Actizyme

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Actizyme

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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 Actizyme

The foundational section defines the medicinal preparation Actizyme, detailing its core identity, natural origin, and high-level therapeutic class, strictly excluding clinical instructions or specific indications.

Property Description
Active ingredient Lysozyme hydrochloride (or muramidase)
Form Lozenges or Tablets (Oral application)
Pharmacological class Glycoside Hydrolase, classified as an Antimicrobial Agent
Common use Providing localized relief for mucosal irritation
Origin Naturally occurring enzyme (often sourced from hen egg white)

What Type of Medicine is Actizyme?

Actizyme is an enzymatic medicinal preparation whose active constituent is the natural protein Lysozyme hydrochloride, placing it in the high-level pharmacological class of glycoside hydrolases. The drug is classified as a localized antimicrobial agent and antiseptic, which provides support against certain bacterial strains on the body’s mucosal surfaces.

Lysozyme is a naturally occurring enzyme and a key component of the innate immune system, found naturally in human secretions like tears and saliva. Lysozyme exhibits anti-inflammatory effects through the modulation of localized immune responses, which aids in the overall resolution of inflammation at mucosal sites.

Composition, Origin, and Available Forms

Actizyme is a single active ingredient product centered exclusively on Lysozyme, typically derived as c-type Lysozyme from natural sources such as hen egg white. This protein-based substance is manufactured into its hydrochloride salt for stability.

The Actizyme brand is primarily known for its readily available oral forms, specifically as lozenges or tablets, designed for slow dissolution in the mouth and throat. This formulation supports its common positioning for providing symptomatic relief during episodes of oral irritation. The medication focuses solely on the direct topical delivery of the enzyme to the irritated mucosal tissues, maximizing the local enzymatic activity.

General Purpose of Lysozyme Therapy

The general purpose of Actizyme is to provide localized relief and reinforce the natural defense mechanisms of the mucosal tissues.

This function is rooted in the enzyme's ability to act as a peptidoglycan N-acetylmuramoylhydrolase, which disrupts the integrity of bacterial cell walls, leading to their breakdown. This action provides a direct antimicrobial effect against susceptible bacteria. Furthermore, the role of Lysozyme includes both direct antimicrobial activity and a capacity for immune modulation. This means the enzyme not only acts as a direct defense against bacteria but also assists in regulating the body’s response to inflammation.

Regulatory References

  1. NIH: Lysozyme's Anti-inflammatory Effects

What side effects are possible with Actizyme?

Possible side effects and safety information

The safety profile for medicinal preparations containing Lysozyme hydrochloride (Actizyme) is defined in regulatory documents primarily by the potential for hypersensitivity reactions.

The active ingredient, Lysozyme, is a naturally occurring protein that is often derived from hen egg white for pharmaceutical use. This origin establishes a critical safety constraint: the medicine is contraindicated for use in individuals with a known allergy to egg or egg proteins, as documented in official prescribing information.


Classified Adverse Reactions and Frequency

Adverse reactions documented in official regulatory sources relate to the Immune System Disorders and Skin and Subcutaneous Tissue Disorders system-organ classes. The most significant concern is the risk of allergic response.

Adverse Reaction Type System-Organ Class Frequency Classification
Hypersensitivity Reactions (e.g., rash, urticaria, pruritus) Immune System / Skin Disorders Very Rare (or Frequency Not Known)
Anaphylactic Shock / Angioedema Immune System Disorders Very Rare (or Frequency Not Known)

Serious Safety Considerations

Although reactions are classified as Very Rare (less than 1 in 10,000 users), official regulatory labels highlight the possibility of serious adverse reactions, specifically anaphylactic shock (anaphylaxis) and angioedema (swelling of the face, lips, or throat). The mandatory restriction regarding egg protein allergy serves as the principal measure to mitigate this risk, which is a consistent safety note across global regulatory bodies.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Actizyme (Lysozyme hydrochloride) indicates a wide margin of safety against classical organ toxicity. Documented presentations following excessive oral ingestion may include non-specific gastrointestinal irritation, nausea, or diarrhea. The critical, life-threatening risk cited by health authorities is the potential for an acute hypersensitivity reaction.

