ACETYLCYSTEINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ACETYLCYSTEINE

Composition:

ACETYLCYSTEINE 200 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine. The compound is a white crystalline powder which melts in the range of 104° to 110°C and has a very slight odor. The structural formula of acetylcysteine is: C5 H9 NO3 S                                                                                                      M.W.=163.19 Acetylcysteine Solution, USP is supplied as a sterile unpreserved solution (not for injection) in vials containing a 10% (100 mg/mL) or 20% (200 mg/mL) solution of acetylcysteine as the sodium salt. The inactive ingredients are edetate disodium, sodium hydroxide and Sterile Water for Injection, USP. The pH of the solution ranges from 6.0 to 7.5. It is administered by inhalation or direct instillation for mucolysis, or orally for acetaminophen overdosage.

Product summary:

Acetylcysteine Solution, USP, is available in rubber stopped glass vials containing 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. Acetycysteine is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows: 20% Acetylcysteine Solution, USP (200 mg acetylcysteine per mL). NDC 54868-5670-0    1 x 30 mL vial Store unopened vials at controlled room temperature, 15° to 30°C (59° to 86°F). Acetylcysteine Solution, USP 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETYLCYSTEINE - ACETYLCYSTEINE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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ACETYLCYSTEINE SOLUTION, USP
RX ONLY
DESCRIPTION
Acetylcysteine is the nonproprietary name for the N-acetyl derivative
of the naturally occurring amino
acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine.
The compound is a white crystalline powder which melts in the range of
104° to 110°C and has a very
slight odor. The structural formula of acetylcysteine is:
C H NO S M.W.=163.19
Acetylcysteine Solution, USP is supplied as a sterile unpreserved
solution (not for injection) in vials
containing a 10% (100 mg/mL) or 20% (200 mg/mL) solution of
acetylcysteine as the sodium salt. The
inactive ingredients are edetate disodium, sodium hydroxide and
Sterile Water for Injection, USP. The
pH of the solution ranges from 6.0 to 7.5. It is administered by
inhalation or direct instillation for
mucolysis, or orally for acetaminophen overdosage.
ACETYLCYSTEINE AS A MUCOLYTIC AGENT
CLINICAL PHARMACOLOGY
The viscosity of pulmonary mucous secretions depends on the
concentrations of mucoprotein and, to a
lesser extent, deoxyribonucleic acid (DNA). The latter increases with
increasing purulence owing to
the presence of cellular debris. The mucolytic action of
acetylcysteine is related to the sulfhydryl
group in the molecule. This group probably “opens” disulfide
linkages in mucous thereby lowering the
viscosity. The mucolytic activity of acetylcysteine is unaltered by
the presence of DNA, and increases
with increasing pH. Significant mucolysis occurs between pH 7 and 9.
Acetylcysteine undergoes rapid deacetylation _in vivo_ to yield
cysteine or oxidation to yield
diacetylcysteine.
Occasionally, patients exposed to the inhalation of an acetylcysteine
aerosol respond with the
development of increased airways obstruction of varying and
unpredictable severity. Those patients
who are reactors cannot be identified _apriori_ from a random patient
population. Even when patients are
known to have reacted previously to the inhalation of an
acetylcysteine