Acetylcysteine (ACETADOTE)

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Trade Name: ACETADOTE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Cumberland Pharmaceuticals Inc.

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 200 mg/mL

Storage and handling

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

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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ACETADOTE 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
ACETADOTE 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 ():
ACETADOTE is hyperosmolar (2600 mOsmol/L), therefore ACETADOTE 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 ACETADOTE concentration.n
Recommended Adult and Pediatric Dosage ():
Repeated Supratherapeutic Acetaminophen Ingestion ():

Injection: 200 mg/mL (6 grams of acetylcysteine in 30 mL) in a single-dose vial.n
Injection: 6 grams/30 mL (200 mg/mL) in a single-dose vial ()n

ACETADOTE is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine .n
Patients with a previous hypersensitivity reaction to acetylcysteine ()n

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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
To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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
ACETADOTE is supplied as a sterile solution in vials containing 20% w/v (200u00a0mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. ACETADOTE contains the following inactive ingredients: sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP.n

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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 in vivo mouse micronucleus test. It was, however, positive in the in vitro 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

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ACETADOTE (acetylcysteine) injection is available as a 20% solution (200 mg/mL) in 30 mL single-dose glass vials. Each single dose vial contains 6 g/30mL (200 mg/mL) of ACETADOTE injection. ACETADOTE is sterile and can be used for intravenous administration. It is available as follows:n
Do not use previously opened vials for intravenous administration.n
Note:
The stopper in the ACETADOTE vial is formulated with a synthetic base-polymer and does not contain Natural Rubber Latex, Dry Natural Rubber, or blends of Natural Rubber.n
Store unopened vials at controlled room temperature, 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]n

Hypersensitivity Reactions
Advise patients and caregivers that hypersensitivity reactions related to administration and infusion may occur during and after ACETADOTE 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
Manufactured for:Cumberland Pharmaceuticals Inc.Nashville, TN 37203n
U.S. Patent Nos.u00a08,148,356, 8,399,445, 8,653,061 8,722,738 and 9,327,028n

PRINCIPAL DISPLAY PANEL u2013 Vial Label
30 mL NDC 66220-207-30Sterilen
Acetadoten- Arrayn- (acetylcysteine) Injection
6 g/30 mLn
MUST BE FURTHER DILUTEDPRIOR TO INTRAVENOUS USE
CUMBERLANDn- Array
PHARMACEUTICALSn

PRINCIPAL DISPLAY PANEL u2013 Carton Label
4 u00d7 30mL Sterile Vials NDC 66220-207-30n
Acetadoten- Arrayn- (acetylcysteine) Injection
6 g/30 mLn
MUST BE FURTHER DILUTEDPRIOR TO INTRAVENOUS USE
CUMBERLANDn- Arrayn- Array
Manufactured for:Cumberland Pharmaceuticals Inc.Nashville, TN, USA, 37203n
Made in USAn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Acetylcysteine (ACETADOTE) which is also known as ACETADOTE and Manufactured by Cumberland Pharmaceuticals Inc.. It is available in strength of 200 mg/mL.

Acetylcysteine (ACETADOTE) 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.