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Acetylcysteine (Acetylcysteine)

Trade Name : Acetylcysteine

Sagent Pharmaceuticals

INJECTION, SOLUTION

Strength 200 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 Sagent Pharmaceuticals. It is available in strength of 200 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

Packaging and Delivery

Validated Cold Chain Shipment

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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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
  • Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).n
  • Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with an acute ingestion or from repeated supratherapeutic ingestion (RSI) ().n
  • Pre-Treatment Assessment Following Acute Ingestion ()
  • Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion.n
  • Nomogram for Estimating Potential for Hepatotoxicity from Acute Acetaminophen Ingestion ():
  • Preparation and Storage of Diluted Solution Prior to Administration ()
  • Acetylcysteine injection is hyperosmolar (2600 mOsmol/L), therefore acetylcysteine injection must be diluted in sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water injection prior to intravenous administration. See Full Prescribing Information for examples of osmolarity depending on the type of solution and acetylcysteine injection concentration.n
  • Recommended Adult and Pediatric Dosage ():
  • Repeated Supratherapeutic Acetaminophen Ingestion ():
  • Acetylcysteine Injection: 200 mg per mL (6 grams of acetylcysteine in 30 mL) in a single-dose vial.n
  • Acetylcysteine Injection: 6 grams per 30 mL (200 mg per mL) in a single-dose vial ().n
  • Acetylcysteine is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine .n
  • Patients with a previous hypersensitivity reaction to acetylcysteine ().n
  • No data
  • Hypersensitivity Reactions, Including Hypotension, Wheezing, Shortness of Breath and Bronchospasm:
  • Fluid Overload:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.n
  • In the literature the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine.n
  • Most common adverse reactions (> 2%) are rash, urticaria/facial flushing and pruritus ().n n
  • No data
  • An initial 150 mg/kg dose of acetylcysteine for a patient weighting 106 kg was mistakenly calculated as 160 g (a decimal point error resulting in a 10-fold higher than prescribed dose). An hour after the infusion started, the patient complained of generalized heat sensation and body pain and developed widespread urticaria and hypotension. The second acetylcysteine infusion was withheld and the patient was treated for anaphylaxis. Despite treatment the patient subcomed to the acute inflammatory reaction and died.n
  • Single intravenous doses of acetylcysteine at 1000 mg/kg in mice, 2445 mg/kg in rats, 1500 mg/kg in guinea pigs, 1200 mg/kg in rabbits and 500 mg/kg in dogs were lethal. Symptoms of acute toxicity in the animals were ataxia, hypoactivity, labored respiration, cyanosis, loss of righting reflex and convulsions.n
  • Acetylcysteine Injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104u00b0 to 110u00b0C and has a very slight odor.n
  • The molecular formula of the compound is CHNOS, and its molecular weight is 163.2. Acetylcysteine has the following structural formula:n
  • Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg per mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg per mL disodium edetate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP.n
  • No data
  • Long-term studies in animals have not been performed to evaluate the carcinogenic potential of acetylcysteine.n
  • Acetylcysteine was not genotoxic in the Ames test or the mouse micronucleus test. It was, however, positive in the mouse lymphoma cell (L5178Y/TK) forward mutation test.n
  • Treatment of male rats with acetylcysteine at an oral dose of 250 mg/kg/day for 15 weeks (0.1 times the recommended total human intravenous dose of 300 mg/kg based on body surface comparison) did not affect the fertility or general reproductive performance.n
  • No data
  • Acetylcysteine Injection is supplied as a 20% solution (200 mg per mL) as follows:n
  • Do not use previously opened vials for intravenous administration.n
  • Note:
  • Storage Conditions
  • Discard unused portion.n
  • Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.
  • Hypersensitivity Reactions
  • Advise patients and caregivers that hypersensitivity reactions related to administration and infusion may occur during and after acetylcysteine treatment, including hypotension, wheezing, shortness of breath and bronchospasm .n
  • For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.n
  • SAGENTn Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA) Made in Indiau00a92019 Sagent Pharmaceuticals, Inc.n
  • Revised: November 2019n
  • SAGENT Pharmaceuticalsn
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Labeln
  • NDC 25021-812-30n
  • Rx onlyn
  • Acetylcysteine Injectionn
  • 6 grams per 30 mLn
  • (200 mg per mL)n
  • For Intravenous Usen
  • Must be Further Dilutedn
  • 30 mL Single-Dose Vialn

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