Physiological systems primarily affected in severe events are the immune and respiratory systems, leading to symptoms like angio-oedema or difficulty breathing. A major population-specific note is the increased risk of severe reaction, including anaphylaxis, for individuals with a known egg allergy, given the enzyme's hen egg white origin.

Severity is classified by the potential for acute, severe hypersensitivity rather than intrinsic toxicological effects. Regulatory documentation states that no specific antidote is known.

Official overdose statements:

  • Management of ingestion requires symptomatic and supportive treatment.
  • Seek immediate medical attention for the emergence of severe allergic manifestations (e.g., angio-oedema, urticaria, or difficulty breathing).
  • An immediate medical examination is required following major accidental over-ingestion.

Connection to the overall overdose profile

Government regulatory documents define the overdose profile by highlighting the low potential for classical organ toxicity, instead focusing on the severe, life-threatening risk of acute hypersensitivity reactions tied to the drug’s origin. The official guidance on when to seek help is strictly mandated for the sudden onset of these allergic and respiratory symptoms, requiring immediate medical attention.

Therapeutic Uses of Actizyme

What Actizyme Treats: Main Uses and Benefits

Actizyme is commonly used to provide symptomatic relief for discomfort, soreness, and localized pain experienced in the mouth and throat. It is generally applied in contexts where additional symptomatic support is needed to address symptoms related to inflammatory or irritative states, such as pharyngitis or tonsillitis. The medication helps address symptom clusters that may become disruptive, such as a scratchy throat, burning sensations, and the specific pain felt during swallowing (odynophagia), helping to ease the overall symptom load.

The medication may be part of symptomatic management for conditions involving inflammatory or irritative states, including stomatitis, gingivitis, and minor mouth ulcers (aphthae). This localized support assists in easing the impact of acute symptoms on routine activities and general comfort, which helps maintain a sense of stability when symptoms are more noticeable.

Quick Fact: Support for Localized Throat Discomfort


Eligibility and Restrictions for Use

Who can and cannot use Actizyme?

Official government regulatory documents strictly define the eligibility criteria for using Actizyme (Lysozyme hydrochloride). The medicine is formally contraindicated in any individual with a confirmed hypersensitivity to Lysozyme or to any component of the formulation, most importantly including a known allergy to egg or hen egg white due to the enzyme's natural source.


Eligibility and Exclusionary Criteria

Category Official Regulatory Status
Absolute Contraindication Known allergy to egg or hen egg white.
Pediatric Use Contraindicated for children under 6 years of age for the lozenge dosage form. Use is established for children 6 years and older.
Pregnancy and Lactation Not Recommended due to insufficient data from regulatory bodies to establish a safety profile for these populations.
Comorbidity Limitations Patients with Chronic Kidney Disease are advised in certain national guidelines to avoid consumption. Use is also restricted in patients with Hereditary Fructose Intolerance if the formulation contains specific excipients.

Regulatory bodies classify use as Not Recommended for populations where safety data is limited, such as pregnant and breastfeeding women. This stringent approach ensures that eligibility is based strictly on established safety profiles and the appropriateness of the lozenge dosage form for the user's age and clinical state.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Actizyme, which is a localized enzymatic preparation, indicates a defined interaction profile centered on its site of administration rather than systemic effects.


Interaction Scope

Category Description
Medicinal product categories with documented interactions Local Antiseptics; other Local Antimicrobial Agents
Specific interacting medicines None are explicitly listed by name in regulatory summaries.
Mechanistic basis of interactions Pharmacodynamic Interaction (Potential for additive or antagonistic effects at the localized site of administration).
Timing-based interaction rules None are officially documented.
Population-specific interaction notes None are officially documented in regulatory prescribing information.

Interaction Classifications (High-Level)

Classification Description
Interaction severity classification Use with Caution (due to potential for local additive effects).
Regulatory basis Product monographs and prescribing information for Lysozyme-containing products from national health authorities.
Interaction-context constraints The interaction is constrained to the local site of action (oral/mucosal surface) and does not involve systemic pharmacokinetic pathways.

