ACC Hexal

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of ACC Hexal

What is ACC Hexal?

ACC Hexal is a medication containing the active ingredient acetylcysteine, a derivative of the amino acid cysteine. It is primarily used as a mucolytic agent, which means it helps to thin and loosen mucus in the airways.

Mechanism of Action

The active substance, acetylcysteine, works through its chemical structure to break down the complex networks of proteins that make mucus thick and sticky. By breaking the disulfide bonds within the bronchial secretions, the medication reduces the viscosity of the mucus. This process makes the phlegm more fluid and easier to clear from the respiratory tract through coughing.

General Properties

ACC Hexal is typically utilized in conditions where there is a production of thick, viscous mucus in the respiratory system. In addition to its mucolytic properties, acetylcysteine also possesses antioxidant characteristics, which can support the body's natural cellular defense mechanisms against oxidative stress in the lungs.

Application Areas

The medication is used to support the management of various respiratory conditions characterized by impaired mucus transport, including:

  • Acute bronchitis
  • Chronic bronchitis
  • Inflammation of the respiratory tract associated with thick secretions

As a mucolytic, its primary role is to assist the natural self-cleaning process of the respiratory system.

Regulatory References

  1. NIH Antidote Information

What side effects are possible with ACC Hexal?

Possible Side Effects and Safety Information

The officially documented adverse reactions and safety characteristics of Acetylcysteine (the active ingredient in ACC Hexal) are categorized according to the standards of major regulatory authorities, such as the EMA and FDA. This information provides a structured understanding of the medicine’s risk profile.


Frequency-Classified Adverse Reactions

Adverse events are grouped based on the frequency of their occurrence:

  • Uncommon (occurring in ge 1/1,000 to < 1/100 patients): Hypersensitivity reactions (e.g., pruritus, urticaria, rash), headache, tinnitus, vomiting, and hypotension.
  • Rare (occurring in ge 1/10,000 to < 1/1,000 patients): Dyspepsia, stomatitis, and respiratory reactions such as bronchospasm.
  • Very Rare (occurring in < 1/10,000 patients): Anaphylactic shock and haemorrhage (bleeding).

System-Organ Classes and Serious Reactions

Adverse reactions are classified by the affected system. The most common events relate to Gastrointestinal Disorders, including nausea and vomiting. Immune System Disorders are associated with hypersensitivity reactions across all frequency tiers.

Specific regulatory warnings highlight extremely rare but serious reactions. These include Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, which have been reported in temporal association with use, often appearing early in treatment. Anaphylactic shock is also documented as a very rare, serious risk.


Population-Specific Safety Considerations

Safety constraints are explicitly documented for certain patient groups. Caution is advised for individuals with bronchial asthma due to the increased risk of bronchospasm. Patients with a history of peptic ulcers or oesophageal varices may have an increased potential for gastrointestinal haemorrhage. Furthermore, co-administration with Nitroglycerin may lead to significant hypotension (low blood pressure), a high-level safety consequence explicitly noted in the regulatory documents.

Overdose and Emergency Response

The official regulatory profile for Acetylcysteine overdose details a range of documented clinical manifestations. Overdose exposures primarily present with gastrointestinal symptoms, including nausea, vomiting, diarrhea, and general stomach upset. Cutaneous signs, such as rashes, hives (urticaria), and pruritus are also formally noted in regulatory documentation.

However, the primary concern is the potential for severe or life-threatening systemic outcomes. Regulatory agencies have documented cases of anaphylactoid reactions, which can rapidly lead to hypotension, cardiovascular collapse, and shock. Severe bronchospasm and potential hepatic damage are also listed as possible serious manifestations requiring urgent intervention.

