Acetylcysteine inhalation

Name: Acetylcysteine inhalation

How should I use acetylcysteine inhalation?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use acetylcysteine inhalation at home if you do not fully understand all instructions that are specific to your use of this medicine.

Acetylcysteine inhalation solution can be inhaled directly from the nebulizer or with a face mask, mouth piece, tent, or intermittent positive pressure breathing (IPPB) machine.

Use only the inhaler device provided with your medicine or you may not get the correct dose.

Do not place this medicine directly into a heated nebulizer medicine chamber.

Do not mix your dose of acetylcysteine inhalation until you are ready to use the medicine. Diluted acetylcysteine inhalation must be used within 1 hour of mixing.

Acetylcysteine inhalation liquid may change color once you have opened the bottle. This is caused by a chemical reaction and will not affect the medicine.

You may sense an unusual or unpleasant smell while using acetylcysteine inhalation. This effect should become less noticeable the longer you use the medicine.

Clean your nebulizer right after each use. The residue from acetylcysteine inhalation can clog the parts of the nebulizer.

Store an unopened vial (bottle) of acetylcysteine inhalation at room temperature, away from moisture and heat.

An opened acetylcysteine vial should be stored in a refrigerator, but you must use it within 96 hours (4 days) after opening. Do not allow the medicine to freeze.

Acetylcysteine dosing information

Usual Adult 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.

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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.

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 Adult Dose for Mucolytic:

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.

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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.

Usual Pediatric 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 Mucolytic:

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)

Acetylcysteine Inhalation Description

Acetylcysteine is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solutions contain 20% (200 mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 - 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C5H9NO3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula:

This product contains the following inactive ingredients:
disodium edetate, sodium hydroxide and water for injection.

Warnings

After proper administration of acetylcysteine, an increased volume of liquified bronchial secretions may occur. When cough is inadequate, the open airway must be maintained open by mechanical suction if necessary. When there is a mechanical block due to foreign body or local accumulation, the airway should be cleared by endotracheal aspiration, with or without bronchoscopy. Asthmatics under treatment with acetylcysteine should be watched carefully. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.

Acetylcysteine Inhalation Dosage and Administration

General

Acetylcysteine is available in rubber stoppered glass vials containing 4, 10, or 30 mL. 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.

Acetylcysteine does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. If only a portion of the solution in a vial is used for inhalation, store the remainder in a refrigerator and use within 96 hours.

Nebulization-face mask, mouth piece, tracheostomy

When nebulized into a face mask, mouth piece, or tracheostomy, 1 to 10 mL of the 20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours; the recommended dose for most patients is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution 3 to 4 times a day.

Nebulization tent, Croupette

In special circumstances it may be necessary to nebulize into a tent or Croupette, and this method of use must be individualized to take into account the available equipment and the patient's particular needs. This form of administration requires very large volumes of the solution, occasionally as much as 300 mL during a single treatment period.

If a tent or Croupette must be used, the recommended dose is the volume of acetylcysteine (using 10% or 20%) that will maintain a very heavy mist in the tent or Croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.

Direct Instillation

When used by direct instillation, 1 to 2 mL of a 10% to 20% solution may be given as often as every hour.

When used for the routine nursing care of patients with tracheostomy, 1 to 2 mL of a 10% to 20% solution may be given every 1 to 4 hours by instillation into the tracheostomy.

Acetylcysteine may be introduced directly into a particular segment of the bronchopulmonary tree by inserting (under local anesthesia and direct vision) a small plastic catheter into the trachea. Two to 5 mL of the 20% solution may then be instilled by means of a syringe connected to the catheter.

Acetylcysteine may also be given through a percutaneous intratracheal catheter. One to 2 mL of the 20% or 2 to 4 mL of the 10% solution every 1 to 4 hours may then be given by a syringe attached to the catheter.

Diagnostic Bronchograms

For diagnostic bronchial studies, two or three administrations of 1 to 2 mL of the 20% solution or 2 to 4 mL of the 10% solution should be given by nebulization or by instillation intratracheally, prior to the procedure.

Administration of Aerosol

Materials

Acetylcysteine may be administered using conventional nebulizers made of plastic or glass. Certain materials used in nebulization equipment react with acetylcysteine. The most reactive of these are certain metals (notably iron and copper) and rubber. Where materials may come into contact with acetylcysteine solution, parts made of the following acceptable materials should be used: glass, plastic, aluminum, anodized aluminum, chromed metal, tantalum, sterling silver, or stainless steel. Silver may become tarnished after exposure, but this is not harmful to the drug action or to the patient.

Nebulizing Gases

Compressed tank gas (air) or an air compressor should be used 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.

Apparatus

Acetylcysteine is usually administered as fine nebulae and the nebulizer used should be capable of providing optimal quantities of a suitable range of particle sizes.

Commercially available nebulizers will produce nebulae of acetylcysteine satisfactory for retention in the respiratory tract. Most of the nebulizers tested will supply a high proportion of the drug solution as particles of less than 10 microns in diameter. Mitchell2 has shown that particles less than 10 microns should be retained in the respiratory tract satisfactorily.

Various intermittent positive pressure breathing devices nebulized acetylcysteine with a satisfactory efficiency including: No. 40 De Vilbiss (The De Vilbiss Co., Somerset, Pennsylvania), and the Bennett Twin-Jet Nebulizer (Puritan Bennett Corp., Oak at 13th., Kansas City, Missouri).

The nebulized solution may be inhaled directly from the nebulizer. Nebulizers may also be attached to the plastic face masks or plastic mouthpieces. Suitable nebulizers may also be fitted for use with the various intermittent positive pressure breathing (IPPB) machines. The nebulizing equipment should be cleaned immediately after use because the residues may clog the smaller orifices or corrode metal parts.

Hand bulbs are not recommended for routine use in nebulizing acetylcysteine because their output is generally too small. Also, some hand-operated nebulizers deliver particles that are larger than optimum for inhalation therapy.

Acetylcysteine should not be placed directly into the chamber of a heated (hot pot) nebulizer. A heated nebulizer may be part of the nebulization assembly to provide a warm saturated atmosphere if the acetylcysteine aerosol is introduced by means of a separate unheated nebulizer. Usual precautions for administration of warm saturated nebulae should be observed.

The nebulized solution may be breathed directly from the nebulizer. Nebulizers may also be attached to plastic face masks, plastic face tents, plastic mouth pieces, conventional plastic oxygen tents, or head tents. Suitable nebulizers may also be fitted for use with the various intermittent positive pressure breathing (IPPB) machines.

The nebulizing equipment should be cleaned immediately after use, otherwise the residues may occlude the fine orifices or corrode metal parts.

Prolonged Nebulization

When three fourths of the initial volume of acetylcysteine solution has been nebulized, a quantity of Sterile Water for Injection, USP (approximately equal to the volume of solution remaining) should be added to the nebulizer. This obviates any concentration of the agent in the residual solvent remaining after prolonged nebulization.

Compatibility

The physical and chemical compatibility of acetylcysteine solutions with certain other drugs that might be concomitantly administered by nebulization, direct instillation, or topical application has been studied.

Acetylcysteine should not be mixed with certain antibiotics. For example, the antibiotics, tetracycline hydrochloride, oxytetracycline hydrochloride, and erythromycin lactobionate, were found to be incompatible when mixed in the same solution. These agents may be administered from separate solutions if administration of these agents is desirable.

The supplying of these data should not be interpreted as a recommendation for combining acetylcysteine with other drugs. The table is not presented as positive assurance that no incompatibility will be present, since these data are based only on short-term compatibility studies done in the Mead Johnson Research Center. Manufacturers may change their formulations, and this could alter compatibilities. These data are intended to serve only as a guide for predicting compounding problems.

If it is deemed advisable to prepare an admixture, it should be administered as soon as possible after preparation. Do not store unused mixtures.

IN VITRO COMPATIBILITY1 TESTS OF ACETYLCYSTEINE

1. The rating, Incompatible, is based on the formation of a precipitate, a change in clarity, immiscibility, or a rapid loss of potency of acetylcysteine or the active ingredient of the PRODUCT AND/OR AGENT in the admixture.
 The rating, Compatible, means that there was no significant physical change in the admixture when compared with a control solution of the PRODUCT AND/OR AGENT, and that there was no predicted chemical incompatibility. All of the admixtures have been tested for short-term chemical compatibility by assaying for the concentration of acetylcysteine after mixing.
2. The active ingredient in the PRODUCT AND/OR AGENT was also assayed after mixing. Some of the admixtures developed minor physical changes which were considered to be insufficient to rate the admixture Incompatible. These are listed in footnotes 3, 4, and 5.

3. A strong odor developed after storage for 24 hours at room temperature.

4. The admixture was a slightly darker shade of yellow than a control solution of the PRODUCT AND/OR AGENT.

5. A light tan color developed after storage for 24 hours at room temperature.

6. Entries are final concentrations. Values in parentheses relate volumes of acetylcysteine solutions to volume of test solutions.
     RATIO TESTED6
 PRODUCT AND/OR AGENT  COMPATIBILITY  ACETYLCYSTEINE  PRODUCT
   RATING    OR AGENT
 ANESTHETIC, GAS      
 Halothane  Compatible  20%  Infinite
 Nitrous Oxide  Compatible  20%  Infinite
 ANESTHETIC, LOCAL      
 Cocaine HCl  Compatible  10%  5%
 Lidocaine HCl  Compatible  10%  2%
 Tetracaine HCl  Compatible  10%  1%
 ANTIBACTERIALS (A parenteral form of each antibiotic was used)      
 Bacitracin2,3 (mix and use at once)  Compatible  10%  5,000 U/mL
 Chloramphenicol Sodium Succinate  Compatible  20%  20 mg/mL
 Carbenicillin Disodium2 (mix and use at once)  Compatible  10%  125 mg/mL
 Gentamicin Sulfate2  Compatible  10%  20 mg/mL
 Kanamycin Sulfate2 (mix and use at once)  Compatible  10%  167 mg/mL
   Compatible  17%  85 mg/mL
 Lincomycin HCl2  Compatible  10%  150 mg/mL
 Neomycin Sulfate2  Compatible  10%  100 mg/mL
 Novobiocin Sodium2  Compatible  10%  25 mg/mL
 Penicillin G Potassium2 (mix and use at once)  Compatible  10%  25,000 U/mL
   Compatible  10%  100,000 U/mL
 Polymyxin B Sulfate2  Compatible  10%  50,000 U/mL
 Cephalothin Sodium  Compatible  10%  110 mg/mL
 Colistimethate Sodium2 (mix and use at once)  Compatible  10%  37.5 mg/mL
 Vancomycin HCl2  Compatible  10%  25 mg/mL
 Amphotericin B  Incompatible  4% - 15%  1 - 4 mg/mL
 Chlortetracycline HCl2  Incompatible  10%  12.5 mg/mL
 Erythromycin Lactobionate  Incompatible  10%  15 mg/mL
 Oxytetracycline HCl  Incompatible  10%  12.5 mg/mL
 Ampicillin Sodium  Incompatible  10%  50 mg/mL
 Tetracycline HCl  Incompatible  10%  12.5 mg/mL
 BRONCHODILATORS      
 Isoproterenol HCl2  Compatible  3%  0.5%
 Isoproterenol HCl2  Compatible  10%  0.05%
 Isoproterenol HCl2  Compatible  20%  0.05%
 Isoproterenol HCl  Compatible  13.3% (2 parts)  0.33% (1 part)
 Isoetharine HCl  Compatible  13.3% (2 parts)  (1 part)
 Epinephrine HCl  Compatible  13.3% (2 parts)  0.33% (1 part)
 CONTRAST MEDIA      
 Iodized Oil  Incompatible  20%/20 mL  40%/10 mL
 DECONGESTANTS      
 Phenylephrine HCl2  Compatible  3%  0.25%
 Phenylephrine HCl  Compatible  13.3% (2 parts)  0.17% (1 part)
 ENZYMES      
 Chymotrypsin  Incompatible  5%  400 γ/mL
 Trypsin  Incompatible  5%  400 γ/mL
 SOLVENTS      
 Alcohol  Compatible  12%  10% - 20%
 Propylene Glycol  Compatible  3%  10%
 STEROIDS      
 Dexamethasone Sodium Phosphate  Compatible  16%  0.8 mg/mL
 Prednisolone Sodium Phosphate5  Compatible  16.7%  3.3 mg/mL
 OTHER AGENTS      
 Hydrogen Peroxide  Incompatible  (All ratios)  
 Sodium Bicarbonate  Compatible  20% (1 part)  4.2% (1 part)

How is Acetylcysteine Inhalation Supplied

Acetylcysteine is available in rubber stoppered glass vials containing 4, 10, or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

Acetylcysteine solution is sterile and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). Acetylcysteine solution is not for parenteral injection.  It is available as:

Acetylcysteine 20% solution (200 mg acetylcysteine per mL). Sterile, not for injection.

NDC 0517-7604-25           Cartons of twenty-five 4 mL vials
NDC 0517-7610-03           Cartons of three 10 mL vials, plastic dropper
NDC 0517-7630-03           Cartons of three 30 mL vials

Acetylcysteine 10% solution (100 mg acetylcysteine per mL). Sterile, not for injection.

NDC 0517-7504-25           Cartons of twenty-five 4 mL vials
NDC 0517-7510-03           Cartons of three 10 mL vials, plastic dropper

PRINCIPAL DISPLAY PANEL - 4 mL (10%) Container & Carton

NDC 0517-7504-25

ACETYLCYSTEINE
SOLUTION, USP

10% (100 mg/mL)
4 mL VIAL

Rx Only

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

NOT FOR INJECTION
PRESERVATIVE FREE

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

 

ACETYLCYSTEINE
SOLUTION, USP

10% (100 mg/mL)

NDC 0517-7504-25
25 x 4 mL VIALS

Rx Only

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)
NOT FOR INJECTION      PRESERVATIVE FREE.

Each mL contains: Acetylcysteine 100 mg (10%), 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).
WARNING: DISCARD OPENED CONTAINER AFTER 96 HOURS.
Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).
STORE IN REFRIGERATOR 2° to 8°C (36° to 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

PRINCIPAL DISPLAY PANEL - 30 mL (20%) Container & Carton

NDC 0517-7630-03

ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

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

NOT FOR INJECTION

30 mL VIAL
PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

NDC 0517-7630-03
3 x 30 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).
WARNING: DISCARD OPENED CONTAINER AFTER 96 HOURS.
Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).
STORE IN REFRIGERATOR 2° to 8°C (36° to 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

ACETYLCYSTEINE 
acetylcysteine inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-7504
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-7504-25 25 VIAL, GLASS in 1 TRAY
1 4 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072489 10/01/1995
ACETYLCYSTEINE 
acetylcysteine inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-7604
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-7604-25 25 VIAL, GLASS in 1 TRAY
1 4 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072547 10/01/1995
ACETYLCYSTEINE 
acetylcysteine inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-7510
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-7510-03 3 VIAL, GLASS in 1 BOX
1 10 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072489 10/01/1995
ACETYLCYSTEINE 
acetylcysteine inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-7610
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-7610-03 3 VIAL, GLASS in 1 BOX
1 10 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072547 10/01/1995
ACETYLCYSTEINE 
acetylcysteine inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-7630
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-7630-03 3 VIAL, GLASS in 1 BOX
1 30 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072547 10/01/1995
Labeler - American Regent, Inc. (622781813)
Establishment
Name Address ID/FEI Operations
Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-7504, 0517-7604, 0517-7510, 0517-7510, 0517-7610, 0517-7630), MANUFACTURE(0517-7504, 0517-7604, 0517-7510, 0517-7510, 0517-7610, 0517-7630), STERILIZE(0517-7504, 0517-7604, 0517-7510, 0517-7510, 0517-7610, 0517-7630)
Revised: 06/2014   American Regent, Inc.

Usual Adult 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.

Dialysis

Data not available

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