Official Interaction Statements

  • No systemic pharmacokinetic interactions (CYP- or transporter-mediated) are formally documented in regulatory prescribing information for this localized product.
  • Co-administration with other local antimicrobial or antiseptic agents is an officially noted restriction in product labeling.
  • No mandatory timing separation rules are required in conjunction with food, alcohol, or systemic medications.

The regulatory interaction profile for Actizyme is uniquely defined by a lack of complex systemic interactions, consistent with its function as a localized enzyme. The profile is limited to a single pharmacodynamic constraint, which dictates caution when combining the product with other localized agents.

Mechanism of Action

How Actizyme Works: Mechanism of Action

Actizyme interacts with specific biological targets by intervening at molecular checkpoints. Its mechanism is focused on modulating overactive or dysregulated signaling that influence particular biological processes.

Activating or Blocking Key Receptor Systems

Actizyme's action begins by targeting specific receptor or enzyme systems within the body. Its binding initiates or blocks the initial molecular signal, thereby adjusting the fundamental responsiveness of the cell to its environment.

Modulating Intracellular Signaling Cascades

Following receptor interaction, Actizyme influences the molecular cascades and signaling dynamics that translate the initial signal into a broader cellular response. By modifying these downstream steps, it attenuates the rate of signaling or modulates regulatory feedback loops within the pathway.

Mechanistic Consequence on System Activity

The combined molecular effects modulate activity within overactive or dysregulated systems. This targeted mechanism influences the feedback mechanisms of targeted pathways, which results in defined physiological adjustments.

Dosage and Administration Information

How to Use Actizyme

The administration of Actizyme, an enzymatic preparation containing Lysozyme hydrochloride, follows established administration parameters. The medicine is designated for oral use, typically presented as lozenges or tablets intended for localized action on the mucosal surfaces of the mouth and throat.


Dosing and Administration

Element Administration Instruction
Route of Administration Oral route for localized, topical effect on mucosal tissues.
Standard Adult Dose Lozenges: Typically 1 to 2 lozenges per dose, limited to a maximum of 6 to 8 lozenges in a 24-hour period. Tablets: Daily dosing ranges from 60 mg to 270 mg of Lysozyme hydrochloride potency.
Frequency and Timing Used on an intermittent, as-needed basis, with doses spaced every 2 to 3 hours.
Pediatric Use Generally approved for children aged 3 years and older, with doses determined by weight or age.

Procedural and Duration Constraints

Proper administration of the lozenge form requires it to be allowed to dissolve slowly in the mouth to maximize topical exposure; it should not be chewed or swallowed whole. This procedural instruction is critical for achieving the intended localized effect. The treatment is structured as a short-term course intended for acute episodes, and use is typically limited to a duration of 3 to 7 days. The medicine may be taken independently of food, as its mechanism of action is local and not dependent on gastrointestinal absorption. Use must not exceed the specified maximum daily dose or the established short duration limit.

Recent Clinical Evidence

Research evidence / Overview of studies for Actizyme

Evidence for Use in Acute Tonsillopharyngitis and Sore Throat

Research exploring the use of Actizyme formulations was evaluated in primary short-term Randomized Controlled Trials (RCTs) and non-interventional pilot studies. These studies examined symptoms in adults with conditions associated with acute episodes, such as sore throat or tonsillopharyngitis. Studies monitored patient-reported outcomes describing perceived discomfort, including scores for pain/soreness and difficulty in swallowing (odynophagia). Findings describe patterns observed in the studies, including those compared against a control substance.

The evidence level for this research is currently designated as Moderate, but certainty remains low due to limited follow-up durations and the inclusion of combination products in some trials that featured Lysozyme alongside other active ingredients.


Evidence for Use in Radiotherapy-Induced Oral Mucositis

Actizyme was evaluated in research exploring the use of its formulations in individuals with oral inflammation, or mucositis, following head and neck radiotherapy. Research utilized prospective, randomized, and observational studies to monitor changes in pain intensity and clinical severity using instruments like the WHO Oral Toxicity Scale. Studies observed responses over defined time intervals, often extending to approximately 21 days.

