Cystaline

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Cystaline

Quick Facts

Property Description
Active Ingredient Acetylcysteine (N-acetylcysteine)
Forms Effervescent tablets, oral solution, injection, inhalation solution
Pharmacological Class Mucolytic Agent, Antidote
Origin Synthetic amino acid derivative

What Type of Medicine is Cystaline (Acetylcysteine)?

Cystaline is a trade name for a medicine containing the active substance Acetylcysteine, which is classified primarily as a mucolytic agent and secondarily as a crucial antidote. Acetylcysteine, or N-acetylcysteine (NAC), is a synthetic derivative of the naturally occurring amino acid L-cysteine. Its classification as a mucolytic is based on its primary function to break down viscous respiratory secretions. This means the medicine is specifically designed to help thin the thick material in the lungs and airways. This compound holds significant international importance and is listed on the World Health Organization’s Model List of Essential Medicines, a status that reflects its established role and broad applicability across diverse healthcare systems.


Composition and General Purpose

The medicine is a single-ingredient product, utilizing the Acetylcysteine molecule. It is often provided in an effervescent tablet form, which allows the drug to be quickly dissolved for oral administration. It is also available as a liquid oral solution and specialized solutions for inhalation and intravenous (IV) injection.

The general purpose of Acetylcysteine is twofold: to relieve breathing difficulties and to provide vital cellular protection. The mucolytic action is utilized for its ability to reduce mucus viscosity, promoting easier clearance of respiratory secretions. Furthermore, its protective function is a key characteristic; NAC acts as a precursor to the antioxidant glutathione, which plays a protective role in the body. This ability means the medicine helps support the body's natural defense systems during certain exposures, making it a versatile compound used across both respiratory care and emergency toxicology.

Regulatory References

  1. EMA-aligned Public Assessment Report for Acetylcysteine
  2. NIH/NCBI Bookshelf - N-Acetylcysteine (StatPearls)

What side effects are possible with Cystaline?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety considerations for Cystadane (betaine anhydrous) based strictly on governmental regulatory documents.


Frequency-Classified Adverse Reactions

Adverse reactions are classified by frequency, reflecting their occurrence in regulatory data:

Frequency Reported Adverse Reactions
Very Common (ge 1/10) Blood methionine increased
Uncommon (ge 1/1,000 to < 1/100) Anorexia, agitation, irritability, brain oedema, diarrhoea, glossitis, nausea, stomach discomfort, vomiting, hair loss, hives, abnormal skin odour, urinary incontinence

Blood methionine increased is the most commonly reported laboratory finding. Brain oedema (cerebral oedema) is categorized under Uncommon serious reactions.


Serious Adverse Reactions and Key Monitoring

The most serious adverse reaction documented in regulatory sources is brain oedema (cerebral oedema), which has been linked to high plasma methionine concentrations, typically in patients with Cystathionine Beta-Synthase (CBS) deficiency. Cases have been reported within two weeks to six months after starting treatment.

As a crucial safety measure, patients with CBS deficiency require regular monitoring of plasma methionine levels, which regulatory documents advise keeping below 1,000 mu M to reduce this risk.


Safety Restrictions and Specific Populations

  • Contraindication: The medicine is restricted for use in individuals with known hypersensitivity to the active substance.
  • Pregnancy and Breastfeeding: Use during pregnancy is generally advised only when clearly necessary, and caution is advised during breastfeeding due to limited data on its transfer to human milk.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Acetylcysteine (Cystaline) is documented in official regulatory sources as potentially resulting in severe systemic reactions and acute toxicity. Documented clinical manifestations of overdose or serious reactions include severe gastrointestinal symptoms like intractable vomiting, cardiovascular changes such as hypotension and tachycardia, and respiratory distress including bronchospasm and wheezing. Severe neurological outcomes have been reported in connection with large doses, including seizures, confusion, and in the most severe cases, cerebral edema or brain herniation.

