US FDA The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter:link

Pregnancy cat. The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk B2 (Aus For at least 40,000 years before European settlement in the late 18th century, Australia was inhabited by indigenous Australians, who belonged to one or more of the roughly 250 language groups. After sporadic visits by fishermen from the immediate north and discovery by Dutch explorers in 1606, Australia's eastern half was claimed by the British) Legal status The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Schedule 4 (Aus For at least 40,000 years before European settlement in the late 18th century, Australia was inhabited by indigenous Australians, who belonged to one or more of the roughly 250 language groups. After sporadic visits by fishermen from the immediate north and discovery by Dutch explorers in 1606, Australia's eastern half was claimed by the British) OTC Over-the-counter drugs are medicines that may be sold to a customer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to customers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are products that are safe and or Rx A prescription medication is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug (U.S. ^ b. English is the de facto language of American government and the sole language spoken at home by 80% of Americans age five and older. Spanish is the second most commonly spoken language) Routes A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is brought into contact with the body inhalation, IV, oral (what is this?) (verify)

Acetylcysteine (rINN An International Nonproprietary Name is the official non-proprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization (WHO)[citation needed]. The plethora of named proprietary preparations containing a given substance can lead to confusion about the identity of the active ingredient. INNs; pronounced /əˌsɛtəlˈsɪstiːn/), also known as N-acetylcysteine or N-acetyl-L-cysteine (abbreviated NAC), is a pharmaceutical drug A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease and nutritional supplement A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as used primarily as a mucolytic agent and in the management of paracetamol US FDA:link (acetaminophen) overdose The term drug overdose describes the ingestion or application of a drug or other substance in quantities that are excessive. An overdose is widely considered harmful and dangerous as it can result in death. Other uses include sulfate repletion in conditions, such as autism, where cysteine and related sulfur amino acids may be depleted. [1]

Contents

Trade names

In addition to being available as an over-the-counter nutritional supplement, acetylcysteine is also marketed under these trade names A trade name, also known as a trading name or a business name, is the name which a business trades under for commercial purposes, although its registered, legal name, used for contracts and other formal situations, may be another:

Dosage forms

Acetylcysteine is available in different dosage forms for different indications:

The IV injection and inhalation preparations are, in general, prescription only, whereas the oral solution and the effervescent tablets are available over the counter Over-the-counter drugs are medicines that may be sold to a customer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to customers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are products that are safe and in many countries.

Clinical use

Mucolytic therapy

Inhaled acetylcysteine is indicated for mucolytic ("mucus-dissolving") therapy as an adjuvant in respiratory conditions with excessive and/or thick mucus production. Such conditions include emphysema Emphysema is a long-term, progressive disease of the lung that primarily causes shortness of breath. In people with emphysema, the tissues necessary to support the physical shape and function of the lungs are destroyed. It is included in a group of diseases called chronic obstructive pulmonary disease or COPD . Emphysema is called an obstructive, bronchitis Bronchitis is inflammation of the mucous membranes of the bronchi, the airways that carry airflow from the trachea into the lungs. Bronchitis can be classified into two categories, acute and chronic, each of which has unique etiologies, pathologies, and therapies, tuberculosis Tuberculosis or TB is a common and often deadly infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis in humans. Tuberculosis usually attacks the lungs but can also affect other parts of the body. It is spread through the air, when people who have the disease cough, sneeze, or spit. Most infections in, bronchiectasis Bronchiectasis is a disease state defined by localized, irreversible dilation of part of the bronchial tree. It is classified as an obstructive lung disease, along with emphysema, bronchitis and cystic fibrosis. Involved bronchi are dilated, inflamed, and easily collapsible, resulting in airflow obstruction and impaired clearance of secretions, amyloidosis In medicine, amyloidosis refers to a variety of conditions in which amyloid proteins are abnormally deposited in organs and/or tissues. A protein is described as being amyloid if, due to an alteration in its secondary structure, it takes on a particular aggregated insoluble form similar to the beta-pleated sheet. Symptoms vary widely depending, pneumonia Pneumonia is an inflammatory condition of the lung. It is often characterized as including inflammation of the parenchyma of the lung and abnormal alveolar filling with fluid (consolidation and exudation), cystic fibrosis Cystic Fibrosis is a common hereditary disease which affects the entire body, causing progressive disability and often early death. The name cystic fibrosis refers to the characteristic scarring (fibrosis) and cyst formation within the pancreas, first recognized in the 1930s. Difficulty breathing is the most serious symptom and results from and COPD Chronic obstructive pulmonary disease , also known as chronic obstructive lung disease (COLD), chronic obstructive airway disease (COAD), chronic airflow limitation (CAL) and chronic obstructive respiratory disease (CORD), refers to chronic bronchitis and emphysema, a pair of commonly co-existing diseases of the lungs in which the airways become Chronic Obstructive Pulmonary Disease Chronic obstructive pulmonary disease refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become narrowed. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and. It is also used post-operatively, as a diagnostic aid, and in tracheotomy Tracheotomy and tracheostomy are surgical procedures on the neck to open a direct airway through an incision in the trachea . They are performed by emergency physicians, and surgeons. Both surgical and percutaneous techniques are now widely used care. It may be considered ineffective in cystic fibrosis Cystic Fibrosis is a common hereditary disease which affects the entire body, causing progressive disability and often early death. The name cystic fibrosis refers to the characteristic scarring (fibrosis) and cyst formation within the pancreas, first recognized in the 1930s. Difficulty breathing is the most serious symptom and results from.[2] However, a recent paper in the Proceedings of the National Academy of Sciences reports that high-dose oral N-acetylcysteine modulates inflammation in cystic fibrosis and has the potential to counter the intertwined redox and inflammatory imbalances in CF.[3] Oral acetylcysteine may also be used as a mucolytic in less serious cases.

