Advertisements

Inflazyme D

Quick links to important sections

Inflazyme D

Advertisements
Advertisements

Treatment option:

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.

Advertisements

Overview of Inflazyme D

Property Description
Active ingredient Diclofenac, Serratiopeptidase
Form Enteric-coated tablet
Pharmacological class NSAID & Therapeutic Proteolytic Enzyme
General purpose Management of pain and swelling
Origin Semi-synthetic (synthetic NSAID, enzyme-derived protease)

Inflazyme D represents a combination medication archetype, primarily categorized as a potent Non-steroidal Anti-inflammatory Drug (NSAID) paired with an enzyme-based drug. It is formulated as an enteric coated oral formulation tablet and is typically indicated for short-term relief from acute discomfort and swelling. This strategic preparation integrates two distinct substances, resulting in a synergistic action that is recognized for its broad anti-inflammatory potential.


What Type of Medicine is Inflazyme D?

Inflazyme D belongs to two separate pharmacological classes. The Diclofenac component is a synthetic NSAID, classified as a Phenylacetic acid derivative recognized globally for its analgesic and anti-inflammatory effects. The enzyme component, Serratiopeptidase (or Serrapeptase), is categorized as a Therapeutic Proteolytic Enzyme, an enzyme-derived substance. This dual classification differentiates the formulation from single-agent NSAIDs by combining chemical pain blocking with enzymatic tissue support. Serratiopeptidase demonstrates fibrinolytic and anti-edema properties, indicating its ability to assist in breaking down cellular debris associated with inflammation.


Composition and Form: Diclofenac and Serratiopeptidase

The core composition features two active ingredients: Diclofenac (often as the salt Diclofenac Potassium) and Serratiopeptidase. The drug is designed for oral administration in the form of a solid tablet, specifically an enteric coated oral formulation. This specialized enteric coating serves as a differentiating factor, as it protects the fragile protein structure of the proteolytic enzyme from degradation by stomach acid, ensuring its integrity for proper systemic absorption and function in the body. The inclusion of Diclofenac Potassium further positions this product for rapid onset, as this salt is chemically favored for quicker absorption.


What is the General Purpose of Inflazyme D?

The general purpose of Inflazyme D is to mitigate both the painful symptoms and the physical manifestations of inflammation. The Diclofenac component works to provide pain relief by dampening the body’s inflammatory response, while Serratiopeptidase enhances the medication's anti-edema properties. This enzyme actively promotes the breakdown of abnormal proteins, such as fibrin, at the inflamed site, contributing to the reduction of localized swelling and accelerating the resolution of the inflammatory process. This combined approach is utilized to address discomfort that involves both pain and associated fluid accumulation.

Regulatory References

  1. Diclofenac Potassium Drug Profile
  2. Non-steroidal anti-inflammatory drugs (NSAIDs) Overview
  3. Therapeutic Proteolytic Enzyme Class Overview
  4. Serratiopeptidase Anti-Edema and Fibrinolytic Properties
  5. Serratiopeptidase (Serrapeptase) Review (NIH)
  6. Review of Serratiopeptidase as a Proteolytic Enzyme (NIH)
  7. NIH Study
  8. Enteric Coating: Function and Purpose (MedlinePlus)
  9. MedlinePlus
  10. Serratiopeptidase Anti-Edema and Fibrinolytic Properties (NIH)
  11. Fibrin: Medical Encyclopedia (MedlinePlus)
Advertisements

What side effects are possible with Inflazyme D?

Possible Side Effects and Safety Information

The safety profile for Inflazyme D is defined by risks identified across specific body systems, as documented by regulatory agencies.


Key Safety Areas

Safety Area Common Adverse Reactions Serious Safety Risks
Gastrointestinal System Nausea, indigestion, stomach pain, diarrhea Gastrointestinal bleeding, perforation, and ulceration
Cardiovascular System Swelling (edema) Increased risk of major adverse cardiovascular thrombotic events (e.g., heart attack, stroke), especially with high doses or long-term use
Other Systems Headache, dizziness, elevated liver enzymes Severe allergic reactions, kidney function impairment, blood disorders (e.g., agranulocytosis)

Regulatory Safety Restrictions

Inflazyme D is subject to specific safety limitations defined by government regulatory documents. The medicine is contraindicated in patients with a known hypersensitivity to its components, active or recurrent peptic ulcers or gastrointestinal bleeding, and severe heart failure. It is also not recommended for use during the last trimester of pregnancy due to documented risks to the fetus and labor.