Required Emergency Actions

Urgent medical attention must be sought immediately if any severe symptoms occur, particularly signs of anaphylaxis, seizures, or profound difficulty breathing. Regulatory documentation mandates that the administration of the medicine be immediately discontinued upon the observation of a serious reaction. The management for Acetylcysteine overdose is primarily symptomatic and supportive, as there is no specific antidote known for toxicity related to the drug itself.

Special considerations are outlined for vulnerable populations, including requiring volume adjustments for low-weight patients (e.g., less than 40 kg) to mitigate the documented risk of fluid overload and hyponatremia.

Therapeutic Uses of Cystaline

What Cystaline Treats: Main Uses and Benefits

Cystaline is commonly used to help with symptoms related to systemic imbalance and symptoms that interfere with daily functioning, applied across domains where additional symptomatic support is needed.

The medicine is relevant in clinical settings that involve acute or unstable symptom patterns, applied in contexts involving systemic imbalance (such as acetaminophen poisoning) and across domains where additional symptomatic support is needed for conditions involving thick or difficult-to-clear mucus.

For respiratory care, it is used to manage viscid secretion syndrome in long-term disorders such as Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), and chronic bronchitis. This application focuses on easing symptoms related to physical discomfort that create noticeable physiological strain in the airways, which assists with maintaining functional stability of the airways and supports improved day-to-day comfort during symptomatic periods.


Quick Fact: Supportive Management for Viscid Secretions
Therapeutic Focus Assisting with managing the physical discomfort of expectoration and supporting airway clearance.
Typical Context Chronic management of conditions where symptoms may intensify temporarily due to persistent, thick mucus.
Symptom Focus Symptoms of physical discomfort caused by difficult-to-clear mucus.

Regulatory References

  1. NIH StatPearls overview

Eligibility and Restrictions for Use

Who can and cannot use Cystaline?

This section details the official population eligibility and restriction rules for Cystaline (Acetylcysteine) as defined by governmental regulatory documents.

Absolute Contraindications

The medicine must not be used by patients with a known hypersensitivity to the active substance or any ingredient in the specific formulation. Additionally, Cystaline is contraindicated for use as a mucolytic agent in children under two years of age. Specific oral formulations are also prohibited for patients with certain metabolic disorders, such as Phenylketonuria (if aspartame is present) or Hereditary Fructose Intolerance (if sorbitol is present).

Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory)
Children (Mucolytic Use) Contraindicated under 2 years; Established use in adolescents over 12 years.
Intravenous Antidote Use Indicated for adults and pediatric patients weighing 5 kg or greater.
Pregnancy Use only if clearly needed (precautionary restriction).
Lactation (Breastfeeding) Not recommended due to insufficient data on excretion in human milk.

Conditional Use and Organ Function

Use requires caution and close monitoring for patients with bronchial asthma or a history of bronchospasm; treatment must be discontinued if breathing difficulties occur. Use is also restricted in patients with severe hepatic damage (as half-life is prolonged) and in those with renal impairment, where pharmacokinetic data is officially unavailable. Furthermore, the total volume of the intravenous formulation must be adjusted for patients weighing less than 40 kg or those requiring fluid restriction.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory authorities document specific interaction patterns for Acetylcysteine (Cystaline) that fall into categories based on pharmacodynamic effects and the need for timing separation.

Pharmacodynamic and Clinical Conflict

The co-administration of antitussive drugs is officially advised against. This is due to the potential for reduced cough reflex, which can lead to the retention and accumulation of bronchial secretions. When Acetylcysteine is taken concurrently with Nitroglycerin, a potentiated effect may occur, resulting in documented significant hypotension (low blood pressure) and enhanced dilation of the temporal arteries.

