Acetylcysteine

Steris Healthcare Pvt Ltd ,

Cipla Ltd

Stylecystin EF Tablet ,

Mucinac 600mg Effervescent Tablet

Amyloidosis ,

Bronchitis

DRUG STATUS

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Approvals

US. FDA / uk mhra / ema / pdma

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Essential Medicine

WHO / India

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Use in Pregnancy

Not Advised / Caution

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Pharmaceutical Class

ama / pdma

Summary

  • Acetylcysteine is used for treating acetaminophen (paracetamol) overdose to prevent liver damage. It's also used for respiratory conditions like chronic obstructive pulmonary disease (COPD) and cystic fibrosis, where it helps clear mucus from the lungs. It can also be used in acute respiratory distress syndrome (ARDS) and to prevent kidney damage during imaging procedures.

  • Acetylcysteine works by replenishing levels of a substance called glutathione in your body. Glutathione helps to detoxify harmful substances. In cases of acetaminophen overdose, it aids in detoxifying harmful metabolites. For respiratory conditions, it breaks down mucus, making it easier to clear from your lungs.

  • For respiratory conditions, it's usually taken orally in doses of 200-600 mg 2-3 times daily or by inhalation of 3-5 mL 10-20% daily. For acetaminophen overdose, it's taken orally with an initial dose of 140 mg/kg, followed by 70 mg/kg every 4 hours for 17 doses.

  • Common side effects of Acetylcysteine include nausea, vomiting, rash, and fever. Some people may experience mild stomach discomfort or diarrhea. Less common but more serious side effects include severe allergic reactions, difficulty breathing, low blood pressure, and chest tightness.

  • Acetylcysteine should be used with caution in people with asthma as it can cause bronchospasm (tightening of the muscles that line the airways). It's also not recommended for those with a history of gastrointestinal bleeding or ulcers. It's contraindicated in patients who are hypersensitive to it and shouldn't be used to treat acetaminophen overdose in patients with severe liver impairment or failure without medical supervision.

Indications and Purpose

How does Acetylcysteine work?

Acetylcysteine works by replenishing glutathione levels in the body, a critical antioxidant that helps neutralize harmful toxins. In the case of acetaminophen overdose, it detoxifies the harmful metabolites by facilitating their elimination through the kidneys. As a mucolytic agent, it breaks down mucus in the respiratory tract, making it easier to clear from the lungs.

 

How does one know if Acetylcysteine is working?

The benefits of Acetylcysteine are evaluated by monitoring the improvement in symptoms and clinical outcomes in the conditions it's used for. In cases of acetaminophen overdose, the effectiveness is assessed by measuring liver function tests (e.g., ALT, AST levels) and tracking the reduction in liver damage markers. For respiratory conditions, its effectiveness is monitored by evaluating changes in mucus production, lung function (through spirometry), and improvements in breathing symptoms. Clinical assessments of symptoms like cough, shortness of breath, and sputum production also help gauge its effectiveness in treating respiratory diseases.

 

 

Is Acetylcysteine effective?

Evidence supporting the effectiveness of Acetylcysteine comes from clinical studies and its widespread use in managing acetaminophen overdoses, where it has been shown to reduce liver damage if administered early. It is also well-established as a mucolytic agent for chronic respiratory conditions, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis, where it helps thin and loosen mucus, improving lung function and reducing symptoms. Studies have demonstrated its ability to reduce the viscosity of mucus and its positive impact on respiratory health.

 

 

What is Acetylcysteine used for?

Acetylcysteine is indicated for the following conditions:

  1. Acetaminophen (paracetamol) overdose: To prevent liver damage by enhancing the detoxification of acetaminophen metabolites.
  2. Chronic obstructive pulmonary disease (COPD) and other respiratory conditions: As a mucolytic agent to help break down and loosen mucus in the airways.
  3. Cystic fibrosis: To help clear thick mucus from the lungs.
  4. Acute respiratory distress syndrome (ARDS): To help manage airway clearance.
  5. Prevention of contrast-induced nephropathy: Occasionally used to reduce kidney damage due to contrast media during imaging procedures.

 

 

Directions for Use

How do I take Acetylcysteine?

Acetylcysteine can be taken with or without food. If taken orally, it may be mixed with water, juice, or soda to mask its unpleasant taste and odor. Ensure adequate hydration during use. No specific food restrictions are required, but follow your doctor's advice, especially in cases like acetaminophen overdose or respiratory conditions.

 

 

How long does it take for Acetylcysteine to start working?