Caution is advised for specific patient populations, including the elderly and those with pre-existing conditions affecting the kidney, liver, or heart. Dose-related safety patterns indicate that higher doses and longer durations of exposure are associated with an increased potential for cardiovascular and renal adverse events. These classifications establish the boundaries for the medicine’s safe use and reflect the official communication of its risk profile.

Advertisements

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory information for an overdose of Inflazyme D is primarily based on the documented risks associated with its Diclofenac component.

Documented Manifestations and Severe Outcomes

An overdose may present with documented clinical signs such as nausea, vomiting, epigastric pain, headache, and drowsiness. More severe neurological manifestations include confusion, agitation, or, rarely, seizures and coma.

The officially listed severe or life-threatening outcomes include gastrointestinal hemorrhage, ulceration, and perforation. Overdose also carries the risk of acute renal failure or hepatotoxicity. Elderly patients and individuals with pre-existing hepatic or renal impairment are documented in labeling as being at greater risk for these serious events.

Emergency Response Mandate

Regulatory authorities mandate that immediate medical attention must be sought for any suspected overdose. Emergency services should be contacted for severe symptoms, including chest pain, shortness of breath, sudden weakness, or slurred speech.

The management of an overdose is limited to symptomatic and supportive treatment, as no specific antidote is known for the Diclofenac component. Hospital monitoring and specific tests, such as an Electrocardiogram (ECG), may be required.

Advertisements

Therapeutic Uses of Inflazyme D

What Inflazyme D Treats: Main Uses and Benefits

Inflazyme D is a medication generally used across conditions presenting with acute or disruptive episodes, relevant when supportive symptom management is appropriate. The primary uses of this class of medicine are in therapeutic domains where additional symptomatic support is needed to address discomfort and tension. This therapeutic class is commonly used for managing symptoms related to physical discomfort, inflammatory or irritative states, and systemic imbalance.

This means Inflazyme D may assist with easing symptoms related to systemic imbalance and is relevant for easing symptoms related to inflammatory or irritative states. It is commonly used to help with symptom clusters that may become intense or disruptive, such as headaches, muscle aches, dental pain, and menstrual cramps. This supportive relief contributes to easing the overall symptom load during difficult episodes.

“This supportive relief contributes to improved comfort during periods of heightened symptoms.”

During phases when symptoms become more noticeable, this medication assists with maintaining functional stability and helps patients cope more steadily.


Quick Fact: Applied in Addressing Acute Symptoms

Regulatory References

  1. NIH StatPearls overview of NSAIDs
Advertisements

Eligibility and Restrictions for Use

Inflazyme D, a combination drug, is subject to the strict population eligibility rules of its NSAID component (Diclofenac) as defined by official regulatory documents. Use of Inflazyme D is contraindicated in specific groups.

Contraindications and Restrictions

Absolute prohibition applies to individuals with known hypersensitivity to the drug or any other NSAID or Aspirin, a history of active gastrointestinal ulceration, bleeding, or perforation, and those with severe organ failure (hepatic or renal). The medicine is also strictly prohibited for treating perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery and for patients with severe established heart failure.

Age and Physiological Status

Eligibility for pediatric patients is generally limited to those aged 12 years and older, as safety and efficacy are not established for younger children. Use requires extreme caution in older adults and patients with pre-existing mild to moderate organ impairment. In pregnancy, the medicine is contraindicated during the last trimester (after 30 weeks gestation) and is not recommended for use while breastfeeding due to insufficient data.

Advertisements

What should I know about interactions with other medicines?

Official Interaction Profile

The interaction profile for Inflazyme D is defined by strict regulatory constraints related to its active components (Diclofenac and Serratiopeptidase).

