ACETYLCYSTEINE inhalant

1. No Title 1572551959
2. No Title 1572452426
3. Principal Display Panel - 4 Ml (10%) Container & Carton
4. Principal Display Panel - 4 Ml (20%) Container & Carton
5. Principal Display Panel - 10 Ml (10%) Container & Carton
6. Prinicpal Display Panel - 10 Ml (20%) Container & Carton
7. Principal Display Panel - 30 Ml (20%) Container & Carton
8. Serialization Label - 30 Ml (20%)
9. Description
10. Clinical Pharmacology
11. Indications And Usage
12. Contraindications
13. Warnings
14. Precautions
15. Adverse Reactions
16. Dosage And Administration
17. Acetaminophen Assays - Interpretation And Methodology
18. Acetaminophen Assay Methodology
19. Selected Techniques (non Inclusive)
20. Dosage Guide And Preparation
21. How Supplied
22. Storage
23. References
24. Package/label Display Panel

No Title 1572551959 ⮝

Sterile
Not For Injection

No Title 1572452426 ⮝

Sterile
Not For Injection

Principal Display Panel - 4 Ml (10%) Container & Carton ⮝

NDC 0517-7504-01

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 - 4 Ml (20%) Container & Carton ⮝

NDC 0517-7604-01

ACETYLCYSTEINE
SOLUTION, USP

20% (200 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

20% (200 mg/mL)

NDC 0517-7604-25
25 x 4 mL VIALS

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

Rx Only

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

Principal Display Panel - 10 Ml (10%) Container & Carton ⮝

NDC 0517-7510-03

ACETYLCYSTEINE
SOLUTION, USP

10% (100 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

10% (100 mg/mL)

NDC 0517-7510-03
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 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). 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 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

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

Principal Display Panel - 30 Ml (20%) Container & Carton ⮝

NDC 0517-7630-01

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

Serialization Label - 30 Ml (20%) ⮝

ACETYLCYSTEINE acetylcysteine inhalant

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-7504 Route of Administration RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-7504-25 25 in 1 TRAY 10/01/1995 1 4 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

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 Item Code (Source) NDC:0517-7604 Route of Administration RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-7604-25 25 in 1 TRAY 10/01/1995 1 4 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

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 Item Code (Source) NDC:0517-7510 Route of Administration RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-7510-03 3 in 1 BOX 10/01/1995 1 10 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

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 Item Code (Source) NDC:0517-7610 Route of Administration RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-7610-03 3 in 1 BOX 10/01/1995 1 10 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

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 Item Code (Source) NDC:0517-7630 Route of Administration RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0517-7630-03 3 in 1 BOX 10/01/1995 1 30 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072547 10/01/1995

Labeler - American Regent, Inc. (002033710)

Establishment
Name	Address	ID/FEI	Business Operations
American Regent, 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)

Revised: 8/2019 Document Id: 87d790b1-9137-4dce-b6fe-d87ae528bc51 34391-3 Set id: f56b4087-db48-4fd7-84ec-9c927962b805 Version: 9 Effective Time: 20190821 American Regent, Inc.

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.

Clinical Pharmacology ⮝

(Antidotal) Acetaminophen is rapidly absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. The parent compound, which is nontoxic, is extensively metabolized in the liver to form principally the sulfate and glucuronide conjugates which are also nontoxic and are rapidly excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite which preferentially conjugates with hepatic glutathione to form the nontoxic cysteine and mercapturic acid derivatives which are then excreted by the kidney. Therapeutic doses of acetaminophen do not saturate the glucuronide and sulfate conjugation pathways and do not result in the formation of sufficient reactive metabolite to deplete glutathione stores. However, following ingestion of a large overdose (150 mg/kg or greater) the glucuronide and sulfate conjugation pathways are saturated resulting in a larger fraction of the drug being metabolized via the P-450 pathway. The increased formation of reactive metabolite may deplete the hepatic stores of glutathione with subsequent binding of the metabolite to protein molecules within the hepatocyte resulting in cellular necrosis.

Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Its effectiveness depends on early oral administration, with benefit seen principally in patients treated within 16 hours of the overdose. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.

Indications And Usage ⮝

Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion.

Contraindications ⮝

There are no contraindications to oral administration of acetylcysteine in the treatment of acetaminophen overdose.

Warnings ⮝

Generalized urticaria has been observed rarely in patients receiving oral acetylcysteine for acetaminophen overdose. If this occurs or other allergic symptoms appear, treatment with acetylcysteine should be discontinued unless it is deemed essential and the allergic symptoms can be otherwise controlled.