Administration Constraints and Exposure Modification

Mandatory timing separation is required for several substances. It is advised that oral antibiotics (such as cephalosporins) and heavy metal salts (including gold, iron, and potassium salts) be administered at least two hours apart from Acetylcysteine. This measure is necessary to prevent in vitro chemical inactivation or reduced bioavailability of the co-administered drug. Official documents also note that Activated Charcoal may reduce the effect of Acetylcysteine, and conversely, co-use with Carbamazepine has been associated with resulting subtherapeutic levels of Carbamazepine. The Acetylcysteine solution should not be mixed with other medicinal products. Formal regulatory documents confirm that the intake of Cystaline with food does not affect its effectiveness.

Mechanism of Action

Chemical Depolymerization of Respiratory Secretions

The mechanism of Cystaline (Acetylcysteine) involves acting as a reducing agent that targets the structural integrity of thick mucus. The molecule's reactive free sulfhydryl ( -SH) group engages in thiol-disulfide interchange, chemically cleaving the strong disulfide bonds ( S-S) that link large mucoprotein networks. This rapid chemical depolymerization results in a lower viscosity and adhesiveness of respiratory secretions, thereby enabling the mucociliary clearance pathway.

Restoration of Glutathione and Cellular Protection

Cystaline is also involved in modulating the cellular defense system against oxidative stress. It functions as a bioavailable precursor to mathbfL-cysteine, which is the rate-limiting amino acid required for the de novo synthesis of reduced glutathione (mathbfGSH). Replenishment of the intracellular GSH pool allows the cell to conjugate toxic electrophiles and actively scavenge Reactive Oxygen Species (ROS), thereby maintaining cellular redox balance and supporting conjugation pathways.

Dosage and Administration Information

The administration of Cystaline (Acetylcysteine) is fundamentally divided by its therapeutic purpose, which dictates the route, dosage, and duration.

Administration Routes and Standard Dosing

Feature Description
Route of administration Oral (effervescent tablets, solution), Inhalation (nebulization), and Intravenous (IV) Infusion.
Mucolytic Use Typically 600 mg once daily for adults, or 3 to 5 mL of a 20% solution, nebulized 3 to 4 times a day. Dosage varies based on patient needs.
Antidote Use A total of 300 mg/kg administered via IV infusion over a 21-hour period, or 1,330 mg/kg administered orally over 72 hours (1 loading dose, 17 maintenance doses).

Procedural Requirements

For IV infusion, the total dose is calculated based on body weight, often using a ceiling weight of 110 kg in obese patients, and is split into three sequential infusions with specific diluents (e.g., 5% Dextrose) and required infusion times.

Oral administration for antidote use requires the solution to be diluted to a 5% concentration with a beverage and consumed within one hour of preparation. In contrast, the effervescent tablet is simply dissolved in water. The treatment course for the antidote is time-bound, lasting either 21 or 72 hours, but may be extended based on laboratory results, whereas mucolytic administration may be long-term.

Recent Clinical Evidence

Research evidence / Overview of studies for Cystaline

Research for Conditions Marked by Acute or Disruptive Episodes

Studies exploring Cystaline was studied for conditions associated with acute or disruptive episodes. These trials primarily focused on research exploring short-term symptom changes and outcomes describing episodic or acute changes. Researchers conducted studies during periods of increased symptom activity, where the goal was to monitor changes in outcomes related to physical discomfort and patient-reported outcomes describing perceived discomfort.

The findings describe patterns observed in the studies, particularly regarding how quickly and to what degree these outcomes changed in the observed populations. In certain studies, research describes patterns related to the reported experiences of participants during these episodes. This research provides insight into short-term changes in a setting of varying symptom burdens. Evidence suggests that changes measured during the study period was associated with the study group receiving Cystaline.

It is important to understand the boundaries of this information. Evidence is limited for some aspects of use, and follow-up durations were limited in many of the key studies. This means long-term effects are not fully established, and results apply only to the populations studied. Also, the comparative evidence is lacking for certain study designs. Certainty remains low, and this research, while helpful, evidence contributes to understanding symptom patterns.

