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Acetylcysteine (Acetylcysteine)

Trade Name : Acetylcysteine

American Regent, Inc.

INHALANT

Strength 100 mg/mL

ACETYLCYSTEINE Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acetylcysteine (Acetylcysteine) which is also known as Acetylcysteine and Manufactured by American Regent, Inc.. It is available in strength of 100 mg/mL per ml. Read more

Acetylcysteine (Acetylcysteine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • SterileNot For Injection
  • 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 CHNOS, 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.
  • No data
  • 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 ``opensu2032u2032 disulfide linkages in mucus 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 to yield cysteine or oxidation to yield diacetylcystine.
  • 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 a from a random patient population. Even when patients are known to have reacted previously to the inhalation of an acetylcysteine aerosol, they may not react during a subsequent treatment. The converse is also true; patients who have had inhalation treatments of acetylcysteine without incident may still react to subsequent inhalation with increased airways obstruction. 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 is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:
  • Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)Pulmonary complications of cystic fibrosisTracheostomy carePulmonary complications associated with surgeryUse during anesthesiaPost-traumatic chest conditionsAtelectasis due to mucous obstructionDiagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)
  • Acetylcysteine is contraindicated in those patients who are sensitive to it.
  • 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.
  • No data
  • Adverse effects have included stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, and bronchoconstriction. Clinically overt acetylcysteine induced bronchospasm occurs infrequently and unpredictably even in patients with asthmatic bronchitis or bronchitis complicating bronchial asthma.
  • Acquired sensitization to acetylcysteine has been reported rarely. Reports of sensitization in patients have not been confirmed by patch testing. Sensitization has been confirmed in several inhalation therapists who reported a history of dermal eruptions after frequent and extended exposure to acetylcysteine.
  • Reports of irritation to the tracheal and bronchial tracts have been received and although hemoptysis has occurred in patients receiving acetylcysteine such findings are not uncommon in patients with bronchopulmonary disease and a causal relationship has not been established.
  • No data
  • No data
  • (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.
  • 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.
  • There are no contraindications to oral administration of acetylcysteine in the treatment of acetaminophen overdose.
  • 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.
  • 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 ) minimizes the propensity of oral acetylcysteine to aggravate vomiting.
  • 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.
  • No data
  • 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. n
  • INTERPRETATION OF ACETAMINOPHEN ASSAYS
  • 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:
  • HPLC:
  • Doses in relation to body weight are:
  • The following nomogram has been developed to estimate the probability that plasma levels in relation to intervals post ingestion will result in hepatoxicity.
  • nPlasma or Serum Acetaminophen Concentration
  • nTime Post-acetaminophen Ingestion
  • 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.u00a0 It is available as:
  • Acetylcysteine
  • NDC 0517-7604-25u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Cartons of twenty-five 4 mL vialsNDC 0517-7610-03u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Cartons of three 10 mL vials, plastic dropperNDC 0517-7630-03u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Cartons of three 30 mL vials
  • Acetylcysteine
  • NDC 0517-7504-25u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Cartons of twenty-five 4 mL vialsNDC 0517-7510-03u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Cartons of three 10 mL vials, plastic dropper
  • Store unopened vials at 20u00b0-25u00b0C (68u00b0-77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) (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.u00a0 A change in color may occur after opening.u00a0 This does not change the efficacy of the drug.
  • Rx Only
  • IN7504 Rev.u00a05/14 MG #11105
  • AMERICANn- REGENT, INC.n- SHIRLEY, NY 11967
  • NDC 0517-7504-01
  • ACETYLCYSTEINEn
  • 10%n- 4 mLn- Rx Onlyn n- NOT FOR INJECTIONn n- AMERICAN REGENT, INC.n
  • ACETYLCYSTEINEn
  • 10%
  • NDC 0517-7504-2525 x 4 mL VIALS
  • Rx Only
  • For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) n u00a0PRESERVATIVE 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). n Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) (See USP Controlled Room Temperature). STORE IN REFRIGERATOR 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) 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.
  • AMERICANREGENT, INC.n
  • Rev. 11/11
  • NDC 0517-7604-01
  • ACETYLCYSTEINEn
  • 20%n- 4 mLn- Rx Onlyn n- NOT FOR INJECTIONn n- AMERICAN REGENT, INC.n
  • ACETYLCYSTEINEn
  • 20%
  • NDC 0517-7604-2525 x 4 mL VIALS
  • For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 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). n Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) (See USP Controlled Room Temperature). STORE IN REFRIGERATOR 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) 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.
  • AMERICANREGENT, INC. n
  • Rev. 11/11
  • NDC 0517-7510-03
  • ACETYLCYSTEINE n
  • 10%
  • NOT FOR INJECTIONn n- 10 mL
  • Rx Only
  • AMERICAN REGENT, INC.n
  • ACETYLCYSTEINE n
  • 10%
  • NDC 0517-7510-033 x 10 mL VIALS
  • Rx Only
  • For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)
  • NOT FOR INJECTION
  • 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).u00a0 CONTAINS ONE PLASTIC DROPPER FOR DISPENSING. n Store at 20u00b0-25u00b0C (68u00b0-77u00b0F), excursions permitted to 15u00b0-30u00b0 (59u00b0-86u00b0F) (See USP Controlled Room Temperature). STORE IN REFRIGERATOR 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) 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. n
  • Rev. 11/11
  • NDC 0517-7610-03
  • ACETYLCYSTEINE
  • 20%
  • For Inhalation (Mucolytic Agent)or Oral Administration(Acetaminophen Antidote)
  • NOT FOR INJECTION
  • 10 mL
  • Rx Only
  • AMERICAN REGENT, INC.n
  • ACETYLCYSTEINEn
  • 20%
  • NDC 0517-7610-03 3 x 10 mL VIALSn- Rx Only
  • For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)
  • NOT FOR INJECTION
  • 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).u00a0 CONTAINS ONE PLASTIC DROPPER FOR DISPENSING. n Store at 20u00b0 -25u00b0C (68u00b0 -77u00b0F); excursions permitted to 15u00b0-30u00b0 (59u00b0-86u00b0F) (See USP Controlled Room Temperature). STORE IN REFRIGERATOR 2u00b0-8u00b0C (36u00b0-46u00b0F) 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. n
  • Rev. 11/11
  • NDC 0517-7630-01
  • ACETYLCYSTEINEn
  • 20%
  • For Inhalation (Mucolytic Agent) or Oral Administration(Acetaminophen Antidote)
  • NOT FOR INJECTIONn n- 30 mLn- Rx Only
  • AMERICAN REGENT, INC.n
  • ACETYLCYSTEINEn
  • 20%
  • NDC 0517-7630-033 x 30 mL VIALS n Rx Only
  • For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)
  • NOT FOR INJECTION
  • 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). n Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) (See USP Controlled Room Temperature). STORE IN REFRIGERATOR 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) 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.
  • AMERICANREGENT, INC. n
  • Rev. 11/11
  • No data
  • No data
  • No data
  • No data
  • No data

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