Acetylcysteine typically begins to work within 1 to 2 hours after administration. The onset may vary depending on the condition being treated. For acetaminophen overdose, it rapidly restores glutathione levels to neutralize toxins, while for respiratory conditions, its mucolytic action starts breaking down mucus soon after dosing.

 

 

How should I dispose of Acetylcysteine?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of the medicines properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How should I store Acetylcysteine?

Keep the Acetylcysteine at room temperature between 68° and 77°F (20° and 25°C). Once you open the Acetylcysteine, store it in the refrigerator between 36° and 46°F (2° and 8°C).

What are the consequences to stopping Acetylcysteine?

Stopping Acetylcysteine prematurely can lead to incomplete treatment of the underlying condition. In cases like acetaminophen overdose, discontinuing it before completing the prescribed regimen may result in insufficient detoxification, posing a risk of liver damage. For respiratory issues, stopping early may prevent the full clearance of mucus, leading to persistent or worsened symptoms. Always consult a doctor before stopping.

 

 

What is Acetylcysteine’s dose and duration?

The dosage of acetylcysteine varies:

  • Respiratory conditions: Oral 200–600 mg 2-3 times daily or inhalation 3-5 mL (10%/20%) daily.
  • Acetaminophen overdose: Oral 140 mg/kg initially, then 70 mg/kg every 4 hours (17 doses); IV as per hospital protocol.

 

What should I do if I miss a dose of Acetylcysteine?

If you forget to take one or more doses: take your next dose at the normal time and in the normal amount. Do not take any more than your doctor prescribed.

Warnings and Precautions

Can Acetylcysteine be taken safely while breastfeeding?

Acetylcysteine is considered safe to use during breastfeeding. It is excreted in small amounts in breast milk, but no significant effects on the infant have been reported. However, as a precaution, it is advised to consult a healthcare provider before using Acetylcysteine while breastfeeding, especially if the infant is very young or has any health concerns.

 

 

Can Acetylcysteine be taken safely while pregnant?

Acetylcysteine is classified as a Category B medication for pregnancy by the FDA, meaning that animal studies have not shown harm to the fetus, but there are limited well-controlled studies in humans. It is considered generally safe to use during pregnancy when needed, especially in cases of acetaminophen overdose. However, it should only be used if the potential benefits outweigh the risks, and a healthcare provider should be consulted before use.

 

 

Can Acetylcysteine be taken safely while trying to conceive?

There is limited data on the direct effect of Acetylcysteine on fertility in men or women of reproductive age. However, studies have not shown any significant negative impact on fertility. Acetylcysteine is generally considered safe, but as with any medication, individuals planning to conceive should consult their healthcare provider for personalized advice.

 

 

Can I take Acetylcysteine with other prescription drugs?

Acetylcysteine may interact with certain prescription medications. Notably, it can enhance the effects of nitroglycerin, leading to an increased risk of headaches and hypotension. It can also interact with activated charcoal, which may reduce the effectiveness of Acetylcysteine in treating acetaminophen overdose. Additionally, Acetylcysteine may reduce the efficacy of certain antibiotics like tetracycline. Always consult a healthcare provider before combining Acetylcysteine with other medications.

 

 

Can I take Acetylcysteine with vitamins or supplements?

Acetylcysteine may interact with certain vitamins and supplements, particularly those containing high doses of vitamin C. High doses of vitamin C could potentially reduce the effectiveness of Acetylcysteine when used for acetaminophen overdose treatment. Additionally, taking Acetylcysteine with other antioxidants may influence its action, although more research is needed to fully understand these interactions. It's important to consult a healthcare provider before combining Acetylcysteine with other supplements.

 

 

What are Acetylcysteine possible harms and risks?

The most common side effects of Acetylcysteine include nausea, vomiting, rash, and fever. Some individuals may experience mild gastrointestinal discomfort or diarrhea. Significant adverse effects, though less common, include severe allergic reactions (anaphylaxis), difficulty breathing, low blood pressure (hypotension), and chest tightness. Rarely, it may cause a reaction known as "acetaminophen toxicity-related symptoms," including liver dysfunction in cases of inappropriate administration.

 

 

Who should avoid taking Acetylcysteine?

Important warnings for Acetylcysteine include caution in individuals with asthma, as it can cause bronchospasm. It should be used with caution in people with a history of gastrointestinal bleeding or ulcers. Acetylcysteine is contraindicated in patients who are hypersensitive to it, and it should not be used to treat acetaminophen overdose in patients with severe hepatic impairment or failure without medical supervision. It should also be avoided in patients with a history of anaphylactic reactions to the drug.

 

 

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