Research for Conditions Presenting with Cycles of Stability and Flare-ups

Cystaline was evaluated in research involving conditions characterized by fluctuating or episodic manifestations—specifically those presenting with cycles of stability and flare-ups. This research examined Cystaline in observational settings evaluating daily-life functioning, applied in research contexts involving fluctuating or unstable symptoms. The focus here was observed in studies that tracked changes in outcomes reflecting daily functioning or activity level and outcomes related to systemic or functional imbalance.

In these studies, which monitored responses over defined time intervals, findings indicate that Cystaline may influence outcomes capturing phases of heightened symptom activity. Research exploring short-term symptom changes suggests that these changes may relate to how patients reported their experience. The evidence derived from settings with varying symptom burdens findings help contextualize how patients reported their experience.

However, the findings were mixed across the full body of evidence, and the evidence quality varies across studies. For instance, subgroup findings are uncertain, meaning that data for certain groups remain insufficient. There is limited information for long-term outcomes in this context as well. As with all research, the study results reflect the specific conditions under which they were conducted. Remember, these findings describe group patterns, not personal outcomes, and the research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Cystaline (FAQ)


Q: Can I take Cystaline if I am on a medicine for high blood pressure?

Official product information describes an interaction with Nitroglycerin, a medicine often used for blood pressure or chest pain. The regulatory documents note that combining the two can potentially lead to significant hypotension, which is severely low blood pressure. Patients taking any blood pressure medication should review the potential interaction risks with a healthcare professional.


Q: What common foods or drinks should be avoided while taking Cystaline?

Official regulatory documents state that the intake of Cystaline with food does not affect its effectiveness. No specific foods are identified in regulatory information as being required to avoid. Furthermore, the documents do not typically advise against any specific non-alcoholic beverages.


Q: Can taking Cystaline cause a false positive on any medical tests?

Regulatory documents note that the use of this medication may be associated with an increase in certain laboratory values. The most commonly reported change in bloodwork is an increase in blood methionine levels. Patients with certain metabolic conditions require regular monitoring of these levels.


Q: Are there specific genetic factors that influence how well Cystaline works?

Regulatory safety information highlights a link between genetic conditions and potential adverse outcomes. Specifically, the potential for the serious reaction of brain oedema is associated with patients who have Cystathionine Beta-Synthase (CBS) deficiency. This suggests that genetic factors may influence how the body handles the medication and its safety profile.


Q: Is Cystaline used for any conditions other than the main one it's approved for?

Official regulatory documents confirm two primary approved uses for the medication. It is indicated as a mucolytic agent to help relieve breathing difficulties by clearing thick secretions, and as an antidote for acute acetaminophen overdose.


Q: What are the common reasons for discontinuing Cystaline?

Regulatory information indicates that treatment should be stopped immediately if a patient experiences specific issues. This includes the development of bronchospasm (sudden breathing difficulty), signs of a hypersensitivity reaction (allergy), or certain other serious adverse reactions.


Q: What happens if someone accidentally misses a dose of Cystaline?

Administration protocols address missed doses differently depending on the use case. Specific instructions are included in the authorized procedures for the time-bound antidote use. The guidelines for mucolytic use generally reference the standard advice for missed maintenance doses.


Q: Is it okay to stop taking Cystaline suddenly, or does it require a gradual reduction?

The approved use as an antidote is a time-bound, set treatment course that does not typically involve a gradual reduction. For mucolytic use, official safety instructions indicate that treatment may require stopping if adverse reactions like bronchospasm occur.


Q: Can Cystaline be split in half if the pill is too large?

Regulatory administration instructions for the effervescent tablet form specify dissolving the tablet entirely in water for oral consumption. The official documents do not contain any instructions that address or authorize splitting, crushing, or otherwise modifying the tablets.


Q: How is Cystaline cleared from the body?

Information from official pharmacokinetics sections indicates how the body processes the medication. The medicine is primarily metabolized in the liver. Its components and inactive metabolites are then mostly eliminated from the body through the kidneys.