Contraindicated Combinations and Timing Restrictions:

  • Co-administration with Aspirin and other systemic NSAIDs must be avoided due to the risk of additive gastrointestinal (GI) adverse events.
  • The product is contraindicated for pain management following Coronary Artery Bypass Graft (CABG) surgery.
  • Due to the enzyme component's documented effect on blood clotting, use must be stopped at least two weeks before scheduled surgery.

Pharmacodynamic and Toxicity Interactions:

  • The co-administration with Anticoagulants (e.g., Warfarin), Antiplatelet agents, SSRIs, or Corticosteroids significantly increases the documented risk of serious GI bleeding and ulceration.
  • Diclofenac may reduce the efficacy of Diuretics and ACE Inhibitors/ARBs and raises the risk of renal deterioration.
  • Plasma concentrations of Lithium and Methotrexate are documented to increase due to impaired renal clearance, which carries a risk of enhanced toxicity.

Pharmacokinetic and Exposure Modification:

  • Diclofenac's metabolism involves the CYP2C9 enzyme. Co-administration with CYP2C9 inhibitors (e.g., Voriconazole) increases the systemic exposure (AUC and Cmax) of Diclofenac. Conversely, CYP2C9 inducers may decrease its overall plasma exposure.

Interaction-Context Constraints:

  • Use with Alcohol is noted to increase the risk of serious gastrointestinal bleeding. Consequences of interactions, such as GI bleeding, are generally more serious in the elderly population.
Advertisements

Mechanism of Action

Chemical Blockade: Attenuation of Eicosanoid Synthesis

Inflazyme D functions through a synergistic dual-domain mechanism, combining enzyme inhibition with protein degradation to modulate pathways involved in the acute vascular response. The Diclofenac component acts as a non-selective inhibitor of the Cyclooxygenase ( COX-1 and COX-2) enzymes. By suppressing COX activity, the compound limits the biosynthesis of prostaglandins ( PGE2), which are key mediators of nociceptive and vascular responses. This action results in the physiological consequence of an elevated pain threshold and systemic attenuation of inflammatory mediator production.

Enzymatic Resolution: Promoting Extravascular Clearance

Serratiopeptidase functions through the mechanistic domain of proteolytic degradation. As an enzyme, it acts within the extravascular space to hydrolyze (break down) specific abnormal proteins, primarily fibrin and kinins, that accumulate as proteinaceous components within the extravascular space. This action reduces the fluid's viscosity, facilitating its clearance via the lymphatic system, which leads to the physiological effect of accelerated edema fluid reabsorption.

These two mechanisms are complementary: the chemical blockade limits the generation of new inflammatory mediators, while the enzymatic action promotes the physical degradation of protein accumulation resulting from the vascular response.

Advertisements

Dosage and Administration Information

Official Administration Guidelines

The usage of Inflazyme D (Diclofenac and Serratiopeptidase combination) is defined by established guidelines, establishing the required administrative pattern for the enteric-coated tablet form.

Administration Scope

Instruction Detail
Route of administration The medication is designed for oral administration only.
Dosing schedule The total daily dose of the Diclofenac component generally ranges from 100 mg to 150 mg in adults and is administered in divided doses. Total intake must not exceed the maximum daily limits specified in the prescribing information.
Frequency and timing Doses are administered in divided use, typically taken two or three times daily. The tablet may be administered either with or without food.
Special procedural conditions The enteric-coated tablet must be swallowed whole with fluid; the tablet should not be crushed, chewed, or split. This constraint is necessary to ensure proper systemic delivery.
Duration of use The medication is intended for short-term use. The primary rule governing the course of treatment is to use the lowest effective dose for the shortest duration required.

Population-Specific Rules

For older adults and individuals with low body weight, guidelines recommend initiating treatment at the lowest effective dose. If a dose is missed, instructions state the patient should skip the missed dose and resume the regular dosing schedule, without doubling the next dose.


Connection to the Overall Protocol

These instructions establish a precise, standardized regimen by defining the exclusive oral route and mandating the integrity of the enteric-coated tablet during ingestion. The treatment protocol is constrained by the principle of short-term use, with strict adherence to the prescribed total daily dosage limit and frequency schedule.

Advertisements

Recent Clinical Evidence

Research Evidence / Overview of Studies for Inflazyme D

Research on Inflazyme D has focused on its evaluation in situations characterized by outcomes related to physical discomfort and outcomes linked to inflammatory or irritative states. The available evidence contributes to the broader research landscape by showing what has been observed so far in specific patient groups under defined study conditions.


Evidence for Acute Pain and Swelling Management

Studies have explored the medicine's evaluation in acute pain and associated swelling following injuries or surgical procedures. Research examined adult populations and monitored changes in pain intensity and local swelling or edema volume. These evaluations were generally short-term, with follow-up durations typically lasting from one day up to two weeks.

The trials and comparative studies data show patterns observed in pain scores and swelling volume during the study periods. When research has examined the combination therapy directly against the Diclofenac component used alone, findings were mixed regarding the presence of an added influence from the Serratiopeptidase component. Long-term effects are not fully established beyond the immediate recovery phase.


Research in Musculoskeletal and Joint Conditions

This research has investigated the combination medicine's evaluation in symptoms related to chronic conditions like osteoarthritis. Studies examined outcomes reflecting daily functioning or activity level, including measures of joint stiffness and functional capacity over intermediate-term follow-up durations of approximately two to four weeks.

Comparative evidence data show patterns related to symptomatic relief, though some direct comparator trials against the NSAID alone findings indicate that patterns observed in the combination therapy did not always differ statistically from the NSAID component used alone. Certainty remains low for this application, and there is limited information for long-term outcomes to establish whether the combination influences functional stability beyond a few weeks.


What is Still Unknown or Under Research

Data for certain groups remain insufficient. The evidence base for subgroup findings are uncertain or lacking for children, older adults, and women who are pregnant or breastfeeding. The overall evidence quality varies across studies, and certainty remains low due to the prevalence of studies with sample sizes were modest and follow-up durations were limited. Comparative evidence is lacking from large-scale studies that would establish whether the fixed-dose combination provides consistent patterns that exceed the outcomes observed with Diclofenac used as a single agent.

Key Studies & References

  1. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): StatPearls [Internet] - General Therapeutic Class Overview
  2. Serratiopeptidase: a systemic anti-inflammatory enzyme. Review of studies.
  3. Diclofenac Potassium: MedlinePlus Drug Information
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Inflazyme D (FAQ)


Q: How quickly can a person expect Inflazyme D to start relieving pain?

According to official product information for the Diclofenac component, the medication often begins to show an effect within 20 to 30 minutes after taking the oral tablet. This indicates when the beginning of the effect may be observed.


Q: What is the role of the enzyme component (Serratiopeptidase) in Inflazyme D?

The Serratiopeptidase component is classified as a proteolytic enzyme. Official sources describe its function as promoting the breakdown of certain abnormal proteins that build up at the site of inflammation. This action helps to accelerate the clearance of accumulated fluid (swelling) from the affected area.


Q: Is it normal to feel dizzy or drowsy after taking Inflazyme D?

Official regulatory documents list both dizziness and somnolence (drowsiness) as possible documented effects reported for the Diclofenac component of the medicine. The presence of these effects requires general caution, as noted in the safety profile.


Q: Is it true that Inflazyme D can be used to help with swelling after surgery?

Research has examined the evaluation of this combination medicine in adult populations for managing swelling and pain following surgical procedures. Studies have monitored changes in pain scores and the volume of swelling during these short-term evaluations.


Q: Can Inflazyme D be taken on an empty stomach?

Official administration guidelines state that the enteric-coated tablet may be administered either with or without food. This is a specific administration condition outlined in the regulatory documentation.


Q: Does Inflazyme D also help with fever or is it only for pain and inflammation?

Diclofenac, which is one of the active ingredients, belongs to a pharmacological class of agents that also exhibit antipyretic (fever reducing) effects. The Diclofenac component's classification indicates that it exhibits antipyretic (fever reducing) effects.


Q: Is Inflazyme D considered an opioid or a steroid?

