ACETADOTE PACKAGE INSERT PDF

Official website of IV Acetadote (acetylcysteine). Find informantion about Acetadote and acetaminophen overdose, a dosage calculator, emergency facility . Drug Label Information do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. IV NAC (Acetadote): Adult Patient Dosing Regimen per Package Insert. Loading Dose: mg/kg in mL of 5% dextrose in water (D5W) infused over

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These factors include market conditions, competition, an inability of manufacturers to produce Cumberland’s products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors discussed in the Company’s acetxdote recent Form K and subsequent Q’s as filed with the SEC.

No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over kg. Acetadte 46, exposures were treated in healthcare facilities. No assurance can be given that these events will occur.

For more information, please visit the company website at www. Single dose vial, preservative-free, discard unused portion.

Acetylcysteine Injection

June 10, – Cumberland Pharmaceuticals Inc. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced. Furthermore, specific dosing guidance is now included for patients weighing over kg. The new labeling revises the product’s indication and offers new dosing guidance for specific patient populations. HRS is a life-threatening condition involving reduced liver function and progressive kidney failure for which there is currently no FDA approved pharmaceutical treatment.

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However, limited case reports of pregnant women exposed to acetylcysteine during various trimesters did not report any adverse maternal, fetal or neonatal outcomes. Patients should receive bronchodilator 15 minutes prior to dose.

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland’s current views on future events based on what it believes are reasonable assumptions.

Acetadote (acetylcysteine) Injection

Although several medications are used to treat the skin disease associated with SSc, there is no universally acetadtoe treatment paclage improve the function of affected internal organs such as the lungs, heart, and gastrointestinal tract, hence the treatment of SSc remains an unmet need. The following depiction of the Rumack-Matthew nomogram has been developed to estimate the probability that plasma levels in relation to intervals post-ingestion will result in hepatotoxicity.

If vial was previously opened, do not use for intravenous administration. Geriatric use The clinical studies do not provide a sufficient number of geriatric subjects to determine whether the elderly respond differently. Based on data from the American Association of Poison Control Centers AAPCCacetaminophen was involved in more thanpoisoning exposures in the United States inincluding more paackagecases of acetaminophen in combination with other medications.

Acetadote is free of EDTA or any other stabilization or chelating agents.

IV Acetadote is

For maximal protection against hepatic injury administer IV Acetadote within 8 hours post-ingestion. Totect can limit such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment. Acetaminophen poisoning and toxicity. Acetadote is sterile and can be used for I. We acquired Vibativ from Theravance Biopharma in November Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

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It combines three well-known and widely prescribed medications packaged together for patient convenience: Symptoms of acute toxicity were ataxia, hypoactivity, labored respiration, cyanosis, loss of righting reflex and convulsions. Therapy should continue until all doses are administered even though the acetaminophen plasma level has dropped below the toxic range. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof.

Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post-ingestion of acetaminophen yields limited efficacy. There are published reports on four pregnant women with acetaminophen toxicity, who were treated with oral or intravenous acetylcysteine at the time of delivery.

In the literature, the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus.

Recommended therapeutic doses inserg acetaminophen are not believed to saturate the glucuronide and sulfate conjugation pathways and therefore are not expected to result in the formation of sufficient reactive metabolite to deplete glutathione stores.

Omeclamox-Pak is available in over 15, retail pharmacies nationwide and is available on many managed care plan formularies.

If an assay for acetaminophen cannot be obtained, it is necessary to assume that the overdose is potentially toxic. Treatment is often in a critical care setting. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately.

The new indication states, “Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen.