Pharcetil is an acetaminophen antidote that helps your body preserve a substance that can help detoxify the liver.
Pharcetil is used to treat acetaminophen overdose and help prevent damage to your liver caused by taking large quantities of acetaminophen (Tylenol).
There are other brands and forms of Pharcetil available, and some can be purchased over the counter. Not all forms of this medicine are effective as an acetaminophen antidote. Treatment of acetaminophen overdose should be managed by a medical doctor.
Pharcetil may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Pharcetil Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incidences are divided into two types; Acute Ingestion or Repeated Supratherapeutic Ingestion (RSI)..
On admission for suspected acute acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with Pharcetil. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately.
Pharcetil Injection should be administered within 8 hours from acetaminophen ingestion for maximal protection against hepatic injury for patients whose serum acetaminophen levels fall above the “possible” toxicity line on the Rumack-Matthew nomogram (line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours);. If the time of ingestion is unknown, or the serum acetaminophen level is not available, cannot be interpreted, or is not available within the 8 hour time interval from acetaminophen ingestion, Pharcetil Injection should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion of an overdose of acetaminophen, regardless of the quantity reported to have been ingested.
The aspartate aminotransferase (AST, SGOT), alanine aminotranferase (ALT, SGPT), bilirubin, prothrombin time, creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes also should be determined in order to monitor hepatic and renal function and electrolyte and fluid balance.
NOTE: The critical ingestion-treatment interval for maximal protection against severe hepatic injury is between 0 to 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.
Acetaminophen Assays Interpretation and Methodology – Acute Ingestion
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. Therefore, plasma or serum acetaminophen concentrations, determined as early as possible, but no sooner than four hours following an acute overdose, are essential in assessing the potential risk of hepatotoxicity. If an assay for acetaminophen cannot be obtained, it is necessary to assume that the overdose is potentially toxic.
Interpretation of Acetaminophen Assays
When results of the plasma acetaminophen assay are available, refer to the nomogram in Figure 1 to determine if plasma concentration is in the potentially toxic range. Values above the line connecting 200 mcg/mL at 4 hours with 50 mcg/mL at 12 hours (probable line) are associated with a probability of hepatic toxicity if an antidote is not administered.
If the predetoxification plasma level is above the line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours (possible line), continue with maintenance doses of Pharcetil. It is better to err on the safe side and thus this line, defining possible toxicity, is plotted 25% below the line defining probable toxicity.
If the predetoxification plasma level is below the line connecting 150 mcg/mL at 4 hours with 37.5 mcg/mL at 12 hours (possible line), there is minimal risk of hepatic toxicity, and Pharcetil treatment may be discontinued.
Estimating Potential for Hepatotoxicity: 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.
The Rumack-Matthew nomogram may underestimate the risk for hepatotoxicity in some patients with risk factors such as chronic alcoholism, malnutrition, or CYP2E1 enzyme inducing drugs (e.g., isoniazid).
Figure 1. Rumack-Matthew Nomogram
Figure 1. Michael J Hodgman, Alexander R Garrard, A Review of Acetaminophen Poisoning. Crit Care Clin. 28 (2012) 499-516.
Stephen J. Wolf, Kennon Heard, et.al, Clinical Policy: Critical Issues in the Management of Patients Presenting to the Emergency Department with Acetaminophen Overdose. Ann Emerg Med. 2007:50:292-313.
Acetaminophen Assays Interpretation and Methodology – Repeated Supratherapeutic Ingestion
Repeated Supratherapeutic Ingestion (RSI) is defined as ingestion of acetaminophen at doses higher than those recommended for extended periods of time. The nomogram does not apply to patients with RSI. Treatment is based on the acetaminophen and elevated AST/ALT levels indicative of potential toxicity due to acetaminophen. For specific treatment information regarding the clinical management of repeated supratherapeutic 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.
1 Acetaminophen levels drawn less than 4 hours post-ingestion may be misleading.
2 With an extended-release preparation, an acetaminophen level drawn less than 8 hours post-ingestion may be misleading. Draw a second level at 4 to 6 hours after the initial level. If either falls above the toxicity line, Pharcetil treatment should be initiated.
3 Pharcetil may be withheld until acetaminophen assay results are available as long as initiation of treatment is not delayed beyond 8 hours post-ingestion. If more than 8 hours post-ingestion, start Pharcetil treatment immediately.
How should I use Pharcetil?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Do not use Pharcetil inhalation at home if you do not fully understand all instructions that are specific to your use of this medicine.
Pharcetil inhalation solution can be inhaled directly from the nebulizer or with a face mask, mouth piece, tent, or intermittent positive pressure breathing (IPPB) machine.
Use only the inhaler device provided with your medicine or you may not get the correct dose.
Do not place this medicine directly into a heated nebulizer medicine chamber.
Do not mix your dose of Pharcetil inhalation until you are ready to use the medicine. Diluted Pharcetil inhalation must be used within 1 hour of mixing.
Pharcetil inhalation liquid may change color once you have opened the bottle. This is caused by a chemical reaction and will not affect the medicine.
You may sense an unusual or unpleasant smell while using Pharcetil inhalation. This effect should become less noticeable the longer you use the medicine.
Clean your nebulizer right after each use. The residue from Pharcetil inhalation can clog the parts of the nebulizer.
Store an unopened vial (bottle) of Pharcetil inhalation at room temperature, away from moisture and heat.
An opened Pharcetil vial should be stored in a refrigerator, but you must use it within 96 hours (4 days) after opening. Do not allow the medicine to freeze.
Uses of Pharcetil in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
When inhaled by mouth, Pharcetil is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia). This effect helps you to clear the mucus from your lungs so that you can breathe easier.
When taken by mouth, Pharcetil is used to prevent liver damage from acetaminophen overdose.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be taken by mouth to prevent kidney damage due to dyes from certain X-ray procedures (such as CT scan).
How to use Pharcetil (bulk)
If you are using this medication to treat lung disease, inhale this medication by mouth as directed by your doctor. A health care professional will show you the proper way to use this medication. Learn all preparation and usage instructions.
You may notice a slight odor when you first breathe in the medication. This odor will quickly go away. If you are using a face mask to breathe in the medication, there may be some stickiness on your face after use. Wash your face with water to remove the stickiness.
Do not mix Pharcetil with other inhaled medications unless directed by the doctor or pharmacist.
If you are taking this medication by mouth, take it as directed by your doctor. The solution is usually mixed with another liquid (such as cola) to decrease nausea and vomiting. Drink the medication within 1 hour of mixing.
Tell your doctor if you vomit within 1 hour after taking your medication. You may need to take another dose.
The dosage is based on your medical condition and response to treatment. For acetaminophen overdose, the dosage is also be based on your weight.
Tell your doctor if your condition does not improve or if it worsens.
Pharcetil (also known as N-Pharcetil or N-acetyl-L-cysteine or NAC) is primarily used as a mucolytic agent and in the management of acetaminophen poisoning. It is a derivative of cysteine with an acetyl group attached to the amino group of cysteine. NAC is essentially a prodrug that is converted to cysteine (in the intestine by the enzyme aminoacylase 1) and absorbed in the intestine into the blood stream. Cysteine is a key constituent to glutathione and hence administration of Pharcetil replenishes glutathione stores. Pharcetil can also be used as a general antioxidant which can help mitigate symptoms for a variety of diseases exacerbated by reactive oxygen species (ROS). For instance, Pharcetil is commonly used in individuals with renal impairment to prevent the precipitation of acute renal failure. Pharcetil has been shown to have efficacy in treating mild to moderate traumatic brain injury including ischemic brain injury, particularly in reducing neuronal losses, and also reducing cognitive and neurological symptoms when administered promptly after injury. N-Pharcetil is now widely used in the treatment of HIV, and it has reported efficacy in chronic obstructive pulmonary disease and contrast-induced nephropathy. Pharcetil is also being successfully used to treat a variety of neuropsychiatric and neurodegenerative disorders including cocaine, cannabis, and smoking addictions, Alzheimer's and Parkinson's diseases, autism, compulsive and grooming disorders, schizophrenia, depression, and bipolar disorder. Recent data also shows that N-Pharcetil inhibits muscle fatigue and can be used to enhance performance in endurance events and in exercise and endurance training.