Inflazyme D is a combination of two pharmacological classes: a Non-Steroidal Anti-inflammatory Drug (NSAID) and a proteolytic enzyme. It is not classified as an opioid or a steroid.


Q: Can Inflazyme D be taken for any kind of muscle ache or joint discomfort?

The general purpose of the medicine is the management of pain and swelling. The Diclofenac component is officially indicated for acute and chronic pain conditions associated with the musculoskeletal system, such as osteoarthritis.


Q: Is Inflazyme D known to be habit-forming or addictive?

Inflazyme D is classified as a combination of an NSAID and an enzyme. This classification does not include any components considered to be habit-forming or controlled substances like opioids, as defined by regulatory bodies.


Q: Can Inflazyme D cause skin sensitivity to sunlight?

Regulatory documents list photosensitivity (an increased sensitivity of the skin to sunlight) as a possible documented effect reported for the Diclofenac component. Caution regarding sun exposure is part of the established safety information.


Q: Does Inflazyme D have any known interactions with birth control pills?

Diclofenac is generally not listed as an agent that reduces the effectiveness of hormonal birth control pills. However, official information notes that caution may be necessary with certain birth control containing drospirenone due to a potential influence on potassium levels.


Q: Why is Inflazyme D generally not recommended for stomach pain?

The drug's safety profile notes that it can cause or worsen gastrointestinal issues, including stomach pain, indigestion, and serious risks like gastrointestinal bleeding and ulceration. The medicine is not intended for the treatment of existing stomach pain.


Q: What information is available about Inflazyme D and its effect on driving or operating machinery?

Due to the possibility of experiencing certain central nervous system (CNS) side effects, such as dizziness or drowsiness, official documents recommend caution when performing activities that require alertness, such as driving or operating machinery.


Q: What are the possible signs of using too much Inflazyme D (overdose)?

Symptoms that may be observed in a case of using too much of the Diclofenac component include stomach pain, nausea or vomiting (possibly with blood), and dizziness. In severe cases, symptoms such as seizures, coma, or confusion may occur.


Q: Is Inflazyme D a prescription-only medicine in most regions?

The medicine is generally classified in many regions as a prescription-only medicine (Rx). Official guidelines, such as those that refer to 'Prescribing Information,' require it to be dispensed under the direction of a healthcare professional.


Q: How does Inflazyme D compare to plain Diclofenac alone, without the Serratiopeptidase?

Research has investigated the combination against the Diclofenac component used alone. The findings were mixed regarding whether the Serratiopeptidase component provided a consistently observed added influence over the Diclofenac component by itself.


Q: Are there official reports about the effectiveness of Inflazyme D for dental pain?

In some regulatory regions, the Diclofenac component is officially indicated for acute pain conditions such as dental pain, and its use in this context has been evaluated in clinical studies. Its general purpose is for the management of pain and swelling.


Q: Is the relief provided by Inflazyme D noticeable after the first use?

The Diclofenac component is described as typically beginning to provide an effect 20 to 30 minutes after taking the tablet. This indicates that the beginning of an effect may be observed after the first use.


Q: Can Inflazyme D be taken by individuals who have high blood pressure?

Regulatory documents advise caution when the medicine is used in individuals with high blood pressure (hypertension). This is because the Diclofenac component may lead to the onset or worsening of this condition.

Advertisements

How should Inflazyme D be stored and disposed of?

Storage and Handling Requirements

Official labeling defines precise conditions for storing Inflazyme D tablets to ensure the stability of the Diclofenac and Serratiopeptidase components. The medication must be stored below 30 C (86 F), commonly referred to as controlled room temperature. It must be kept in its original container and maintained in a cool, dry place, protected from both moisture and direct light. It is essential to keep the medicine out of the sight and reach of children.

Disposal Instructions

Unused or expired Inflazyme D must be disposed of safely and responsibly. The product should not be flushed down the toilet or poured into any drain to avoid environmental contamination. Disposal must be carried out according to local regulations for pharmaceutical waste, which often involves utilizing community drug take-back programs or authorized collection points.

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

Equivalent of Inflazyme D found in:

A-Z Index: