Acetylcysteine (Page 5 of 5)

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

Figure
(click image for full-size original)

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 55154-5731-5 Overbagged with five 4 mL vials

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

NDC 55154-5730-5 Overbagged with five 4 mL vials

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

Distributed By:

Cardinal Health

Dublin, OH 43017

L35753541118

L35753391118

Package/Label Display Panel

Acetylcysteine Solution, USP

10% (100 mg/ml)

5 x 4 ml Vials

bag label
(click image for full-size original)

Package/Label Display Panel

Acetylcysteine Solution, USP

20% (200 mg/ml)

5 x 4 ml Vials

Bag Label
(click image for full-size original)
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 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
SODIUM HYDROXIDE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5731-5 5 VIAL in 1 BAG contains a VIAL
1 4 mL in 1 VIAL This package is contained within the BAG (55154-5731-5)
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 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
SODIUM HYDROXIDE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5730-5 5 VIAL in 1 BAG contains a VIAL
1 4 mL in 1 VIAL This package is contained within the BAG (55154-5730-5)
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: 07/2019 Cardinal Health

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