Pharcetil AS A MUCOLYTIC AGENT
Pharcetil Solution, USP (n-acetyl-l-cysteine) is available in rubber stoppered glass vials containing 10 mL or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.
Pharcetil does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. If only a portion of the solution in a vial is used, store the remainder in a refrigerator and use for inhalation only within 96 hours.
Nebulization- Face Mask, Mouthpiece, Tracheostomy: When nebulized into a face mask, mouthpiece, or tracheostomy, 1 to 10 mL of the 20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours; the recommended dose for most patients is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution three to four times a day.
Nebulization - Tent, Croupette: In special circumstances it may be necessary to nebulize into a tent or Croupette, and this method of use must be individualized to take into account the available equipment and the patient's particular needs. This form of administration requires very large volumes of the solution, occasionally as much as 300 mL during a single treatment period.
If a tent or Croupette must be used, the recommended dose is the volume of Pharcetil (using 10 or 20%) that will maintain a very heavy mist in the tent or Croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.
Direct Instillation: When used by direct instillation, 1 to 2 mL of a 10% to 20% solution may be given as often as every hour.
When used for the routine nursing care of patients with tracheostomy, 1 to 2 mL of a 10% to 20% solution may be given every 1 to 4 hours by instillation into the tracheostomy.
Pharcetil may be introduced directly into a particular segment of the bronchopulmonary tree by inserting (under local anesthesia and direct vision) a small plastic catheter into the trachea. Two to 5 mL of the 20% solution may then be instilled by means of a syringe connected to the catheter.
Pharcetil may also be given through a percutaneous intratracheal catheter. One to 2 mL of the 20% or 2 to 4 mL of the 10% solution every 1 to 4 hours may then be given by a syringe attached to the catheter.
Diagnostic Bronchograms: For diagnostic bronchial studies, 2 or 3 administrations of 1 to 2 mL of the 20% solution or 2 to 4 mL of the 10% solution should be given by nebulization or by instillation intratracheally, prior to the procedure.
Administration of Aerosol
Materials: Pharcetil solution (n-acetyl-l-cysteine) may be administered using conventional nebulizers made of plastic or glass. Certain materials used in nebulization equipment react with Pharcetil. The most reactive of these are certain metals (notably iron and copper) and rubber. Where materials may come into contact with Pharcetil solution (n-acetyl-l-cysteine), parts made of the following acceptable materials should be used: glass, plastic, aluminum, anodized aluminum, chromed metal, tantalum, sterling silver, or stainless steel. Silver may become tarnished after exposure, but this is not harmful to the drug action or to the patient.
Nebulizing Gases: Compressed tank gas (air) or an air compressor should be used to provide pressure for nebulizing the solution. Oxygen may also be used but should be used with usual precautions in patients with severe respiratory disease and CO if prothrombin time ratio exceeds 1.5 or fresh frozen plasma if the prothrombin time ratio exceeds 3.0.
Diuretics and forced diuresis should be avoided.
Dosage Guide and Preparation
Doses in relation to body weight are:
Loading Dose of Pharcetil* Solution
Adapted from Rumack and Mathews, Pediatrics 1975; 55:871-876.
Pharcetil Solution, USP (n-acetyl-l-cysteine), is available in rubber stopped glass vials containing 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.
Acetycysteine is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows:
10% Pharcetil Solution, USP (n-acetyl-l-cysteine) (100 mg Pharcetil per mL).
NDC 0054-3027-02....................................10 mL vials; carton of 3
NDC 0054-3025-02....................................30 mL vials; carton of 3
20% Pharcetil Solution, USP (n-acetyl-l-cysteine) (200 mg Pharcetil per mL).
NDC 0054-3028-02.....................................10 mL vials; carton of 3
NDC 0054-3026-02.....................................30 mL vials; carton of 3
Store unopened vials at controlled room temperature, 15° to 30°C (59° to 86°F).