Immediate action is mandated by regulatory authorities. In all cases of known or suspected overdose, the requirement is to seek immediate medical attention by contacting emergency services or a poison control center without delay. Since no specific antidote is known for Acetylcysteine when used as a mucolytic, management is explicitly defined as symptomatic and supportive treatment. This may include procedural steps like gastric lavage, administering activated charcoal, and continuous hospital monitoring of cardiac and respiratory function. Individuals with conditions like bronchial asthma are noted to be at an increased risk for complications such as severe bronchospasm during an overdose event.

Therapeutic Uses of ACC Hexal

What ACC Hexal Treats: Main Uses and Benefits

The therapeutic utility of ACC Hexal (Acetylcysteine) addresses two distinct, primary clinical domains, generally contributing to symptomatic relief and supportive care in specific medical scenarios.


Symptomatic Relief for Viscous Respiratory Secretions

This medication is commonly used in conditions where the respiratory system produces abnormally thick, dense, or sticky mucus (inspissated secretions). It is commonly used across conditions characterized by periods of heightened symptoms, including acute bronchitis, pneumonia, and chronic conditions like COPD or cystic fibrosis. The primary benefit is to liquefy these dense secretions, which may assist patients in managing the symptom of difficulty in expectoration (coughing up phlegm). By facilitating clearance, it contributes to easing the effort associated with breathing and supports the patient in coping with the discomfort associated with a persistent, mucus-laden cough.

“This application supports the management of symptoms that interfere with daily functioning and create noticeable physiological strain.”

Critical Support in Acute Toxicity

A notable application of the active ingredient is its function as the specific antidote for Acetaminophen (Paracetamol) overdose. In this setting, the medication is employed to address acute systemic toxicity. The core therapeutic benefit in this acute context is providing supportive detoxification for the liver and other organs. This is relevant in acute medical settings where temporary assistance in symptom stabilization is needed following a potentially toxic ingestion.


Quick Fact: Support for Impaired Mucus Clearance

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Eligibility Profile

ACC Hexal (Acetylcysteine) eligibility is strictly defined by regulatory documents, which establish clear restrictions based on age, existing health conditions, and patient sensitivities. Absolute prohibition is placed on individuals with known hypersensitivity to acetylcysteine or any excipients, and those with active peptic ulceration.

Category Regulatory Status (Mucolytic Use)
Children under 2 years Contraindicated (prohibited)
Children ge 2 to <14 years Use restricted; high-dose products not established
Adults and Adolescents ge 14 years Generally permitted

Condition-Based Restrictions: The medicine must be used with caution and close monitoring in patients with bronchial asthma; if bronchospasm occurs, treatment must be discontinued. Caution is also advised for patients with a history of gastric ulcers and those with a reduced cough reflex.

Pregnancy and Lactation: Use during pregnancy is not recommended as a precautionary measure due to insufficient data. Caution should be exercised during breastfeeding due to a lack of sufficient information regarding excretion into human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes officially documented drug interactions for ACC Hexal (Acetylcysteine) based on authoritative regulatory information. The focus is strictly on documented changes in efficacy, exposure, or clinical effect when combined with other products.


Documented Interaction Categories

Interaction Type Interacting Agent(s) Official Constraint / Requirement
Pharmacodynamic Conflict Antitussives (Cough Suppressants) Co-administration is generally advised against due to the risk of bronchial secretion accumulation.
Pharmacodynamic Potentiation Nitrates (e.g., Nitroglycerin) Concurrent use is documented to lead to significant hypotension and headaches, requiring caution and monitoring.
Exposure Interference Activated Charcoal May result in a documented reduction of acetylcysteine’s efficacy, especially in overdose treatment.
Systemic Exposure Change Carbamazepine Concurrent use may result in subtherapeutic levels of Carbamazepine as documented in regulatory information.

Timing and Procedural Constraints

  • Oral Antibiotics: It is officially recommended to administer oral antibiotics, such as cephalosporins, at least two hours before or after acetylcysteine to manage the potential for in vitro inactivation.
  • Nebulizer Use: Mixing acetylcysteine with other drugs in a nebulizer is not recommended due to stability and safety concerns that have not been established in regulatory documents.