For this indication, acetylcysteine acts to reduce mucus viscosity by splitting disulfide bonds In chemistry, a disulfide bond is a covalent bond, usually derived by the coupling of two thiol groups. The linkage is also called an SS-bond or disulfide bridge. The overall connectivity is therefore R-S-S-R. The terminology is widely used in biochemistry. Formally the connection is called a persulfide, in analogy to its congener, a peroxide (R-O- linking proteins present in the mucus (mucoproteins).

Paracetamol (Acetaminophen) overdose

Main article: Paracetamol poisoning

Intravenous acetylcysteine is indicated for the treatment of paracetamol US FDA:link (acetaminophen) overdose. When paracetamol is taken in large quantities, a minor metabolite called N-acetyl-p-benzoquinone imine (NAPQI) accumulates within the body. It is normally conjugated Xenobiotic metabolism is the set of metabolic pathways that modify the chemical structure of xenobiotics, which are compounds foreign to an organism's normal biochemistry, such as drugs and poisons. These pathways are a form of biotransformation present in all major groups of organisms, and are considered to be of ancient origin. These reactions by glutathione Glutathione is a tripeptide. It contains an unusual peptide linkage between the amine group of cysteine and the carboxyl group of the glutamate side chain. Glutathione, an antioxidant, helps protect cells from reactive oxygen species such as free radicals and peroxides, but when taken in excess, the body's glutathione reserves are not sufficient to inactivate the toxic NAPQI. This metabolite is then free to react with key hepatic enzymes, therefore damaging hepatocytes. This may lead to severe liver damage and even death by fulminant Fulminant is any event or process that occurs suddenly and quickly, and is intense and severe to the point of lethality, i.e., it has an explosive character. The word comes from Latin fulmināre, to strike with lightning. It is most frequently used in medicine, and there are several diseases described by this adjective: liver failure Liver failure is the inability of the liver to perform its normal synthetic and metabolic function as part of normal physiology. Two forms are recognised:.

For this indication, acetylcysteine acts to augment the glutathione reserves in the body and, together with glutathione, directly bind to toxic metabolites. These actions serve to protect hepatocytes A hepatocyte is a cell of the main tissue of the liver. Hepatocytes make up 70-80% of the liver's cytoplasmic mass. These cells are involved in: in the liver from NAPQI toxicity.

