. Published literature does not indicate a need for dose reduction.

Dose Adjustments

Data not available

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