Population-Specific Notes

Caution is advised for long-term therapy in patients with a known histamine intolerance, as acetylcysteine may moderately affect histamine metabolism. Patients with a history of asthma or bronchospasm should also use this medicine with caution due to the increased risk of related reactions.

Mechanism of Action

ACC Hexal (acetylcysteine) functions through a dual pharmacodynamic mechanism involving direct mucolysis and the modulation of intracellular redox balance.

As a direct mucolytic agent, the drug contains a free sulfhydryl group that acts as a reducing agent on the respiratory mucus structure. This chemical interaction leads to the cleavage of disulfide bonds that stabilize high-molecular-weight mucoprotein polymers. This modification decreases the viscosity and elasticity of thick secretions, which assists in the physical movement of secretions from the airways.

The drug also acts as a prodrug for the amino acid cysteine, which is released via deacetylation. Cysteine is the rate-limiting precursor for the synthesis of the tripeptide glutathione (GSH). By increasing the cellular availability of cysteine, acetylcysteine replenishes intracellular GSH stores. This enhancement increases the capacity of cells to neutralize reactive oxygen species (ROS), thereby modulating the intracellular redox potential in the respiratory system.

Dosage and Administration Information

How to Use ACC Hexal: Official Administration Guidelines

Acetylcysteine (the active ingredient in ACC Hexal) is administered via distinct routes and dosing regimens depending on its clinical context.


Administration Routes and Dosing

The medicine is officially approved for Oral, Inhalation, Direct Instillation, and Intravenous (IV) Infusion.

Use Context Standard Labeled Dosing Frequency and Timing
Mucolytic (Oral) Adults and adolescents over 12 years are prescribed 200 mg three times daily or 600 mg once daily. Once daily or three times daily. Use should not exceed 8–10 days without re-evaluation.
Antidote (IV) A total dose of 300 mg/kg is administered in a three-dose sequential protocol. Fixed total duration of 21 hours (sequential infusions).

Procedural and Preparation Requirements

The preparation method depends strictly on the administration route. Oral forms (tablets, granules) must be dissolved completely in a small amount of water immediately prior to consumption. The IV injection solution (200 mg/mL) is hyperosmolar and must be diluted in compatible intravenous fluids, such as 5% Dextrose, before administration.

For inhalation, equipment that contains materials like iron, copper, or rubber must be avoided due to chemical incompatibility.

Age-specific instructions require that IV administration for antidote use in pediatric patients be performed using strictly weight-based total dilution volumes to prevent fluid issues. Furthermore, the 600 mg oral strength is generally restricted for children under two years of age.

Recent Clinical Evidence

Research evidence / Overview of Studies for ACC Hexal (Acetylcysteine)

This overview summarizes the available research evidence for Acetylcysteine, the active ingredient in ACC Hexal, drawing from official scientific studies like large trials and meta-analyses. It focuses on what researchers have explored, what has been observed in some studies, and where the evidence is limited or still developing.


Evidence for Chronic Respiratory Conditions (COPD and Chronic Bronchitis)

Studies for mucolytic use—the action of clearing mucus—have primarily used Randomized Controlled Trials (RCTs) and meta-analyses to examine the medicine's use in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. Research explored the influence on the annual rate of acute exacerbations (flares) of the condition and the time until the first episode of heightened symptom activity. Findings describe patterns observed in the studies where a lower measured rate of exacerbations was observed in the medicine group compared to the control group. However, when research examined the objective lung function over time, the findings were mixed; some trials reported measurements that showed no clear difference regarding the decline of lung function.


Evidence for Acute Toxicity (Acetaminophen Overdose)

Research describes the evidence base—largely systematic reviews and observational studies—which supports the medicine's use as a standard detoxification agent. The research examined patients, including both adults and children, presenting with acute ingestion of toxic doses of Acetaminophen, detailing outcomes measured, such as changes in liver injury markers. Due to the critical nature of this indication, the evidence level is high for use as a standard detoxification agent.