Q: Are there special considerations for older adults (over 65) taking Cystaline?

Official dosing guidelines for the mucolytic use typically refer to 'adults including the elderly.' This indicates that, for the main treatment purpose, no specific dosage adjustment is generally recommended based on age alone in regulatory documents.


Q: Is Cystaline safe for people who have diabetes?

Regulatory documents note that certain formulation components, such as sorbitol or other sweeteners in effervescent tablet forms, may be relevant for individuals with diabetes or specific metabolic conditions.


Q: Does Cystaline work by affecting hormones?

The mechanism of action described in regulatory documents does not involve hormones. The medicine is defined as a reducing agent that chemically breaks down mucus structures, and as a precursor required to generate the antioxidant glutathione for cellular protection.


Q: Does Cystaline cause weight gain?

According to the frequency-classified side effect lists provided in official regulatory documents, weight gain is not listed as a known or expected adverse reaction for this medication.


Q: Can Cystaline affect sleep or cause insomnia?

The official regulatory documents that classify side effects by frequency do not list insomnia or other sleep disturbances as a known or expected adverse reaction to the medication.


Q: Is it normal to feel a bit tired when first starting Cystaline?

Fatigue or generalized tiredness is not listed as a frequency-classified adverse reaction in official regulatory documents. Patients who experience any unexpected symptoms should consult with a healthcare professional.


Q: Is there a generic version of Cystaline available, and is it the same?

The active ingredient, Acetylcysteine, is a non-proprietary chemical name, meaning it is the generic substance. Its inclusion on the WHO Model List of Essential Medicines supports the conclusion that the active ingredient is widely available in generic formulations.


Q: Does Cystaline interact with alcohol?

Official regulatory documents that list known interactions with other drugs or food generally do not list alcohol as a specified contraindication or a formal interaction.


Q: How long does Cystaline stay in your system after the last dose?

Pharmacokinetic data in the official documents indicates how quickly the substance is cleared. Following administration, the plasma half-life (the time it takes for the concentration to reduce by half) is documented to be approximately 6.25 hours in adults.


Q: What should a patient do if they think they are having a mild reaction to Cystaline?

Official regulatory documents reflect the importance of contacting a healthcare professional immediately if a patient suspects they are experiencing an adverse reaction or show any signs of a hypersensitivity reaction.


Q: Is Cystaline habit-forming or addictive?

The regulatory documents that classify drug properties and dependence risks generally do not classify Cystaline as a substance with known potential for abuse or dependence.


Q: Can Cystaline cause dizziness or affect driving ability?

Dizziness itself is not listed as a frequency-classified side effect. However, regulatory labeling indicates that the ability to drive or operate machinery may be affected if the patient experiences central nervous system adverse reactions.


Q: Does Cystaline affect fertility in men or women?

Regulatory non-clinical data reports no specific effect on fertility in animal studies. However, clinical data (human studies) on the long-term effects on fertility in men or women is not generally available in the official product information.

How should Cystaline be stored and disposed of?

How to Store and Dispose of Cystaline (Acetylcysteine)

Official regulatory guidelines define specific storage and disposal requirements for Cystaline (Acetylcysteine) to maintain its stability and ensure safety.


Mandatory Storage and Stability

Item Requirement
Unopened Vials Store at Controlled Room Temperature (20 to 25 C / 68 to 77 F).
Opened Vials Must be immediately stored in a refrigerator (2 to 8 C) and discarded after 96 hours (4 days).
Packaging Keep the medicine in its original, tightly closed container to protect it from excess heat and moisture.

Disposal and Protection Rules

Item Requirement
Child Safety The medication must be kept out of the sight and reach of children.
Disposal Unused or expired medication must be discarded according to local regulations.
Environmental Precautions are required to avoid release to the environment due to the substance being harmful to aquatic life.

These official instructions must be followed, and prepared (diluted) solutions must be used immediately and not stored.

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

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