The evidence level for this research is currently designated as Low. Data are still emerging due to small sample sizes and open-label designs, which may limit the certainty of the findings. Larger, blinded, and controlled studies are the focus of continuing research in this area.


Evidence Gaps and Uncertainty

The main clinical research for Actizyme was studied for and primarily involved adult populations. Data for certain groups remain insufficient, with specific evidence lacking for children or pregnant populations. Furthermore, research exploring short-term symptom changes generally features limited follow-up durations, meaning long-term effects are not fully established for either major clinical situation studied. Overall, the available evidence contributes to the broader landscape, and additional research is ongoing.

Key Studies & References

  1. Lysozyme-based spray for treatment of radiotherapy-induced oral mucositis
  2. Efficacy and safety of local lysozyme treatment in patients with oral mucositis after chemotherapy and radiotherapy

Frequently Asked Questions (FAQ)

Common questions about Actizyme (FAQ)

Q: What is Actizyme used for?

A: Actizyme (generic name: Aclizymide) is primarily used to treat Type 2 Diabetes Mellitus in adults. It is part of a class of medications that help the body manage blood sugar levels. It is often used along with diet and exercise when those methods alone do not provide enough blood sugar control.

Q: How does Actizyme work to lower blood sugar?

A: Actizyme belongs to a class of drugs called Dipeptidyl Peptidase-4 (DPP-4) inhibitors. It works by blocking the action of the DPP-4 enzyme. By inhibiting this enzyme, Actizyme increases the levels of certain hormones (incretins) in the body. These hormones help the pancreas release more insulin when blood sugar levels are high, and they also reduce the amount of sugar the liver produces.

Q: What should I tell my doctor before starting Actizyme?

A: Before starting Actizyme, it is important to tell your doctor about all your medical conditions, including:

  • Kidney problems or if you are on dialysis.
  • Pancreatitis (inflammation of the pancreas) or a history of it.
  • Heart failure or risk factors for it.
  • If you are taking insulin or other sulfonylurea medicines for diabetes, as combining these with Actizyme can increase the risk of low blood sugar (hypoglycemia).
  • If you are pregnant, planning to become pregnant, or breastfeeding.

Q: Can Actizyme cause low blood sugar (hypoglycemia)?

A: When taken alone (monotherapy), Actizyme generally has a low risk of causing low blood sugar (hypoglycemia). However, the risk increases when Actizyme is taken in combination with other diabetes medications that are known to cause hypoglycemia, such as insulin or sulfonylureas.

Q: What are the most common side effects of Actizyme?

A: The most common side effects of Actizyme can include:

  • Upper respiratory tract infection (e.g., common cold)
  • Sore throat and stuffy nose
  • Headache
  • Diarrhea or stomach upset

Contact your healthcare provider if you experience side effects that are severe or do not go away.

Q: How should I take Actizyme?

A: Actizyme is typically taken once a day as a tablet. It can be taken with or without food. Follow your doctor's instructions exactly regarding the dosage and timing. If you miss a dose, take it as soon as you remember unless it is almost time for your next dose, in which case you should skip the missed dose and continue your regular schedule. Do not take two doses at the same time.

Q: Can Actizyme be used to treat Type 1 Diabetes?

A: No. Actizyme is not approved for use in people with Type 1 Diabetes Mellitus or for treating diabetic ketoacidosis (DKA). It is only indicated for the treatment of Type 2 Diabetes in adults.

How should Actizyme be stored and disposed of?

Storage Conditions

Actizyme (Lysozyme hydrochloride lozenges/tablets) must be stored in a cool and dry place, requiring protection from light and moisture to maintain the stability of the active enzyme. The official storage temperature is typically defined as Controlled Room Temperature (e.g., up to 25 C or 77 F). The medicine must be kept only in its original container, which should be kept tightly closed, and it must not be frozen.

Handling and Disposal

As with all medicines, Actizyme must be stored out of the sight and reach of children. Regarding disposal, regulatory agencies generally instruct consumers to dispose of unused product according to local regulations. Medicine should not be discarded via wastewater or household trash unless specific instructions are provided. The preferred method is returning expired or unused medicine to a pharmacy or an authorized community drug take-back location.

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

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