Pharcetil Solution, USP (n-acetyl-l-cysteine) does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of Pharcetil 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.
1. Bonanomi L, Gazzaniga A. Toxicological pharmacokinetic and metabolic studies on Pharcetil. Eur J Respir Dis 1981 61 (Suppl III):45-51.
2. Amer Rev Resp Dis 1960 82:627-639.
Mfd. by Ben Venue Laboratories, Inc., Bedford, Ohio 44146. Revised March 2007. Mfd. for Boehringer Ingelheim Roxane Laboratories. FDA Rev date: 8/28/2000
With simultaneous use of antacids containing magnesium and / or aluminum hydroxide, slow down and reduce the absorption of acetylsalicylic acid.
With simultaneous use of calcium channel blockers, means limiting intake of calcium or increasing the excretion of calcium from the body, increases the risk of bleeding.
With simultaneous use with acetylsalicylic acid enhances the action of heparin and indirect anticoagulants, hypoglycemic funds derived sulfonylureas, insulin, methotrexate, phenytoin, valproic acid.
With simultaneous use of Pharcetil Millet Roux Produtos Farmaceuticos with SCS increases the risk of ulcerogenic effect and occurrence of gastrointestinal bleeding.
With simultaneous use of decreasing the effectiveness of diuretics (spironolactone, furosemide).
With simultaneous use of other NSAIDs increases the risk of side effects. Acetylsalicylic acid may reduce plasma concentrations indomethacin, piroxicam.
With simultaneous use of gold drugs acetylsalicylic acid can induce liver damage.
With simultaneous use decreases effectiveness of uricosuric medications (including probenecid, sulfinpirazon, benzbromarone).
With simultaneous use of acetylsalicylic acid and alendronate sodium may develop severe esophagitis.
With simultaneous use of griseofulvin may be in breach Absorption of acetylsalicylic acid.
There is one case of spontaneous hemorrhage in the iris while taking Ginkgo Biloba extract on the background of prolonged use of aspirin in a dose of 325 mg / day. It is believed that this may be due to additive inhibitory effect on platelet aggregation.
With simultaneous use of dipyridamole may increase Cmax of salicylate in plasma and AUC.
When applied simultaneously with acetylsalicylic acid increased concentration of digoxin, barbiturates and lithium salts in the blood plasma.
With simultaneous use of salicylates in high doses with carbonic anhydrase inhibitors can intoxication salicylates.
Acetylsalicylic acid in doses of less than 300 mg have little effect on the effectiveness of captopril and enalapril. When aspirin (acetylsalicylic acid) is admistered in high doses may decrease the effectiveness of captopril and enalapril.
With simultaneous application of caffeine increases the rate of absorption, plasma concentrations and bioavailability of acetylsalicylic acid.
With simultaneous use of Pharcetil Millet Roux Produtos Farmaceuticos with metoprolol may increase Cmax of salicylate in blood plasma.
In the application of pentazocine on the background of long-term use of aspirin in high doses there is a risk of severe adverse reactions in the kidneys.
With simultaneous application phenylbutazone reduces uricosuria caused by acetylsalicylic acid.
With simultaneous application of ethanol may exacerbate the effects of acetylsalicylic acid on the gastrointestinal tract.
In addition to its needed effects, some unwanted effects may be caused by Pharcetil (the active ingredient contained in Pharcetil). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking Pharcetil, check with your doctor or nurse as soon as possible:
Wheezing, tightness in chest, or difficulty in breathing (especially in asthma patients)
Skin rash or other irritation
Minor Side Effects
Some of the side effects that can occur with Pharcetil 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:
increase in amount of mucus in lungs
irritation or soreness of mouth, throat, or lungs
nausea or vomiting
For patients using a face mask for inhalation of Pharcetil: the mask may leave a stickiness on your face. This can be removed with water.
When you use Pharcetil, you may notice that the medicine has an unpleasant odor at first. However, this smell will go away soon after you use the medicine.
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