If encephalopathy due to hepatic failure becomes evident, acetylcysteine treatment should be discontinued to avoid further administration of nitrogenous substances. There are no data indicating that acetylcysteine influences hepatic failure, but this remains a theoretical possibility.

Precautions ⮝

Occasionally severe and persistent vomiting occurs as a symptom of acute acetaminophen overdose. Treatment with oral acetylcysteine may aggravate the vomiting. Patients at risk of gastric hemorrhage (eg, esophageal varices, peptic ulcers, etc.) should be evaluated concerning the risk of upper gastrointestinal hemorrhage versus the risk of developing hepatic toxicity, and treatment with acetylcysteine given accordingly.

Dilution of the acetylcysteine (see Preparation of Acetylcysteine for Oral Administration) minimizes the propensity of oral acetylcysteine to aggravate vomiting.

Adverse Reactions ⮝

Oral administration of acetylcysteine, especially in the large doses needed to treat acetaminophen overdose, may result in nausea, vomiting and other gastrointestinal symptoms. Rash with or without mild fever has been observed rarely.

Dosage And Administration ⮝

General

Regardless of the quantity of acetaminophen reported to have been ingested, administer acetylcysteine immediately if 24 hours or less have elapsed from the reported time of ingestion of an overdose of acetaminophen. Do not await results of assays for acetaminophen level before initiating treatment with acetylcysteine. The following procedures are recommended:

1. The stomach should be emptied promptly by lavage or by inducing emesis with syrup of ipecac. Syrup of ipecac should be given in a dose of 15 mL for children up to age 12 and 30 mL for adolescents and adults followed immediately by drinking copious amounts of water. The dose should be repeated if emesis does not occur in 20 minutes.
2. In the case of a mixed drug overdose activated charcoal may be indicated. However, if activated charcoal has been administered, lavage before administering acetylcysteine treatment. Activated charcoal adsorbs acetylcysteine in vitro and may do so in patients and thereby may reduce its effectiveness.
3. Draw blood for predetoxification acetaminophen plasma assay and baseline SGOT, SGPT, bilirubin, prothrombin time, creatinine, BUN, blood sugar and electrolytes.
4. Administer the loading dose of acetylcysteine, 140 mg per kg of body weight. (Prepare acetylcysteine for oral administration as described in the Dosage Guide and Preparation table).
5. Determine subsequent action based on predetoxification plasma acetaminophen information. Choose ONE of the following four courses of therapy.
   1. Predetoxification plasma acetaminophen level is clearly in the toxic range (See Acetaminophen Assays - Interpretation and Methodology below):
      Administer a first maintenance dose (70 mg/kg acetylcysteine) 4 hours after the loading dose. The maintenance dose is then repeated at 4-hour intervals for a total of 17 doses. Monitor hepatic and renal function and electrolytes throughout the detoxification process.
   2. Predetoxification acetaminophen level could not be obtained
      Proceed as in A.
   3. Predetoxification acetaminophen level is clearly in the non-toxic range (beneath the dashed line on the nomogram) and you know that acetaminophen overdose occurred at least 4 hours before the predetoxification acetaminophen plasma assays
      Discontinue administration of acetylcysteine.
   4. Predetoxification acetaminophen level was in the non-toxic range, but time of ingestion was unknown or less than 4 hours
      Because the level of acetaminophen at the time of predetoxification assay may not be a peak value (peak may not be achieved before 4 hours post-ingestion), obtain a second plasma level in order to decide whether or not the full 17-dose detoxification treatment is necessary.
6. If the patient vomits an oral dose within 1 hour of administration, repeat that dose.
7. In the occasional instances where the patient is persistently unable to retain the orally administered acetylcysteine, the antidote may be administered by duodenal intubation.
8. Repeat SGOT, SGPT, bilirubin, prothrombin time, creatinine, BUN, blood sugar and electrolytes daily if the acetaminophen plasma level is in the potentially toxic range as discussed below.

Preparation of Acetylcysteine for Oral Administration

Oral administration requires dilution of the 20% solution with diet cola or other diet soft drinks, to a final concentration of 5% (see Dosage Guide and Preparation table). If administered via gastric tube or Miller-Abbott tube, water may be used as the diluent. The dilutions should be freshly prepared and utilized within one hour. Remaining undiluted solutions in opened vials can be stored in the refrigerator up to 96 hours.

ACETYLCYSTEINE IS NOT APPROVED FOR PARENTERAL INJECTION.

