Acetadote

Drug List

Acetadote

Drug Name

Acetadote (Acetylcysteine)

Manufactured By

Cumberland Pharmaceuticals Inc.

Drug Savings


Nationwide Prescription Connection (NPC) is an experienced advocacy service that helps connect patients to manufacturer provided free and discount programs. We can help the uninsured, under insured, those in the Medicare gap also known as the "doughnut hole", or even those needing help with expensive co-pays.  Our web site makes it easy for you to enter the medications you are taking, along with some basic patient information, and then finds the program that is right for you.



Nationwide Prescription Connection (NPC) is an experienced advocacy service that helps connect patients to manufacturer provided free and discount programs. We can help the uninsured, under insured, those in the Medicare gap also known as the "doughnut hole", or even those needing help with expensive co-pays.  Our web site makes it easy for you to enter the medications you are taking, along with some basic patient information, and then finds the program that is right for you.


Class

Treats Disease/Condition

Uses

Acetadote (acetylcysteine) injection will be used in an emergency room setting to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, the leading cause of drug toxicity

How To Use

Assess the history and timing of acetaminophen ingestion as an overdose. The reported history of the quantity of acetaminophen ingested as an overdose is often inaccurate and is not a reliable guide to therapy. Obtain the following laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, international normalized ratio (INR), creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes. Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. Acetaminophen concentrations obtained earlier than 4 hours post-ingestion may be misleading as they may not represent maximum acetaminophen concentrations. If the time of acute acetaminophen ingestion is unknown: Administer a loading dose of Acetadote immediately [see Dosage and Administration (2.4)]. Obtain an acetaminophen concentration to determine need for continued treatment [see Dosage and Administration (2.2)]. If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity: Administer a loading dose of Acetadote immediately and continue treatment for a total of three doses over 21 hours [see Dosage and Administration (2.4)]. If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of Acetadote immediately [see Dosage and Administration (2.4)] Obtain an acetaminophen concentration to determine need for continued treatment [see Dosage and Administration (2.2)]. If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known: Use the Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with Acetadote [see Dosage and Administration (2.2)]. Nomogram for Estimating Potential for Hepatoxicity from Acute Acetaminophen Ingestion and Need for Acetadote Treatment Acetadote is an antidote for acetaminophen overdose. The critical ingestion-treatment interval for maximal protection against severe hepatic injury is between 0 – 8 hours. Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post-ingestion of acetaminophen yields limited efficacy. However, it does not appear to worsen the condition of patients and it should not be withheld, since the reported time of ingestion may not be correct. If the timing of the acute acetaminophen ingestion is known and the results of the acetaminophen assay are available within 8 hours: Refer to the Rumack-Matthew nomogram (see Figure 1) to determine whether or not to initiate treatment with Acetadote. Initiation of Acetadote depends on the plasma or serum acetaminophen concentration and also the clinical presentation of the patient. The nomogram may underestimate the hepatotoxicity risk in patients with chronic alcoholism, malnutrition, or CYP2E1 enzyme inducing drugs (e.g., isoniazid), and consideration should be given to treating these patients even if the acetaminophen concentrations are in the nontoxic range. Loading dose For patients whose acetaminophen concentrations are at or above the “possible” toxicity line (dotted line in nomogram): Administer a loading dose of Acetadote [see Dosage and Administration (2.4)] For patients with an acute overdose from an extended-release acetaminophen, if the acetaminophen concentration at 4 hours post ingestion is below the possible toxicity line then obtain a second sample for acetaminophen concentration 8 to 10 hours after the acute ingestion. If the second value is at or above the “possible” toxicity line (dotted line in nomogram): Administer a loading dose of Acetadote [see Dosage and Administration (2.4)] For patients whose values are below the “possible” toxicity line, but time of ingestion was unknown or sample was obtained less than 4 hours after ingestion: Administer a loading dose of Acetadote [see Dosage and Administration (2.4)] For patients whose values are below the “possible” toxicity line and time of ingestion is known and the sample was obtained more than 4 hours after ingestion, do not administer Acetadote because there is minimal risk of hepatotoxicity.

Side Effects

Less common: Wheezing, tightness in chest, or difficulty in breathing (especially in asthma patients) Rare Skin rash or other irritation Minor Side Effects Some of the side effects that can occur with acetylcysteine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional: Less common: Clammy skin fever increase in amount of mucus in lungs irritation or soreness of mouth, throat, or lungs nausea or vomiting runny nose

Drug Interactions

A total of 6 drugs (42 brand and generic names) are known to interact with Acetadote (acetylcysteine)

In Case of Overdose

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.

In Case of Missed Dose

Storage

Because Acetadote is hyperosmolar (2600 mOsmol/L), Acetadote must be diluted in sterile water for injection, 0.45% sodium chloride injection (1/2 normal saline), or 5% dextrose in water prior to intravenous administration [see Warnings and Precautions (5.2)]. Dilution in these three solutions results in different osmolarity of the solution for intravenous administration (see Table 1 for examples of different osmolarity of the solution depending on the type of solution and the Acetadote concentration). Visually inspect for particular matter and discoloration prior to administration. The color of the diluted solution ranges from colorless to a slight pink or purple once the stopper is punctured (the color change does not affect the quality of the product). The diluted solution can be stored for 24 hours at room temperature. Discard unused portion. If a vial was previously opened, do not use for intravenous administration.