Although both IV and oral acetylcysteine are equally effective for this indication, oral administration is poorly tolerated, owing to the high doses required (due to low oral bioavailability In pharmacology, bioavailability is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via,[4]) very unpleasant taste and odour, and adverse effects An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dose. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as (particularly nausea and vomiting). Studies conducted by Baker and Dilger[5] suggest that the prior pharmacokinetic studies of N-acetylcysteine did not include Acetylation Acetylation describes a reaction that introduces an acetyl functional group into an organic compound. Deacetylation is the removal of the acetyl group as a reason for the low bioavailability In pharmacology, bioavailability is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via of N-acetylcysteine. In the research conducted by Baker,[5] it was concluded that oral N-acetylcysteine was identical in bioavailability to Cysteine precursors. (However, 3% to 6% of people given intravenous acetylcysteine show a severe, anaphylaxis Anaphylaxis is an acute multi-system severe type I hypersensitivity reaction. The term comes from the Greek words ανα ana and φύλαξις phylaxis (protection)-like allergic reaction, which may include extreme breathing difficulty (due to bronchospasm Bronchospasm or a bronchial spasm is a sudden constriction of the muscles in the walls of the bronchioles. It is caused by the release of substances from mast cells or basophils under the influence of anaphylatoxins. It causes difficulty in breathing which can be very mild to severe), a decrease in blood pressure In physiology and medicine, hypotension is abnormally low blood pressure. This is best understood as a physiologic state, rather than a disease. It is often associated with shock, though not necessarily indicative of it. Hypotension is the opposite of hypertension, which is high blood pressure. Blood pressure is the force of blood pushing against, rash, angioedema Angioedema is the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues. It is very similar to urticaria, but urticaria, commonly known as hives, occurs in the upper dermis.. The term angioneurotic oedema was used for this condition in the belief that there was nervous system involvement but this is now thought, and sometimes also nausea and vomiting.[6] Repeated overdoses will cause the allergic reaction to progressively worsen.)

Several studies have found this anaphylaxis-like reaction to occur more often in people given IV acetylcysteine despite serum levels of paracetamol not high enough to be considered toxic.[7][8][9][10]

In some countries, a specific intravenous formulation does not exist to treat paracetamol US FDA:link overdose. In these cases, the formulation used for inhalation may be used intravenously.

Nephroprotective agent

Oral acetylcysteine is used for the prevention of radiocontrast Radiocontrast agents are a type of medical contrast medium used to improve the visibility of internal bodily structures in an X-ray based imaging techniques such as Computed tomography or Radiography (commonly known as X-ray imaging). Radiocontrast agents are typically iodine or barium compounds-induced nephropathy (a form of acute renal failure). Some studies show that prior administration of acetylcysteine markedly decreases (90%) radiocontrast nephropathy,[11] whereas others appear to cast doubt on its efficacy.[12][13] Worth considering is the newest data published in two papers in the New England Journal of Medicine and the Journal of the American Medical Association. The authors' conclusions in those papers were:

  1. "Intravenous and oral N-acetylcysteine may prevent contrast-medium–induced nephropathy with a dose-dependent effect in patients treated with primary angioplasty and may improve hospital outcome."[14]
  2. "Acetylcysteine protects patients with moderate chronic renal insufficiency from contrast-induced deterioration in renal function after coronary angiographic procedures, with minimal adverse effects and at a low cost"[15]

Acetylcysteine continues to be commonly used in individuals with renal impairment to prevent the precipitation of acute renal failure.[citation needed]

Microbiological use

N-Acetyl L-Cysteine can be used in Petroff's method i.e. liquefaction and decontamination of sputum, in preparation for diagnosis of tuberculosis.

Interstitial lung disease

Acetylcysteine is used in the treatment of interstitial lung disease to prevent disease progression.[16] [17][18][19]

Schizophrenia, bipolar disorder and depression

Acetylcysteine has been shown to reduce the symptoms of both schizophrenia[20] and bipolar disorder[21] in two placebo controlled trials conducted at Melbourne University. It is thought to act via increasing glutathione, although it increases glutamate, enhances neurogenesis and has anti-inflammatory properties[citation needed]. Replicatory trials in bipolar disorder, schizophrenia and depression are underway.

Investigational

The following uses have not been well-established or investigated:

Complexing agent

N-Acetylcysteine has been used to complex palladium, to help it dissolve in water. This helps to remove palladium from drugs or precursors synthesized by palladium-coupling reactions.[42]

Chemistry

Acetylcysteine is the N-acetyl derivative of the amino acid L-cysteine, and is a precursor in the formation of the antioxidant glutathione in the body. The thiol (sulfhydryl) group confers antioxidant effects and is able to reduce free radicals.

Possible toxicity

Researchers at the University of Virginia reported in 2007 study using very large doses in a mouse model that acetylcysteine, which is found in many bodybuilding supplements, could potentially cause damage to the heart and lungs.[43] They found that acetylcysteine was metabolized to S-nitroso-N-acetylcysteine (SNOAC), which increased blood pressure in the lungs and right ventricle of the heart (pulmonary artery hypertension) in mice treated with acetylcysteine. The effect was similar to that observed following a 3-week exposure to an oxygen-deprived environment (chronic hypoxia). The authors also found that SNOAC induced a hypoxia-like response in the expression of several important genes both in vitro and in vivo.

The implications of these findings for long-term treatment with acetylcysteine have not yet been investigated. The dose used by Palmer and colleagues was dramatically higher than that used in humans;[43] nonetheless, the drug's effects on the hypoxic ventilatory response have been observed previously in human subjects at more moderate doses.[44]

See also

References

  1. ^ http://www.ncbi.nlm.nih.gov/pubmed/16825783
  2. ^ Rossi S, editor. Australian Medicines Handbook 2006. Adelaide: Australian Medicines Handbook; 2006.
  3. ^ Tirouvanziam R, Conrad CK, Bottiglieri T, Herzenberg LA, Moss RB, Herzenberg LA (2006). "High-dose oral N-acetylcysteine, a glutathione prodrug, modulates inflammation in cystic fibrosis". PNAS 103 (12): 4628–33. doi:10.1073/pnas.0511304103. PMID 16537378.
  4. ^ Borgström, L., B. Kågedal, and O. Paulsen (1986). "Pharmacokinetics of N-acetylcysteine 310 in man". Eur. J. Clin. Pharmacol. 31: 217–222. doi:10.1007/BF00606662.
  5. ^ a b Dilger, R. N., Baker, D. H. (2007). "Oral N-acetyl-L-cysteine is a safe and effective precursor of cysteine". Journal of Animal Science 85 (7): 1712. doi:10.2527/jas.2006-835. PMID 17371789.
  6. ^ Kanter MZ (2006). "Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning". American Journal of Health-System Pharmacy 63 (19): 1821. doi:10.2146/ajhp060050. PMID 16990628. http://www.ajhp.org/cgi/content/full/63/19/1821.
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  8. ^ Bailey B, McGuigan MA (June 1998). "Management of anaphylactoid reactions to intravenous N-acetylcysteine". Ann Emerg Med 31 (6): 710–5. doi:10.1016/S0196-0644(98)70229-X. PMID 9624310.
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Barbiturate overdose Bemegride · Ethamivan
Benzodiazepine overdose Cyprodenate · Flumazenil
GHB overdose Physostigmine · SCH-50911
Reversal of neuromuscular blockade Sugammadex
Cardiovascular
Heparin Protamine#
Digoxin toxicity Digoxin Immune Fab
Beta blocker Glucagon
Other
Methanol / Ethylene glycol poisoning Ethanol · Fomepizole
Paracetamol toxicity (Acetaminophen) Acetylcysteine# · Glutathione · Methionine#
Arsenic poisoning Dimercaprol# · Succimer
Cyanide poisoning nitrite (Amyl nitrite, Sodium nitrite#) · Sodium thiosulfate# · 4-Dimethylaminophenol · Hydroxocobalamin
Toxic metals (cadmium, mercury, lead, thallium) Edetates · Dimercaprol# · Prussian blue#
Hydrofluoric acid Calcium gluconate#
Other Prednisolone and promethazine · oxidizing agent (potassium permanganate) · iodine-131 (Potassium iodide) · Methylthioninium chloride#
Emetic Ipecacuanha (Syrup of ipecac) · Copper sulfate
#WHO-EM. ‡Withdrawn from market. CLINICAL TRIALS: †Phase III. §Never to phase III

Categories: Antioxidants | Antidotes | Thiols | Amino acid derivatives | World Health Organization essential medicines | Excipients | Treatment of bipolar disorder | Acetamides

 

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'Acetylcysteine' News
What's New in Pediatric Orthopaedics - Journal of Bone and Joint Surgery (subscription)
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What's New in Pediatric Orthopaedics - Journal of Bone and Joint Surgery (subscription)
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Journal of Bone and Joint Surgery (subscription) 70 demonstrated that treatment of injured articular cartilage explants with N- acetylcysteine can decrease the amount of chondrocyte death that would occur ...
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Plasma paracetamol concentrations in relation to time after overdosage as a guide to prognosis From guidelines agreed by National Poisons Centres June 1995 Parvolex is indicated in patients

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'Acetylcysteine' Blogs
N- Acetyl Cysteine is a Liver's Ally | Liver Support Health News
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ue, 20 May 2008 17:06:24 GM

Because it is readily absorbed and rapidly metabolized to glutathione, N-. Acetyl Cysteine. (NAC) is the glutathione building block most favored by healthcare practitioners. In the case of an acetaminophen overdose, NAC is administered by ...

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'Acetylcysteine' Answers
what is the risk of combination of N-acetylcysteine with metaclopramide?
Q. drug -drug interaction
Asked by OaCE U - Mon Nov 17 18:22:36 2008 - - 1 Answers - 0 Comments

A. Low to none.
Answered by Mr. Peachy - Mon Nov 17 20:43:43 2008

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