What is Still Uncertain About the Research Evidence

A key uncertainty lies in the inconsistent findings across various studies regarding the medicine's influence on the objective decline of lung function in COPD. Long-term effects are not fully established concerning the durability of any observed effect after patients cease using the medicine, and the sustained impact on disease progression is not fully established. Additionally, data for certain groups remain insufficient; for instance, subgroup findings are uncertain in large-scale trials concerning its routine use for chronic mucus clearance in pediatric patients.

Key Studies & References

  1. WHO Collaborating Centre for Drug Statistics Methodology: ATC Code R05CB01 (Mucolytics)
  2. National Institutes of Health (NIH) MedlinePlus Drug Information: Acetylcysteine
  3. NIH National Library of Medicine Review: N-acetylcysteine for acetaminophen toxicity

Frequently Asked Questions (FAQ)

Common questions about ACC Hexal (FAQ)

Q: What should I do if I experience bronchospasm (sudden airway tightening) while taking this medicine?

Official guidance states that if bronchospasm (sudden tightening of the airways) occurs, treatment is typically discontinued. This is a documented, though rare, adverse reaction, particularly for patients with a history of asthma. Official guidelines often note that the condition is often relieved with the use of a nebulized bronchodilator.

Q: What are the signs of a severe allergic reaction (like anaphylaxis) to ACC Hexal?

Regulatory documents indicate that serious reactions, such as anaphylactic shock, are very rare, but they are a documented risk. Signs of a hypersensitivity reaction may include hives (urticaria), rash, flushing, itching (pruritus), and a severe drop in blood pressure known as hypotension. Patients are advised to seek emergency medical attention if a severe allergic reaction is suspected.

Q: How long can I safely use the oral mucolytic form of ACC Hexal?

For its primary use as a mucolytic (to clear mucus), official prescribing information states that treatment is generally not recommended to exceed 8–10 days without re-evaluation. While long-term use has been explored in studies for certain chronic respiratory conditions, this requires ongoing medical supervision.

Q: How soon after taking the oral dose should I expect to feel the effect on my breathing?

Regulatory documents focusing on the medicine's pharmacology note that the label for the inhalant solution mentions a quick onset of action. However, the official product information does not provide a specific timeframe for the onset of the mucolytic effect after taking the oral form of the medication.

Q: Does ACC Hexal contain any sugar, lactose, or artificial sweeteners?

Official product labels list all excipients, or inactive ingredients, in the medicine. Depending on the specific formulation (such as tablets or powders), the product may contain excipients like lactose, sorbitol, mannitol, or saccharin sodium. Patients with sensitivities should review the full list of excipients provided in the patient information leaflet for their specific package.

Q: What is the specific difference between the 200 mg and the 600 mg oral tablet (besides the dose)?

Beyond the difference in dosage strength, the official eligibility profile indicates a key restriction based on age. The higher strength, 600 mg, is generally reserved for use in older patients and is restricted for use in children under two years of age.

How should ACC Hexal be stored and disposed of?

How to Store and Dispose of ACC Hexal?

The official storage requirements for ACC Hexal are defined by the product's packaging and stability needs.

Storage Conditions

Requirement Rule based on Regulatory Documents
Temperature Must not be stored above 30 C for tube presentations; no specific temperature rule for sachet packaging.
Container Integrity Store in the original package to protect contents from moisture.
Stability Do not use after the expiry date. After first opening, some packages have an in-use shelf life of 10 to 20 days.
Child Safety Must be kept out of the sight and reach of children.

Disposal Instructions

Medicines must not be disposed of in wastewater or household waste. Patients are instructed to ask a pharmacist how to dispose of unused or expired product, ensuring that disposal complies with local environmental requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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