Acetaminophen Assays - Interpretation And Methodology ⮝

The acute ingestion of acetaminophen in quantities of 150 mg/kg or greater may result in hepatic toxicity. However, the reported history of the quantity of a drug ingested as an overdose is often inaccurate and is not a reliable guide to therapy of the overdose. THEREFORE, PLASMA OR SERUM ACETAMINOPHEN CONCENTRATIONS, DETERMINED AS EARLY AS POSSIBLE, BUT NO SOONER THAN 4 HOURS FOLLOWING AN ACUTE OVERDOSE, ARE ESSENTIAL IN ASSESSING THE POTENTIAL RISK OF HEPATOTOXICITY. IF AN ASSAY FOR ACETAMINOPHEN CANNOT BE OBTAINED, IT IS NECESSARY TO ASSUME THAT THE OVERDOSE IS POTENTIALLY TOXIC.

INTERPRETATION OF ACETAMINOPHEN ASSAYS

1. When results of the plasma acetaminophen assay are available refer to the nomogram below to determine if plasma concentration is in the potentially toxic range. Values above the solid line connecting 200 mcg/mL at 4 hours with 50 mcg/mL at 12 hours are associated with a possibility of hepatic toxicity if an antidote is not administered. (Do not wait for assay results to begin acetylcysteine treatment.)
2. If the predetoxification plasma level is above the broken line continue with maintenance doses of acetylcysteine. It is better to err on the safe side and thus the broken line is placed 25% below the solid line which defines possible toxicity.
3. If the predetoxification plasma level is below the broken line described above, there is minimal risk of hepatic toxicity and acetylcysteine treatment can be discontinued.

Acetaminophen Assay Methodology ⮝

Assay procedures most suitable for determining acetaminophen concentrations utilize high pressure liquid chromatography (HPLC) or gas liquid chromatography (GLC). The assay should measure only parent acetaminophen and not conjugated. The assay procedures listed below fulfill this requirement:

Selected Techniques (non Inclusive) ⮝

HPLC:

1. Blair D, Rumack, BH, Clin Chem, 1977; 23(4):743-745.
2. Howie D, Andriaenssens Pl, Prescott LF. J. Pharm Pharmacol, 1977; 29(4):235-237. GLC
3. Prescott LF. J. Pharm Pharmacol, 1971; 23(10):807-808. Colorimetric
4. Glynn JP. Kendal SE, Lancet 1975; 1(May 17):1147-1148.

Supportive Treatment of Acetaminophen Overdose

1. Maintain fluid and electrolyte balance based on clinical evaluation of state of hydration and serum electrolytes.
2. Treat as necessary for hypoglycemia.
3. Administer vitamin K1 if prothrombin time ratio exceeds 1.5 or fresh frozen plasma if the prothrombin time ratio exceeds 3.0.
4. Diuretics and forced diuresis should be avoided.

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

How 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

Storage ⮝

Store unopened vials at 20 -25 C (68 -77 F); excursions permitted to 15 -30 C (59 -86 F) (see USP Controlled Room Temperature).

Acetylcysteine solution does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of acetylcysteine should be used freshly prepared and utilized within one hour. If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours. A change in color may occur after opening. This does not change the efficacy of the drug.

References ⮝

1. Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis, 1981; 61 (Suppl III): 45-51.
2. Am Rev Respir Dis, 1960; 82:627-639.

Rx Only

IN7504
Rev. 5/14
MG #11105

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Package/label Display Panel  ⮝

Acetylcysteine Solution, USP

20% (200 mg/ml)

5 x 4 ml Vials

ACETYLCYSTEINE acetylcysteine inhalant

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5731(NDC:0517-7604) Route of Administration RESPIRATORY (INHALATION), ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acetylcysteine (UNII: WYQ7N0BPYC) (acetylcysteine - UNII:WYQ7N0BPYC) acetylcysteine 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength edetate disodium (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) water (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-5731-5 5 in 1 BAG 05/06/2011 1 4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072547 05/06/2011

ACETYLCYSTEINE acetylcysteine inhalant

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5730(NDC:0517-7504) Route of Administration RESPIRATORY (INHALATION), ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acetylcysteine (UNII: WYQ7N0BPYC) (acetylcysteine - UNII:WYQ7N0BPYC) acetylcysteine 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength edetate disodium (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) water (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-5730-5 5 in 1 BAG 05/06/2011 1 4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072489 05/06/2011

Labeler - Cardinal Health (603638201)

Revised: 7/2019 Document Id: 6fc4ca0f-bd63-4931-bf50-57737fe7540a 34391-3 Set id: c90fca12-12fb-4cf6-bd6f-83bc0d95df81 Version: 7 Effective Time: 20190718 Cardinal Health